Getting to Zero Among Highest HIV Incidence (HHI) Men Who Have Sex With Men (MSM) in the American South: Testing an Integrated Strategy
Phase: NA
Conditions: HIV Infections
Sponsor: HIV Prevention Trials Network

HPTN 096 
Getting to Zero among Highest HIV Incidence (HHI) Men who have Sex with 
Men (MSM) in the American South: Testing an Integrated Strategy 
 
DAIDS Document ID: 38561 
 
A Study by the HIV Prevention Trials Network (HPTN) 
 
Sponsored by: 
Division of AIDS (DAIDS), United States (US) National Institute of Allergy and Infectious 
Diseases (NIAID), US National Institutes of Health (NIH) 
 
Non-IND Study 
 
Protocol Co-Chair: 
LaRon E. Nelson, PhD, RN, FNP, FNAP, FAAN  
 
Protocol Co-Chair: 
Chris Beyrer, MD, MPH 
 
FINAL Version 5.0 
27 JUNE 2025 
 
 
 
 

HPTN 096, FINAL Version 5.0 
 
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HPTN 096 
Getting to Zero among HHI MSM in the American South: 
Testing an Integrated Strategy 
TABLE OF CONTENTS 
 
1.1 
Background ....................................................................................................................... 18 
1.2 
Rationale for an Integrated Strategy Approach................................................................. 26 
2.1 
Primary Objectives ........................................................................................................... 44 
2.2 
Secondary Objectives ....................................................................................................... 44 
2.3 
Primary Intervention Process Measures ............................................................................ 44 
2.4 
Exploratory Objectives ..................................................................................................... 45 
2.5 
Endpoints and Data Sources for Primary Objectives, Secondary Objectives and Primary 
Intervention Process Measures ......................................................................................... 45 
3.1 
Study Duration .................................................................................................................. 50 
4.1 
Description and Selection of the Five Study Communities .............................................. 51 
4.2 
Priority Populations for Components of the Integrated Strategy ...................................... 51 
4.3 
Study Population for Primary and Secondary Endpoint Data Collection at PHASE HCF
 .......................................................................................................................................... 53 
5.1 
Component Description .................................................................................................... 57 
5.2 
Health Access Coalition Component Activities................................................................ 60 
5.3 
Primary Intervention Process Measure for the Health Access Coalition Component ...... 63 
5.4 
Additional Process Measures Related to the Health Access Coalition Component ......... 63 
6.1 
Component Description .................................................................................................... 64 
6.2 
Social Media Component Activities ................................................................................. 66 
6.3 
Primary Intervention Process Measure for the Social Media Component ........................ 70 
6.4 
Additional Process Measures for the Social Media Component ....................................... 71 
6.5 
Guidance for Future Implementors ................................................................................... 72 
7.1 
Component Description .................................................................................................... 72 
7.2 
Training ............................................................................................................................. 73 
7.3 
Collaborators ..................................................................................................................... 74 
7.4 
Promotion and Community Engagement .......................................................................... 74 
7.5 
Location ............................................................................................................................ 74 
7.6 
Component Size ................................................................................................................ 75 
7.7 
Primary Intervention Process Measure for the Peer Support Component ........................ 76 
7.8 
Additional Process Measures related to the Peer Support Component ............................. 76 
8.1 
Component Description .................................................................................................... 77 

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8.2 
PHASE Intervention Activities ......................................................................................... 82 
8.3 
Primary Intervention Process Measures for PHASE ........................................................ 88 
8.4 
Additional Process Measures related to the PHASE Component ..................................... 88 
9.1 
Synergies to Enhance Health Access Coalitions............................................................... 89 
9.2 
Synergies to Enhance Social Media .................................................................................. 89 
9.3 
Synergies to Enhance Peer Support .................................................................................. 89 
9.4 
Synergies to Enhance PHASE .......................................................................................... 90 
10.1 
Levels of Engagement ...................................................................................................... 91 
11.1 
Cross-Sectional HHI MSM Client Assessment ................................................................ 93 
11.2 
Collection of Electronic Medical Record (EMR) Data ..................................................... 95 
11.3 
Qualitative Data Collection............................................................................................... 97 
13.1 
Review of Study Design ................................................................................................. 100 
13.2 
Objectives and Endpoints ............................................................................................... 100 
13.3 
Considerations for Power ................................................................................................ 102 
13.4 
Accrual and Retention .................................................................................................... 110 
13.5 
Data and Feasibility Monitoring and Interim Analyses .................................................. 111 
13.6 
Statistical Analysis .......................................................................................................... 112 
15.1 
Ethical Review ................................................................................................................ 118 
15.2 
Orientation to the Human Subjects Consideration Section ............................................. 118 
15.3 
Health Access Coalition Component Human Subjects Considerations .......................... 118 
15.4 
Social Media Component Human Subjects Consideration ............................................. 119 
15.5 
Peer Support Component Human Subjects Considerations ............................................ 121 
15.6 
PHASE Component Human Subjects Considerations .................................................... 124 
15.7 
Cross-Sectional HHI MSM Assessment Human Subjects Considerations ..................... 125 
15.8 
EMR Data Collection Considerations ............................................................................. 126 
15.9 
Qualitative Data Collection Considerations .................................................................... 128 
15.10 Confidentiality for all Study Activities ........................................................................... 129 
15.11 Study Discontinuation ..................................................................................................... 129 
16.1 
Source Documentation and Direct Data Entry ................................................................ 129 
16.2 
Protocol Registration ...................................................................................................... 129 
16.3 
Study Activation ............................................................................................................. 130 
16.4 
Study Coordination ......................................................................................................... 130 
16.5 
Study Monitoring ............................................................................................................ 130 
16.6 
Protocol Compliance ....................................................................................................... 131 
16.7 
Study Records ................................................................................................................. 131 
16.8 
Use of Information and Publications .............................................................................. 132 
16.9 
ClinicalTrials.gov ........................................................................................................... 132 

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HPTN 096 
Getting to Zero among Highest HIV Incidence (HHI) Men who have Sex with Men (MSM) 
in the American South: 
Testing an Integrated Strategy 
 
PROTOCOL SIGNATURE PAGE 
 
DAIDS Document ID #38561 
 
FINAL Version 5.0 
27 June 2025 
I will conduct the study in accordance with the provisions of this protocol and all applicable 
protocol-related documents. I agree to conduct this study in compliance with United States (US) 
Health and Human Service regulations (45 CFR 46); applicable US Food and Drug 
Administration regulations; standards of the International Council for Harmonisation Guideline 
for Good Clinical Practice (E6); Institutional Review Board/Ethics Committee determinations; 
all applicable in-country, state, and local laws and regulations; and other applicable requirements 
(e.g., US National Institutes of Health, Division of AIDS) and institutional policies. 
I have read and understand the information in this protocol and will ensure that all associates, 
colleagues, and employees assisting in the conduct of the study are informed about the 
obligations incurred by their contribution to the study.  
 
__________________________________ 
Name of Investigator (print name) 
 
__________________________________         
 
_______________________ 
Signature of Investigator 
 
 
 
 
Date (DD/MONTH/YYYY) 
  

 
HPTN 096, FINAL Version 5.0 
 
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HPTN 096 
Getting to Zero among HHI MSM in the American South: 
Testing an Integrated Strategy 
LIST OF ABBREVIATIONS AND ACRONYMS 
ACASI 
Audio Computer Assisted Self-Interview 
AIDS  
Acquired Immunodeficiency Syndrome 
AL 
 
Alabama 
AOR  
adjusted odds ratio 
API 
 
Application Programming Interface 
ART  
antiretroviral therapy 
BAC  
blood alcohol content 
CAB-LA 
Long-Acting Injectable Cabotegravir 
CABs  
Community Advisory Boards 
CAG  
Community Advisory Group 
CSG  
Community Strategy Group 
CBO  
Community-Based Organization 
CBPR  
Community-Based Participatory Research 
CDC  
Centers for Disease Control and Prevention 
CFIR  
consolidated framework for implementation research 
CI 
 
confidence interval 
CLO  
Coalition Lead Organization 
COVID-19 
Coronavirus Disease 2019 
DAIDS 
Division of AIDS 
DHHS  
(US) Department of Health and Human Services 
ECHO  
Extension for Community Healthcare Outcomes 
EHE 
 
Ending the HIV Epidemic: A Plan for America 
ESAP  
Expanded Syringe Access Program 
FHIR  
Fast Healthcare Interoperability Resources 
FL 
 
Florida 
FQHC  
federally qualified health center 
GA 
 
Georgia 
GEE 
 
Generalized Estimating Equation 
HCF  
health care facility 
HHI 
 
Highest HIV Incidence 
HIPAA 
Health Insurance Portability and Accountability Act 
HIV 
 
human immunodeficiency virus 
HPTN  
HIV Prevention Trials Network 
HRSA  
Health Resources and Services Administration  
ICFs  
informed consent forms  
IRB 
 
Institutional Review Board 
IRLM  
Implementation Research Logic Model 
ITS 
 
Interrupted Time Series 
LGB  
lesbian, gay, bisexual 

 
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LGB+  
lesbian, gay, bisexual 
LOC  
(HPTN) Leadership and Operations Center 
MOP  
(HPTN) Manual of Operations 
MSM  
men who have sex with men 
NIAID  
(US) National Institute of Allergy and Infectious Diseases 
NIH 
 
(US) National Institutes of Health  
NIR 
 
network-individual-resource 
OR 
 
odds ratio 
nPEP  
non-occupational post-exposure prophylaxis 
PHASE 
Promoting Human Autonomy Supportive Environments 
PrEP  
pre-exposure prophylaxis  
PTID  
participant ID 
QI 
 
quality improvement 
RCT(s) 
randomized controlled trial(s) 
SDMC  
(HPTN) Statistical and Data Management Center 
SDT 
 
self-determination theory  
sIRB  
single IRB 
SMC  
(HPTN) Study Monitoring Committee 
SMI 
 
social media influencer 
SSDOH 
Social and Structural Determinants of Health 
SSP 
 
Study-specific Procedures (Manual) 
STI(s)  
sexually transmitted infection(s) 
TA 
 
technical assistance 
TN 
 
Tennessee 
TX 
 
Texas 
UK 
 
United Kingdom 
US 
 
United States 
UTM  
Urchin Tracking Module 
VL 
 
viral load 
 
 

 
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HPTN 096 
Getting to Zero among HHI MSM in the American South: 
Testing an Integrated Strategy 
PROTOCOL TEAM ROSTER 
 
Protocol Co-Chairs: 
 
LaRon E. Nelson, PhD, RN, FNP, FNAP, 
FAAN 
Independence Foundation Professor of 
Nursing 
Yale University, School of Nursing 
400 West Campus Drive 
New Haven, CT 06477 
Phone: 203-785-5797 
Email: laron.nelson@yale.edu 
 
Chris Beyrer, MD, MPH 
Director, Duke Global Health Institute 
Professor of Medicine 
Duke University School of Medicine 
310 Trent Drive, Room 103 
Durham, NC, 27708 
Phone: 919-668-2956 
Email: chris.beyrer@duke.edu 
 
National Institutes of Health (NIH): 
 
Lydia Soto-Torres, MD, MPH 
Branch Chief 
Senior Medical Officer 
Prevention Sciences Program, DAIDS, 
NIAID, NIH 
Phone: 240-292-4807 
Email: lsoto-torres@niaid.nih.gov 
 
Michael J. Stirratt, PhD 
Scientific Program Officer 
NIMH Division of AIDS Research 
5601 Fishers Lane, Room 9G21A 
Rockville, MD 20852 
Phone: 240-627-3875 
Email: michael.stirratt@nih.gov  
 
Centers for Disease Control and 
Prevention (CDC): 
 
Kevin P. Delaney, PhD, MPH 
Division of HIV/AIDS Prevention, 
NCHHSTP, CDC 
1600 Clifton Road, Mailstop US8-4 
Atlanta, GA 30329 
Phone: 404-639-8630 
Email: kdelaney@cdc.gov  
 
Karen Hoover, MD, MPH 
Division of HIV/AIDS Prevention, 
NCHHSTP, CDC 
1600 Clifton Rd NE, MS US8-4  
Atlanta, GA 30329 
Phone: 404-639-8534 
Email: khoover@cdc.gov 
 
CAPT Anna Satcher Johnson, MPH 
Division of HIV/AIDS Prevention, 
NCHHSTP, CDC 
1600 Clifton Road, Mailstop US8-2  
Atlanta, GA 30329 
Phone: 404-639-6167 
Email: asatcherjohnson@cdc.gov 
 

 
 
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Jeffrey A. Johnson, MS PhD 
Lead, HIV Diagnostics, Division of HIV 
Prevention Laboratory 
1600 Clifton Rd, N.E., Mailstop 18-2 
Atlanta, GA 30329 
Ph. 404-639-4976 
Email: jjohnson1@cdc.gov 
 
HPTN Leadership and Operations Center 
(LOC): 
 
Amber Babinec 
Clinical Research Manager I 
FHI 360 
359 Blackwell Street, Suite 200 
Durham, NC 27701 
Phone: 919- 627- 6407 
Email: ababinec@fhi360.org 
 
Nicholas Emard, MS 
Clinical Research Manager 
FHI 360 
359 Blackwell Street, Suite 200 
Durham, NC 27701 
Phone: 202-464-3749 
Email: nemard@fhi360.org 
 
Leo Fitz 
Social Media Manager 
FHI 360 
359 Blackwell Street, Suite 200 
Durham, NC 27701 
Phone: 919-321-3330 
Email: lfitz@fhi360.org 
 
Theresa Gamble, PhD 
Scientist II 
FHI 360 
359 Blackwell Street, Suite 200 
Durham, NC 27701 
Phone: 919-321-3520 
Email: tgamble@fhi360.org  
 
Elizabeth Greene, MPH 
Sr. Clinical Research Manager 
FHI 360 
359 Blackwell Street, Suite 200 
Durham, NC 27701 
Phone: 919-321-3411 
Email: egreene@fhi360.org  
 
CaTiffaney Griswould, MPH 
Sr. Community Programs Manager 
FHI 360 
359 Blackwell Street, Suite 200 
Durham, North Carolina 27701  
Phone: 202-884-8909 
Email: cgriswould@fhi360.org 
 
Jayla Harris, MPH 
Clinical Research Manager  
FHI 360 
359 Blackwell Street, Suite 200 
Durham, NC 27701 
Phone: 919-544-7040 
Email: jharris@fhi360.org 
 
Martine Harrington-Powell, MA 
Community Programs Manager 
FHI 360 
359 Blackwell Street Suite 200 
Durham, North Carolina 27701  
Phone: 919-321-3915 
Email: mharrington-powell@fhi360.org 
 
Kameron Jacobs, MA 
Communications Manager 
FHI 360 
359 Blackwell Street, Suite 200 
Durham, NC 27701 
Phone: 253-219-1041 
Email: kjacobs@fhi360.org 
 

 
 
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Sherri Johnson, MPH 
Sr. Clinical Research Manager 
FHI 360 
2101 L Street NW, Suite 700 
Washington, DC 20037 
Phone: 202-884-8677 
Email: sjohnson@fhi360.org  
 
Rita Labbett, MPH, CCRC 
Clinical Research Manager 
FHI 360 
359 Blackwell Street, Suite 200 
Durham, NC 27701 
Phone: 919-321-3821 
Email: rlabbett@fhi360.org  
 
Jonathan Paul Lucas, MPH 
Director, Community Programs 
FHI 360 
359 Blackwell Street Suite 200 
Durham, North Carolina 27701  
Phone: 919-321-3574 
Email: jlucas@fhi360.org 
 
Tracy Lyons 
Clinical Trials Assistant II 
FHI 360 
359 Blackwell St. Suite 200  
Durham, NC, 27701 
Phone: 919-321-3504 
Email: mtlyons@fhi360.org   
 
Markay Russell, MPH 
Social Media Content and Data Specialist II 
FHI 360 
359 Blackwell St. Suite 200  
Durham, NC, 27701 
Phone: 919-321-3604 
Email: mrussell@fhi360.org 
 
HPTN Community Advisory Group 
Representatives: 
 
Ernest Brown 
Protocol Team Representative 
Columbia Housing Authority 
1917 Harden St 
Columbia, SC 29201 
Phone: 803-261-1856 
Email: brownnebb@gmail.com 
 
Rameses Frederick 
Protocol Team Representative 
Program Coordinator 
The Hope Clinic-Emory Vaccine Center 
500 Irvin Court, Suite 200 
Decatur, GA 30030 
Phone: 404-712-9076 
Email: rameses.frederick@emory.edu  
 
Corey Oden 
HPTN 096 Protocol Team CAG 
Representative 
2312 Center Place Se 
Birmingham, AL 35205 
Phone: 205-705-7091 
Email: coden@hptn.org 
 
J. Donté Prayer 
HPTN 096 Protocol Team CAG 
Representative 
3320 Magnolia Hill Drive 
Charlotte, NC 28205 
Phone: 252-702-5166 
Email: jdonteprayer@gmail.com 
 
HPTN Black Caucus Representatives: 
Donte T. Boyd, PhD, MSW 
Co-Chair, HPTN Black Caucus 
The Ohio State University,  
College of Social Work 
1947 College Rd N 
Columbus, OH 43210 
Phone: 323-540-9783 
Email: Boyd.465@osu.edu 

 
 
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Christopher Hucks-Ortiz, MPH 
HPTN Black Caucus 
HealthHIV 
1630 Connecticut Ave, NW, Ste 500 
Washington DC, 20009 
Phone: 202-232-6749 
Cell: 323-404-4101 
Email: chortiz@live.com  
 
Craig S. Hutchinson, MA. MPH 
Chair, HPTN Black Caucus 
Gilead Sciences, Inc. 333 Lakeside Drive 
Building: FC324-1; Location: 384321F 
Foster City, California 94404 
Phone: 650-484-3196  
Email: Craig.Hutchinson@gilead.com 
 
Melissa M. Turner, MSW, MPA 
HPTN Community Working Group 
Representative 
Veterans Affairs Medical Center 
50 Irving Street NW, Mail Code: 151B 
Washington, DC 20422 
Phone: 202-494-7933 
Email: Melissa.Turner@va.gov  
 
HPTN Statistical and Data Management 
Center (SDMC): 
 
Devang Agravat, MPH 
Statistical Research Associate II 
1100 Fairview Avenue N, M2-C200. 
Seattle, WA 98109 
Phone: 817-683-5827  
Email: dagravat@scharp.org 
 
Geetha Beauchamp, PhD 
Director of Research Operations, HPTN 
Vaccine and Infectious Disease Division 
Fred Hutch Cancer Center 
1100 Fairview Avenue N, M2-C200. 
Seattle, WA 98109 
Phone: 206-667-6167 
Email: geetha@fredhutch.org  
 
Paul Butler 
Clinical Data Manager 
SCHARP-FHCRC 
1100 Fairview Ave N 
Mail Stop Number E3-129 
Seattle, WA 98109-1024 
Phone: 206-667-7928 
Email: pbutler@scharp.org 
 
Sayan Dasgupta, PhD 
Senior Staff Scientist, 
Vaccine and Infectious Disease Division 
Fred Hutchinson Cancer Center 
1100 Fairview Avenue N, M2-C200. 
Seattle, WA 98109 
Phone: 206-667-4871 
Email: sdasgup2@fredhutch.org 
 
Jean de Dieu Tapsoba, PhD 
Staff Scientist 
Vaccine and Infectious Disease Division  
Fred Hutchinson Cancer Center 
1100 Fairview Avenue N, M2-B500 
Seattle, WA 98109 
Phone: 206-667-4119 
Email: jtapsoba@fredhutch.org 
 
Deborah Donnell, PhD  
Professor, Vaccine and Infectious Disease 
Division (VIDD) 
Fred Hutchinson Cancer Center  
1100 Fairview Avenue N  
Seattle, WA 98109 
Office Phone: 206-667-5661 
Cell Phone: 206-250-9250  
Email: deborah@fredhutch.org  
 
Julie Ngo, MPH 
Clinical Data Manager 
SCHARP-FHCRC 
1100 Fairview Ave. N. 
P.0. Box 19024 
Seattle, WA  98109-1024 
Phone: 206-667-2094 
Email: jhngo@scharp.org  

 
 
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HPTN Laboratory Center (LC): 
 
Susan Eshleman, MD, PhD 
Virologist 
Johns Hopkins Univ. School of Medicine 
646 Ross Building, 720 Rutland Ave. 
Baltimore, MD 21287 
Phone: 410-614-4734 
Email: seshlem@jhmi.edu  
 
Protocol Team Members: 
 
Bruce Agins, MD, MPH 
Division of Infectious Disease 
Epidemiology 
Institute for Global Health Sciences 
University of California San Francisco 
San Francisco, CA 
Phone: 646-267-0644 
Email: Bruce.Agins@ucsf.edu  
 
Gloria Aidoo-Frimpong, PhD, MPH, MA 
Department of Epidemiology and 
Environmental Health 
School of Public Health 
State University of New York at Buffalo 
 193 Farber Hall 
Buffalo, NY   14214 
Phone: 510-362-9240 
Email: gloriaai@buffalo,edu 
 
Marie-Claude Boily, PhD 
Professor of Mathematical Epidemiology 
MRC Center for Global Infectious Disease 
Analysis, School of Public Health 
Imperial College London 
South Kensington Campus 
London, SW7 2AZ, UK 
Phone: +44 (0)20 7594 3263 
Email: mc.boily@imperial.ac.uk 
 
 
Donaldson Conserve, PhD, MS 
George Washington University 
Milken Institute School of Public Health 
950 New Hampshire Ave, NW 
Washington DC 20052 
Phone: 917-443-6124 
Email: dxc341@gmail.com 
 
Patricia Coury-Doniger, FNP, ANCC-
FNP-C 
University of Rochester, Infectious Diseases 
Division 
2737 Lake Road 
Williamson, NY 14589 
Phone: 315-589-5150 
Email: patricia_coury-
doniger@urmc.rochester.edu  
 
Melissa Curry, MBA/HCM, BSN, ACRN, 
RN, CCP 
Project Management Consultant 
Abounding Prosperity, Inc. 
2311 Dr. Martin Luther King, Jr. Blvd. 
Dallas, TX 75215 
Phone: 469-778-0017 
Email: mcurry@aboundingprosperity.org 
 
Daniel D. Driffin, DrPH, MPH 
Protocol Team Representative 
HIV Vaccine Trials Network 
2038 Stanton Road 
Atlanta, GA 30344 
Phone: 678-852-3959 
Email: ddriffin@gmail.com  
 
Errol L. Fields, MD, PhD, MPH 
Johns Hopkins University 
School of Medicine 
733 N Broadway 
Baltimore, MD 21205 
Phone: 410-502-8317  
Email: errol.fields@jhmi.edu  
 

 
 
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Sheldon D. Fields, PhD, RN, FNP-BC, 
AACRN, FAANP, FNAP, FAAN 
Penn State University 
301 Nursing Sciences Building  
University Park, PA16802 
Phone: 814-863-8215  
Email: SheldonDEI@psu.edu  
 
Aditya Gaur, MD 
Director, Division of HIV Medicine 
St. Jude Children’s Research Hospital 
262 Danny Thomas Place 
Memphis, TN 38105 
Phone: 901-595-2862 
Email: aditya.gaur@stjude.org  
 
Ian Le'Ron Haddock 
Executive Director 
The Normal Anomaly Initiative, Inc.  
2310 Arbor Street, Houston, TX 77004 
Phone: 832-853-7709 
Email: ian@normalanomaly.org 
 
Mandy J. Hill, DrPH, MPH 
Department of Emergency Medicine 
McGovern Medical School 
The University of Texas Health Science 
Center at Houston 
6431 Fannin Street, JJL 475G 
Houston, Texas 77030 
Phone: 713-500-7661 
Email: Mandy.J.Hill@uth.tmc.edu  
 
Damon Jones, MPH, MSW 
HELO – Ft. Lauderdale, FL 
Executive Director 
4850 W Oakland Park Blvd STE 145 
Fort Lauderdale, FL 33313 
Phone: 954-951-2911 
Email: Damon@afroprideflorida.org 
 
Shakita B. Jones, MPA, MSW 
HELO – Montgomery, AL 
Executive Director 
Central Alabama Alliance, Resource & 
Advocacy Center (CAARAC) 
5770 Carmichael Parkway 
Montgomery, AL 36117 
Phone: 334-224-6663 
Email: sbjones@caarac.org 
 
Venton C. Jones, MSHCAD 
Southern Black Policy and Advocacy 
Network 
1075 Griffin Street West, Suite 211 
Dallas, TX 75216 
Phone: 214-335-2227 
Email: vhill-jones@SBPAN.org 
 
Alex S. Keuroghlian, MD, MPH 
The Fenway Institute 
126 Brookline Avenue, 3rd Floor 
Boston, MA 02215 
Phone: 617-927-6204 
Email: akeuroghlian@fenwayhealth.org  
 
Carmen Logie, PhD, MSW 
Factor-Inwentash Faculty of Social Work 
University of Toronto 
246 Bloor Street West 
Toronto, ON M5S 1V4 
Phone: 647-454-4203 
Email: carmen.logie@utoronto.ca  
 
Kenneth H. Mayer, MD 
Beth Israel Deaconess Medical Center, 
Harvard Medical School 
Harvard T. H. Chan School of Public Health 
The Fenway Institute, Fenway Health 
1340 Boylston St. 
Boston, MA 02215 
Phone: 617-927-6087 
Email: kmayer@fenwayhealth.org 
  

 
 
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Peter McGrath, MPH 
University of Rochester Center for 
Community Practice 
St. Paul Street, 5th Floor 
Rochester, New York 14604 
Phone: 585- 274 -3044  
Email: peter_mcgrath@urmc.rochester.edu 
 
Ofole Mgbako, MD 
Columbia University Medical Center 
630 W. 168th St. Box 32 
New York, NY 10032 
Phone: 908-797-9637 
Email: om2292@cumc.columbia.edu  
 
Uzoji Nwanaji, PhD, FNP 
Yale University, School of Nursing 
400 West Campus Drive 
Orange, CT 06477 
Phone: 704-960-5221 
Email: uzoji.nwanaji-enwerem@yale.edu 
 
Julie Pulerwitz, ScD 
Population Council 
4301 Connecticut Avenue, NW 
Suite 280 
Washington, DC 20008 
Phone: 202-237-9400 
Email: julterwitz@popcouncil.org 
 
Robert H. Remien, PhD 
Professor of Clinical Medical Psychology 
(in Psychiatry) 
Director, HIV Center for Clinical and 
Behavioral Studies 
Co-Director, Division of Gender, 
Sexuality and Health, NY State Psychiatric 
Institute and Columbia University 
722 West 168th Street, Floor R3, Room 308 
New York, NY 10032 
Phone: 646-774-6933 
Email: rhr1@cumc.columbia.edu 
 
Justin C. Smith, MS, MPH 
Director, Campaign to End AIDS 
Positive Impact Health Centers 
2800 Century Parkway NE Suite 550  
Atlanta, GA 30345 
Phone: 404-977-5133 
Email: justin.smith@PIHCGA.org  
 
DeAnne Turner, PhD, MPH 
University of South Florida 
College of Nursing 
12901 Bruce B. Downs Blvd., MDC 22  
Tampa, FL 33612  
Phone: 727-515-8187 
Email: dturner@usf.edu 
 
Tequetta Valeriano, MS 
Yale University, School of Nursing 
400 West Campus Drive 
Orange, CT 06477 
Phone: 203-737-2312 
Email: Tequetta.valeriano@yale.edu 
 
David Vlahov, PhD, RN, FNYAM, FAAN 
Yale School of Nursing 
250 E. 87th St., Apt 25AJ 
New York, NY 10128 
Phone: 646-232-3583 
Email: David.Vlahov@yale.edu  
 
Darren L. Whitfield, PhD, MSW 
University of Maryland  
School of Social Work 
525 W. Redwood Street, Suite 5E43 
Baltimore, MD 21201  
Phone: (410) 706-6340 
Email: darren.whitfield@ssw.umaryland.edu

 
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HPTN 096 
Getting to Zero among HHI MSM in the American South: 
Testing an Integrated Strategy 
SCHEMA 
Purpose: The overall purpose of this study is to evaluate a status-neutral integrated strategy to 
improve access to and uptake of HIV prevention and treatment services for the highest HIV 
incidence (HHI) men who have sex with men (MSM) in participating communities. The ultimate 
goal is to establish a strategy to reduce HIV incidence among HHI MSM in the southern United 
States (US) by increasing the number of HHI MSM accessing prevention and treatment services, 
increasing uptake and use of pre-exposure prophylaxis (PrEP) among those living without HIV 
and increasing retention in care, and thus viral suppression, among those living with HIV.  
Design: HPTN 096 is a hybrid implementation-efficacy trial that uses a single arm interrupted 
time series (ITS) design to test whether a status-neutral integrated strategy improves access to 
and uptake of HIV prevention and treatment services for HHI MSM. ITS measures a change in 
slope for the primary outcomes pre- and post-intervention using four one-year look backs of 
EMR data. The integrated strategy will be delivered in up to five selected communities in the 
southern US. 
Integrated Strategy Components: The four study components of the integrated strategy are 
described below. 
• Health access coalitions: This component will use a community coalition program as its 
base model for reducing structural barriers, shaping community social norms and raising 
awareness to reduce HIV among HHI MSM. This will be achieved through: 1) 
facilitating a reduction in social, structural, and policy barriers to HIV testing, PrEP, and 
viral suppression through fostering collective efficacy, promoting norms within the local 
service sectors (e.g., social, legal, economic, etc.), and advancing advocacy efforts that 
support the strategic prioritization of access to resources and services for HHI MSM; and 
2) amplifying awareness, education, and capacity building around HIV prevention and 
treatment resources and messaging (including other HPTN 096 components).  
• Social media: In this component, a robust social media strategy will be used to reach and 
engage HHI MSM throughout each participating community. Utilizing a multitude of 
social media communication and marketing tactics, social media content will be used to 
educate and empower HHI MSM so that they can make informed decisions and 
behavioral changes to stop HIV acquisition and transmission, with emphasis on accessing 
HIV prevention and treatment services, the uptake of PrEP and the importance of staying 
engaged in care and achieving viral suppression. In addition, the strategy will promote 
other study components, encouraging HHI MSM to engage in care at PHASE healthcare 
facilities (HCFs), seek help from peer supporters and take advantage of the 
environmental changes put in place via the health access coalitions. 

 
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• Peer support: In this component, peer supporters, who may possess a shared and/or 
lived experience, will provide HHI MSM with emotional and practical support, using a 
HIV-status neutral approach, as well as share information on locally available sexual 
health and HIV-related resources and support services. Peers may provide support 
in-person or virtually and may be housed at local community-based organizations. In 
addition, when appropriate, the use of PHASE HCFs will be encouraged for those 
seeking healthcare services. 
 
• Promoting Human Autonomy Supportive Environments (PHASE). The PHASE 
component is an HCF-level training and quality improvement program designed to 
improve the provision of healthcare services for HHI MSM. PHASE aims to create an 
autonomy-supportive healthcare environment that supports HHI MSM engagement in 
HIV-related care and services and helps to promote increased HIV/STI testing, PrEP and 
ART uptake, retention in care, and viral suppression rates for HHI MSM. The primary 
study outcomes will be collected at all HCFs participating in PHASE. 
Intervention Assessments: Primary outcomes will be measured using facility level evaluations 
based on electronic medical record (EMR) data from approximately 40 PHASE HCFs that 
provide HIV prevention services and approximately 20 PHASE HCFs that provide HIV 
treatment services across all five study communities. Secondary outcomes and primary 
intervention process outcomes will be measured via EMR data, questionnaires, qualitative data 
collection and social media metrics from 1) PHASE HCF staff and clients, 2) health access 
coalition members, 3) peer supporters and their clients, and 4) HHI MSM and other individuals 
who see and/or engage with the intervention’s social media content. 
Study Communities: The integrated strategy will be implemented in up to five southern 
communities, each made up of one or more counties. The five study communities are:  
• Dallas, TX 
• Montgomery, AL 
• Ft. Lauderdale/Miami, FL 
• Atlanta, GA 
• Memphis, TN 
Study Population: The study population will be HHI MSM residing in the five study 
communities. Primary study outcomes will be measured among HHI MSM at PHASE HCFs. 
Additionally, a subset of HHI MSM at PHASE HCFs, as well as PHASE HCF staff, community 
coalition members, peer supporters, and both HHI MSM and other individuals who engage with 
the intervention’s social media content will also be assessed for secondary outcomes and primary 
intervention process outcomes. 
Study Duration: Each study community will participate in the study for approximately 3.3 
years, which includes one year of pre-implementation activities, 2 years of implementation of the 
integrated strategy, and 2.3 years of data collection (see Schema Figure 1). There is a 12-month 
window during which all five study communities will begin implementation. Therefore, the 
overall duration of the study is expected to be approximately 4.3 years. 

 
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Study Objectives:  
Primary Objectives: 
• To evaluate whether the HPTN 096 integrated strategy increases the number of HHI 
MSM clients at PHASE healthcare facilities 
• To evaluate whether the HPTN 096 integrated strategy increases retention in care among 
HHI MSM living with HIV at PHASE healthcare facilities 
• To evaluate whether the HPTN 096 integrated strategy increases PrEP prescriptions for 
HHI MSM not living with HIV at PHASE healthcare facilities 
Secondary Objectives: 
• To evaluate whether the HPTN 096 integrated strategy increases viral suppression (<200 
copies/mL) in HHI MSM living with HIV at PHASE healthcare facilities  
• To evaluate whether the HPTN 096 integrated strategy increases PrEP initiation, 
adherence and persistence for HHI MSM not living with HIV at PHASE healthcare 
facilities 
• To assess changes in the experience of autonomy support among HHI MSM at PHASE 
healthcare facilities 
• To assess how autonomy support, social support, stigma, barriers to healthcare and 
individual agency among HHI MSM at PHASE healthcare facilities are associated with 
engagement in care (including PrEP prescriptions and viral suppression) 
Primary Intervention Process Measures 
• Self-reported coalition effectiveness among health access coalitions 
• Reach of social media content to intended HHI MSM audience 
• Acceptability, satisfaction and perceived usefulness of the peer support component 
among peer supporters and their clients 
• Knowledge and attitudes among staff at PHASE healthcare facilities after completion of 
PHASE trainings as compared to before training 
• Qualitative characterization of staff experiences implementing PHASE 
Exploratory Objectives: 
• To explore community-level viral suppression in HHI MSM in intervention and selected 
southern communities using CDC HIV surveillance data 
• To use mathematical modeling to assess the potential population-level impact of the 
integrated strategy on HIV incidence among HHI MSM in the southern US 
 

 
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Schema Figure 1: Overall HPTN 096 Study Design and Study Duration 
 

 
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1 
INTRODUCTION 
1.1 
Background 
Men who have sex with men (MSM) bear the most disproportionate burden of human 
immunodeficiency virus (HIV) incidence and prevalence of any community in the United States 
(US) [1]. Despite the fact that only 4.5% of US men identify as gay or bisexual [2], in 2023, 
MSM accounted for more than 66% of new HIV diagnoses in the US, which is a percentage that 
increased by 8% between 2019 and 2023 [1]. Within this relatively small and highly burdened 
MSM population, there are regions and subgroups in the US that share an even more 
disproportionate burden. For example, in 2023, the rate of HIV diagnoses was the highest in the 
southern US (18.4 per 100,000), and within that region, Black MSM accounted for 43% of the 
new diagnoses, followed by Latino (33%) and White (20%) MSM [1]. In addition, in 2023, 
young Black MSM made up 47% of the new HIV diagnoses in US MSM, compared to 36% in 
young Latino and 12% in young White MSM [1]. Relatedly, research shows that multiple social 
and structural factors undermine prevention and treatment outcomes for MSM subgroups who 
consistently have the highest HIV diagnoses through their negative effects on health access, 
healthcare service quality and healthcare seeking behaviors [3]. Consequently, these factors lead 
to higher rates of undiagnosed and unsuppressed HIV and increased risk for HIV transmissions 
[4]. These differences make it critical to target HIV prevention activities towards MSM 
subgroups with the highest HIV incidence (HHI) and prioritize these HHI MSM subgroups for 
intensified HIV prevention and treatment.  
Differences in health outcomes in the HIV epidemic among MSM have persisted unabated by the 
advent and broad supply of highly effective antiretroviral therapy (ART) and pre-exposure 
prophylaxis (PrEP) discoveries. It is well-established in the current state of genomic science that 
the practice of grouping of humans, based largely on skin color, is a social classification system 
rather than a biological taxonomy [5-7]. This evidence is corroborated by public health 
epidemiological analyses that determined that genetic factors did not explain the global 
geographic differences observed in HIV incidence. Given the growing recognition that observed 
patterns in HIV incidence were “social patterns,” public health officials also began to re-consider 
previous attempts at searching for biological explanations towards examining social conditions 
as an explanatory pathway for HIV incidence differences. In the US, the Centers for Disease 
Control and Prevention has long acknowledged its mounting evidence that overlapping social 
and structural factors were key contributors to differences in rates of HIV infection [8]. To date, 
social and structural factors exert determinative influences on the impact of HIV on HHI MSM 
across the HIV continuum of care. These differences are increasingly understood as the 
outcomes of social and structural determinants of health (SSDOH) that must be addressed if we 
are to relieve the epidemic burden on these communities. 
Many publications in the epidemiologic, sociologic, and health services literature have described 
and investigated these SSDOHs and sought to understand and address them. The findings across 
multiple disciplines have been consistent — individual level behaviors play only modest roles in 
risks for HIV acquisition and poor clinical HIV outcomes. The critical drivers for HIV outcomes 
among HHI MSM occur at the social, structural and health care system levels [9-12]. Lower 
levels of health care access and insurance, lower rates of disease screening, poverty, and multiple 
stigmas, including stigma in healthcare settings, all also play determinative roles in the 

 
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longstanding health outcomes seen among HHI MSM. Yet there are few interventions that seek 
to address the SSDOH for HHI MSM. HPTN 096 is a pioneering trial of an integrated strategy 
that seeks to improve HIV prevention and treatment outcomes for HHI MSM across the most 
HIV-affected region in the country — the South. 
1.1.1 HIV Epidemic in the Southern US 
The epidemiology of HIV in the US shows an increasing concentration of the epidemic in a 
relatively small number of high prevalence geographic areas. The US has over 3,100 counties, 
but just 48, along with the District of Columbia and Puerto Rico, accounted for almost half of all 
new HIV diagnoses in 2023 [1]. The South has roughly one-third of the US population but 
accounted for 51% of new infections in 2023 [1, 13]. This is also the region with many of the 
lowest rates of access to health care services and health insurance. Many southern states where 
these high prevalence counties are located do not participate in the Medicaid expansion 
component of the Affordable Care Act, which is designed to increase health care insurance 
access for low-income individuals [14]. In this region, both HIV testing [15] and viral 
suppression rates [16] are low. In the most recent CDC surveillance report, the South had a viral 
suppression rate of only 67% [1]. All these factors have been described as part of a syndemic of 
multiple overlapping risks and vulnerabilities that have generated and maintain this striking 
health disparity [17, 18]. The pernicious effects of SSDOH in the region has heightened the 
awareness that interventions to protect the health of HHI MSM must target the intersecting 
multi-level systems that impede healthcare access and care. 
1.1.2 Ending the HIV Epidemic Initiative 
HPTN 096 is designed to strategically align with the US federal initiative “Ending the HIV 
Epidemic: A Plan for America,” referred to as EHE. The EHE plan is based on the current 
epidemiology of HIV in the US [19]. The plan asserts that we now have the scientific and public 
health tools to end HIV in the US by 2030, but that a relatively small number of high 
transmission jurisdictions will require greatly intensified efforts to reduce the health outcome 
differences at the heart of the US epidemic. It identifies 48 counties, Washington, DC and San 
Juan, Puerto Rico (which collectively accounted for 46% of new HIV infections in 2023), as well 
as seven states with disproportionately high HIV incidence in rural areas, as the highest priority 
areas for these intensified EHE efforts [1, 20]. The plan also recognizes, in the words of former 
Secretary Azar of the US Department of Health and Human Services (DHHS), that “stigma, 
which can be a debilitating barrier preventing someone living with HIV or at risk for HIV from 
receiving the healthcare, services, and respect they need and deserve—still tragically surrounds 
HIV” [21]. Four key areas are targeted for funding increases to implement the plan: Diagnose, 
increase the proportion of Americans living with HIV who know their status and link them 
immediately to care; Treat, rapidly and effectively achieve viral suppression; Prevent, rapidly 
increase the proportion of at-risk persons on pre-exposure prophylaxis (PrEP); and Respond, 
detect and respond to HIV clusters and prevent new infections. HPTN 096 will address the 
Prevent and Treat pillars of EHE in its integrated strategy.  
A number of federal agencies are tasked with engagement in the EHE plan and its 
implementation, including the National Institutes of Health (NIH), Centers for Disease Control 
and Prevention (CDC), and Health Resources and Services Administration (HRSA). NIH, 

 
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specifically the Division of AIDS (DAIDS) within the National Institute of Allergy and 
Infectious Diseases (NIAID), will lead the research effort for EHE, which centers on 
implementation science for the plan. The CDC and HRSA efforts in these counties will be led 
and funded by the respective agencies, with the CDC taking a lead in enhancing diagnoses and 
prevention efforts, and HRSA, through its Ryan White Program, supporting enhanced treatment 
and viral suppression outcomes. HPTN 096 is sponsored by the NIH and will be in collaborative 
partnership with the other federal agencies above, namely CDC and HRSA. The study will 
engage with up to 5 communities (some comprised of multiple counties) selected from among 
the 28 southern EHE counties (see Section 4.1 for additional detail). HPTN 096 will enhance 
these ongoing EHE efforts by adding a four-component multi-level, status-neutral integrated 
strategy that targets factors at the interpersonal, organizational, and community levels. 
1.1.3 Proven HIV Prevention Methods: A Status Neutral Approach  
There now exists an evidence-based repertoire of biomedical strategies for HIV prevention that 
include HIV PrEP for those who are not living with HIV but are at risk of acquiring HIV, and 
effective ART and treatment as prevention for those living with HIV. Yet, it has been known for 
years now that many people – particularly those negatively impacted by SSDOH – are not 
benefiting from these extraordinary biomedical advances in HIV prevention and treatment 
science [22]. Identifying people living with HIV who are unaware of their HIV serostatus and 
linking them to either prevention or treatment services, and reducing differences in HIV 
prevention and treatment outcomes are important national goals [23].  
Figure 1. Status Neutral HIV Prevention and Care [24]  
 
  
 

 
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1.1.3.1 HIV Testing 
HIV testing (Figure 1) is the entry point into the HIV status neutral prevention and care cascade 
[24, 25], serving either as the point of diagnosis and opportunity for entry into HIV treatment 
services or as the point of ruling out an HIV infection and thus presenting the opportunity for 
entry into prevention services, including PrEP services. There have been important innovations 
in HIV testing that increases both its ease and accessibility, including rapid point-of-care HIV 
tests and HIV self-tests [26]. The CDC encourages health departments to consider HIV 
self-testing as an additional testing strategy to reach persons most affected by HIV [27]. 
Evidence also indicates that integrating HIV testing services with sexual health screening 
services is an efficient and effective strategy for identifying undiagnosed people living with HIV 
for onward linkage to treatment [28, 29]. Moreover, HIV testing is one of the EHE pillars [30], 
given its essential role in helping to target the appropriate health resources (e.g., prevention or 
treatment) to the relevant populations at the right time to maximize their clinical impact [31]. 
Over the years HIV testing has experienced significant scientific innovations (e.g., the 
development of rapid point of care testing and home-based self-testing) and policy innovations 
(e.g., opt-out testing, clinical laboratory improvement amendments [CLIA] waivers). Moreover, 
HIV testing technology has advanced such that testing devices are now produced at a scale and 
price point that significantly expands its accessibility to individuals regardless of income. HIV 
testing is now the first step in accessing PrEP and is incorporated in all clinical guidelines for 
prescribing and managing individuals on PrEP.  
1.1.3.2 PrEP 
Several randomized clinical trials have demonstrated the efficacy of PrEP in preventing HIV 
acquisition [32, 33]. The CDC recommends PrEP as an HIV prevention strategy, based on 
evidence that taking PrEP medication, as prescribed, reduces the risk of HIV transmission via 
sexual contact by approximately 99% [34]. Currently, there are two oral medications - 
emtricitabine and tenofovir disoproxil fumarate (brand-name Truvada and generic versions), and 
emtricitabine and tenofovir alafenamide (Descovy) - approved for daily oral use as HIV PrEP. 
Furthermore, an off-label use, on-demand oral PrEP, is highly effective at preventing HIV 
infection among high-risk MSM, is endorsed for MSM by the WHO [35] (although not by the 
CDC [36]), and represents an alternative to daily PrEP and expanding choices for HIV 
prevention [37]. However, differences remain, with HHI MSM consistently demonstrating lower 
levels of PrEP access and use [38]. Moreover, the interaction of multiple stigmas (e.g., PrEP, 
HIV, and sex) is a widely known barrier in healthcare facilities, with limited interventions 
developed to address it [39]. Recent and exciting results from HPTN 083, a global randomized, 
controlled, double-blind study that compared the safety and efficacy of long-acting injectable 
cabotegravir (CAB-LA) to daily oral Truvada PrEP, showed that CAB-LA was superior to oral 
daily Truvada for reducing HIV incidence among men who have sex with men [40-42]. CAB-LA 
was approved for use in HIV prevention by the FDA in 2021, providing an added alternative to 
oral PrEP. It is critical to ensure that HHI MSM in the South have access to all available HIV 
prevention strategies, including both oral and injectable PrEP. 

 
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1.1.3.3 Viral Suppression 
Prompt linkage to and retention in HIV medical care is essential to achieve viral suppression 
among persons newly diagnosed with HIV and those who were previously diagnosed but are not 
in care. It is now well established that early ART initiation carries clear short and long-term 
benefits to anyone living with HIV and also significantly contributes to reduced onward 
transmission of HIV to sexual partners when there is sustained viral suppression [43]. As with 
PrEP, differences exist with regard to ART access, uptake, and retention. In an analysis of seven 
studies from Canada, 13 from the UK, and 174 from the US, HHI MSM in each country were 
less likely to initiate combination ART [22]. In the US, HHI MSM living with HIV were also 
less likely to have health insurance, have a low CD4 count, adhere to ART, or be virally 
suppressed [22]. There were also greater structural barriers (i.e., unemployment, low income, 
previous incarceration, less education) associated with poor HIV health outcomes among HHI 
MSM [22]. These structural factors affect availability and choice of sex partners and are also 
associated with living in neighborhoods with a high background HIV prevalence and community 
viral load, which increases the odds of sexual exposure to HIV. Elimination of different rates in 
HIV infection in HHI MSM cannot be accomplished without addressing social determinants of 
health associated with HIV clinical care access and outcomes, an important focus of our 
integrated strategies approach in HPTN 096. A long-acting injectable anti-viral regimen, 
Cabenuva, is also approved for treatment of HIV among adults in the US, and this alternative has 
demonstrated superiority for maintenance of viral suppression in patients challenged by oral 
dosing [44]. Regardless of the treatment regimen chosen, a driving predictor of viral suppression 
is the ability of clinics to retain patients in medical care. Thus, we turn our attention to retention 
in care for which evidence indicates its failure will eclipse viral suppression goal attainment. 
1.1.3.4 Retention in HIV Care 
Retention in care is an indicator of quality HIV primary care. When combined with effective 
anti-retroviral treatment, it leads to HIV viral load suppression. There are a finite number of 
ART regimens that are known to be effective for the treatment of HIV. The evidence of their 
efficacy is well-established and, as such, there is very little variation or uncertainty in their 
expected clinical effect on HIV viral load. However, there is wide variation in the quality of HIV 
primary care. Poor quality care undermines retention of patients, which interrupts the 
maintenance of ART treatment and undermines progress towards attainment of viral suppression. 
There is overwhelming evidence substantiating the link between retention in care and viral load 
suppression. Overall, the evidence from multiple studies indicates that those who are retained in 
care are more likely to be virally suppressed [45-49]. For example, there are a few studies on the 
association of viral suppression with multiple different definitions of retention in care. Retention 
definitions included (1) having 2 or more HIV visits separated by greater than or equal to 90 
days during a calendar year (which is also the definition used by the HRSA Ryan White 
HIV/AIDS program), (2) having 1 HIV visit in each half of the calendar year at least 60 days 
apart, (3) having 6 months between sequential outpatient visits with no gap, and (4) the number 
of 3-month intervals in a calendar year in which a patient completes at least 1 HIV visit (range, 
1–4). Regardless of how it was measured, retention in care was significantly associated with 
higher likelihood of viral suppression for individuals. The magnitude of these associations was 
higher for individuals aged 18-29 and 30-39 years, which is significant given the 
disproportionate HIV incidence in individuals younger than 40 years old [49]. Furthermore, a 

 
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study of early retention in care found that it was associated with decreased time to viral 
suppression among patients newly linked to HIV treatment [47]. 
Evidence in the research literature also indicates that various indicators of poor retention are 
associated with detectable HIV viral load [45, 47, 50]. In one study that measured the proportion 
of scheduled clinic visits that were “no show”, researchers found that each “no show” visit added 
a 17% increased risk of delayed viral suppression [47]. In another study, retention in care was 
defined as having at least one clinic visit every three months (visit constancy) and viral rebound 
was defined as a viral load >400 copies/ml. Retention in care was categorized into four groups: 
(1) optimal retainers (100% retention), (2) suboptimal retainers (75%), (3) sporadic retainers 
(50%), and (4) poor retainers (<25%) [46]. The odds of a viral load rebound were much greater 
for suboptimal (odds ratio [OR]: 2.28; 95% confidence interval [CI]: 1.44–3.63) and poor (OR: 
15.1; 95% CI: 6.82–33.41) retainers compared to optimal retainers. “Appointment 
nonadherence” defined as the number of missed appointments over the previous year, was a 
significant predictor (p < .05) of having a detectable viral load among patients in a 
community -based HIV primary care clinic [45]. Among patients with an undetectable viral load 
at the earliest visit, the only predictor of declining to a detectable viral load was the number of 
missed appointments (p < .003) [45]. The evidence overwhelmingly indicates that poor rates of 
retention in quality HIV primary care is a main contributor to detectable viral load. Interventions 
are needed to address intersectional stigma and other factors in HIV primary care HCFs that 
contribute to disengagement, disconnection and evasion of care among HHI MSM. 
Due to its strong positive association with viral suppression, retention in care has emerged as a 
viable and more proximal measure of quality HIV primary care than viral suppression. There are 
several important reasons for this. First, there is a lag time between retention and viral 
suppression. Therefore, monitoring retention in care is important for early identification of 
facility’s likely progress (or lack of progress) towards reaching viral suppression goals. 
Monitoring retention in care also affords time to identify and implement improvement measures 
that can still affect viral suppression outcomes. Second, retention in care is likely to be more 
sensitive to a change in response to an intervention targeted to improve quality of the HIV 
primary care experience. For example, the rates of viral suppression among HHI MSM retained 
in care is very high (approaching 90% in some estimates) [51]. This high proportion of viral 
suppression is a successful achievement that nonetheless nears a ceiling, which represents a point 
of diminishing returns on intervention efforts to further improve it. Conversely, retention in care 
metrics generally trail viral suppression by 10 percentage points or more (because retention 
metrics include individuals poorly engaged in care who have not received viral load testing), 
affording ample room for improvement in response to an intervention [51]. In the most recent 
Ryan White HIV/AIDS annual report of client-level data, 75.6% of HHI MSM were retained in 
care (defined as 2 visits in the past 12 months at least 90 days apart) and among those HHI MSM 
retained in care, 86.1% were virally suppressed as measured by the most recent viral load test 
within the last 12 months [51]. Moreover, situations where intervention activities lead to 
increases in newly diagnosed HHI MSM entering care (or previously diagnosed HHI MSM 
returning to care after a significant time gap), will initially depress viral suppression estimates 
due to the high probability of viremia among the men newly engaged/reengaged in care. 
However, retention in care is far less susceptible to this type of measurement volatility. Unlike 
viral suppression, which is a time-independent absolute value, “retention in care” is a relatively 

 
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stable indicator of quality in HIV treatment in HCF settings because its fluctuation is minimized 
by time and activity parameters.  
1.1.4 Electronic Health Records: A Promising Tool for Monitoring Prevention, 
Treatment, and Service Outcomes 
Electronic health records (EHRs) have emerged as an indispensable tool that enables the delivery 
of high-quality services [52-54]. The benefits of EHRs are well-established and include 
efficiency in data retrieval [55, 56], standardizations that allow for longitudinal monitoring of 
individual-level health indicators and clinic-level performance indicators [57-59], increased 
patient ability to access and interact with health data [60-62] and enhanced portability of health 
data [63, 64]. EHRs have proliferated across the US over the past two decades [65] and are now 
a cornerstone of the healthcare system. Moreover, their use in research is legitimized by the US 
Food & Drug Administration that has issued guidance about EHR data practices [66]. Recent 
advances in computing, statistical analytics, data simulation, and artificial intelligence are fueling 
a rise in innovations in the use of data that is stored in EHRs [67-69]. For example, a recent 
study reported on the development and validation of an automated algorithm to identify 
candidates for HIV pre-exposure prophylaxis indicators, by using EHR data to predict likelihood 
of a future HIV infection among enrolled patients [69, 70]. EHRs have also been used as an 
epidemiologic tool such as its deployment as a networked surveillance system for the early 
detection of trends in disease occurrence [71]. This epidemiologic function can also be helpful in 
assessing the impact of community- and clinic-delivered interventions whose effects are 
hypothesized to result in improved clinical (e.g., PrEP use, HIV viral load suppression) and 
service (e.g., increased patient volume, retention in HIV care) outcomes [72].  
Notwithstanding the myriad advantages offered by EHRs, they have some existing limitations. 
First, EHR databases are still largely dependent on humans to populate them using data that is 
either collected through direct observation or biometric assessment. Humans can introduce both 
random and systematic error into EHR data through actions (on inactions) that bias how data are 
collected, managed, and interpreted [73]. For example, while clinicians make assessments of 
patient eligibility for PrEP using published clinical guidelines, there is evidence that several 
major guidelines for PrEP do not sufficiently predict risk of HIV acquisition for all individuals, 
including HHI MSM  [74-76]. Therefore, data that are input into EHRs (or excluded from entry 
into EHRs) based on biased clinical guidelines will introduce a corresponding bias into the 
database. Another limitation is that data contained in EHRs may not be a complete representation 
of social, behavioral and clinical realities of patients in a healthcare facility. There are several 
important sources for this type of mismatch. One key source is the non-systematic collection of 
sexual orientation data [77, 78]. Collection of sexual orientation data is important for clinicians 
to be able to have a more holistic understanding of their patients that inform health screening, 
health promotion guidance and prevention/treatment planning [79, 80]. However, recent analysis 
of data from 1,297 federally qualified health centers (FQHCs) found that sexual orientation data 
was missing for one-quarter to one-third of patients [81]. EHR databases that are incomplete and, 
consequently, inaccurate will complicate efforts to rely on them as a source for assessing the 
intervention effects on clinical and service outcomes. 
Intervention strategies that are designed to systematize sexual orientation assessments of patients 
can help to improve both the data completeness (i.e., minimizing the volume of missing fields) 

 
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and data quality (i.e., the data accurately characterizes the patient’s social, behavioral, and 
clinical realities). Several recent studies have tested strategies to improve sexual orientation data 
collection in health care facilities [82, 83]. One quasi-experimental trial tested the effects of a 
quality improvement collaborative approach combined with a skills-based knowledge exchange 
model could improve data collection and service outcomes (i.e., STI/HIV screening) [83]. The 
intervention was conducted in a sample of 123 clinical sites that accounted for 441,387 patients 
[83]. This resulted in a 276% increase in sexual orientation documentation (from 14% to 51% of 
patients) [83]. There were also substantial increases in clinical screening of LGB patients for 
HIV (132% increase), syphilis (87% increase), and gonorrhea/chlamydia (109% increase) [83]. 
This is evidence of the impact of interventions on sexual orientation documentation and its effect 
on clinical practice.  
Improvements in sexual orientation data completeness may uncover an important conundrum, 
which is that baseline estimates on clinical outcomes among the LGB census at an HCF are 
likely to be an overestimate because the “known” denominator of LGB individuals at baseline 
may be substantially smaller than the “true” LGB census. Over time, as the proportion of the 
LGB census becomes “known” due to systematic increases in sexual orientation assessments, the 
gap closes between the known census and the true census. However, as the denominator of LGB 
census grows due to increased data completeness at later time points, it may have the effect of 
reducing proportions on clinical outcomes observed at baseline and undermining the ability to 
detect intervention effects. Take for example a scenario where the known number of HHI MSM 
in an HCF at baseline is N=10. If nine of these 10 men were prescribed PrEP, then the proportion 
of PrEP prescriptions among HHI MSM in that HCF is 90%. After increasing the completeness 
of sexual orientation data, we may later find (after 12-months) that the true number of HHI MSM 
at the HCF was actually N=90; thus, bringing the proportion of HHI MSM prescribed PrEP 
down from 90% at baseline to 10% at 12-months post-intervention. The implication of this 
specific phenomenon is that the positive intervention effects on data completeness could 
contribute to a null (or inverse) finding on the clinical outcome. To correct this issue, researchers 
have taken sexual orientation data that were assessed at the end of the intervention period and 
used it to back-calculate missing data in the earlier period to ensure that both the baseline and 
end of intervention denominators are more accurate approximations of the HCF’s true LGB 
census [83].  
Notwithstanding their range of limitations and complexities, EHRs still represent a modern 
available tool for assessing the impact of community- and clinic-delivered interventions whose 
effects are hypothesized to result in improved clinical (e.g., PrEP use, HIV viral load 
suppression) and service (e.g., increased patient volume, retention in HIV care) outcomes [72]. 
In fact, collection of sexual orientation data in FQHC EHRs has improved over time and has 
been documented as being higher in clinics in the Southern US [81]. This higher data completion 
rate observed in Southern FQHCs may signal that other relevant data fields are more complete 
than sexual orientation data, thus potentially allowing the use of data on men with the same 
demographic characteristics as HHI MSM as a back-up/proxy for data on HHI MSM. Multi-level 
integrated strategies that leverage HCFs to improve HIV prevention, treatment and service 
outcomes may benefit from harnessing the potential of EHRs to assess intervention effects. 
As a technical note, the term “electronic health record” or “EHR” refers to the health information 
for a person across multiple healthcare providers and organizations. The term “electronic 

 
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medical record” or “EMR” refers to the health information for a person within one healthcare 
clinic. For the purposes of this study, we are using EMR data and will use the term “EMR” 
throughout the remainder of the protocol. 
1.2 
Rationale for an Integrated Strategy Approach 
HPTN 096 is based on scientific and programmatic evidence that individual-level behaviorally 
focused interventions alone are insufficient to significantly affect HIV prevention and treatment 
pathway outcomes among HHI MSM [84-86]. While highly efficacious biomedical HIV 
prevention tools—such as HIV PrEP and treatment—are available to consumers within the 
healthcare market [87-89], their broad availability alone has not translated into prevention gains 
for HHI MSM [90, 91], despite evidence that HHI MSM are interested in and willing to take 
antiretroviral medication for PrEP and treatment [92, 93]. Cost is a known barrier to accessing 
PrEP and other healthcare services, but other evidence indicates that healthcare provider attitudes 
and prescribing practices are also barriers to access to these products and services [92, 94]. These 
attitudes are manifested in the institutional policies and practices of HCFs as well as HCF staff; 
and, are not isolated phenomena, but reflect larger social attitudes that stigmatize gayness, HIV 
seropositive status and HIV-related health-seeking behaviors. In sum, the key factors driving the 
HIV epidemic among HHI MSM operate at multiple levels that intersect to reinforce barriers that 
impede the uptake of biomedical HIV prevention and treatment goals [95-97]. These levels 
include community, organizational and interpersonal levels. 
1.2.1 Implementation Framework 
The overall approach to HPTN 096 
utilizes the convergence framework 
(Figure 2) [98, 99] for integrating 
strategies across multiple levels. The 
integration of strategies across multiple 
levels is based on the premise that there 
are multiple levels of social, political, 
and economic influencing factors that 
affect whether implementation will be 
successful and whether it will improve  
health outcomes [100]. In HPTN 096, 
our multi-level implementation 
approach is centered around the clinical 
encounter where a desired outcome for 
the patient is influenced by factors 
within the HCF and larger healthcare system in a community. It advances the concept that social, 
political, and economic forces exert strong external pressures that influence implementation at 
the HCF level and its possibilities for scaling across a broader set of local HCFs. This logic also 
guides our approach to addressing primary intervention process measures (Section 2.3) that 
focuses on characterizing the experience of HCF staff implementing autonomy support (an 
implementation strategy), including examining the dynamics of the HCF contexts and identifying 
what factors influenced variation in study outcomes between the participating HCFs. It will, as 
A Note on Frameworks, Figures, and Theories. The 
study’s integrated strategy supports the implementation 
of HIV PrEP and workflows that improve retention in 
HIV care. The figures included in the introduction do 
not represent competing frameworks. They are 
provided to give visual illustration of what is descried 
in the text such as how the components of the 
integrated strategy function together to affect study 
outcomes (Figure 2), and the logic for how specific 
implementation determinants addressed by the 
integrated strategy are hypothesized to improve 
implementation of clinical interventions within HCFs 
(Figure 3). Moreover, each component of the 
integrated strategy has its own theoretical basis that we 
articulate in the section where the component itself is 
described.  

 
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well, guide our qualitative exploration of the experiences of patients in participating HCFs (see 
Section 2.2 Secondary Objectives) and whether or how their experiences influenced PrEP use, 
ART use, and retention in HIV care. 
We have identified four strategies that address factors at multiple (societal/community, 
organizational, and patient/interpersonal) levels. The four components will be combined into one 
integrated strategy implemented to address the multi-level drivers of HIV incidence in HHI 
MSM. Intervening at multiple levels is needed because structural determinants, community-level 
norms, lack of autonomy support in HCFs, and decreased access to peer-based social support act 
interdependently to impede health service utilization, PrEP use and retention in HIV care; 
therefore, intervening at a single level—while necessary—is insufficient to achieve measurable 
impact among a non-cohort sample of HHI MSM attending real world HCFs [101].  
Figure 2. Theorized Pathway of Integrated Strategy Effects on Study Outcomes 
 
Community Level – Structural Determinants in Local Municipalities Are Barriers to HIV 
Prevention and Care. Data from HPTN 061 identified economic, social and legal hardships 
across six sites that were associated with increased HIV/STI risks among HHI MSM [102]. 
These economic (e.g., job loss, recent financial crisis) and social (e.g., unstable housing) 
hardships may have salience for HIV prevention and treatment in communities without robust 
social safety net programs. Other social hardships (e.g., no health insurance) can have a more 
severe impact on those who are unemployed in states that did not expand their Medicaid 
programs under the affordable care act. HPTN 061 also found very high levels of police contact 
among HHI MSM [103], with an estimated incarceration incidence of 35% (95% confidence 
interval [CI] 31-38) during the study period [97]. HHI MSM who reported legal hardships (i.e., 
recent conviction) were more likely to have an STI in the past six months (adjusted odds ratio 
[AOR]=3.97; 95% CI 1.58-9.94) [102]. In another national sample of HHI MSM (N=1,172), a 
high percentage (43%) reported police discrimination that was associated with recent arrests 
[104]. Recent arrest and incarceration history were both associated with sexual exposure to HIV. 
Additionally, incarceration and recent arrests were associated with lower willingness to use PrEP 
[104]. The impacts of these structural determinants on HIV incidence are problems that are not 

 
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solved by either PrEP use or HIV treatment alone; on the contrary, structural determinants thwart 
the attempts of individuals to prioritize HIV prevention and treatment approaches due to other 
daily, tangible and immediate threats to their physical health, psychological well-being and 
survival [105, 106]. Consequently, health promotion approaches that engage multi-sectoral 
coalition building are needed to mitigate the impact of structural determinants on health service 
utilization, PrEP use and retention in HIV care among HHI MSM. 
Community Level – Stigmatizing Attitudes and Social Norms Undermine Health Seeking 
Behaviors. HHI MSM who live in the South must make decisions whether to seek healthcare 
services in settings where they can be the subject of mistreatment, discrimination and 
harassment. In addition, these stigmatizing attitudes are sometimes applied directly to the 
products (e.g., PrEP), services (e.g., HIV testing) or HCFs (e.g., lesbian, gay, and bisexual 
(LGB)-centered care) themselves, which can lead to evasion of prevention services to avoid the 
stigma and potential material consequences (e.g., job loss, housing loss, social exile) of being 
associated with them. Moreover, these community-level attitudes can be internalized by HHI 
MSM themselves, which may lead to self-undermining of health seeking behavior [107]. Social 
media has emerged as a powerful platform that can be leveraged to positively influence 
community-level social norms—counteracting the stigmatized attitudes and norms that 
undermine HIV prevention and treatment outcomes for HHI MSM. 
Organizational Level – HCF Policies, Practices and Staff Attitudes and Behaviors Impede 
Access and Retention in HIV Prevention and Treatment Services. HCFs are selected as one of the 
targets for integrated strategy because, even if HHI MSM are sufficiently motivated to attempt 
access of PrEP or HIV treatment services, these services are typically performed in an HCF. The 
socio-environmental conditions in HCFs can either be synergistic or antagonistic to the men’s 
motivation to engage in PrEP or engage treatment services [108, 109]. There are numerous 
studies documenting that stigmas embedded in attitudes, logics and practices of healthcare 
workers actively impede access to HIV-related services, undermine the quality of the healthcare 
encounter experience and, consequently, diminishes the effectiveness of healthcare services in 
improving health outcomes [94, 108, 110, 111]. 
Interpersonal Level – A peer support component was chosen because of the positive influence 
that HHI MSM can have on one another. Peers can positively influence the health behaviors of 
other HHI MSM as well as address the potential negative influence of enacted and internalized 
forms of stigma [112-117]. Another key reason that the HPTN 096 integrated strategy is targeted 
to the interpersonal level is because chronic exposure to stigma (whether at the larger 
community-level or the organizational level) can lead to internalization of the stigmas, which can 
impede HIV testing and prevention service engagement [118-120]. Stigma can also compromise 
psychological well-being due to the strain that HHI MSM may experience in response to 
pressures from peers and families to conform to expectations of masculinity that can often 
conflict with self expression [121]. Peer support is designed to combat the internalization of 
stigma through the provision of educative and emotionally supportive encounters with peers, 
while also guiding men towards autonomy supportive and comprehensive health and social 
services and supporting PrEP and ART initiation and adherence. Table 1 details the levels of 
intervention and outcomes described above.  

 
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Table 1: HPTN 096 Levels, Drivers, Integrated Strategy Components and Outcomes  
LEVEL 
DRIVER 
COMPONENT 
OUTCOMES IMPACTED 
Health 
Service 
Use 
PrEP 
Use 
Retention in 
Care 
Community 
Structural determinants 
manifested through 
economic, social and legal 
hardships that impede HIV 
prevention. 
Health Access 
Coalitions 
Indirect 
Indirect 
Indirect 
Community 
Stigma and social norms 
non-supportive of 
HIV-related service use. 
Social Media  
Indirect 
Indirect 
Indirect 
Organizational 
Stigmas and lack of 
autonomy support 
institutionalized in policies 
and practices of HCFs and 
staff. 
PHASE 
Direct 
Direct 
Direct 
Interpersonal 
Internalized stigma and 
lack of social support. 
Peer Support 
Direct 
Direct 
Direct 
 
1.2.2 The Implementation Research Logic Model: A Method for Explaining the Influence 
of the Integrated Strategy on Clinical Interventions and Study Outcomes 
HPTN 096 is an integrated strategy designed to support the HCF-level implementation of two 
clinical interventions (HIV PrEP and HIV ART) among HHI MSM attending selected health 
care facilities that participated in the PHASE intervention component [122]. We employ the 
Implementation Research Logic Model (IRLM) as an explanatory method that accommodates 
the hybrid implementation-efficacy character of HPTN 096 [123] by framing the relationships 
between the implementation strategies, the clinical interventions, the mechanisms of action and 
the study outcomes (implementation, service and clinical). Our use of an implementation science 
framework necessitates defining “the communities” as the site of implementation. We also take 
into account the theorized pathway of the integrated strategy’s effect on the study outcomes 
(Figure 2) and situate it within the context of implementation determinants, implementation 
outcomes and service outcomes (Figure 3). Together these are the core elements of the IRLM: 
clinical interventions, determinants, strategies, mechanisms and outcomes. 
Clinical Interventions are evidence-based practices that have been shown through rigorous 
research testing to have efficacy in producing a particular health outcome. In HPTN 096, the two 
clinical interventions are HIV PrEP, which has demonstrated efficacy in preventing the 
acquisition of an HIV infection; and ART, which has demonstrated efficacy in suppressing viral 
load and preventing the onward transmission of HIV.  
Determinants are factors that can either impede or facilitate the adoption of the clinical 
intervention. The IRLM uses determinants from the Consolidated Framework for 
Implementation Research (CFIR) [124]. These determinants are categorized into five domains: 
intervention characteristics, outer setting, inner setting, characteristics of individuals, and 
process. These five domains are represented in the HPTN 096 IRLM (Figure 3). We identified 

 
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16 relevant determinants from across the five domains. The general conceptual CFIR definitions 
of each of the selected determinants used in HPTN 096 are listed below. Their corresponding 
operational descriptions are listed in the HPTN 096 IRLM (Figure 3). 
Intervention Characteristics 
1. Relative Advantage – Stakeholder’s perception of the advantage of implementing the 
intervention versus an alternate solution. 
2. Complexity – Perceived difficulty of implementing the intervention reflected by the 
radicalness, disruptiveness and intricacy of the steps required to implement. 
3. Cost – Costs of the intervention or costs associated with its implementation. 
Inner Setting 
4. Networks and Communication – The nature and quality of webs of social networks and 
the formal and informal communications in the implementation context. 
5. Culture – Norms, values and basic assumptions in the implementation context. 
6. Implementation Climate/Relative Priority – The shared perception of the importance of 
the intervention and the extent to which the use of the intervention will be supported and 
rewarded within the implementation context. 

 
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Figure 3. HPTN 096 Implementation Research Logic Model 
  
 

 
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Outer Setting 
7. Patient Needs and Resources – The extent to which patient needs, as well as barriers and 
facilitators to meet those needs, are accurately known and prioritized in the 
implementation context. 
8. Peer Pressure – Competitive pressure to implement an intervention, typically because key 
peer implementers have already implemented or are trying to gain a competitive edge. 
9. External Policies and Incentives – External strategies to spread interventions, including 
external mandates and public or benchmarking reporting. 
Characteristics of Individuals 
10. Knowledge/Beliefs about Intervention – Individuals’ attitudes toward and value placed 
on the intervention as well as familiarity with facts, truths and principles related to the 
intervention. 
11. Self-Efficacy – Individual’s belief in their own capabilities to execute a course of action 
to achieve implementation goals. 
12. Tolerance of Ambiguity/Learning Style – The degree to which implementers can cope 
with and benefit from any needs to “learn as you go” versus knowing in advance exactly 
what are all the steps. 
Process 
13. Engaging – Attracting and involving appropriate individuals in the implementation and 
use of the intervention through a combined strategy of social marketing, education, 
training and other similar activities. 
14. Planning – The degree to which a scheme or method of behavior and tasks for 
implementing an intervention are developed in advance and is high quality. 
15. Executing – Carrying out or accomplishing the implementation according to plan. 
16. Reflecting and Evaluating – Quantitative and qualitative feedback about the progress and 
quality of the implementation accompanied with regular debriefing on the experience. 
Implementation Strategies are techniques and methods used to optimize the implementation of 
clinical interventions, including products/tools, programs or healthcare practices [125]. Strategies 
optimize the HCF-level implementation of clinical interventions by addressing determinants—
either mitigating determinants that impede implementation or enhancing determinants that 
facilitate implementation [126]. Research has identified a great number of potential 
implementation strategies [125, 127]. In HPTN 096, we selected strategies from among the 73 
identified in the Expert Recommendations for Implementing Change project [125]. Detailed 
background (see Section 1.2.5), theoretical rationale (see Section 1.2.6), and description of each 
component of the integrated strategy (see Sections 5, 6, 7 and 8) are presented in subsequent 
sections of this protocol. Figure 3 itemizes the specific discrete activities involved in each 
component of the integrated strategy. 
Mechanisms of Action are the ways in which the implementation strategies are theorized to 
impact on outcomes. The mechanisms of action of HPTN 096 are shown in Figure 2. 

 
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Outcomes. In using the IRLM, we are concerned with effecting three types of outcomes: 
implementation, service and clinical. 
Implementation outcomes are the indicators of the success of the process of implementing the 
integrated strategy and precedes service outcomes and clinical outcomes. Services outcomes 
relate to the quality of clinical operations and/or patient care, which should be positively affected 
by successful implementation. The implementation and service outcomes selected for HPTN 096 
are drawn from the research evidence-base [123, 128, 129] as well as formative information 
gained from our consultations with community stakeholders and EHE councils from across the 
South. Clinical outcomes are individual/patient-level indicators directly impacted by the 
optimized implementation of the clinical interventions. The general conceptual definitions of 
each the selected implementation and service outcomes used in HPTN 096 are listed below. 
Their corresponding operational definitions are presented in the HPTN 096 IRLM (Figure 3). 
Implementation Outcomes 
• Appropriateness – The perceived fit of the innovation or evidence-based practice to 
address a particular issue or problem [123, 129].  
• Fidelity – The degree to which an intervention was implemented as prescribed in the 
protocol or as it was intended by the program developers [123, 129].  
• Penetration – The integration of a practice within an implementation setting [123, 129].  
Service Outcomes 
• Proportionality – Providing care that does not vary in quality because of personal 
characteristics such as sex, geographic location and socioeconomic status [129]. In HPTN 
096 this is the co-primary endpoint measuring the proportional increase in HHI MSM 
healthcare service enrollees (patients) at PHASE HCFs. 
• Patient-centeredness – Providing care that is responsive to individual patient preferences, 
needs and values [129].  
Clinical Outcomes. 
• In HPTN 096 these are what we have described in this protocol as our co-primary and 
secondary study endpoints—these are: 
o PrEP use among HHI MSM without HIV 
o Retention in HIV care among HHI MSM living with HIV 
o HIV viral load suppression among HHI MSM living with HIV 
1.2.3 Primacy of Community Engagement for an Integrated Strategy 
The HPTN 096 integrated strategy also builds skills, supports collective efficacy and harnesses 
sociocultural assets in the study communities to mobilize coalitions and collective action to 
identify and address barriers to PrEP use, retention in HIV care and viral suppression among 
HHI MSM [106, 130]. The study team utilized elements of a community-based participatory 
research (CBPR) [131, 132] approach by conceptualizing HPTN 096 in collaboration with broad 

 
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and frequent input from representatives of the study population, allies and stakeholders from 
communities across the South.  
Additionally, the CBPR process led the HPTN 096 co-chairs to actively avoid approaches that 
position HHI communities as sites of risk and vulnerability that require external intervention and 
instead adopted a lens which recognized (a) the resilience and sociocultural assets that already 
exist in HHI communities and (b) that HPTN 096 would be strengthened by working in 
partnership with national, southern region and local community organizers to achieve the study 
objectives. HPTN 096 is further institutionalizing the community engagement process through 
the intentional inclusion of HHI MSM as members of the protocol team and by incorporating a 
community engagement component into the infrastructure of the study design via the 
Community Advisory Group (CAG), as well as the peer support and social media components. 
(1) HPTN 096 CAG – The community advisory body for the study, active during pre-
implementation and implementation periods, with representation for the study 
communities as well as national stakeholders. The CAG will guide both the national and 
local community level community engagement activities for HPTN 096. This group will 
be the primary point of community input on HPTN 096 study components of the 
integrated strategy from a community perspective. 
(2) Peer Support Component – In consultation with the CAG, peer supporters will develop 
site-specific community engagement strategies to promote awareness of HPTN 096. They 
will be encouraged to implement various community engagement strategies in the local 
communities and across their network to establish and maintain rapport with local 
community stakeholders. 
(3) Social Media Component – The social media advisory group will provide input and 
guidance specifically for the study’s social media strategy and its various campaigns. 
This group is made up of HHI MSM from each study community with the purpose of 
bringing a wide range of voices from within the HHI MSM community to support the 
development and implementation of the social media component.  
Community engagement in HPTN 096’s integrated strategy builds on successful approaches 
from previous multi-level studies [93, 106, 130, 133]. This integrated strategy seeks to 
strengthen partnerships between HHI MSM, HCFs and local community stakeholders and allies 
whose collaborative efforts will support study implementation. 
1.2.4 Critical Partnerships: CDC, HRSA, EHE Committees, Local Health Departments 
and Third-Party Payers 
As outlined in Section 1.1.2, the overall EHE strategy is also influenced by the collaborative 
work of the CDC, local health departments and EHE committees. It is also influenced by 
industries that are involved in payment for healthcare services and prescription antiretroviral 
medication for PrEP and treatment. For this study to work synergistically with these entities, 
strong partnerships with them are critical. Key colleagues from Division of HIV/AIDS 
Prevention at the CDC have helped design some aspects of the study, are members of the 
protocol team and will continue to provide input into ramp-up and implementation activities. 

 
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Specifically, the CDC will provide the aggregated data for the study’s exploratory endpoints that 
rely on HIV surveillance data (see Section 2.4). We have sought buy-in for community 
participation from all EHE committees, which are housed in local health departments, and 
include representation from community-based organizations (CBOs) and HIV-related service 
facilities. Members of EHE committees and health departments are invited to serve as protocol 
team members, actively engage in our working groups, work with the team to identify facilities 
for the PHASE intervention and participate in the implementation of various aspects of the 
integrated strategy. We have also built a relationship with Blue Cross Blue Shield of Florida 
(Florida Blue), which is the major third-party payer of healthcare services in one of the 096 
communities (Fort Lauderdale/Miami). Florida Blue contributes insights from an insurer 
perspective about strategies to maximize the reimbursement of services of HCFs and the use of 
PrEP benefits among HHI MSM. These insights inform multiple elements of the integrated 
strategy, including health access coalitions, PHASE and peer support. 
1.2.5 Components of the Integrated Strategy 
1.2.5.1 Health Access Coalitions 
The current (and historically) observed differences in HIV incidence and clinical outcomes are 
not randomly distributed across the US population but exhibit characteristics that are systematic 
[22, 134-136]. These systematic differences often manifest in patterns of disease between social 
groups. There are no biologically plausible explanations for why HIV infection rates would be 
consistently higher among MSM of specific social groups living in the south compared to any 
other population or region in the US [6, 137-139]. These social patterns of disease are observed 
across multiple health domains, including Coronavirus Disease 2019 (COVID-19) case and 
mortality rates [140]. The current state of the science is unequivocal that these differences in 
health outcomes are the product of structured social arrangements that assign undeserved 
exposure to risk and hardship (economic, social, legal) to one group while conferring unearned 
protections and benefits to another group [102, 141]. The character and enforcement of these 
structured social arrangements, as well as their impacts on health outcomes, may vary from one 
city to another (or from one region to another). Moreover, the interoperable systems that 
maintain structural imbalances in health are not only “healthcare systems” but involve (1) 
multiple human social institutions such as education, law, employment, and housing sectors, 
[142-144] and (2) multiple processes of exclusion of communities from exercising self-
determination over the material conditions of their lives [145, 146]. Therefore, approaches to 
reducing gaps in disease rates and outcomes must include approaches that extend beyond the 
healthcare sector to include education, legal, economic, civic, housing, and community 
development sectors and that are tailored to the realities affecting HIV prevention for HHI MSM 
in their local context [147, 148].  
The current scientific evidence indicates that interventions with the highest impact on reducing 
social group differences in health involve local community mobilization that foster collaboration 
with governmental and non-governmental partners inside and outside of the health sectors [149-
153]. The patterns that characterize effective interventions are principally (1) information sharing 
and exchange, (2) optimizing the impact of scarce resources through cooperation between 
partners, and (3) actively working together in joint coordination to increase efficiency of access 
to services and resources [152, 154]. One example of an intervention is an intersectoral 

 
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partnership formed between CBOs, the local health department and academic institutions in 
Harlem, New York [155]. This partnership identified HIV prevention as a shared priority and 
sought to reduce sharing and re-using of injection drug equipment by launching the Expanded 
Syringe Access Program (ESAP) coalition. The ESAP coalition cooperated on the development 
of materials describing the benefits of syringe exchange through dissemination of consistent 
messaging through their individual platforms (e.g., churches, community forums, drug 
counseling programs) in an effort to raise awareness of ESAP among injecting drug users 
(IDUs), to sensitize the community to the needs of injection drug users and to reduce stigma 
[130, 155]. The ESAP coalition developed a survival guide for substance users (information 
sharing) that included evidence-based health education guidance, a reference list of community 
services such as drug treatment, housing services and job placement services [130]. The efforts 
to increase the efficiency of access to clean syringes was accomplished in coordination with local 
pharmacists who agreed to provide the non-prescription sale of syringes. The multi-sectoral 
coalition resulted in a significant increase in their awareness of ESAP and decrease in the 
proportion of pharmacist with unsupportive attitudes about ESAP [130]. Moreover, there was an 
increase in use of pharmacies for obtaining syringes among IDUs (22% v. 5%, p<.02) in the 
intervention community and no significant change in pharmacy use among IDUs in the 
comparison community [130].  
These three characteristics (sharing, cooperating and coordinating) of successful interventions 
are observed in other studies that range from an intervention that demonstrated evidence in 
increasing service engagement among MSM living with HIV through increasing community-
level sensitization and acceptance in India [156] to an HIV prevention intervention in San 
Francisco that engaged gay bar owners to collaboratively provide free self-service access to 
water and used media inside their bars to share information encouraging the use of water to pace 
alcohol intake [157]. The bars also coordinated an online networked platform in which patrons 
who used a breathalyzer could visualize their individual blood alcohol content (BAC) on an iPad 
alongside real-time comparisons to the average BAC of patrons in the bar as well as the average 
BACs of patrons in the other intervention bars [157]. The health access coalition model in 
HPTN 096 is grounded in promoting principles of fairness and justice and is premised on the 
abundance of scientific evidence that local community coalitions and intersectoral collaborations 
are the most effective approach to tackling the enduring structural impediments driving HIV 
outcomes among HHI MSM in the South. 
1.2.5.2 Social Media 
The social media component of the HPTN 096 integrated strategy is grounded in the Diffusion of 
Innovation Theory. This theory, developed by E.M. Rogers, explains how new ideas spread 
throughout a population [158]. Initially new ideas and information may be perceived as risky: 
individuals may be uncertain about the validity of the assertion, or if this new idea or information 
is something they should act on for themselves. To overcome this uncertainty, most people seek 
out others, often people like themselves who they trust and find credible, before adapting the 
idea for themselves and recommending it to others. Normally this process can take years; 
however, social media has accelerated this process, allowing information exchange and 
subsequent behavior change to take place much more rapidly.  

 
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The use of social media for health promotion and behavior change [159-161], including for 
HIV [162], has increased exponentially as more individuals use social media as their primary 
source of information and method of communication. YouTube and Facebook are the most 
widely used social media platforms, with half of adults in the US reporting that they use 
Instagram [163]. Table 2 outlines the use of these top three platforms by demographic 
characteristics relevant to HPTN 096’s study population [163], demonstrating the potential to 
reach a large majority of the HHI MSM community. In addition, between 21% and 36% of US 
adults report using Pinterest, TikTok, LinkedIn, WhatsApp, Snapchat, X (formerly Twitter), 
Reddit and Nextdoor [163]. Furthermore, there are other virtual environments, such as dating 
apps that are used by the majority of gay men [164], which can be considered non-traditional 
social media platforms for the purposes of this study.  
Table 2: Percentage of US Adults Reporting Use of Top Three Social Media Platforms  
Demographic 
YouTube 
Facebook 
Instagram 
Age: 18 - 29 
93% 
68% 
76% 
Age: 30 - 49 
94% 
78% 
66% 
Age: 50 - 64 
86% 
70% 
36% 
Age: 65+ 
65% 
59% 
19% 
Men 
87% 
61% 
44% 
Black 
88% 
73% 
52% 
White 
82% 
70% 
45% 
Hispanic 
89% 
69% 
59% 
 
The HHI MSM community is not homogeneous. It includes a wide variation in HIV knowledge 
and behaviors, ranging from people who are proud of their sexual orientation, know about HIV 
prevention tools and use them to those who are ashamed of their sexual preferences and 
activities, know little about HIV or how to protect themselves or their sexual partners. Using a 
persona-based methodology, the study’s social media strategy will tailor messaging to reach 
multiple segments of the HHI MSM population. By meeting people where they are and not 
relying on a one-size-fits-all approach, this component has the potential to reach HHI MSM 
throughout all study communities.  
 
During the integrated strategy pilot (see Section 3), the team engaged micro-level social media 
influencers, who were HHI MSM themselves, to create and disseminate HIV-related content. 
Five influencers from Dallas, TX, Houston, TX, and Montgomery, AL created and disseminated 
a total of 63 posts. These posts were viewed 39,101 times in Dallas, 921 times in Houston, and 
6,467 times in Montgomery. In addition, the study team used some of the influencer-generated 
video content to create eight social media advertisements. These ads were disseminated to men 
with interests common to the gay community for a little more than three weeks in Dallas and 
Montgomery. These ads were seen approximately 250,000 times by roughly 72,000 individuals, 
of whom about 8,000 clicked on a link to learn more about the advertisement’s content (for 
example to learn more about HIV testing). Table 3 shows the results of the same video, created 
by an influencer in Dallas, distributed as a social media post versus as a social media 
advertisement. Given the current targeting and metric reporting capacity of the social media 
platforms used for the 63 posts and eight ads (Facebook and Instagram), it was not possible to 
determine how many of the people who saw the post or advertisement were HHI MSM. 

 
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However, using 2022 CDC surveillance data and baseline cross-sectional assessment data 
collected during the pilot, the study team estimates that the number of HHI MSM in Dallas is 
approximately 17,000. Thus, the combination of social media posts and advertising has the 
potential to reach a large majority of the HHI MSM population.  
Table 3: Social Media Post vs Social Media Advertisement Metrics 
HIV-testing video 
Distribution time 
Views 
Reach1 
Engagement2 
Social media post 
4 weeks 
9,4643 
7,4233 
516 
Social media ad 
3.5 weeks 
24,0384 
13,6964 
998 
1Reach is the number of unique individuals who saw the post or ad. 
2Engagment includes reactions (e.g., likes), comments, shares, saves, replies and link clicks. 
338% of the SMI’s followers were in Dallas, so the posts were seen beyond Dallas. 
4The social media ad was only seen by those in Dallas. 
Note: It was not possible to determine how many of the people who saw the post or ad were HHI MSM given the current targeting and metric 
reporting capacity of social media platforms used for this video (Facebook and Instagram).  
 
The study team will continue to harness the power of social media to educate, engage and 
empower HHI MSM using all available social media tools, including but not limited to, the 
establishment of study-specific social media accounts, utilization of existing content when 
possible, and the creation and dissemination of new social media content. As before, individuals 
who are recognized by or are known to have influence in the HHI MSM community will be 
approached to create content; however, existing content will also be considered, such as HIV-
related content made by public health institutions, foundations, public-private partnerships, or 
other organizations that support HHI MSM. While existing content may be readily available and 
professionally produced, new content may have the advantage of resonating with the target 
audience because it is non-establishment, relatable, based on lived experience and unique. This 
combination of new and existing content will allow the team to ensure a constant stream of 
content and keep the messaging fresh. Table 4 outlines the advantages, disadvantages and 
leverage of social media posts, advertising and social medial influencers. While social media has 
been used by others to disseminate health information with the goal of behavioral change, the 
innovation of this approach will be that the campaign takes place within a community where the 
barriers that HHI MSM face with regard to HIV prevention and care are being lowered by the 
other three study components. The study’s social media content will encourage HHI MSM to 
seek HIV testing, PrEP and care, and they will be doing so in an environment where these 
options are more accessible and welcoming. 

 
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Table 4: Advantages, Disadvantages and Leverage of Posts and Advertisements 
 
Advantages 
Disadvantages 
Leverage 
Existing 
content via 
social media 
posts and 
social media 
advertisement 
• Eliminates need to create 
content; may be readily 
available 
• Approach could be easily 
replicated by Departments of 
Health, if found to be helpful 
• Geo-targeting ads allows 
distribution to specific study 
communities 
• Broad community-level reach 
• May not be tailored to or able to 
engage HHI MSM in the 
southern US 
• May not be possible to 
use/license for study purposes 
• May not be changed or revised 
Leverages existing 
HIV-related content 
and campaigns 
New content 
via social 
media posts 
and social 
media 
advertisement 
• Broad choice of content creators  
• Content can be tailored to HHI 
MSM in the southern US  
• Geo-targeting ads allows 
distribution to specific study 
communities 
• Broad community-level reach 
• Requires resources for content 
creation; not readily available 
Leverages the broad 
knowledge and 
lived experience of 
the community to 
create content for 
HHI MSM 
Social media 
posts by 
social media 
influencers 
with HHI 
MSM 
followers 
• Content can be tailored to HHI 
MSM from the southern US  
• Followers have existing 
relationship with social media 
influencers 
• Requires resources for content 
creation; not readily available 
• Limited community-level reach 
(primarily to followers, unless 
post goes viral) 
• Social media influencers may 
not be willing to create and 
disseminate HIV-related content  
Leverages existing 
relationship between 
social media 
influencers and 
followers 
One of the current limitations of social media advertising is that it cannot be used to target ads 
based on certain demographics, including sexual orientation. Instead, advertisers try to reach 
their intended audience by choosing interests – for example specific entertainers or popular 
celebrities – that the social media algorithms use to distribute the content. However, how social 
media platforms currently work, it is not possible to determine who sees the ads beyond location, 
age and sex. For example, an ad can be sent to men in Dallas who have expressed interest in 
well-known celebrities and entertainers – but social media metrics do not measure and report if 
HHI MSM have seen the ad. HPTN 096 will attempt to gather data directly from the people who 
see these ads to determine if they are reaching the study population. 

 
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1.2.5.3 Peer Support 
Peer support programs in various forms have been an important intervention for HHI MSM in 
both preventing HIV and maintaining HIV care retention. A recent study focused on the 
acceptability of peer navigators among HHI MSM in navigating PrEP and other HIV prevention 
services showed overwhelming openness to peer interventions, particularly if peers were of the 
same social group [165]. Studies have shown that effective peer support and social networks can 
increase PrEP awareness, education, trust and help overcome PrEP stigma and misinformation 
that are contributing to differences in PrEP use for HHI MSM. This study points to the potential 
role of peers to increase PrEP uptake in this population (107). Several studies have shown that 
peer support, whether with peer outreach workers proficient in motivational interviewing or 
other HHI MSM within social networks, is associated with reductions in sexual exposure to HIV 
[166, 167]. The use of technology in delivering peer support interventions, including through text 
messaging or through the use of other virtual platforms, has also been proven effective for HHI 
MSM in HIV care engagement [168]. 
A recent global meta-analysis of peer interventions for people living with HIV confirmed an 
overall trend towards increased linkage and retention [169]. The CDC has endorsed multiple peer 
support interventions for people living with HIV, which have been shown to increase HIV care 
engagement and treatment adherence [170], and in turn reduce the risk of onward sexual 
transmission. Successful evidence-informed community-based peer interventions specifically 
focused on HHI MSM, including d-up: Defend Yourself! and STYLE (Strength Through Livin’ 
Empowered), have shown promising outcomes along the HIV care continuum [171, 172]. 
The inclusion of peer support in HPTN 096 is a direct contribution of community input received 
during the formative phase of developing the concept that was the basis for the HPTN 096 
protocol. Multiple members of the HPTN 096 study team (including Drs. Nelson, Beyrer, 
Gamble, Remien and Driffin) bore witness to community testimony regarding the highly valued 
yet precarious predicament of peer support due to frequent staff turnover. These abrupt 
discontinuities in the therapeutic relationships between the peer mentor and their clients were 
described as painful losses that negatively affected their psychological well-being, often 
accompanied by experiences of grief and despair. Moreover, HPTN 096 representatives learned 
that it was not uncommon for HHI MSM to drop out of care for various reasons (e.g., loss of 
insurance coverage; stigmatizing or discriminatory clinical encounter), which led to the forfeiture 
of access to any peer support that they may have used as part of the HCF service offering. These 
real-life community testimonies regarding the need for durable access to peer support was 
consistent everywhere we convened onsite community listening sessions, including the 2018 
Southern Region Ball House & Pageant Conference (Dallas TX), 2019 National CFAR 
Community Advisory Board Meeting (Chapel Hill, NC), 2019 Saving Our Selves/SOS 
conference (2019 Charleston, SC), and the 2019 South Carolina MSM HIV Prevention Institute 
(Columbia, SC). Ongoing community guidance continues to support the need and desire for the 
availability of peer support for HHI MSM in the HPTN 096 intervention communities. 
Specifically, communities have advocated for peer support that does not require that they register 
as a patient/client of a specific organization, and is available during evening, late night and 
weekend hours. However, the study team did learn during the pilot that it takes considerable time 
to develop trust in the community before men will take advantage of the HPTN 096 peer support 
program. Thus, we have adjusted our strategies to more directly and purposefully engage with 

 
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established community-based agencies and networks to implement the HPTN 096 peer support 
component. Additionally, the team will more strongly synergize with other HPTN 096 
components to enhance the visibility and trust for men in the community to connect with 
HPTN 096 peer supporters (See Section 7). 
1.2.5.4 PHASE 
The intersection of multiple stigmas (e.g., skin color, social status, economic position, sex and 
health status), produces a unique and synergistic effect on access and engagement in HIV 
prevention and treatment services. Skin color has been used a basis for a system of structuring 
opportunity and distributing both privilege and disadvantage based on an individual’s or 
community’s assignment to social categories [173]. The system is multi-dimensional in that it 
operates at societal, institutional, interpersonal and intrapersonal levels [174-177]. Organizing 
people based on skin color is inherently dehumanizing because it operates on a hierarchy where 
individuals are assigned value based on the “lightness” (highest) and “darkness” (lowest) of the 
pigment in their epidermis [178, 179]. HHI MSM are subjected to this social taxonomy 
intertwined with HIV, sexual and feminine stigmas, and this combined stigma can be 
experienced, perceived, anticipated, and internalized. At the organizational (HCF) level, stigma 
[180] is imposed on clients in a range of forms from verbal harassment (e.g., harsh, intrusive, 
unnecessary questioning) to unwillingness to provide care (or an attitudinal preference not to 
provide care) to MSM [110, 181]. HIV stigma manifests globally in multiple forms ranging from 
verbal abuse to refusal to treat and avoidance behaviors like double gloving only with patients 
living with HIV; the latter driven by unwarranted fears of HIV transmission [182, 183]. 
The experience of multiple stigmas is a significant barrier to engagement in the HIV prevention 
and treatment cascades. Stigma prevents HHI MSM from seeking healthcare services and from 
engaging in HIV prevention practices—such as PrEP use or retention in HIV care that is critical 
for viral suppression and preventing onward transmission of HIV among people living with HIV. 
The presence of multiple interacting stigmas, including gossiping and a lack of supportive 
interpersonal disclosure, leads to guarded disclosures that are disruptive to HIV testing and early 
linkage to care [184, 185]. Qualitative studies found that sexual stigma is a barrier to seeking 
general health and HIV treatment services among MSM [110, 186, 187]. Within HCFs, negative 
interactions with staff can discourage MSM from staying engaged in medical care [108]. At the 
interpersonal and individual levels, perceived stigma can lead MSM to avoid health care services 
due to fear that someone will discover that they have sex with men. Anticipated stigma can 
generate fear of potential discriminatory treatment at HCFs, which may lead MSM to avoid or 
delay accessing services [188, 189]. At the individual level, internalized stigma may undermine 
motivation for engagement in HIV prevention and care activities and services [190].  
The science of intersecting stigmas is not yet mature and is currently characterized by a high 
level of exploration and innovation  . The current evidence-based stigma-reduction interventions 
in HCFs only address one type of stigma such as HIV stigma, LGB stigma or mental illness 
stigma [191, 192]. Nonetheless, key insights can be learned from the current stigma-reduction 
interventions and applied to multiple interacting stigma-reduction interventions. Lessons can also 
be garnered from the application of Quality Improvement (QI) approaches to reducing stigma 
and improving quality of care in HIV-related healthcare settings [193, 194].  

 
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While not the only element, the provision of intensive, participatory, skills-based training has 
emerged as an integral piece of comprehensive and effective stigma reduction interventions in 
HCFs [108, 195]. Approaches that facilitate knowledge exchange, and collaborative peer-
learning have also been shown to extend the effects of stigma reduction interventions by 
translating principles into actions that result in practice improvements and changes in clinical 
outcomes [196, 197]. Contemporary models, such as the Extending Community Health 
Outcomes (ECHO) model, fuse videoconference technology and participatory techniques to help 
reinforce learning by grounding the content in practice-based experiences [198-201]. These types 
of models also enable the sharing of practical lessons learned between organizations and 
individuals that may be separated by long distances, but who nonetheless are attempting to 
achieve similar quality improvement and clinical outcome goals [83].  
There is a precedent for an intensive workshop approach addressing stigma reduction in HCFs. 
For example, the Health Policy Plus Project, a global HIV stigma reduction program funded by 
United States Agency for International Development (USAID), published an extensive training 
guide describing a modular training program with prescribed content that can be flexibly 
implemented and recommended that a base training program be a whole facility approach 
(training all staff) over a minimum of a two-days [202]. Nyblade et al. describe elements of 
successful stigma reduction programs, including one in Vietnam that involved a participatory 
multi-day training [195]. A systematic review of HIV stigma reduction interventions describes 
the majority as skills-building and delivered over multiple sessions and over the course of many 
hours or days [203]. While feasibility is an important consideration, changing complex 
organizational- and healthcare worker-level psychosocial processes and behaviors requires 
complex training modalities.  
1.2.6 Theoretical Premise for Integrated Strategies 
The design of this study is informed by the network-individual-resource (NIR) model of HIV 
prevention with components integrated from self-determination theory (SDT) [204]. The NIR 
model is a recent innovation in HIV prevention theory development that takes into account the 
influence of communities, institutional systems and close others (e.g., peers) on an individual’s 
agency (i.e., motivation to act and capacity to act) for enactment of behaviors that contribute to 
HIV prevention (e.g., PrEP use, retention in HIV care, HIV treatment adherence) [204]. This 
model also proposes that peers can affect health through social support, social behavioral 
regulation, and facilitating access to resources. In the NIR model, both mental and tangible 
resources must be engaged in order to optimize HIV prevention [204]. Tangible resources are 
assets that structure conditions to facilitate healthy behaviors. Mental resources refer to the 
psychosocial characteristics of people and networks that serve as assets for the avoidance of 
HIV/STI exposure behaviors. In this study, we used NIR to guide the selection of integrated 
strategy components that serve as assets with positive influence at the community (engaging 
social media content), organizational (increasing autonomy supportive care in HCFs), and 
interpersonal (peer social support) levels, as well as tangible resources at the community 
(community coalitions mobilizing to address structural barriers), organizational (reducing stigma 
as access barriers in healthcare facilities) and interpersonal (decentralized virtual access to peer 
support) levels. 

 
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SDT is a social psychological theory of human motivation that contends that healthy behavior 
change is optimized in environments that support humans’ basic psychological needs for 
autonomy (freedom from control), competence (acquisition of skills and resources needed to 
master goal attainment), and relatedness (authentic connection) [205]. In this study, SDT 
concepts of autonomy, competence and relatedness are integrated into the NIR model by 
operationalizing them as qualities of the psychosocial assets operating within the HCF and online 
peer support environments to facilitate PrEP use, retention in HIV care, HIV treatment adherence 
and viral suppression among HHI MSM. SDT concepts are further integrated by operationalizing 
them as qualities of tangible resources that support autonomy and competence at the community 
(addressing local community-identified priority issues impeding PrEP use, retention in HIV care 
and viral suppression), organizational (increasing proportion of HCF staff trained in autonomy 
supportive approaches to care) and interpersonal (increased access to various forms of social 
support including affirmational, emotional, informational and instrumental support) levels. It is 
also important to distinguish “independence” from the concept of “autonomy” as defined in 
SDT. Independence is the exercise of thought or action without external input. This is different 
from autonomy that involves the experience of one’s actions as fully willing and without external 
controls, while accommodating the input and influence of important others such as healthcare 
providers and peers [206], or via social media. Moreover, as demonstrated in studies across 
various cultural contexts—including US, Brazil, Canada, China, Ghana, India, Nigeria, Russia 
and Ukraine—SDT is similar to the local community coalition approach that characterizes the 
health access coalition component of HPTN 096, in that SDT does not presume “independence” 
in decision-making [207-211]. Decisions and/or behaviors that are derived from collective-
centered thought can still be experienced as willful and volitional (not forced) with those 
involved assenting to act “together” or in the interest of the group. SDT accommodates the 
reality that, for many MSM in HHI communities across the American South, even while 
behaviors are expressed at the individual-level, antecedent psychosocial processes and 
social/structural determinants are at times influenced at the group or community-level. 
2 
STUDY OBJECTIVES AND ENDPOINTS 
The overall purpose of this study is to evaluate a status-neutral integrated strategy to improve 
access to and uptake of HIV prevention and treatment services for HHI MSM in participating 
communities. The ultimate goal is to establish a strategy to reduce HIV incidence among HHI 
MSM in the southern US by increasing the number of HHI MSM accessing prevention and 
treatment services, increasing uptake and use of PrEP among those living without HIV and 
increasing retention in care, and thus viral suppression, among those living with HIV. 
The primary and secondary objectives reflect this goal, using a mix of quantitative and 
qualitative measurements. Explicitly, primary measures are derived based on clinical data 
routinely available in the electronic medical record (EMR) as follows: 
• HIV prevention and treatment services uptake is measured as the number of HHI MSM 
clients with healthcare visits at PHASE healthcare facilities. 
• Use of PrEP is measured as prescriptions given to HHI MSM not living with HIV. 

 
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• Retention in care among HHI MSM living with HIV is measured as a proxy for viral 
suppression because of the high correlation between retention in care and viral 
suppression.   
In addition, primary intervention process measures are designed to capture the implementation of 
each intervention component. Finally, exploratory objectives are included to investigate the 
potential impact of the intervention at the community level, as well as the potential contribution 
of each component to the overall intervention.  
2.1 
Primary Objectives 
The primary objectives of this study are: 
• To evaluate whether the HPTN 096 integrated strategy increases the number of HHI 
MSM clients at PHASE healthcare facilities 
• To evaluate whether the HPTN 096 integrated strategy increases retention in care among 
HHI MSM living with HIV at PHASE healthcare facilities 
• To evaluate whether the HPTN 096 integrated strategy increases PrEP prescriptions for 
HHI MSM not living with HIV at PHASE healthcare facilities 
2.2 
Secondary Objectives  
The secondary objectives of this study are: 
• To evaluate whether the HPTN 096 integrated strategy increases viral suppression (<200 
copies/mL) in HHI MSM living with HIV at PHASE healthcare facilities  
• To evaluate whether the HPTN 096 integrated strategy increases PrEP initiation, 
adherence and persistence for HHI MSM not living with HIV at PHASE healthcare 
facilities 
• To assess changes in the experience of autonomy support among HHI MSM at PHASE 
healthcare facilities 
• To assess how autonomy support, social support, stigma, barriers to healthcare and 
individual agency among HHI MSM at PHASE healthcare facilities are associated with 
engagement in care (including PrEP prescriptions and viral suppression) 
2.3 
Primary Intervention Process Measures 
The primary intervention process measures of this study are: 
• Self-reported coalition effectiveness among health access coalitions 
• Reach of social media content to intended HHI MSM audience 
• Acceptability, satisfaction and perceived usefulness of the peer support component 
among peer supporters and their clients 

 
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• Knowledge and attitudes among staff at PHASE healthcare facilities after completion of 
PHASE trainings as compared to before trainings 
• Qualitative characterization of staff experience implementing PHASE  
2.4 
Exploratory Objectives 
The exploratory objectives of this study are: 
• To explore community-level viral suppression in HHI MSM in intervention and selected 
southern communities using CDC HIV surveillance data 
• To use mathematical modeling to assess the potential population-level impact of the 
integrated strategy on HIV incidence among HHI MSM in the southern US 
2.5 
Endpoints and Data Sources for Primary Objectives, Secondary Objectives and 
Primary Intervention Process Measures 
Table 5 below presents the endpoints and data sources for each primary and secondary objective, 
as well as the primary intervention process measures. The impact of the integrated strategy will 
be evaluated using repeated EMR-based assessments of the primary and a subset of the 
secondary endpoints throughout the two years before and the two years during implementation of 
HPTN 096 integrated strategy. All EMR-based endpoints will be repeated over the 4-year period. 
Each measurement point will use EMR data from the HCFs participating in the PHASE 
component over the prior 12 months. The same 12-month periods will be used for all EMR 
endpoints including the number of HHI MSM clients at participating HCFs, retention in care, 
PrEP prescriptions and viral suppression. The retention in care and viral suppression endpoints 
are intended to be consistent with the definitions used for Ryan White HIV/AIDS program 
reporting [51]. These are widely used measures and will increase the feasibility of ascertainment. 
In addition, a cross-sectional assessment will be repeated throughout the two-year 
implementation period to provide data for a subset of the secondary objectives.  
Although the primary endpoints (number of clients, retention in care, and PrEP uptake) will be 
measured among HHI MSM clients at a facility, an analog of these endpoints (termed 
‘supportive’ endpoints) will also be collected from all HHI men at each PHASE HCF. Given the 
implementation nature of this trial, the primary endpoints may be influenced by the quality of the 
data used to identify HHI MSM within the client population. Thus, in the scenario that the 
primary endpoints are limited by data availability and completeness, the supportive endpoints 
will help interpret and understand the effect of the integrated strategy on the primary and a subset 
of the secondary endpoints. 

 
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Table 5: Map of HPTN 096 Objectives and Intervention Process Measures to Endpoints 
and Source of Evaluation Data 
Objective 
Endpoints 
Data Source 
Primary Objectives 
To evaluate whether the 
HPTN 096 integrated 
strategy increases the 
number of HHI MSM clients 
at PHASE healthcare 
facilities  
• (primary) Number of HHI MSM 
with a visit at the HCF in the 
previous 12 months 
• (supportive) Number of HHI men* 
with a visit at the HCF in the 
previous 12 months 
Primary: EMR  
Supportive: EMR 
To evaluate whether the 
HPTN 096 integrated 
strategy increases retention 
in care among HHI MSM 
living with HIV at PHASE 
healthcare facilities 
• (primary) Number of HHI MSM 
living with HIV with at least two 
HIV medical visits to the HCF at 
least 90 days apart within the 
previous 12 months 
• (supportive) Number of HHI men* 
living with HIV with at least two 
HIV medical visits to the HCF at 
least 90 days apart within the 
previous 12 months 
Primary: EMR 
Supportive: EMR 
To evaluate whether the 
HPTN 096 integrated 
strategy increases PrEP 
prescriptions for HHI MSM 
not living with HIV at 
PHASE healthcare facilities 
• (primary) Any PrEP prescription 
among all HHI MSM without HIV 
with a medical visit at the HCF 
within the previous 12 months  
• (supportive) Any PrEP 
prescription among all HHI men* 
without HIV with a medical visit at 
the HCF within the previous 12 
months 
Primary: EMR 
Supportive: EMR 

 
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Objective 
Endpoints 
Data Source 
Secondary Objectives 
To evaluate whether the 
HPTN 096 integrated 
strategy increases viral 
suppression (<200 
copies/mL) in HHI MSM 
living with HIV at PHASE 
healthcare facilities 
• (primary) Viral suppression of the 
most recent viral load (VL) done 
among all HHI MSM living with 
HIV who had a VL measurement 
at the HCF in the previous 12 
months 
• (supportive) Viral suppression of 
the most recent VL done among 
all HHI men* living with HIV 
who had a VL measurement at the 
HCF in the previous 12 months 
Primary: EMR 
Supportive: EMR 
To evaluate whether the 
HPTN 096 integrated 
strategy increases PrEP 
initiation, adherence and 
persistence for HHI MSM 
not living with HIV at 
PHASE healthcare facilities  
• Self-report of PrEP initiation and 
adherence in the previous 12 
months 
 
• (primary) Repeat PrEP 
prescriptions among HHI MSM 
not living with HIV in the 
previous 12 months 
 
• (supportive) Repeat PrEP 
prescriptions among HHI men* 
not living with HIV in the 
previous 12 months.  
Cross-sectional 
assessment in sample of 
HHI MSM at PHASE 
HCFs (questionnaires) 
 
Primary: EMR 
 
Supportive: EMR 
To assess changes in the 
experience of autonomy 
support among HHI MSM at 
PHASE healthcare facilities  
• Self-reported scale measuring 
autonomy support  
• Individual-level qualitative data 
with a subset of HHI MSM clients 
exploring autonomy support 
Cross-sectional 
assessment in sample of 
HHI MSM at PHASE 
HCFs (questionnaires, 
healthcare climate 
section) 
 
Cross-sectional 
assessment in sample of 
HHI MSM at PHASE 
HCFs (qualitative 
interviews) 

 
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Objective 
Endpoints 
Data Source 
To assess how autonomy 
support, social support, 
stigma, barriers to healthcare 
and individual agency 
among HHI MSM at PHASE 
healthcare facilities are 
associated with engagement 
in care (including PrEP 
prescriptions and viral 
suppression) 
• Self-reported data related to 
autonomy support, social support, 
stigma, barriers to healthcare, 
individual agency. 
• Any PrEP prescription in last 12 
months for HHI MSM not living 
with HIV 
• Viral load suppression and 
retention in care in last 12 months 
for HHI MSM living with HIV 
Cross-sectional 
assessment in sample of 
HHI MSM at PHASE 
HCFs (questionnaires) 
 
Cross-sectional 
assessment in sample of 
HHI MSM at PHASE 
HCFs (case report 
forms) 
Primary Intervention Process Measures 
Self-reported coalition 
effectiveness among health 
access coalitions  
• Self-reported data related to 
coalition effectiveness reported by 
coalition and CLO members at 
periodic intervals 
Coalition effectiveness 
inventory tool 
Reach of social media 
content to intended HHI 
MSM audience 
• Social media/website metrics; self-
identified demographics and 
qualitative data from HHI MSM 
who engage with the campaign; 
and the number and proportion of 
reached/engaged who are HHI 
MSM, if possible. 
Social media platforms, 
website analytics, 
surveys and qualitative 
data 
Acceptability, satisfaction 
and perceived usefulness of 
the peer support component 
among peer supporters and 
their clients 
• Self-reported data on acceptability, 
satisfaction, and perceived 
usefulness of the peer support 
component 
Acceptability, 
satisfaction, and 
usefulness surveys 
among component 
participants 
 
Qualitative and 
quantitative forms 
summarizing support 
activities among peer 
supporters  
Knowledge and attitudes 
among staff at PHASE 
healthcare facilities after 
completion of PHASE 
trainings as compared to 
before training 
• Individual-level survey data on 
knowledge and attitudes related to 
healthcare provision to HHI MSM  
Pre- and post-workshop 
survey in all consenting 
workshop participants 

 
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Objective 
Endpoints 
Data Source 
Qualitative characterization 
of staff experience 
implementing PHASE  
• Individual-level qualitative data 
with a subset of HCF staff 
addressing benefits and challenges 
of PHASE implementation and 
facilitators of success 
Qualitative interviews – 
HCF staff  
*HHI men will have the same demographic characteristics as HHI MSM, with the exception of 
sexual orientation.  
3 
OVERVIEW OF STUDY DESIGN 
HPTN 096 is a hybrid implementation-efficacy trial that uses a single arm interrupted time series 
(ITS) design. The integrated strategy will be delivered in up to five communities in the southern 
US (See Schema Figure 1 for an overview of the study design). The integrated strategy was 
piloted for one year in two communities (Dallas, TX and Montgomery, AL) under Version 2.0 
and 3.0 of the protocol, and information from the pilot has been incorporated into the study and 
integrated strategy design. 
Study outcomes will be measured at participating healthcare facilities where HHI MSM are 
receiving HIV-related prevention or treatment services, which will closely link implementation 
of the integrated strategy to the measured outcomes. An ITS approach was selected as the 
quasi-experimental design for assessing change in outcomes resulting from the intervention. A 
time series is a continuous sequence of observations taken on a population over time. In this ITS 
design, a time series of observations (for client volume, uptake of PrEP and retention in HIV 
care) for two years prior to the intervention will establish an underlying trend. This trend will be 
interrupted by the study intervention at a known time point and the subsequent two years of 
observations during the intervention period will determine if the integrated strategy has changed 
the expected trend [212, 213]. 
HPTN 096 is evaluating a four component, multi-level integrated strategy. The four components 
of the integrated strategy include: 1) a health access coalition component using a community 
coalition model to develop a local community-wide response to improving HIV outcomes for 
HHI MSM through addressing social and structural barriers, increasing community education 
and awareness, and implementing local advocacy approaches; 2) use of social media to raise 
awareness, reduce stigma, increase motivation for positive health behaviors, and inform HHI 
MSM of available HIV-related and other relevant services within their communities; 3) peer 
support for HIV/STI testing, PrEP and HIV prevention, ART initiation and ongoing adherence, 
and provision of information about access/assistance programs; and 4) a Promoting Human 
Autonomy Supportive Environments (PHASE) training and quality improvement program 
designed for healthcare facilities to create a supportive healthcare environment that fosters HHI 
MSM autonomous engagement in HIV-related services and promotes increased HIV/STI testing, 
PrEP and ART uptake, retention in care, and viral suppression.  
The effect of these four components is expected to be synergistic, with each component having 
the possibility of increasing the impact of the other three (see Section 9, Intervention Component 
Synergies). As such, these four components will be implemented in parallel together over the 

 
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course of two years in each intervention community. Because health access coalitions, social 
media and peer support activities are expected to increase demand for prevention and care at 
PHASE healthcare facilities (HCFs), these components will need to be operational at a low level 
in each community before starting the PHASE component. When PHASE begins, all four 
components will be fully implemented at scale. These three components will be established 
during a pre-implementation period, which will begin approximately one year prior to the start of 
PHASE. Although these components could (and will to some extent) drive demand for services 
at PHASE and non-PHASE HCFs during pre-implementation, successful (and measurable) 
healthcare engagement is only expected when the most effective services are provided for HHI 
MSM at PHASE HCFs. Additionally, it will take time for these components to be built and gain 
traction within each community. Thus, the impact of pre-implementation activities on baseline 
measurements is expected to be minimal. 
The primary study endpoints will use data extracted from the EMRs of clients seen at the HCFs 
participating in PHASE. These data will be collected at pre-baseline, baseline, midpoint, and 
post-intervention for the HHI MSM seen in these HCFs (see Figure 10). The secondary study 
endpoints will rely on these same EMR data, as well as additional data collected from a subset of 
HHI MSM. This subset will complete a cross-sectional assessment at baseline, after one year 
(midpoint) and at the end of the two-year implementation of the integrated strategy (post-
intervention) and some will be invited to participate in qualitative interviews. In addition, 
specific HIV-related clinical data will be abstracted from their medical records and collected via 
case report forms to assess correlates of successful engagement in HIV care and prevention. 
There will be a unique and independent subset of HHI MSM for the cross-sectional assessment 
at each timepoint: no longitudinal data will be collected on any individuals. 
Primary intervention process measures will use data inherent to each integrated strategy 
component to assess key implementation outcomes. The experience of healthcare workers 
participating in PHASE activities will be collected via surveys and qualitative interviews. The 
effectiveness of the heath access coalitions will be assessed using data from a coalition 
effectiveness inventory tool. The experience of peer support component users will be captured 
via acceptability and usefulness surveys. Lastly, the social media strategy will be assessed using 
standard social media platform data, website analytics and both quantitative and qualitative data 
collected from those who engage with the campaign in order to understand the extent to which 
the strategy reaches and engages HHI MSM in the five communities. In addition to the primary 
intervention process measures, a number of additional process measures will also be captured for 
each study component to assess and characterize the fidelity and dose of each component as 
implemented as compared to the design.   
3.1 
Study Duration 
Each study community will participate in the study for approximately 3.3 years, which includes 
one year of pre-implementation activities, 2 years of implementation of the integrated strategy, 
and 2.3 years of data collection (see Schema Figure 1). There is a 12-month window during 
which all five study communities will begin implementation. Therefore, the overall duration of 
the study is expected to be approximately 4.3 years. 

 
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4 
STUDY POPULATION 
The primary study population will be HHI MSM residing in the five study communities. All 
primary study outcomes will be measured among HHI MSM attending a PHASE facility for 
health care. Additionally, a subset of HHI MSM at PHASE HCFs, as well as healthcare facility 
staff, health access coalition members, peer supporters and individuals who engage with the 
social media component will also be assessed for secondary outcomes and primary intervention 
process measures. 
4.1 
Description and Selection of the Five Study Communities 
This version of the protocol will be conducted in up to five study communities, including a total 
of approximately 40 HIV prevention and approximately 20 HIV treatment facilities within these 
communities. A minimum number of three study communities will receive the study 
intervention, involving approximately 36 healthcare facilities (24 HIV prevention and 12 
treatment). For the original community-randomized design (described in protocol Version 1.0), 
16 communities were selected from the 28 EHE counties, Washington, DC and the six high-
burden rural EHE states in the South, all of which have high burdens of HIV prevalence and 
recent HIV diagnoses among MSM. These 16 communities were chosen on an epidemiologic 
basis, using CDC surveillance and other available data on demographics, geographic distance, 
HIV burdens in men, MSM, and HHI MSM, as well as viral suppression in HHI MSM. Previous 
versions of the protocol outline the specific process used for study community selection. The five 
communities selected for the current protocol design represent all states where the original eight 
intervention communities were located and include the two communities where the study was 
piloted. These five study communities encompass many of the various cultures and norms found 
in the southern US. In addition, these five study communities have enough healthcare facilities to 
provide the pre-specified number (40 HIV prevention and 20 HIV treatment facilities) needed to 
determine the outcomes for the three primary objectives.  
The five study communities are: 
• Dallas, TX (Dallas county) (pilot) 
• Montgomery, AL (Montgomery, Elmore and Autauga counties) (pilot) 
• Fort Lauderdale/Miami, FL (Broward and Miami-Dade counties) 
• Memphis, TN (Shelby county) 
• Atlanta, GA (Cobb, DeKalb, Fulton and Gwinnett counties) 
 
4.2 
Priority Populations for Components of the Integrated Strategy 
The population being prioritized for the study through implementation of the integrated strategy 
is all HHI MSM in the participating five study communities, regardless of HIV status. Each 
component of the integrated strategy may prioritize additional populations for component 
activities as described in the subsections below. Populations to be assessed in each component 
for primary intervention process measures and additional process measures are also described in 
subsections below.  

 
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4.2.1 Health Access Coalition Component Study Population 
The health access coalition component activities will focus on broader community members and 
service providers, including HHI MSM, within each study community. Primary intervention and 
additional process measures will be assessed among coalition members and coalition lead 
organization (CLO) staff, as well as the Coalition Manager.  
4.2.2 Social Media Component Study Population 
Social media component activities will be tailored for HHI  MSM within each study community. 
Primary intervention and additional process measures will be assessed among those who are 
exposed to and engage with the study’s social media content. A subset, based on their level of 
engagement and willingness to participate, will be invited to participate in surveys and 
qualitative data collection to determine if the social media strategy is reaching its intended 
audience.  
4.2.3 Peer Support Component Study Population 
Peer support component activities will prioritize HHI MSM who reside in the study 
communities. Peer support will be offered with an HIV-status neutral approach to HHI men who 
self-report a lifetime history of anal sex with other men (meaning at any time in their life), are 15 
years and older, and live in an study community (based on self-reported provision of a county 
and state of residence). Primary intervention and additional process measures will be assessed 
among all peer support participants who are willing to provide their feedback, as well as all peer 
supporters.  
4.2.3.1 Recruitment Process for Peer Support Component 
Recruitment for the peer support component will be carried out in an ongoing fashion by the peer 
supporters, the local partner organizations implementing the component, and via the study’s 
website and social media strategy. Participants will be recruited from a variety of sources 
including, but not limited to, universities, health and social service providers, community-based 
locations, online websites, and social networking applications. The local partner organizations 
will be responsible for developing recruitment strategies deemed appropriate for their local 
communities. Potential participants will be screened for eligibility and offered study participation 
throughout the entire study. Active recruitment will end at least one month prior to the end of 
study implementation so that all participants have the opportunity for at least a short period of 
ongoing support. There is no upper limit for enrollment. Peer supporter workload will be 
monitored, and the number of peer supporters and active recruitment efforts will be adjusted, as 
needed, throughout study implementation.  
4.2.4 PHASE Component Study Population  
PHASE component activities will include staff at each participating PHASE HCF. Primary 
intervention process measures will be assessed among all HCF staff completing the Foundation 
workshops as well as those staff members completing each ECHO session who agree to 
complete the assessments. Additional process measures will be assessed at the facility-level to 
determine fidelity to program elements of PHASE. 

 
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4.3 
Study Population for Primary and Secondary Endpoint Data Collection at PHASE 
HCF 
Primary and secondary study endpoints will be measured through EMR data collected from 
participating PHASE HCFs. In addition, a cross-sectional assessment will be conducted with a 
subset of HHI MSM clients at participating PHASE HCFs. At a subset of these facilities, 
qualitative interviews will also be conducted with a subset of HHI MSM clients and PHASE 
HCF staff. These study populations are further described in sub-sections below.  
4.3.1 EMR Data Collection Study Population 
Primary study endpoints will be assessed using a limited data set from EMR for a subset of 
clients at all participating PHASE HCFs. This subset will include all clients aged 15 years and 
older who are identified as male, who have the demographic characteristics that match the 
demographic characteristics of HHI MSM, and who have at least one encounter recorded in the 
EMR anytime between the 24 months before the start of PHASE intervention implementation at 
that HCF and throughout the two years of the intervention (see Figure 10).  
4.3.2 Cross-Sectional HHI MSM Client Assessment Study Population 
Approximately 900 eligible HHI MSM recruited from HCFs participating in PHASE will be 
included in a cross-sectional assessment at each of three timepoints (for a total of approximately 
2700 HHI MSM). At each timepoint, approximately 400 men living with HIV will be enrolled 
from PHASE HIV treatment facilities, and approximately 500 men not living with HIV will be 
enrolled from PHASE prevention facilities. Within each group, participants will be further 
stratified by care status (for those living with HIV) and PrEP prescription (for those not living 
with HIV), as shown in Figure 4: 
Figure 4. Cross-Sectional HHI MSM Client Assessment Sample Stratification 
 
The stratification definitions are not intended to directly align with primary endpoint definitions, 
but rather to allow exploration of themes among dichotomous sub-groups of men (e.g., those 
who have accepted PrEP and those who have not). Participants will be selected for cross-

 
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sectional assessment participation according to criteria in Sections 4.3.2.1 and 4.3.2.2. 
Participants will be recruited as described in Section 4.3.2.3.  
Each cross-sectional assessment cohort will be independent of previous cohorts, although it is 
possible that individuals may participate in more than one cohort.  
4.3.2.1 Cross-Sectional HHI MSM Client Assessment Inclusion Criteria 
Individuals who meet all of the following criteria are eligible for inclusion in the cross-sectional 
assessment: 
• At least 18 years of age  
• Man  
• Self-reports a lifetime history of anal sex with another man (i.e., at any time in their life) 
• Determined to be HHI within the study community per CDC surveillance data  
• Willing and able to provide consent to participate in the study 
• Have a medical visit scheduled during the designated sampling period at a PHASE 
treatment or prevention healthcare facility 
4.3.2.2 Cross-Sectional HHI MSM Client Assessment Exclusion Criteria 
Individuals who have any condition that, in the opinion of the Investigator of Record (IoR) or 
designee, would make participation in the study unsafe, complicate interpretation of study 
outcome data, or otherwise interfere with achieving the study objectives, will be excluded from 
the cross-sectional assessment. There are no co-enrollment restrictions for participation in this 
assessment. 
4.3.2.3 Recruitment Process for the Cross-Sectional HHI MSM Client Assessment 
Recruitment of each cross-sectional sample of participants will occur over a 4-month period 
during or after the PHASE intervention, and there will be a total of three sampling periods: at 
baseline (1-4 months), midpoint (12-15 months) and post-intervention (24-27 months). 
Recruitment activities will be conducted by designated site staff at each participating PHASE 
HCF. All potentially eligible participants will be approached until accrual targets are met to 
avoid selection bias. PHASE HCFs will be responsible for developing appropriate recruitment 
processes that are geared toward their respective local communities. They will also be 
responsible for determining site-specific strategies for identifying all potentially eligible clients 
and ensuring that all such scheduled clients are approached during the sampling period until 
target accrual is met. 
4.3.3 Qualitative Data Collection 
An estimated 120 in-depth interviews (IDIs) will be conducted with two sets of participants: 1) 
HHI MSM who are clients at PHASE HCFs (n=60), and 2) healthcare providers and staff who 
are participating in the PHASE component of the integrated strategy (n=60). Interviews will be 
conducted at a subset of PHASE HCF in all five study communities. Participants will be selected 
based on the criteria outlined in sections 4.3.3.1 and 4.3.3.2.  

 
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4.3.3.1 HHI MSM Clients  
IDIs will be conducted around the midpoint (12-17 months) of the intervention after one year of 
implementation with 30 clients from six PHASE treatment facilities and 30 clients from six 
PHASE prevention facilities (N=60 total). Participants will be purposively sampled aiming for 
balance of individuals across prevention and treatment strata (e.g., those prescribed PrEP and not 
prescribed PrEP, those engaged in care, retained in care, newly diagnosed, etc.). (See Figure 5 
below) 
Figure 5. HHI MSM Client IDIs 
 
The following criteria will be used:  
Inclusion Criteria:  
• Met inclusion criteria for the cross-sectional HHI MSM client assessment (defined in 
Section 4.3.2.1) 
• Completed the cross-sectional HHI MSM client assessment  
• Willing and able to provide assent/consent 
Exclusion Criteria:  
• Individuals who have any condition that, in the opinion of the Investigator of Record 
(IoR) or designee, would make participation in the study unsafe, complicate 
interpretation of study outcome data, or otherwise interfere with achieving the study 
objectives, will be excluded from the qualitative interview.  
 
There are no co-enrollment restrictions for these interviews. 

 
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4.3.3.2 PHASE HCF Staff 
IDIs will be conducted at the conclusion of the PHASE intervention (months 18-23) with 30 staff 
from six PHASE treatment facilities and 30 staff from six PHASE prevention facilities (total 
N=60). Staff will be purposively sampled based on their engagement with PHASE, aiming for a 
subset of clinical providers (including physicians, advanced practice provider, etc.), social 
support staff (peer navigators, social workers, etc.), quality improvement staff, data managers, 
and administrative and executive staff (receptionists, C-Suite, etc.) (see Figure 6 below). 
Figure 6. PHASE HCF Staff IDIs 
 
The following criteria will be used:  
Inclusion Criteria:  
• Is a staff member at a participating PHASE facility  
• Participated in at least one PHASE activity (e.g., attended a PHASE Foundation 
training, participated in ECHO training, member of PHASE quality improvement 
team)  
• Willing and able to provide consent 
Exclusion Criteria:  
• Individuals who have any condition that, in the opinion of the Investigator of Record 
(IoR) or designee, would make participation in the study unsafe, complicate 
interpretation of study outcome data, or otherwise interfere with achieving the study 
objectives, will be excluded from the qualitative interview.  
 
There are no co-enrollment restrictions for these interviews. 

 
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5 
HEALTH ACCESS COALITIONS COMPONENT  
5.1 
Component Description 
The health access coalitions component will use a community coalition program as its base 
model for reducing structural barriers, shaping community social norms and raising awareness to 
reduce HIV among HHI MSM. The coalition model will do this through:  
• Facilitating a reduction in social, structural, and policy barriers to HIV testing, PrEP, and 
viral suppression through fostering collective efficacy, promoting norms within the local 
service sectors (e.g., social, legal, economic, etc.), and advancing advocacy efforts that 
support the strategic prioritization of access to resources and services for HHI MSM. 
• Amplifying awareness, education, and capacity building around HIV prevention and 
treatment resources and messaging (including other HPTN 096 components).  
The community coalition program will be initially implemented through partnership with local 
CBOs contracted in each community, referred to as the Coalition Lead Organization (CLO), to 
build and establish the coalition in their community. After the coalitions are established, they 
will transition to be largely self-governing, but a continuing contracted Coalition Manager role 
will ensure that there is ongoing administrative support for each coalition.   
The coalition model will impact the study outcomes through the two strategy pathways of 
facilitation and amplification [100]. A logic model depicting how the coalition program is 
expected to achieve short-, medium-, and long-term objectives through facilitation and 
amplification pathways is shown in Figure 7.  

 
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Figure 7. Health Access Coalition Program Logic Model 
 
  
 

 
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5.1.1 Implementers  
The health access coalition component will be implemented by the CLO initially, and after 
establishment, by each local coalition and their Coalition Manager. Coalition activities may be 
implemented in partnership with other CBOs and service providers in the communities as well.  
5.1.1.1 CLO and Coalition Manager Role 
The CLO is primarily responsible for building and establishing the coalition. Until the coalition 
is fully established and self-governing, the CLO will assume the role of convening the coalition 
and will assume significant responsibility for its operations. The ultimate goal will be for the 
coalition to transition to being fully self-governing with respect to their efforts to realize the 
study goals and drive their activities, with a Coalition Manager playing a support role throughout 
the duration of the study period. The coalition will be determined to be self-governing after 
completion of all study-specific training activities, and upon approval from the study team.  
A competitive selection process will be used in each community to select the organization best 
suited for the CLO role. The Coalition Manager may be affiliated with the CLO or independent 
from the organization. The Coalition Manager will be responsible for ensuring continued 
administrative and logistical support for the coalition to implement the study-specific activities 
(see Section 5.2.2) after the coalition is established and has transitioned fully to self-governance. 
5.1.1.2 Formative Work and CLO Selection Process 
In many HPTN 096 communities, it is likely that at least some efforts are already ongoing by 
grassroots community organizations for HHI MSM with similar goals as this study. Prior to 
selecting CLOs through a competitive contracting process, formative work will take place to 
better understand the existing community structures and organizations in each intervention 
community that are currently operating within the HIV field and/or doing work related to HHI 
MSM. Attempts will be made to engage with existing organizations and groups to increase their 
awareness of the HPTN 096 study and its goals, and to ensure they are informed of and have the 
opportunity to participate in the competitive CLO selection process. The selection process will 
be standardized across communities. Selection will be done by committee, and the evaluation 
criteria and selection process will be fully documented and transparent to community members. 
CLO selection will occur in the study pre-implementation period.  
5.1.1.3 Coalition Role 
For the purpose of HPTN 096, a coalition is defined as multiple relevant organizations and/or 
individuals who have agreed to work together towards a common goal, in this case, to create an 
environment that is supportive of HIV treatment and prevention goals for HHI MSM. The CLO 
will be responsible for recruiting and assembling the initial coalition members. Coalition 
recruitment will occur in the study pre-implementation period. There is no minimum or 
maximum required number of coalition members; however, membership should be varied and 
comprised of traditional and non-traditional partners of different demographic groups, 
representing sectors from across the social determinants of health. The coalition members are 
responsible for carrying out the overall mission of the coalition and its activities. The coalition 
will develop its own identity (name/branding) and has autonomy to govern itself in accordance 

 
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with HPTN 096 study guidance and its own by-laws. The Coalition Manager is tasked with 
ensuring that the coalition’s operations and activities are consistent with the study guidelines and 
maintaining direct lines of communication with the study team. 
5.1.2 Location 
One coalition will be established in each study community. Coalition activities may take place at 
any location deemed suitable or necessary in the community or that would benefit and/or reach 
members of the community. Coalition meetings and/or activities may also take place virtually.  
5.1.3 Health Access Coalition Toolkit 
Study-specific operational guidance for CLOs, Coalition Managers, and coalitions will be 
outlined in the HPTN 096 Health Access Coalition Toolkit and associated supporting documents 
that will be made available to all CLO staff and coalition members. The Toolkit will serve as an 
implementation guide for CLOs, coalition managers, and coalition members on coalition 
building and recruitment, governance, and operations of the coalition (including leadership and 
committee structure), training expectations and plans, activity expectations and processes, 
monitoring and evaluation, and sustainability planning. The purpose of the Toolkit will be to 
provide consistency in guidance and structure across all coalitions, alleviate administrative 
burden, streamline establishment of coalition leadership and governing by-laws, and generally 
facilitate and support successful functioning of the coalition in alignment with study goals and 
the study protocol.  
5.2 
Health Access Coalition Component Activities 
5.2.1 CLO Activities  
After selection, CLOs will complete study-specific training prior to any coalition recruitment 
activities. CLOs will be expected to build an initial coalition within the pre-implementation 
period, and to transition its management to the coalition, with support of a Coalition Manager, 
for the majority of the implementation period. CLOs will be expected to lead initial community 
engagement and recruitment activities for coalition building. CLOs will work in collaboration 
with, and with supportive technical assistance (TA) and consultation from, members of the 
HPTN 096 study team. CLOs will communicate closely with key study team leads about all 
study-related coalition establishment activities in their community. 
5.2.2 Coalition Manager Activities 
Coalition Managers will provide administrative and logistical support to the coalitions. Coalition 
Managers will submit coalition activity proposals to the study team, monitor and track coalition 
activities and attendance, and report process data to the study team monthly. The Coalition 
Manager will attend all coalition meetings and activities and serve as a representative in the 
coalition leadership body, as well as attend protocol team meetings and calls.  

 
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5.2.3 Coalition Activities 
Once established, each coalition will be expected to implement a minimum set of study-specific 
activities, as shown in the Coalition Logic Model (Figure 7) and further described in the Toolkit. 
These activities are summarized in the sub-sections below; however, each coalition will have the 
flexibility to implement the activities in the ways in which they believe will be most effective in 
their community. All activities will be documented as part of process measures (Section 5.4) to 
enable activity characterization, and to assess levels of uniformity and adherence to the health 
access coalition model. 
5.2.3.1 Trainings and Initial Coalition Meetings  
Prior to implementing coalition activities, each CLO/coalition, will receive study-specific 
training on topics such as the HPTN 096 study components and design, study objectives 
(especially primary objectives), structural competency [214-216], HIV 101 and epidemiology of 
HIV in the South, conducting needs assessments, policy and advocacy approaches, coalition 
governance, and other topics as detailed in the Toolkit. The initial training will also include a 
team building element. The structure of the first several coalition meetings will be pre-
determined per the Toolkit and will be utilized for ongoing study-specific training as well as pre-
specified coalition business. At the conclusion of these pre-specified trainings/meetings, 
coalitions will be expected to have leadership structures and identity (i.e., name/brand) in place, 
and full management of coalition meetings will be transitioned to coalition leadership. 
Supplemental training will be provided on an as-needed basis.  
5.2.3.2 Needs Assessment 
Coalitions will first work to understand the local situation by conducting a rapid needs 
assessment exercise to identify local services and resources that address social determinants of 
health, as well as assessing the barriers experienced by HHI MSM in their community. The rapid 
needs assessment is the first required activity that coalitions will undertake and will serve as the 
basis for all future activities. This needs assessment will help coalitions use facts and data to 
decide what activities should be prioritized. The needs assessment process will include 
evaluating existing needs assessments that have been done in the community, as well as potential 
collection of supplemental information. Supplemental information that is collected will be for the 
purposes of helping coalitions make decisions about which activities to implement and how best 
to do so in their community. Information collected from the needs assessment is not considered 
HPTN 096 study data and will not be analyzed by the HPTN 096 team for the purposes of 
assessing study outcomes, nor will it be presented as such in study publications. Once the 
coalition has determined that sufficient information has been collected and reviewed and unmet 
needs have been identified, the coalition will begin the work of priority setting and action 
planning within the two activity pathways of facilitation and amplification. 
5.2.3.3 Facilitation Component 
Facilitation activities will primarily be locally determined activities that can help to address or 
offset underlying social and structural issues such as poverty, homelessness, substance use, and 
access to education, which can impact the risk of HIV transmission and the ability to access care. 

 
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As a starting point for these activities, after the needs assessment, coalitions will convene a 
Service Provider Forum(s) to bring together multi-sector service providers representing resources 
and/or needs identified that are key to supporting a more comprehensive community system for 
HHI MSM. The goals of the Forum(s) will be to: 
• Raise awareness of service providers to differences in HIV outcomes experienced by HHI 
MSM; 
• Raise awareness of service providers of the needs of HHI MSM to create better health 
outcomes; 
• Discuss together ways in which services can be optimized to better meet the needs of 
HHI MSM as they relate to HIV outcomes; and 
• Develop an action plan to address barriers that can be implemented by forum attendees, 
as well as next steps for reporting back on progress and outcomes. 
 
Coalition members will also be expected to identify representatives to participate in PHASE 
Foundation training workshops along with PHASE HCF staff in their community once full study 
implementation begins. During these workshops, barriers to HCF access will be raised and 
discussed and coalition members will have an opportunity to be part of these conversations and 
learning. Coalitions will determine appropriate activities to address HCF-related barriers in their 
community after participation in these workshops.  
 
Additionally, coalitions will work to support or recommend causes or policies that strengthen 
HIV services, human rights, and/or foster patient-centered healthcare practices for HHI MSM in 
their community. Coalitions may engage in policy and advocacy related activities through 
advocating for/against new policies and/or laws, suggesting ways in which implementation of 
existing policies and/or laws could be improved, and monitoring to ensure agencies are held 
accountable to what they are funded to do in their community.  
5.2.3.4 Amplification Component 
To amplify the effects of the other HPTN 096 activities as well as local HIV 
prevention/treatment and health/wellness strategies, and to address barriers related to knowledge, 
awareness, understanding, and stigma, coalitions will conduct activities that relate to the 
following domains:  
• Promoting HIV education and awareness, including HIV testing, engagement in care, 
viral suppression or U=U, and PrEP messaging. 
• Destigmatizing  HIV, PrEP, and HIV testing. 
• Promoting other HPTN 096 study resources and activities, specifically, the PHASE 
intervention with participating HCFs in the community, the peer support component, and 
amplifying HPTN 096 messaging using multimedia channels where appropriate, 
including social media and traditional (e.g., print, radio, television) media, and online 
(websites, webinars) media channels. 

 
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• Establishing local coalition brand identity, social media presence, and a strategy for 
clout-building activities that will increase their influence and enhance their ability to steer 
public attention to HPTN 096 activities. 
Additionally, coalitions will engage in targeted leadership development and capacity building 
efforts with HHIM in their community, implemented in partnership with the study team, with the 
goal of equipping HHIM with the skills, knowledge, and connections to be leaders in their 
communities.   
5.2.3.5 Timeline of Activities 
CLO selection and award will occur early in the pre-implementation period such that coalition 
building may also occur during the pre-implementation period. Once the coalition is assembled, 
the initial training and coalition meetings will begin as specified in Section 5.2.2.1 and the 
Toolkit. These initial meetings are likely to, but are not required to, occur during the study pre-
implementation period. The initial meetings and trainings will follow the schedule specified in 
the Toolkit. If a coalition completes the pre-specified initial meetings and trainings and moves 
into self-governance during the pre-implementation period, the coalition may commence 
planning and executing coalition activities. However, it is expected that in most communities, the 
implementation period will begin (or will be close to starting) by the time the initial meetings 
and trainings have been completed, at which point coalition activities are expected to start 
ramping up. Other details specific to timing of activities will be specified in the Toolkit.  
5.3 
Primary Intervention Process Measure for the Health Access Coalition Component 
The primary intervention process measure for the health access coalition component will be self-
reported coalition effectiveness among health access coalition members. This information will be 
captured via the Coalition Effectiveness Inventory tool [217] implemented biannually with each 
coalition.  
5.4 
Additional Process Measures Related to the Health Access Coalition Component 
Additional process measure data will be collected monthly to evaluate fidelity to and penetration 
of the planned health access coalition component. These measures are intermediary between the 
implementation of the component activities and achievement of the expected health access 
coalition outcomes and reflect key implementation outcomes of the overall implementation 
research logic model framework (see Section 1.2.2). Thus, they will be important in 
understanding the role that this particular strategy may (or may not) have in producing the 
primary and secondary outcomes. Coalition Managers will be responsible for providing monthly 
process data reports to the study team. Further, all process measure data may be reviewed by the 
study team and/or the Study Monitoring Committee (SMC) during the study period to make 
real-time adjustments to the deployment of the component to improve its effectiveness. 
Additional process measures for health access coalitions will include: 
• Measures of penetration of the component activities: 
o Agreement in place with a local organization to serve as CLO in each intervention 
community 

 
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o CLO establishment of community coalition in each community and length of time 
required for establishment 
o Number of meetings and attendance at each meeting for each coalition 
o Composition and demographics of each coalition (number of people, number and 
types of organizations represented, roles/positions of members, sexual orientation, 
and sex of members)  
o Metrics of engagement of coalition members (e.g., number and percentage of 
members who participate in each type of coalition activity) 
o Number of sectors and agencies represented in the multi-sector service provider 
forum (including % that agree to be on a resource list) 
• Measures of fidelity to the planned implementation of the component: 
o Number, type, and timing of coalition activities completed by each coalition within 
the study pre-implementation and implementation periods 
6 
SOCIAL MEDIA COMPONENT  
6.1 
Component Description 
The social media component is a robust social media strategy designed to reach and engage HHI 
MSM throughout each participating community. The purpose of the strategy is to educate and 
empower HHI MSM so they can make informed decisions and behavioral changes to stop HIV 
acquisition and transmission. The strategy will utilize a multitude of social media 
communication and marketing tactics, such as campaigns and advertisements. Messaging will be 
ultimately designed to impact the outcomes of the primary and the first two secondary 
objectives, which include increasing the number of HHI MSM who are engaged and retained in 
prevention and care, the uptake of PrEP and the achievement of viral suppression. 
Simultaneously, the social media strategy will promote other study components, with the 
intention of creating inter-component synergy to amplify the benefit of these components. For 
example, a social media campaign will encourage HHI MSM to engage in care at PHASE HCFs 
(if the HCFs agree to be identified in a campaign), seek help from peer supporters, and take 
advantage of the environmental changes put in place via the health access coalitions. Ultimately, 
the social media strategy will take advantage of the features of social media that make it so 
powerful. Built into this component are ways to determine if the campaign is reaching the 
intended audience and what characteristics of creators, distribution and content are most 
successful. Finally, an outcome of this component will be a guidance document for future 
implementors: this guidance document will provide the details for how to execute a successful 
social media campaign for HHI MSM. 
6.1.1 Content Description 
All social media activity produced by this component will use tailored, HIV-status-neutral, 
resonant messaging that prioritizes HHI MSM and recognizes that this is not a monolithic 
audience. In particular, the strategy will recognize that HHI MSM are on a spectrum from fully 
transparent about their sexuality to completely secretive; thus, a wide range of approaches must 

 
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be included to reach the entire study population. The HIV-status-neutral approach allows for 
messaging that is relevant for those living with HIV, those not living with HIV and those who 
are not aware of their HIV status. In addition, other variables for audience segmentation (such as 
messages tailored for age or the stages of change) may be considered when determining content. 
Ultimately, content will promote HIV testing, engagement in prevention and care services, PrEP 
uptake and the benefits of viral suppression. In addition, the promotion of the other three study 
components will be integrated seamlessly into the social media strategy. An example of this 
would be that messaging about HIV-related services will provide information about the PHASE 
HCFs (not just “get tested” but rather “get tested here”).  
6.1.2 Types of Content 
All modes of social media communication will be used in the campaign: posting and re-posting 
newly created and existing content, social media advertisement, and the engagement of social 
media influencers. There will be various sources of content including event-driven (e.g., 
conferences, Pride or college events), credible authorities (e.g., the CDC, health departments), 
HPTN 096 partner-driven (e.g., content created by social media partners participating in other 
study components), campaign-driven (content created specifically for the study’s social media 
campaign), and user-generated (created by users in response to a campaign). Content from these 
streams may be in any format (e.g., short video, long video, image, text) that is supported by the 
social media platforms selected for the study.  
6.1.3 Content Platforms 
The social media campaign will be distributed across traditional (e.g., Facebook, Instagram) and 
non-traditional (e.g., gay dating apps, websites) social media platforms. As these platforms and 
their audiences evolve over time, the exact platforms will be determined in an ongoing fashion. 
When appropriate, specific HPTN 096 social media accounts will be created for the 
dissemination of content. For example, study specific HPTN 096 Facebook and Instagram 
accounts will be created centrally for content distribution to local communities (via advertising) 
and more globally (posting to all followers). Each partner will have the option to use existing 
social media accounts or create study-specific accounts; however, it will be encouraged for 
partners to use their existing accounts that already have an established following. All partners 
will be informed of the central, study-specific social media accounts, and asked to provide 
information about their own social media presence. 
6.1.4 Implementers 
A core social media working group will be established and responsible for implementation and 
oversight of the social media strategy. This group will be made up of members of the HHI MSM 
community (including individuals from the study communities), HPTN Leadership and 
Operations (LOC) staff, social media experts and a standing member of the study’s CAG. In 
addition, a social media advisory group will be established to provide insight and guidance to the 
core social media working group from a wider range of voices within the HHI MSM community. 

 
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6.2 
Social Media Component Activities 
6.2.1 Creation of a Social Media Strategy Document 
The core social media working group will create a social media strategy document that will 
outline the goals, tactics and metrics of the social media strategy. As the strategy is expected to 
evolve over the course of the study, a living document will be created that will capture this 
evolution. The social media strategy document will guide all activities and be the foundation of 
the guidance document created for future implementors.  
6.2.2 Establishment and Maintenance of Content Creation Streams 
Five content creation streams will be established prior to full implementation, as outlined below: 
• Event-driven: The core social media working group will work closely with community 
engagement staff and other team members to provide information and a presence at local, 
regional and national events. Examples of local events include colleges homecoming, 
festivals/fairs and HIV-related fundraising events. Examples of regional and national 
events include conferences such as the Annual Alabama AIDS Symposium, the Saving 
Ourselves Symposium (SOS), the US Conference on HIV and AIDS (USCHA), HIV 
Implementation Science to Optimize Research Impact (HISTORI), and the Association of 
Nurses in AIDS Care (ANAC) conference. Content will be generated for distribution via 
social media before, during and immediately after these events, highlighting new 
information and the study’s presence at the meeting. Event-driven content will often 
overlap with partner-driven content, as this content stream may highlight events 
implemented by partnering organizations. 
• Credible authorities: The core social media working group will identify sources of 
credible health information to generate content. This stream may be re-posting existing 
content made by these credible authorities (e.g., the CDC, HRSA, local health 
departments) or content made by the study team that summarizes new and/or factual 
information (e.g., summarizing information from a newly published study, the various 
kinds of PrEP options).  
• HPTN 096 partner-driven: There will be two types of partner-driven content. The first 
will be made by external partners who are already participating in the study. For example, 
healthcare facilities may generate content about their participation in PHASE or the peer 
supporters may generate content to promote the peer support component. The second will 
be partnerships formed specifically for the social media campaign. An example of this 
may be a partnership with a popular food or fashion brand that is willing to promote the 
study’s key messages. This content stream will be distributed in one of two ways: 1) it 
will be distributed by these partners and then re-posted and/or reacted to by the HPTN 
096 social media accounts, or 2) it will be provided to the core social media working 
group for initial distribution with partners then re-posted and/or reacted to the content. 
• Campaign-driven: The core social media working group will oversee the generation of 
original content for multiple campaigns. Examples of how this might be done include 

 
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working with recognized members of the study communities, those with expertise in the 
sub-cultures of the HHI MSM community, those with specific knowledge and experience 
with HIV-related prevention and care topics, and social media influencers who have 
established relationships with the study population on social media platforms. The core 
social media working group will work with experienced photographers, videographers, 
graphic designers and other professionals to create a comprehensive look and feel for 
each campaign. 
• User-driven: User generated content is created in response to any of the content created 
by the streams outlined above. This content is expected to be generated spontaneously or 
may be encouraged by the campaign – for example by asking social media users to 
upload videos in response to specific content. 
The individuals selected to create campaign-driven content will be evaluated on both their 
experience with the HHI MSM community in the southern US and their familiarity with creating 
content for social media. Ideally, these content creators will have a basic understanding of HIV; 
however, extensive knowledge is not required, as training will be provided on HIV-related 
topics, as required. In addition, individuals who represent the broad and varied sub-cultures of 
the HHI MSM population in the southern US will be chosen. Content creators will be selected in 
an on-going basis driven by the need for new content creation. Partnering organizations, such as 
the PHASE HCFs, the health access coalitions, and the local peer support partner organizations, 
will select and manage their own content creators. 
6.2.3 Training 
Study-specific training will be provided to any content creators making campaign- or 
partner-driven content who need it. This training may include information about the study and/or 
technical information related to HIV, such as testing, PrEP uptake and the benefits of viral 
suppression. Content creators will be assumed to have the technical skills to create content 
themselves, or the study team will engage professional services (e.g., photographers, 
videographers, graphic designers, etc.). All content creators will receive guidance on the creative 
and technical parameters of the content (for example, the elements that describe the look and feel 
of the campaign or the expected video length).  
6.2.4 Content Creation 
6.2.4.1 Existing Content 
Event-driven, credible authorities and partner-driven content streams will all take advantage of 
existing content by re-posting information put out by other creators on social media. The core 
social media working group is responsible for identifying this type of content with input from the 
social media advisory group and study CAG. Priority will be given to content that resonates with 
and engages HHI MSM. Existing content may be created by, but is not limited to, event and 
conference organizers, study partner organizations, organizations that support and represent HHI 
MSM, the CDC, U.S. Department of Health and Human Services (HHS), health departments, 
foundations, public-private partnerships, and HIV-related organizations.  

 
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6.2.4.2 Newly Created Content 
Event-driven, credible authorities, partner-driven and campaign-driven content streams will all 
require the creation of new content. The core social media working group is responsible for 
overseeing the generation of newly created content with input from the social media advisory 
group and study CAG. A wide range of individuals will be approached to make new content, 
including HHI MSM, who may or may not be social media influencers, individuals who are 
recognized by or are known to have influence in the HHI MSM community (e.g., women, 
recognized artists, or entertainers), experts in HIV or other aspects of the study (HIV-providers, 
peer supporters and peer support partner organizations, PHASE participants and organizations, 
health access coalition members), and study members and staff (e.g., those attending community 
events and conferences). The study team will provide the content creators with guidance for 
content-related information (e.g., talking points or resources for specific topics), as well as any 
technical specifications required for the content (e.g., format, duration). In addition, the study 
team will provide professional services (photographers, videographers, graphic designers) when 
needed. Content creators will be asked to create both situational/local/short-lived and 
“evergreen” content, meaning that it could be used in multiple communities or multiple times 
throughout the duration of the study.  
6.2.5 Review 
All existing content that is re-posted and all newly created content will be reviewed and 
approved prior to distribution on HPTN 096 social media accounts by at least one member of the 
core social media working group to ensure relevance and accuracy. There may be some 
exceptions, such as posts made by study staff attending conferences and events, when timeliness 
is critical. The specific review process and any exceptions will be described in the social media 
strategy document. Partner organizations will be provided with guidance for the creation of their 
own content for the study; however, they will be responsible for ensuring that accurate and 
appropriate information is being distributed for the study.  
6.2.6 Distribution 
All content (both pre-existing and newly created) will be distributed via social media by either 
posting, re-posting or advertising. The way that posts and ads appear to users will be dictated by 
the social media platform used for distribution.  
Whenever possible, social media platform tools will be used to target distribution, for example 
social media ads can be geotargeted to the study communities. Any other available and relevant 
parameters will be used to reach the study population (e.g., for Facebook and Instagram, sex, 
age, and interests can be used to target content). When identifying interests is an option, the core 
social media working group will work with the social media advisory group and the study CAG 
to determine any interest lists required for distribution. In addition, tools such as hashtags will be 
used to help individuals looking for certain social media content to find the study’s content, 
when appropriate. 
In order for posts and re-posts to reach the study population, it will be critical to create a 
recognized and trusted brand and to build the HPTN 096 social media following over time. This 

 
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approach will take advantage of the full power of social media, allowing content to reach the 
majority of HHI MSM in each community.  
Some content will be distributed centrally, via HPTN 096 specific social media accounts or via 
paid advertising, and other content will be distributed by partner organizations. For example, it is 
expected that the peer support component (either by the peer supporters themselves or by the 
peer support partner organizations) will create and distribute their own social media content to 
promote themselves. The core social media working group will work closely with all study 
partners to provide guidance for their social media content and amplify their efforts. In return, 
local partners will be expected to amplify central messaging. Amplification can happen in 
different ways, depending on the social media platform and the original post; for example, on 
most social media platforms original posts can be re-posted, commented on, responded to, liked, 
shared, etc. Partners will be expected to provide information about their use of social media to 
the central team. The mechanism for reporting partner social media activities and engagement to 
the social media core working group will be outlined in the social media strategy document.  
All content distributed centrally will be assessed to determine if it should be delivered to all 
study communities or only specific study communities. For example, information that is only 
relevant to a specific community will only be distributed to that community. 
6.2.7 Frequency of Messaging 
The core social media working group will establish a content calendar that will dictate the 
timeframe for content creation and dissemination. The frequency of posting, re-posting and ad 
distribution will depend on ongoing activities – for example event-driven content will be tied to 
local events and conferences – and on the overall goal of building and sustaining an active social 
media presence. The team will use social media campaign management tools, which can 
recommend optimal frequency and days/times to post content. Social media ads will be run for a 
limited time (never longer than three months) in any given study community. The general 
principle will be to continuously refresh the content being distributed for the study to strengthen 
engagement.  
6.2.8 Evaluation of Reach and Engagement 
All social media posts, re-posts and advertisements distributed via the HPTN 096 social media 
accounts will be monitored for reach, engagement and the response to calls to action. These data 
will be captured in real-time and used to adjust content and content distribution. Whenever 
possible, all content will contain a link back to an HPTN 096 webpage; therefore, the team will 
also be able to monitor website metrics. A list of both social media and website metrics is 
included in the Sections 6.3 and 6.4. This monitoring will include the temporal relationship 
between social media content distribution and engagement.  
In addition, the team will try different ways to collect information from at least a subset of 
individuals who engage with the social media content to determine if HHI MSM are being 
reached. This data collection will include surveys ranging from very short and non-invasive (e.g., 
a pop-up window that asks, “Is the information on this website useful to you?” to longer, more 
personal questionnaires (e.g., brief surveys that include questions about sexual orientation). The 

 
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team will explore using various qualitative methods and user experience techniques, such as 
individual interviews and/or focus groups, to collect more nuanced information about how the 
content is able to engage the study population. The details of the minimal level, frequency and 
schedule for these evaluations will be included in the social media strategy document.  
In addition to determining whether the social media ads are reaching the study population, the 
team will conduct A/B testing to compare different ads, or different distribution elements (e.g., 
the interests used to target the ads), to determine which approach works best. Some social media 
platforms (e.g., Meta, which includes Facebook and Instagram) have the capacity to distribute 
two ads simultaneously to two equivalent segments of the intended audience, ensuring that no 
one sees both ads. This allows for a head-to-head comparison of the performance of each ad. 
Whatever is learned from this testing will be incorporated into the next iterations of ad 
distribution.  
Finally, those that enroll into the peer support component or who participate in the cross-
sectional surveys will be asked if they have seen examples of recent content being disseminated 
for the social media campaign. This measurement may provide some insight into the impact the 
social media campaign is having on behavior.  
6.2.9 Timeline of Activities 
The social media component will be implemented in an ongoing fashion with the following 
activities taking place continuously:  
• Establishment and maintenance of HPTN 096 social media platform accounts 
• Identification and review of existing content for re-posting 
• Identification of events and conferences for event-driven content 
• Identification of individuals and organizations as credible authorities, or to create partner- 
or campaign-driven content 
• Content creation, review and approval from all content streams 
• Content distribution via posts, re-posts and ad distribution 
• Use social media and website metrics to monitor engagement and process measures 
• Use quantitative and qualitative feedback to determine if the social media content is 
reaching the study population 
The specific details for all these activities will be included in the social media strategy document. 
The study team will continuously incorporate improvements to the process of content selection, 
creation and distribution to optimize HHI MSM engagement.  
6.3 
Primary Intervention Process Measure for the Social Media Component 
The primary intervention process measure for the social media component will be the reach of 
the social media content to the intended HHI MSM audience. This information will be captured 
via quantitative and qualitative assessments as described in the Section 6.2.8. 

 
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6.4 
Additional Process Measures for the Social Media Component 
Additional process measure data will be collected to evaluate fidelity to and penetration of the 
planned social media activities. These measures are intermediary between the implementation of 
the social media component and achievement of the primary and first two secondary outcomes 
and reflect key implementation outcomes of the logic model framework (see Section 1.2.2). They 
will be important in understanding the role that this component of the integrated strategy may (or 
may not) have in producing the primary and first two secondary outcomes. Further, all process 
measure data may be reviewed by the study team and/or the SMC during the study period to 
make real-time adjustments to component implementation in order to improve its effectiveness. 
Additional process measures for social media will include: 
• Measures of penetration of the social media content: 
o Number, topic, type (e.g., video, text-based, etc.) and the social media platform used 
for distribution of all social media posts, reposts and advertisements deployed in each 
study community 
o Metrics of social media engagement, including the following: 
▪ Impressions (number of views) and reach (number of unique individuals viewing 
each post, re-post or ad) 
▪ Clicks on embedded links 
▪ Number and types of other engagement (e.g., saves, likes, comments, reposts, 
etc.) 
• Measures of engagement with and use of the HPTN 096 website 
o For all content that includes links back to the HPTN 096 website, website analytics 
will be used to capture engagement. The engagement parameters may include, but are 
not limited to: 
▪ New and repeat visitors 
▪ Page views and duration 
▪ Engagement 
▪ Session tracking (captures information about page views that last a certain amount 
of time) 
▪ Event tracking (captures actions visitors do on the page, for example clicking a 
link or playing a video) 
• Estimates of the number of HHI MSM in the study communities reached and engaged:  
▪ Derived from the overall number of people reached and engaged as measured by 
social media metrics and the responses to surveys and individual interviews. 
▪ These data will be compared to the estimated number of HHI MSM in each study 
community. 
• Measures of fidelity to the planned social media activities:  

 
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o Creation and distribution of social media content compared to the social media 
strategy  
o When possible, partner-driven content will include a link to the HPTN 096 website in 
their social media posts and ads. These links will include a special code (called a 
UTM [Urchin Tracking Module]), which will allow the team to distinguish if a 
website visitor arrived via content distributed by partner organizations.  
6.5 
Guidance for Future Implementors 
As the study team will gain valuable experience in the creation and implementation of a social 
media campaign designed to reach and engage HHI MSM, the study team will generate a 
guidance document to capture what they find to be best practices. This guidance document will 
include information such as:  
• How to find and work with content creators and partners to create engaging content for 
HHI MSM 
• The elements of social media content that optimize engagement with HHI MSM 
• The overall costs affiliated with a social media campaign that engages HHI MSM 
• The advantages and disadvantages of different content streams when engaging HHI 
MSM 
• Technical details about content distribution, for example, interest lists that help target 
social media ads to HHI MSM 
7 
PEER SUPPORT COMPONENT   
7.1 
Component Description 
The peer support component will promote and provide peer support to HHI MSM for HIV 
prevention in the intervention communities. Peer supporters will accomplish this by supporting 
and enhancing motivation for positive health behaviors, as well as facilitating linkage to HIV 
prevention and treatment, and other needed social and support services. Peer support may be 
provided in-person or virtually using a third-party communication platform (such as Google 
Voice, WhatsApp, etc.). 
The peer support component will not serve as, nor is it intended to replace any traditional peer 
navigation or case management services. Peer navigators serve to guide peers through the 
healthcare system and work to overcome obstacles that are in the way of the peer receiving the 
care and treatment they require, including but not limited to health financing obstacles that could 
be overcome with insurance solutions. They help to identify needs and link peers to appropriate 
resources and health care. Similarly, case managers provide an assessment of care needs, 
provides referrals, and coordinates and ensures client access to a range of comprehensive 
medical care and social services.  
Peer supporters will work collaboratively with applicable community resources (including 
identified peer navigators and case managers) to ensure comprehensive support services are 

 
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extended beyond the reach of the clinical setting and reachable for all seeking responsive and 
sustained care and support. This support seeks to augment their current network of support and 
reinforce positive and healthy behavior change.  
Peer supporters who use their experiential knowledge which will be supplemented with formal 
training. Peer supporters will provide practical motivational, emotional, and informational 
support to peers who may be matched based on limited characteristics (e.g., age, location) and 
availability, taking client preference into account when possible. Once enrolled, program 
participation will continue throughout study implementation and will end when the study 
concludes.   
7.2 
Training  
Peer supporters will be trained on the core skills and competencies of peer support as well as the 
scope and expectations of their role. They will also be trained on the following topics, including 
but not limited to: 
• HIV, PrEP, non-occupational post-exposure prophylaxis (nPEP), other current HIV 
prevention options, and antiretroviral therapy (ART) education 
• Adherence to PrEP, ART and medical care 
• HIV/STI testing 
• New HIV diagnosis 
• Addressing stigma 
• Self-care 
• Resources and programs (at the national, state, and local level, as applicable) that 
prioritize HHI MSM in the provision of healthcare and other supportive services, 
including those that assist with healthcare coverage and insurance options, and 
accessing preventive and treatment medications and care services 
• Multicultural competency (as it relates to the heterogeneity of the HIV epidemic for 
HHI MSM in the southern US) 
The peer supporters will also be trained to share information about local resources and 
organizations that provide additional support resources including, but not limited to, legal, social, 
food, housing, substance use, mental health, and health care and insurance assistance programs 
available in the community. A resource directory of local organizations that provide HIV 
prevention and care services, as well as other support resources in each community will be 
established and maintained for use by peer supporters.  
Peer supporters will receive standardized oversight, which will consist of ongoing monitoring 
and check-ins. In addition, they will receive ongoing support from a licensed mental health 
professional that will routinely assess their well-being and whether they are experiencing distress 
or any negative impacts from providing peer support. During check-ins, resources and tools for 
self-care (e.g., managing support fatigue or vicarious trauma), support for difficult scenarios, and 
guidance for maintaining appropriate boundaries will be provided. 

 
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Peer supporter training (initial and ongoing development) as well as supervision may take place 
virtually or in person. 
7.3 
Collaborators 
This component of the integrated strategy will be implemented by peer supporters located in 
each community as well as those who oversee the program centrally. In addition, community-
based organizations (CBOs) may serve as implementing partners to support the implementation 
of the peer support component locally and provide operational and administrative oversight for 
HPTN 096 study-specific activities. The implementing partner will also support community 
engagement efforts to expand the network of service provision in the community. Local CBOs 
have existing community or social service delivery programs serving HHI MSM, thus, 
coordinating a collaborative approach with local service providers will ideally strengthen and 
facilitate a holistic approach to service and support delivery. This approach is essential to 
building and sustaining trust and in providing autonomy support and tailored strategies in the 
provision of peer support for HHI MSM. Collaborating with a local community organization in 
support of the peer support component offers the added benefit of having care providers, social 
workers, counselors, nurses, etc. in close proximity to further support the peer supporters, as well 
as their engagement in referring participants to the program.  
7.4 
Promotion and Community Engagement  
The peer support component will be promoted via various types of community engagement and 
outreach to raise awareness about the component and to support participant recruitment. This 
includes, but is not limited to, listservs, study website and newsletter, printed promotion 
materials (brochures, flyers), in-person engagement activities, webinars, conferences, social 
media, social networking sites and online dating sites and applications as appropriate.  
Potential recruitment strategies may include, but are not limited to, tabling and conducting 
educational presentations at local universities/academic institutions, wellness fairs, community 
forums, public health conferences and disseminating promotion materials throughout the 
community (i.e., on local community bulletin boards and in public areas on college campuses as 
well as in common areas in clinics and local service providers). This collective outreach could 
also enact the identification of potential and key stakeholders for the peer support component.  
The peer support component and/or its staff may be integrated throughout the other HPTN 096 
study components, furthering the objective of implementing a successful integrated strategy 
approach. This includes, but is not limited to, peer supporters participating in the PHASE 
training activities and collaborating with participating PHASE HCFs to ensure care and support 
services are appropriately in place for participant care coordination, unifying community 
engagement efforts to promote the peer support component to and within the care facilities, and 
liaising with the health access coalitions (by participating in associated coalition activities 
including attending coalition meetings, trainings and service provider forums as appropriate).  
7.5 
Location  
The peer support component will take place virtually or in-person. All communication between 
the participant and peer supporters will be private and confidential. If a support session is 

 
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conducted virtually, all communications will be facilitated using a third-party communication 
application (such as Google Voice) that permits voice and/or video calls or short service 
messaging [i.e., texting]). Local organizations that serve as implementing partners for the peer 
support component may provide a venue for face-to-face support sessions.  
When in-person support sessions occur, the peer supporter (with necessary support/resources 
provided by the local partnering organization) and client will discuss and agree upon the desired 
date, time, and safe and accessible location to meet. Before the meeting, the peer supporter and 
participant will set expectations for their face-to-face meeting, such as deciding what the purpose 
of the meeting is, or what they are and are not comfortable discussing. Peer supporters will be 
trained in best practices for protecting the identity and privacy of anyone they work with, 
including in the context of face-to-face meetings.  
7.6 
Component Size 
We anticipate that at least 10% of the minimum number of new HHI MSM clients needed to 
detect an intervention effect in each PHASE HCF will come from peer support referrals that 
originated in the community. The primary endpoint of increasing HHI MSM census at PHASE 
HCFs is powered to detect a 17% increase from baseline. The actual number will vary between 
HCFs because baseline HHI MSM census will vary. Moreover, the baseline HHI MSM census is 
likely to also vary within a PHASE HCF over time as EMR data are backfilled to address the 
data limitations described in Section 1.1.4.  
In support of peer support’s contribution to the primary endpoint, our first goal is to raise 
awareness of the peer support component among at least 50% of the estimated HHI MSM in 
each study community. The community-specific estimates for 50% of HHI MSM are 13,150 in 
Atlanta, 8,500 in Dallas, 4800 in Memphis, 900 in Montgomery and 5,600 in Ft 
Lauderdale/Miami. These figures are based on population size estimates from the CDC based on 
census and CDC surveillance data, and from data collected during the study pilot (see Section 3) 
in Dallas and Montgomery. We expect that by reaching this awareness goal for HHI MSM 
population in a community, we will reach a spillover tipping point where awareness of peer 
support expands beyond those directly reached by HPTN 096. This spillover phenomenon is a 
naturally occurring characteristic of how information is socially transmitted through 
communities via networks [218, 219]. Evidence from HPTN 037 indicated a spillover 
(unintended exposure to HPTN 037 content by individuals who were not in direct contact with 
HPTN 037 study personnel) of 39% [220]. Informed by these data from HPTN 037, we project 
that “awareness” of peer support in the remaining 50% of HHI MSM that are not directly 
reached will be approximately 25% to 35%. Achieving a high degree of awareness of peer 
support in the community (50% to 85% of the HHI MSM population) enables a synergy with the 
PHASE component wherein: (1) most HHI MSM at any given PHASE HCF will have at least 
heard of HPTN 096 peer support and (2) HHI MSM’s familiarity with HPTN 096 peer support 
will increase their likelihood of enrollment in the component when PHASE HCF staff offers to 
connect them to peer support. Regarding clinic-based awareness, we anticipate that 60% to 75% 
of HHI MSM at PHASE HCFs will have the peer support component discussed with them (see 
Section 9, Intervention Component Synergies). We conservatively estimate that the uptake of the 
peer support component from the clinic setting will range between 10% and 25% (defined as 
enrollment into peer support and at least one interaction with a peer supporter).  

 
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Accrual into the peer support component is expected to increase over the course of the study, 
which may be enhanced through the increased number of organizational partnerships established 
and/or the utilization of impactful community outreach and engagement by the local peer support 
team. The number of implementing partner organizations and/or the number of local peer 
supporters in each community will also be scaled to increase over time to ensure adequate 
coverage for program needs and demands.  
The level of effort required by the peer supporters will vary based on their individual capacity 
and the fluctuation in needs of the program participants assigned to them. The conduct of 
community engagement and outreach activities will also contribute to the peer supporters’ level 
of effort. It is anticipated that there will be a wide variety of support sessions (from one-time to 
repeat support sessions and durations ranging from a few minutes to potentially lasting an hour). 
The effort spent by each peer supporter will be monitored throughout study implementation and 
adjusted as needed.  
7.7 
Primary Intervention Process Measure for the Peer Support Component 
The primary intervention process measure for the peer support component will be assessed via 
self-reported satisfaction, acceptability and perceived usefulness of the peer support component 
among peer supporters and their clients. This information will be captured via qualitative and 
quantitative forms summarizing support activities among peer supporters. 
7.8 
Additional Process Measures related to the Peer Support Component 
Additional process measure data will be collected to evaluate program implementation and 
penetration of the peer support component activities. These measures are intermediary between 
the implementation of the component and achievement of the secondary outcomes. They will be 
important in understanding the role that this component may (or may not) have in producing the 
secondary outcomes. Further, all process measure data may be reviewed by the study team 
and/or the SMC during the study period to make real-time adjustments to deployment of the 
component to improve its implementation and impact.  
The additional peer supporter-level process measures may include:  
• Measures of penetration: 
o Number of peer/client matches 
o Number of interactions with clients (e.g., to assess penetration/reach across 
communities) 
• Measures of implementation: 
o Completion of acceptability assessment (at intervals throughout implementation and 
at the end of program participation); frequency to be outlined in the implementation 
manual  
o Measurement of the type of support provided during each session (e.g., topic areas) 
Peer supporters may also be asked to provide input about the component throughout 
implementation and to share their experiences with providing peer support. The component will 

 
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also be assessed to determine whether the component is progressing towards its goals and what 
the overall impact the component is having for those being served. The areas of the component 
felt to be most and least effective, areas for improvement and supporting roles and 
responsibilities across the component will be evaluated.  
The additional participant-level process measures may include: 
• Measures of penetration: 
o Number of participants engaged in the program, sociodemographic characteristics, 
and frequency of program use  
o Measurement of where participants learned about the program 
• Measures of implementation: 
o Satisfaction survey (e.g., brief assessment evaluating participant satisfaction with the 
program and overall feedback)  
o Acceptability and usefulness assessment (e.g., assessment evaluating the participant’s 
overall experience with the program including, but not limited to, how accessible the 
program is, satisfaction with the support received, etc.) 
Participant-level  acceptability measures will be administered after each support session at 
varying intervals as outlined in the implementation manual. The team will also explore various 
qualitative methods, such as individual interviews and/or focus groups, to elicit and capture 
additional information about the experiences of participants who engaged with the peer support 
component. This includes, but is not limited to, assessing their overall experience obtaining peer 
support and engaging with a peer supporter, any barriers they experienced accessing services, 
which elements were seen to be most beneficial and appealing, as well as those elements found 
least beneficial and least attractive. This will also serve as an opportunity for the participants to 
cross-share their experiences and identify themes across their experiences that will provide 
valuable insights and knowledge into how the participants perceived and responded to receiving 
peer support.  
 
8 
PROMOTING HUMAN AUTONOMY SUPPORTIVE ENVIRONMENTS (PHASE) 
COMPONENT 
8.1 
Component Description 
The PHASE component is a health care facility (HCF)-level training and quality improvement 
program designed to improve autonomy supportiveness in the provision of health care services 
for HHI MSM. PHASE aims to create an autonomy-supportive healthcare environment that 
supports HHI MSM engagement in HIV-related care and services and helps to promote increased 
HIV/STI testing, PrEP and ART uptake, retention in care, and viral suppression rates for HHI 
MSM. 
PHASE will take place at selected HCFs (see Section 8.1.3) in each study community. The 
PHASE component is designed to optimize the healthcare environment for HHI MSM by 

 
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addressing the multiple key intersecting factors that undermine autonomy support. This will be 
accomplished through a comprehensive package of five activities that are aligned with the EPIS 
(exploration, preparation, implementation and sustainment) model [221] delivered over the 
course of a two-year implementation period in each community:  
• Exploration: A majority of relevant staff (e.g., the clinical staff who directly provide 
HIV treatment or prevention services, and the non-clinical staff who support or provide 
administrative leadership to them) at each HCF will participate in the PHASE 
Foundation workshop on autonomy supportive HIV prevention and treatment services 
for HHI MSM, including content on informed decision-making, stigma, structural 
competency, skills practice, and accountability.  
• Preparation Phase: HCF representatives from key clinical and non-clinical roles will 
engage in continued learning and skills application within their HIV prevention and/or 
treatment practice settings, achieved through participation in an Extension of Community 
Healthcare Outcomes (ECHO) distance learning curriculum; tailored capacity building 
assistance such as state-level seminars on insurance options, financing, and business 
development; quality improvement (QI) preparatory and data collection activities; and 
client-instructor mentoring for providers.   
• Implementation Phase: HCFs will develop, implement, and monitor site-specific QI 
interventions [222], and share lessons learned through QI peer learning networks that 
will foster practice transformation by facilitating knowledge exchange and technical 
assistance between the HCFs participating in PHASE. 
The PHASE model is shown below in Figure 8 and further described in Section 8.2. The PHASE 
component will generally employ a “whole facility” approach, recognizing the sources of 
intersectional stigma do not only come from clinical providers, but also any HCF staff that may 
encounter clients/patients, such as front desk and administrative personnel.  
It is important to differentiate between PHASE component activities that are part of the 
integrated strategy intervention, and data collection activities taking place at PHASE HCFs that 
are intended to measure the outcomes of the overall integrated strategy. The latter are described 
in Section 11.0. This section describes only those activities that are considered part of the 
PHASE component of the integrated strategy.  

 
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Figure 8: PHASE Model  
 
8.1.1 Implementers  
PHASE will primarily be implemented by teams of interventionists who may include, but are not 
limited to, individuals with expertise in various types of stigma, training methodologies used 
with HCFs, clinical provision of HIV prevention and treatment services, and working with HCFs 
to improve the quality of the services provided for HHI MSM.  
Expertise of interventionist teams will be supplemented by external ECHO and capacity building 
faculty and experts, QI coaches, and HHI MSM who will be trained to implement the client-
instructor methodology.  
8.1.2 Location 
The Foundation phase of the PHASE component will involve multiple offerings of a 
synchronous workshop that will take place, in person, at central locations in each community 
accessible to participating HCF staff. All other PHASE activities will take place at each HCF and 
will involve a combination of virtual synchronous and asynchronous web-based activities as well 
as virtual or on-site technical assistance and coaching.   
8.1.3 Health Care Facility (HCF) Selection  
A total of approximately 40 HIV prevention and approximately 20 HIV treatment facilities 
across the five study communities will participate in the PHASE component (with intent of 
selecting facilities that yield a baseline average of 90 HHI MSM per HIV treatment facility and 
54 HHI MSM per prevention facility). At these facilities, both PHASE intervention activities, as 
well as study endpoint data collection and assessment activities, will take place. HCF selection 
must thus be undertaken with a goal of selecting HCFs that are appropriate for both types of 
activities (intervention and assessment).  
HCF selection will involve six core steps that may be iterative:  

 
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1. General study community engagement will be conducted at the local level to raise 
awareness about the study and the PHASE component, particularly among healthcare 
providers. 
2. HCFs that provide HIV-related treatment and/or prevention services in each study 
community will be identified.  
3. Identified HCFs may be prioritized for recruitment. 
4. Targeted recruitment of identified and/or prioritized HCFs will be undertaken in order to 
gain their buy-in and willingness to participate. 
5. Recruited HCFs will be requested to submit information about their facility to ensure 
they meet criteria to participate and to assist in selection decisions. 
6. If more HCFs express interest than are needed to participate in the study, a sub-
committee of the study team will review submitted information from all interested HCFs 
in each community and determine which HCFs to select for participation.   
8.1.3.1 HCF Identification and Prioritization 
HCFs may include any type of facility that provides HIV-related treatment and/or prevention 
services, including but not limited to primary care clinics, health system and/or hospital 
outpatient clinics, health department sexual health clinics, FQHCs, Ryan White-funded clinics, 
general medicine clinics, private health care offices, infectious disease clinics, pharmacies 
providing walk-in clinic services, and CBOs within the PrEP continuum. Eligible HCFs must be 
located within an HPTN 096 study community (see Section 4.1).  
An iterative and formative HCF identification process will use a combination of information 
from quantitative databases and qualitative data sources. Efforts will be made to identify all HIV 
primary care facilities and all facilities that provide PrEP – or have the capability of providing 
PrEP – to HHI MSM in each study community; through an iterative process, some facilities 
(prevention and treatment) may be ruled out of selection if they serve relatively few HHI MSM 
to ensure that HCFs across all five communities can participate.  
Data sources include:  
• Facility-based viral suppression and care surveillance data for HHI MSM (CDC) 
• Ryan White-funded clinics (HRSA) 
• Health Center Program Awardee Data (HRSA) 
• HIV care and PrEP service locations (AIDSVu) 
• Sexually transmitted infection (STI) surveillance data (local/state jurisdictions) 
• Census tract data 
Supplemental qualitative information will be elicited from the sources below:  
• HCF preferences and perceptions survey data (pre-pilot formative web-based survey 
implemented with HHI MSM in potential HPTN 096 communities) 

 
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• HPTN 096 CAG input 
• EHE planning council and local expert (e.g., community groups, health department, etc.) 
recommendations 
Additional sources may be used to supplement information about current facilities or identify 
potential new facilities/providers (e.g., of PrEP). The existing data sources will then be used to 
prioritize identified facilities for recruitment, taking into consideration those facilities that are 
most likely to serve (and those with the capacity to serve) HHI MSM, where the majority of HHI 
MSM diagnosed with HIV received care, and where the majority of HHI men or HHI MSM were 
diagnosed with STIs, as well as those that demonstrate the most need for improvement in 
services to HHI MSM. Prioritization will also take into consideration population size of each 
study community and ensure a representative number of facilities across each community (for 
example, larger communities may have more HCFs prioritized for recruitment than smaller 
communities). Prioritized HCFs will be approached first for recruitment, but all identified HCFs 
in each community may be informed about PHASE and asked to express interest in participating.  
8.1.3.2 HCF Recruitment and Selection 
A comprehensive HCF recruitment strategy will be developed with input from community 
members, partners (i.e., CDC, HRSA, local health departments and EHE councils), and 
individuals with expertise in health care leadership and quality improvement, practice 
transformation, and provision of HIV services in the southern US. The strategy will be informed 
by the HPTN 096 pilot lessons learned and include proactive measures to address feasibility, 
such as soliciting HCF feedback on incentives (e.g. financial compensation, continuing education 
credits, facility certification, access to technical assistance, etc.) that may facilitate their 
participation, and how the training approach could be tailored to meet their preferences. The 
strategy will also emphasize how participation in this component can help communities achieve 
EHE goals. Recruitment strategies may be tailored to each study community.  
The recruitment strategy will be implemented with the identified HCFs by study team members 
during the study pre-implementation period. Recruitment will begin with broad community 
education and engagement activities in each community, in order to gain trust and establish a 
presence among those providing healthcare in the community, before moving into targeted 
discussions around the details of study participation with specific HCFs.   
Recruitment of HCFs will explain expectations around participation in the PHASE component of 
the integrated strategy, as well as expectations related to research partnership for data collection 
and study endpoint assessment activities that will occur at PHASE HCFs but are not considered 
PHASE intervention activities.  
In order to participate in PHASE, HCF must agree to participate in all PHASE intervention 
activities as well as all HPTN 096 data collection activities at PHASE HCFs, including provision 
of EMR data for study endpoint assessments.  
Interested HCFs will be asked to provide basic information about their facility, including recent 
HHI MSM patient census data, and information to ensure that data provision requirements for 
study endpoint assessments can be met. HCFs that do not meet these basic criteria and/or that 

 
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would be unable to contribute to study endpoint assessments will not be eligible to participate. If 
more HCFs express interest than there are available spots, a selection process will be 
implemented based on information collected about each facility to prioritize facilities that would 
have the highest probability of serving HHI MSM in that community, and to ensure fair, 
representative, and adequate coverage of HCFs across communities to meet the study needs.  
8.2 
PHASE Intervention Activities 
The PHASE intervention involves an integrated package of five activities that each PHASE HCF 
will participate in. As many PHASE activities will involve multiple HCFs either within a 
community or potentially across communities, PHASE will not begin in a given community until 
all participating HCFs in that community are prepared to begin PHASE activities. PHASE will 
be implemented over a period of two years concurrently in each community, dependent upon 
when each community begins PHASE. The PHASE activities are further described below. Data 
collection activities that will take place at PHASE HCF to measure study outcomes but are not 
considered part of the PHASE intervention are described in Section 11.0.  
8.2.1 Foundation Workshop 
Staff from each participating HCFs will take part in a community-wide (i.e., inclusive of 
multiple participating HCFs in a given community) synchronous training on autonomy 
supportive healthcare for HHI MSM across the HIV continuum. This two-day workshop will be 
frequently offered during Year 1 of PHASE implementation in each community. Additional 
workshops may be offered into Year 2 if requested to provide an opportunity for new staff to 
complete the training. A target of >75% of relevant (i.e., clinical and non-clinical staff related to 
provision and support of HIV services) staff at each participating HCF will be trained. Multiple 
workshop dates will be offered in each community to allow HCF staff to cycle through the 
training in a way that does not place undue burden on clinic operations and provides enough 
opportunities to ensure the target number of HCF staff are reached. Continuing education credits 
will be provided.  
The standard curriculum to be used for this Foundation workshop will be derived from existing 
evidence-based training curricula on autonomy supportiveness, HIV stigma reduction, human-
centered practices in health care, contributions and resilience of HHI MSM in the southern US 
and similar topics, but will be tailored by the PHASE training team to meet the specific needs of 
this study. Topics covered in the training will include (but are not limited to) the following:  
• Presentation of HIV epidemiological data for HHI MSM, including intersectional 
patterns of demographics, transmission category, and geography with an emphasis on the 
southern US 
• Review of evidence related to health outcomes of HHI MSM in relation to PrEP, general 
HIV prevention, viral suppression, and HIV testing 
• Understanding intersecting stigmas  
• Identification of sociocultural assets of HHI MSM 
• Building structural competency in HIV prevention and treatment services 

 
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• Skills practice for supportive provider-client interactions 
• Creating autonomy supportive health care settings for HHI MSM 
• Overview of the PHASE intervention and synergies with the other components of HPTN 
096 
As a lead-in to the Foundation workshop, each HCF will be offered an opportunity to receive a 
simulated patient prior to the start of the Foundation workshops. This simulated patient visit will 
involve a trained individual with lived social experience and similar demographic characteristics 
as HHI MSM in their community, including same-sex experience. The visit entails enacting a 
full simulation of a typical visit for the initiation of HIV PrEP and/or treatment (depending on 
services offered by that HCF). The simulated patient will use a quantitative and qualitative 
feedback tool (adapted from the healthcare climate questionnaire) to characterize their 
experience of the clinic environment, including their interactions with HCF personnel in various 
roles. Summaries of the simulated experience will be used in the Foundation workshop training 
to provide HCF-specific feedback that workshop participants can use to curate draft menus of 
stigma-reduction options for their respective HCFs. Summaries will characterize the simulated 
patients’ general experiences of the HCF and are not an assessment or evaluation of any 
individual employed by or otherwise affiliated with the PHASE HCF. 
8.2.2 Extension for Community Healthcare Outcomes (ECHO) 
The Extension for Community Healthcare Outcomes (ECHO) component will build on themes 
highlighted in the Foundation Workshop by using an ECHO-based model for case-based learning 
and knowledge exchange [223, 224] to facilitate translation of the Foundational workshop 
concepts into best practices for providing HIV prevention and care services to HHI MSM within 
HCF settings. The ECHO-based model will employ a train-the-trainer approach and will be 
delivered over a series of synchronous web-based sessions to a subset of HCF staff, called a 
Champion Team, who represent key clinical and non-clinical roles in the facility. ECHO content 
will build on content covered in the Foundation training by extending it to clinical application 
and will include a brief didactic presentation on a pre-specified theme followed by a related case 
presentation and discussion related to that theme. A standard thematic curriculum for the ECHO 
sessions will be developed centrally and related cases will be submitted by the participating 
HCFs to reflect actual clinical and systems-level challenges they are experiencing. During 
ECHO sessions, discussion of challenges may lead to identification of potential solutions that 
can inform the QI work. For example, identification of systems-level processes that can address 
barriers to retention in care or PrEP prescription. A minimum of 12 sessions will be offered 
beginning in the first year of the PHASE implementation period, after the Foundation workshops 
are completed. Continuing education credits will be offered for each session, and sessions will be 
recorded and housed on the PHASE web-based portal for future viewing.  
Champion teams will be assembled at each HCF and will include at least one representative from 
key functional areas at each facility; for example, a combination of clinical staff, front-line staff, 
peer navigator, C-suite member, data manager, and human resources representative. Champion 
team composition specific to each HCF will be based on organizational composition of each 
HCF and determined as part of the onboarding process with the HCF. Champions must complete 
the Foundation workshop of PHASE as a pre-requisite to ECHO participation. 

 
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8.2.3 Tailored Capacity Building Assistance  
Tailored capacity building assistance will be offered to PHASE HCFs in order to meet additional 
extracurricular needs not addressed through the existing training curricula or QI work. The 
primary focus of this capacity building will be to provide additional training and technical 
assistance related to navigating insurance coverage for PrEP and ART as well as using PHASE 
to enhance business development of HCFs. At a minimum, the following capacity building 
assistance will be provided:  
• Supplemental state-specific workshops, similar to the ECHO model, will be offered and 
geared towards executive and administrative roles, in addition to clinical roles, that will 
focus on insurance options and financing of PrEP and HIV treatment options. Technical 
assistance will also be available from the external faculty experts leading the workshops.   
• Access to technical assistance related to increasing clinicians’ knowledge of 
documentation practices that support billing to maximize revenue.  
• Access to training on implementing a long-acting injectable PrEP program, with a 
connection to one-on-one technical assistance when needed provided by the PrEP 
manufacturer, ViiV.  
Assistance may be provided on other topics as needs are identified by participating HCFs 
8.2.4 Client Instructor Coaching 
Clinical providers at each HCF will be offered an opportunity to practice and reinforce the skills 
learned in the Foundation workshop through the Client Instructor (CI) supportive feedback 
methodology (analogous to “standardized patients” in the medical literature) [225-227]. CI will 
act as independent raters of structural, procedural, and interpersonal manifestations of  stigma 
and provide supportive feedback on strengths-based communication skills based on client 
readiness specifically in the context of ART and/or PrEP initiation communications. CI will be 
individuals with lived experience and similar demographic characteristics as HHI MSM in their 
community who are and trained to assess and coach providers and provide constructive and 
supportive feedback to HCFs using the study-specific methodology. The CI coaching component 
will seek to reach a majority of clinical HIV-related providers at each HCF. The number of 
providers targeted to complete CI coaching sessions at each HCF will depend on the clinical 
workforce composition of each participating HCF and is expected to be between 2 and 10 
providers each. Eligible clinicians must have completed the Foundation workshop prior to their 
coaching session and will be offered an initial coaching session with optional additional follow-
up coaching sessions provided upon request throughout the two-year intervention period.  
8.2.5 Quality Improvement (QI)  
Defined QI approaches and methodologies will be used to assist HCFs in translating their 
learnings from PHASE trainings into improvements in outcomes for HHI MSM related to HIV 
testing, PrEP use, engagement and retention in care, and viral suppression. PHASE QI methods 
and learning networks will support HCFs in addressing stigma as a barrier to improving care and 
prevention outcomes for HHI MSM. Through the QI work, HCFs will identify root causes of 
stigmas affecting HIV prevention and care for HHI MSM and accelerate the adoption of targeted 

 
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interventions to address them, as well as be supported in adopting evidence-based strategies for 
increasing HIV testing, PrEP use, retention in care, and viral suppression among HHI MSM. 
Application of QI methods at participating HCFs will offer an innovative approach to identify 
the complex and confluent multifaceted factors and root causes contributing to intersectional 
stigma, enabling them to be addressed through data-informed adaptation of interventions in a 
local setting. Through continuous measurement and tests of change, facilities will develop 
interventions that reduce  stigma, thereby improving care-seeking and sustained engagement, 
which, in turn, may lead to individual and population-health aims. When supported by strong 
leadership, process improvement methodology, peer-to-peer learning, and coaching, QI activities 
can strengthen participating organizations’ capabilities to predictably deliver prevention and care 
services that are effective, equitable, people-centered, and outcomes-oriented. The PHASE QI 
approach is based on cycles of continuous measurement with testing of changes targeting gaps 
identified from the data and will be guided by five activities: 1) QI pre-work; 2) QI data 
collection; 3) tailored QI coaching; 4) QI learning network peer exchange; and 5) QI action 
periods. QI activities will be detailed in HPTN 096 QI Operational Manual and are summarized 
in the sub-sections below.  
8.2.5.1 QI Pre-Work 
Participating HCFs will begin their PHASE QI process with four pre-work activities: 1) PHASE 
QI orientation; 2) assembly of a site-specific team of QI stakeholders (if not already in 
existence); 3) QI organizational assessment; and 4) QI measurement pre-work. The pre-work 
stage will set expectations for the QI activities; introduce QI coaches and supporting staff, as 
well as terminology and alignment with overall PHASE programming; allow QI coaches to 
assess and determine baseline competency for QI work; introduce the QI principles and 
methodology to be used; determine HCF capacity to collect relevant data, including 
disaggregated data (i.e., stratified) by demographic variable; facilitate customization of 
standardized QI data collection tools including both the healthcare worker survey and 
client/patient assessments; and define the project scope. Pre-work activities are further detailed 
in the QI Operational Manual.   
8.2.5.2 QI Data Collection 
Data collection will be required at the clinic level for QI as part of routine performance 
measurement based on the PHASE QI indicators (specified in the QI Operational Manual) so that 
an HCF can understand whether its efforts are having an impact. HCF collection and self-
monitoring of data is an important part of the QI process. PHASE QI data collection activities 
will include:  
1. HIV prevention and treatment cascade clinical performance measures related to study 
primary and secondary endpoints, disaggregated by demographics  
2. Healthcare worker stigma survey 
3. Patient experience and health literacy data  
 
The QI Operational Manual will guide QI data collection methods and definitions of measures. 
Data collection will be expected to occur approximately quarterly. QI coaches will work with 

 
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HCFs to review QI data to help determine root causes and areas for targeting QI interventions. In 
addition to the above data sources, site-specific summary reports generated from the Foundation 
workshops supplement collected QI data to inform root cause analysis and QI interventions. Data 
collected as part of QI activities will not be submitted to or retained in the study database and 
will not be considered study data for endpoint assessment. 
8.2.5.3 Tailored QI Coaching 
Each HCF will be supported by a QI coach who will facilitate discussions and appropriate peer 
exchange and provide feedback on application of QI tools and methods. To foster the application 
of varied and scalable QI concepts, coaching will utilize interactive, project-based learning with 
relevant examples addressing gaps along the HIV care and prevention continuum. Recognizing 
that each HCF will have different baseline QI experience and capacity, and some may have 
robust ongoing QI initiatives, coaching will be tailored to the level of need determined for each 
HCF during the QI pre-work organizational assessment stage, with the coaching scheduled 
determined between coach and HCF. Each HCF will designate at least one staff member to serve 
as QI contact to lead their local QI efforts and work directly with the QI coach throughout the 
duration of the PHASE intervention.  
8.2.5.4 QI Learning Network Peer Exchanges  
QI learning network peer exchange sessions will further support practice transformation, the 
accomplishment of PHASE goals, and improvement in clinical outcomes through sustaining 
connections with other participating HCFs workings towards similar goals. HCFs within the 
same PHASE cohort will form a QI learning network and participate together in quarterly peer 
exchange sessions. This approach will facilitate learning and sharing of best practices across 
these HCFs, and will allow for additional targeted training, technical assistance, or other skills-
building activities in support of related goals over the intervention period. QI learning networks 
will be facilitated by QI coaches and members of the QI team with expertise in QI methods. 
Additional details about the QI learning network sessions are provided in the QI Operational 
Manual.   
8.2.5.5 Action Periods 
Action periods are the time frame between QI learning network peer exchange sessions, where 
the local HCF PHASE QI team plans and carries out a QI project(s). During the action periods, 
teams are expected to implement tests of interventions based on data and root cause analysis and 
monitor their data on the outcomes and custom measures relevant to tests of change. The tests of 
change are intended to be very small tests of improvement ideas such as changing or adding a 
step in the process in response to data and feedback. QI efforts are directed towards objectives of 
addressing stigma for HHI MSM and to improve their clinical outcomes related to HIV 
prevention (PrEP prescription) and HIV treatment (retention in care and viral suppression).  
8.2.6 Timeline of Activities 
PHASE activities over the 2-year implementation period for any given cohort are depicted in 
Figure 9: PHASE Journey Map.  

 
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Figure 9. PHASE Journey Map 
 

 
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8.3 
Primary Intervention Process Measures for PHASE 
The primary intervention process measures for the PHASE component will be knowledge and 
attitudes of staff at PHASE HCF after completion of PHASE trainings as compared to before 
trainings, and qualitative characterization of staff experience implementing PHASE. Knowledge 
and attitude change information will be captured via pre- and post-test surveys administered to 
HCF staff participating in PHASE trainings and workshops. Qualitative information will be 
captured via qualitative in-depth interviews with a subset of staff at PHASE HCFs.   
8.4 
Additional Process Measures related to the PHASE Component 
Additional process measure data at the HCF level will be collected on an ongoing basis to 
evaluate fidelity to and penetration of the planned implementation of the PHASE component. 
These measures are intermediary between the implementation of the PHASE component and 
achievement of the primary and secondary outcomes and reflect key implementation outcomes of 
the logic model framework (see Section 1.2.2). Thus, they will be important in understanding the 
role that this particular strategy may (or may not) have in producing the primary and secondary 
outcomes. Further, all process measure data may be reviewed by the study team and/or the SMC 
during the study period to make real-time adjustments to deployment of the component to 
improve its effectiveness. The additional process measures for PHASE will include: 
• Measures of penetration of the component activities: 
o Number and types of participating HCF in each intervention community 
o Number and types of staff who complete PHASE Foundation workshop 
o Number of PHASE Foundation workshops conducted 
o Numbers and roles of staff participating as ECHO Champions at each HCF 
o Number and roles of providers completing Client Instructor coaching sessions at each 
HCF, and proportion of providers completing Client Instructor coaching sessions out 
of all eligible providers 
• Measures of fidelity to planned implementation of PHASE 
o Proportion of staff completing PHASE Foundation workshops at each HCF 
o Proportion of total ECHO sessions completed by HCF staff 
o Ability of HCF to collect specified QI data 
o Number and type of QI interventions implemented at each HCF in QI action periods 
o Number of QI learning network peer exchanges sessions completed  
o Number of QI coaching sessions completed at each HCF 
9 
INTERVENTION COMPONENT SYNERGIES 
The four components of the integrated strategy are designed to work synergistically, with each 
component having the potential to enhance the effect of the other three components. In addition, 
the health access coalition, social media and peer support components are designed to help 

 
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motivate and facilitate HHI MSM who are not engaged in healthcare to access HIV prevention 
and treatment services, particularly at HCFs participating in the PHASE component of the 
intervention. Throughout the study, the team will consistently look for ways to identify and 
implement potential synergies.  
9.1 
Synergies to Enhance Health Access Coalitions 
The overall goal of the health access coalition component is to lower the barriers that HHI MSM 
face accessing HIV prevention and treatment services at the structural, community and policy-
level. 
• Through attending the PHASE Foundation Workshop, health access coalition members 
will gain a better understanding of the barriers that PHASE HCFs face in serving HHI 
MSM and the barriers that HHI MSM face in accessing HIV prevention and treatment 
services. 
• The peer support component will amplify health access coalition engagement with the 
local HHI MSM community. For example, peer supporters may serve as non-voting 
members of the coalitions. 
• Social media can be used to advertise health access coalition activities to increase 
participation and inform the HHI MSM community how they can take advantage of any 
environmental changes put in place via the health access coalitions.  
9.2 
Synergies to Enhance Social Media 
The overall goal of the social media component is to educate and empower HHI MSM to make 
informed decisions and behavioral changes to stop HIV acquisition and transmission. There are 
three primary ways that the other three components can enhance the social media component, 
including:  
• Consistently encouraging HHI MSM to follow the HPTN 096-specific social media 
accounts. 
• Informing the social media team of upcoming events and ongoing services or programs 
for HHI MSM so that they can be promoted via social media centrally. 
• Having local HPTN 096 partners use their own social media accounts to inform HHI 
MSM about their services as well as other HPTN 096 activities and programs. 
9.3 
Synergies to Enhance Peer Support 
The goal of the peer support component is to provide individual HHI MSM with the support they 
need to access HIV prevention and treatment services.  
• 
Peer supporters will attend PHASE Foundational workshop to strengthen their 
understanding of how stigma impedes obtainment of care and support.  

 
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• 
PHASE HCF staff may promote the peer support component and make referrals to it, 
when appropriate. 
• 
The health access coalitions may also promote the peer support component and help to 
overcome barriers to accessing peer support.  
• 
Social media will be used to promote the peer support component locally and centrally. 
9.4 
Synergies to Enhance PHASE 
The goal of PHASE is to change the healthcare environment so that more HHI MSM can access 
HIV prevention and treatment services, take PrEP and remain in HIV care.  
• Health access coalitions will work to lower the barriers to HIV prevention and care 
services for HHI MSM. Working to lower medical mistrust and addressing local 
structural, community and policy-level barriers are examples of this type of synergy. 
• The peer support component will serve as a resource for PHASE HCFs to leverage as 
much or as little as they choose and will provide referrals to PHASE HCFs, when 
appropriate. Including PHASE HCFs in the resource guide used by the peer support 
component and peer supporters sharing resources and information with their clients  
about preventive, treatment and/or care resources, including programs that assist with 
healthcare coverage and insurance options, are examples of the potential synergistic 
efforts between PHASE and peer support.  
• Social media is expected to drive the demand for HIV-related services by raising 
awareness about HIV status and increasing knowledge about PrEP and ART. This is 
particularly important for HHI MSM who are not currently engaged in HIV prevention or 
treatment services. It can also be used to promote the PHASE HCFs to HHI MSM, both 
locally by the PHASE HCFs themselves and centrally via the HPTN 096 social media 
accounts.  
10 COMMUNITY ENGAGEMENT 
Given the community stigma and discrimination related to homosexuality in the southern US, 
innovative community involvement approaches will be utilized to proactively address concerns 
related to social harms, strengthen community rapport, and plan for community engagement. 
Utilizing core principles for Community Based Participatory Research (CBPR) is key to 
incorporating community input into the development and conduct of the HPTN 096 study 
through meaningful community engagement. CBPR is an approach to public health and 
environmental research that aims to increase the value of research for both researchers and the 
community for whom or in which the research is conducted [228]. This approach is particularly 
useful when dealing with persistent problems related to disparate health care outcomes among a 
variety of populations (e.g., socioeconomic status sexual orientation) [228]. Through the sharing 
of knowledge and experiences, CBPR builds bridges between scientists and communities [228]. 
Furthermore, this collaboration facilitates the development of appropriate measurement 
instruments, thereby increasing the efficiency and effectiveness of projects [228]. Finally, CBPR 
fosters mutual trust that increases both the quality and quantity of data collected [228]. 

 
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Collaborations of this type of result in a deeper understanding of the unique circumstances of a 
particular community [228].  
The HPTN 096 team recognized, through community forums and community input, the need for 
a multilevel, comprehensive community engagement strategy. The goals of community 
engagement are to build trusting relationships, create partnerships, share resources, create and 
improve communications, and improve health outcomes [229]. The NIH defines community 
engagement as “a process in research of inclusive participation that supports mutual respect of 
values, strategies, and actions for authentic partnership of people affiliated with or self-identified 
by geographic proximity, special interest, or similar situations to address issues affecting the 
well-being of the community focus” [229]. Community engagement will be directed at two 
levels: 1) general awareness of the study and 2) component-specific engagement. Each level of 
engagement will specifically target appropriate audiences using various methods of engagement. 
10.1 Levels of Engagement 
10.1.1 General Awareness 
The main purpose for general awareness-raising community engagement is to generate 
awareness around and support for HPTN 096 to raise the level of community acceptability of the 
study presence and the intervention components that will be implemented. Community 
engagement for the purposes of general awareness-building will focus on the creation of 
awareness. These activities are separate from how community engagement will be conducted for 
the specific study components and the cross-sectional assessment (described further in sections 
below).  
The establishment and use of community advisory boards (CABs) is a critical strategy in 
achieving the goals of community engagement [230-232]. CABs, which typically include a 
representative group of non-researchers, have been a part of HIV research since the late 1980s 
[230, 233]. Originally, CABs provided consultation and communicated community needs, which 
later expanded to a collaborative relationship with researchers [230, 232, 234].  
Although establishing a Community Advisory Board (CAB) is a vital component of community 
engagement, this method alone does not comprise a comprehensive community engagement 
strategy [232, 233, 235]. Additional community engagement approaches include planning with 
community input, increased and consistent communication to the community and study 
participants, providing community resources, and involving researchers representative of the 
community [231-233, 235]. Some other ways to engage and greatly impact the community are to 
provide trainings on health or resources available to bring awareness and increase its capacity; 
support events by attending or volunteering; foster collaborative programs such as health fair; 
and create ongoing, sustainable partnerships [235]. 
The HPTN 096 Community Advisory Group (CAG) will serve as the CAB to the protocol team 
and will support stakeholder engagement activities and planning for HPTN 096. The group 
includes HHI MSM from each of the HPTN 096 study communities. It will meet monthly to 
discuss stakeholder engagement strategies and receive regular updates on the progress of the 
study. CAG members will provide high-level input and guidance to the HPTN 096 study team 

 
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related to community awareness and acceptability. The CAG will bring a variety of perspectives 
and expertise, connecting issues and opportunities across stakeholder engagement, agencies, and 
local stakeholder sectors. Recognizing that there is no one-size-fits-all community awareness 
strategy, each CAG member will work with the HPTN 096 study team and local community 
stakeholders to find ways to create opportunities for continued engagement of new stakeholders 
and raise awareness for HPTN 096 overall. 
10.1.2 Component-Specific Community Engagement Activities 
Each study component will involve tailored community engagement activities for the purposes of 
gaining participation in, awareness of, or acceptability for each component. These community 
engagement activities are largely integrated into the activities of the study components 
themselves, and as such, the success of community engagement as it relates to specific 
components will be assessed from a subset of outcome measures already identified for each 
component. A CAG representative will serve as a liaison for each of the HPTN 096 study 
components to provide real time guidance and enhance communication between the team 
working on each component and the HPTN 096 CAG. 
10.1.2.1 Health Access Coalitions 
Community engagement activities for the health access coalitions component will be carried out 
in conjunction with local CBOs to establish community coalitions in each intervention 
community. Guidance on organizations and individuals to engage for membership in the 
coalitions will be provided by the local CAG representative and local peer support staff. 
10.1.2.2 Social Media  
Community engagement activities for the social media component will be focused on identifying 
and vetting appropriate social media content; providing messaging on HIV-related topics; and 
promotion of the other study components. The HPTN 096 CAG will provide guidance on the 
identification and creation of social media content, and strategies for disseminating social media 
messages. 
10.1.2.3 Peer Support  
Community engagement methods will be used for promotion of the peer support component. In 
consultation with local CBOs and other stakeholders, peer supporters from each intervention 
community will develop site-specific community engagement strategies to promote awareness of 
HPTN 096 and the peer support component. They will be encouraged to implement various 
community engagement strategies in the local communities and across their network through the 
following (including but not limited to): peer outreach/word of mouth referrals, 
formal/informational educational sessions, and distribution of promotional materials at local 
venues and events. Community engagement activities may also leverage invaluable networks 
such as the CAG members and other community partners to raise awareness and generate interest 
in the peer support component.  

 
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10.1.2.4 PHASE 
Community engagement activities for the PHASE component will be focused on supporting the 
recruitment of healthcare facilities who provide service to HHI MSM and relationship building 
with targeted facilities to gain their agreement to participate in the component activities. The 
HPTN 096 CAG may provide guidance to the PHASE component on identification of healthcare 
facilities. 
11 STUDY PROCEDURES FOR DATA COLLECTION AT PHASE HEALTHCARE 
FACILITIES 
This section provides an overview of data collection procedures that will be conducted at 
PHASE HCFs. Data collection activities include the EMR endpoint data collection (see Schema 
Figure 1), a cross-sectional HHI MSM client assessment (inclusive of a questionnaire and chart 
extraction), and qualitative data collection with HHI MSM clients and HCF staff. A summary of 
these data collection activities is shown in Figure 10. In addition, a brief schedule of evaluations 
is provided in Appendix I. Additional detailed instructions to guide and standardize procedures 
across PHASE HCFs are provided in the HPTN 096 PHASE HCF Study-Specific Procedures 
(SSP) Manual (Participant Accrual, Informed Consent, Enrollment Section and Visit Procedures 
and Visit Checklists Section). 
Figure 10: Summary of Data Collection Activities at each PHASE HCF 
 
* May extend to M 24-27 if needed to complete accrual 
11.1 Cross-Sectional HHI MSM Client Assessment 
11.1.1 Pre-Screening 
It is the responsibility of each PHASE HCF to determine the best approach to screen potential 
participants for the cross-sectional HHI MSM client assessment. Generally, it is expected that 
each HCF will have a designated study coordinator (e.g., a nurse or manager) who will be 
responsible for pre-screening client records. Study coordinators will identify and flag charts of 
clients who appear to meet eligibility criteria in Section 4.3.2, and who have a scheduled 
appointment during one of the four-month sampling timeframes: baseline (1-4 months), midpoint 
(12-15 months) or post-intervention (24-27 months).  

 
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11.1.2 Recruitment, Screening and Eligibility Confirmation 
Generally, it is expected that potential participants will be recruited, screened, enrolled, and will 
complete their questionnaire all in the same day as their scheduled medical visit. Before 
enrollment takes place, stratification must be determined by the study coordinator based on 
information in the medical record. Each PHASE HCF will be assigned a target accrual number 
for each stratification category during each sampling timeframe (see Section 4.3.2.1 for 
stratification), and study coordinators will be expected to locally track enrollment and 
stratification of each participant. 
To mitigate selection bias, all individuals who were flagged during the pre-screening process as 
potentially eligible will be approached at their regularly scheduled medical visit by the study 
coordinator until the desired sample size is achieved within each 4-month sampling timeframe. 
The study coordinator will invite each approached individual to participate in the study and will 
review a study information sheet with them. 
The questionnaire will be accessible via a web-based platform. If the participant is interested in 
moving forward, the study coordinator will confirm the eligibility criteria (per section 4.3.2.1) 
within the web-based platform. Potential participants who meet the eligibility criteria and 
stratification will be prompted to provide electronic consent via a checkbox within the 
questionnaire platform (see Section 15.7.1).  
11.1.3 Questionnaire Completion and Enrollment 
Once the participant has consented, the participant will be prompted to complete the 
questionnaire. 
The questionnaire will ask participants their thoughts and personal experiences/perspectives on a 
variety of topics, including, but not limited to:   
• Structural barriers to healthcare access 
• Healthcare climate and autonomy support  
• PrEP use initiation, adherence, and persistence 
• Individual agency & PrEP/HIV care barriers 
• U=U knowledge 
• Multi-level social support 
• Stigma 
• Mental health 
• Sexual behavior and vulnerability 
• Exposure to the integrated strategy 
• Demographics 
An audio computer-assisted self-interview (ACASI) will be offered as well as a Spanish 
translation of the questionnaire. The questionnaire will be reviewed by the CAG prior to 
implementation.  

 
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Once the questionnaire is completed, the participant will be offered compensation for their time. 
A participant is considered enrolled into the cross-sectional HHI MSM client assessment once 
the questionnaire is complete and submission is confirmed.  
11.1.4 Chart Abstraction 
The study coordinator will abstract protocol-required medical history and laboratory results 
information from the participant’s medical record and enter them into an electronic case report 
form (eCRF) after the participant has completed the questionnaire. The eCRF data will also be 
used for the purposes of stratification of each sample during the analysis, per Section 4.3.2.1. 
Data entry can be completed immediately after the participant’s questionnaire is submitted or at a 
later date, but must be completed within a seven-day window from questionnaire submission. 
Data elements to be abstracted at HIV treatment HCFs (for HHI MSM living with HIV) include: 
1. Demographics (not to include any direct identifiers) 
2. HIV diagnosis and date 
3. ART prescriptions within the past 12 months 
4. Viral load results within the past 12 months 
5. STI diagnoses within the past 12 months 
6. Retention in care over the past 12 months 
7. Date of first medical visit to the HCF 
Data elements to be abstracted at HIV prevention HCFs (for HHI MSM not living with HIV) 
include: 
1. Demographics (not to include any direct identifiers) 
2. Most recent HIV test date and result 
3. PrEP prescriptions/injections within the past 12 months 
4. STI diagnoses within the past 12 months 
5. Medical visits over the past 12 months 
6. Date of first medical visit to the HCF 
Accrual by stratification status will also be monitored across PHASE HCFs through the study 
database once data elements are entered from the medical record for each participant. Accrual 
targets may be adjusted across HCFs based on actual enrollment. 
11.2 Collection of Electronic Medical Record (EMR) Data 
11.2.1 EMR Data Collection Elements 
A limited data set (deidentified per 45 CFR 164.514e), will be abstracted periodically over the 
PHASE intervention period from EMRs of all 60 PHASE HCFs to evaluate primary and 
secondary study objectives. Section 4.3.1 defines the subset of clients whose records will be 
abstracted from the EMR. 

 
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The general data elements to be abstracted within the study period include: 
1)  HHI male and MSM clients 
a) Age 
b) Cultural identity 
c) Sex 
d) Sexual orientation 
e) Type (e.g., primary, HIV prevention or treatment, STI testing, lab, medical) and 
date for each visit/encounter 
f) Other MSM-behavioral variables as available 
2) HIV care  
a) HIV viral load and CD4 test dates and results 
b) Medication information (medication name, type of record, dose, quantity and date 
for each HIV treatment medication) 
c) Diagnosis codes related to AIDS/HIV infection and date for each diagnosis 
d) Other HIV care variables as available  
3) HIV prevention 
a) HIV diagnosis tests results and dates 
b) PrEP medication (medication name, type of record, dose, quantity and date for 
each prescription) 
c) Other HIV prevention variables as available 
4) Indicators of substantial risk of HIV acquisition 
a) High risk diagnosis code and dates for each visit/encounter 
b) STI tests within the study period (test description, test result and date) 
c) STI diagnosis and date for each diagnosis 
d) Other HIV acquisition risk variables as available 
 
Specific EMR data codes and other details about data to be extracted will be provided in the 
PHASE HCF SSP (Data Collection and Management Section) and data extraction guide. 
11.2.2 EMR Data Collection Procedures for PHASE HCFs 
Each HCF will use an Application Programming Interface (API) to connect their EMR system to 
a secure third-party platform designated to capture EMR data from the HCF. Once the 
integration is complete, the third-party vendor will be responsible for accessing the EMR data on 
a periodic basis as directed by the study team (approximately quarterly), deidentifying the data, 
creating a limited dataset per protocol specifications, and transferring it to a central database that 
is accessible to the HPTN SDMC for analysis and reporting. Any direct patient identifiers and 
medical record identifiers will be replaced by the third-party vendor with study specific 
participant identifiers (PTIDs) such that no direct identifiers are available in the central database. 
A business associates’ agreement and data use agreement will be in place between the third-party 
vendor and each HCF to allow the third-party vendor to generate and share the limited data set 
with the HPTN SDMC for research purposes; a data use agreement in place between the third-
party vendor and HPTN SDMC will govern the HPTN SDMC’s use of the data. Additional 

 
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operational procedures will be provided to HCFs in the PHASE HCF SSP (Data Collection and 
Management Section) and via technical training. 
11.2.3 EMR Data Quality and Completeness 
EMR data are expected to evolve and improve during the study due to the PHASE intervention 
and EMR data verification processes. EMR data will be continuously assessed for quality and 
completeness, using, for example, consistency checks across repeated data transfers from the 
same clinic, monitoring for increased completeness of critical data elements (e.g., MSM defining 
fields), direct verification of accuracy (e.g., number of clients) with participating clinics, and 
comparison of pre-intervention outcome proportions and trends between sites. 
11.3 Qualitative Data Collection 
11.3.1 Qualitative Data Collection with PHASE HHI MSM Clients 
At a subset of PHASE HCF (see Section 4.3.3.1), participants completing the cross-sectional 
client assessment will be invited to participate in qualitative interviews. Participants who agree 
will be asked for permission to provide contact information to study team members conducting 
the qualitative interviews. These participants will be contacted by study team members trained in 
qualitative data collection methods. Qualitative IDIs with HHI MSM clients will take place 
around the midpoint (12-17 months) and, if necessary to reach accrual targets, post-intervention 
(24-27 months). 
Qualitative research staff who are members of the HPTN 096 study team will contact potential 
qualitative IDI participants and confirm that they are willing to participate. Interviews will be 
arranged at a time and location convenient to the participant and interviewer. All IDIs will be 
conducted in a private setting, either virtually or in-person, based on the participant's preference.  
Prior to proceeding with the interview, verbal consent will be obtained. IDIs will explore HHI 
men’s (specifically men with a history of same-sex sexual practices) experience with stigma, 
client-centeredness, and service satisfaction in healthcare-related settings including at the 
PHASE HCF. To further elucidate these experiences, interviews will explore: 
• What effect, if any, have autonomy supportive efforts of the PHASE HCF had on their 
uptake of antiretrovirals for PrEP or HIV treatment? 
• How could PHASE HCFs improve their client-centeredness? 
• What structural barriers do they face when seeking care for HIV prevention or treatment? 
• What individual (self) agency do they feel to access PrEP or HIV treatment services 
despite the existence of barriers? What has contributed to their sense of (increased, 
decreased, or static) agency? 
Interviewers will use a semi-structured interview guide to provide a general structure to the 
discussion. However, the interview guide will include the flexibility to ask probing questions as 
needed or welcomed. Interviewers will be encouraged to let the interview participants expound 
on their experience in a way that’s most comfortable to them – guided by the interview topics.  

 
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Interviews will last approximately 45-60 minutes. All interviews will be digitally recorded and 
transcribed. Interviews will be conducted in English or Spanish, depending on the participant's 
preference. Interviews conducted in Spanish will be translated and transcribed into English.  
11.3.2 Qualitative Data Collection with PHASE HCF Staff 
At a subset of PHASE HCFs, staff who meet the criteria outlined in section 4.3.3.2 will be 
invited by a member of the qualitative research team to participate in an interview. Staff 
members who agree to participate will provide contact information to study team members 
conducting the qualitative interviews for follow-up and interview scheduling. Qualitative IDIs 
with HCF staff will take place prior to the study conclusion (between 18-23 months).  
Interviews will be arranged at a time and location convenient to the participant and interviewer. 
All IDIs will be conducted in a private setting, either virtually or in-person, based on the 
participant's preference. 
Prior to proceeding with the interview, verbal consent will be obtained. IDIs with PHASE HCF 
providers and staff will be conducted to help interpret and understand implementation  barriers 
when implementing the PHASE integrated strategy. To characterize the experience of 
implementing the PHASE component among HCF providers and staff, interviews will examine:  
• How relevant is PHASE to the HCF providers and staff?  
o What aspects of PHASE benefit HCF staff? What aspects of PHASE are difficult 
to implement? 
• How does PHASE training affect clinical encounters or client/patient-provider 
interactions? 
• What factors have contributed to successful outcomes?  
o What has been integrated into the HCFs workflow?  
• In what context does the PHASE intervention work best/worst (e.g., hospital settings, 
CBOs, FQHCs, etc.)? Why? 
• Factors that may lead to sustainability of any PHASE effects at the HCF. 
Interviewers will use a semi-structured interview guide informed by the convergence framework 
and constructs from the implementation science literature (see section 1.2.2). While interviewers 
will ask questions about the implementation process, they will have the flexibility to ask probing 
questions as needed or appropriate. Interviewers will be encouraged to let participants expound 
on their experiences with PHASE to help build rapport and facilitate discussion. 
Interviews will last approximately 30-45 minutes, depending on availability and workflow. All 
interviews will be digitally recorded and transcribed. Interviews will be conducted in English or 
Spanish, depending on the participant's preference. Interviews conducted in Spanish will be 
translated and transcribed into English. 
 
12 USE OF CDC HIV SURVEILLANCE DATA 
One of the exploratory objectives of the study is to see if there is any evidence that the integrated 
strategy is having an impact on community-level viral suppression in HHI MSM using CDC HIV 

 
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surveillance data. As such, a comparison will be made of community-level viral suppression in 
HHI MSM between the five study intervention communities and the five communities with 
which they were matched for a previous version of the study design (see V3.0 of the protocol). 
The five study intervention communities were matched with standard-of-care communities based 
on demographics (community size and percent of the population that are HHI) and baseline rates 
of viral suppression (based on CDC HIV surveillance data). All ten communities were included 
in the EHE counties and states designated as those with the highest burden of HIV prevalence 
and new HIV infections in the US.  
The comparisons will be made between the following matched pairs:  
• Dallas, TX (Dallas county) vs Houston, TX (Harris county) 
• Montgomery, AL (Montgomery, Elmore and Autauga counties) vs Greenville, SC 
(Greenville and Spartanburg counties) 
• Fort Lauderdale/Miami, FL (Broward and Miami-Dade counties) vs New Orleans/Baton 
Rouge, LA (Orleans, Jefferson and East Baton Rouge parishes)  
• Memphis, TN (Shelby county) vs Charlotte, NC (Mecklenburg county) 
• Atlanta, GA (Cobb, DeKalb, Fulton and Gwinnett counties) vs Washington DC/MD 
suburbs (Washington DC, Montgomery and Prince George’s counties) 
HPTN 096 will use data from the CDC’s National HIV Surveillance System to conduct this 
exploratory analysis. The CDC maintains the National HIV Surveillance System, which is the 
primary source of data for monitoring HIV-related trends in the US [236]. The CDC does this by 
funding and assisting state and local health departments to collect information about the 
diagnosis and prevalence of HIV infection. In turn, these health departments report de-identified 
data to the CDC so that HIV-related information from around the country can be consolidated 
and analyzed. Some of the critical parameters collected include basic demographic information, 
date of diagnosis, acquisition risk and laboratory values (CD4 and viral load measurements) 
[236]. The ultimate goal of this surveillance system is to provide an integrated database that 
includes diagnosed HIV infection, disease progression, and the behaviors and characteristics of 
people with diagnosed HIV infection. The CDC uses this living database to understand the HIV 
epidemic in the US and to direct HIV prevention and treatment funding where it is needed most.  
In addition to guiding public health policy, the CDC’s National HIV Surveillance System can be 
used for research purposes, as data are continuously collected in a prospective manner. As the 
data are geographically linked, they can be categorized by location (e.g., state, county, city, 
facility), which allows the data to be used to measure outcomes for interventions made at the 
community-level. The use of surveillance data for this exploratory objective is feasible because 
the study intervention and their matched standard-of-care communities are contributing data to 
the CDC’s National HIV Surveillance System.  
For the exploratory analysis, viral load data from HHI MSM with diagnosed HIV who are alive 
at the end of each year will be used to compare rates of viral suppression between the study 
intervention and standard-of-care communities at various timepoints.  

 
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All data for this analysis will be collected and maintained by the CDC and CDC staff will 
conduct the analysis. The decision to pursue the analysis will be made in collaboration with the 
protocol team, including the DAIDS Medical Officer. If pursued, the analysis will be performed 
in collaboration with the protocol team. 
13 STATISTICAL CONSIDERATIONS 
13.1 Review of Study Design 
HPTN 096 is a hybrid implementation-efficacy trial the aim of which is to evaluate a status-
neutral integrated strategy to improve access to and uptake of HIV prevention and treatment 
services for HHI MSM. A single arm interrupted time series (ITS) design will be implemented to 
evaluate the integrated strategy, which will be delivered in up to five selected communities in the 
US South. 
13.2 Objectives and Endpoints 
The overall goal of this study is to establish a strategy to reduce HIV incidence among HHI 
MSM in the southern US by increasing the number of HHI MSM accessing prevention and 
treatment services, increasing uptake and use of preexposure prophylaxis (PrEP) among those 
living without HIV and increasing retention in care, and thus viral suppression, among those 
living with HIV in the study communities. The primary and secondary objectives reflect this 
goal, using a mix of quantitative and qualitative measurements. Explicitly, primary measures will 
be derived based on clinical data routinely available in the EMR. 
It is expected that sexual orientation and/or sexual behavior data may not be complete within all 
EMR records. As such, supportive endpoints will be measured among the population of “HHI 
men,” who will have the same demographic characteristics as HHI MSM except for sexual 
orientation/sexual behavior.  
13.2.1 Primary Study Objectives and Endpoints 
• To evaluate whether the HPTN 096 integrated strategy increases the number of HHI 
MSM clients at PHASE healthcare facilities. 
Endpoint:  
o (Primary) Number of HHI MSM with a visit at the HCF in the previous 12 
months (Source: EMR). 
o (Supportive) Number of HHI men with a visit at the HCF in the previous 12 
months (Source: EMR). 
 
• To evaluate whether the HPTN 096 integrated strategy increases retention in care among 
HHI MSM living with HIV at PHASE healthcare facilities. 

 
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Endpoint:  
o (Primary) Number of HHI MSM living with HIV with at least two HIV medical 
visits to the HCF at least 90 days apart within the previous 12 months (Source: 
EMR).  
o (Supportive) Number of HHI men living with HIV with at least two HIV medical 
visits to the HCF at least 90 days apart within the previous 12 months (Source: 
EMR).  
  
• To evaluate whether the HPTN 096 integrated strategy increases PrEP prescriptions for 
HHI MSM not living with HIV at PHASE healthcare facilities. 
Endpoint:  
o (Primary) Any PrEP prescription among all HHI MSM without HIV with a 
medical visit at the HCF within the previous 12 months (Source: EMR). 
o (Supportive) Any PrEP prescription among all HHI men without HIV with a 
medical visit at the HCF within the previous 12 months (Source: EMR). 
13.2.2 Secondary Study Objectives and Endpoints 
• To evaluate whether the HPTN 096 integrated strategy increases viral suppression (<200 
copies/mL) in HHI MSM living with HIV at PHASE healthcare facilities.  
Endpoint:  
o (Primary) Viral suppression of the most recent VL done among all HHI MSM 
living with HIV who had a VL measurement at the HCF in the previous 12 
months (Source: EMR). 
o (Supportive) Viral suppression of the most recent VL done among all HHI men 
living with HIV who had a VL measurement at the HCF in the previous 12 
months (Source: EMR). 
 
• To evaluate whether the HPTN 096 integrated strategy increases PrEP initiation, 
adherence and persistence for HHI MSM not living with HIV at PHASE healthcare 
facilities.  
Endpoint: 
o Self-report of PrEP initiation and adherence in the previous 12 months (Source: 
Cross-sectional assessment in sample of HHI MSM at PHASE HCFs 
[questionnaires]) 
o (Primary) Repeat PrEP prescriptions among HHI MSM not living with HIV in the 
previous 12 months. (Source: EMR).  
o (Supportive) Repeat PrEP prescriptions among HHI men not living with HIV in 
the previous 12 months. (Source: EMR). 

 
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• To assess changes in the experience of autonomy support among HHI MSM at PHASE 
healthcare facilities. 
Endpoint:  
o Self-reported scale measuring autonomy support (Source: Cross-sectional 
assessment in sample of HHI MSM at PHASE HCFs [questionnaires, healthcare 
climate section]) 
o Individual-level qualitative data with a subset of HHI MSM exploring autonomy 
support (Source: Cross-sectional assessment in sample of HHI MSM at PHASE 
HCFs [qualitative interviews]). 
 
• To assess how autonomy support, social support, stigma, barriers to healthcare and 
individual agency among HHI MSM at PHASE healthcare facilities are associated with 
engagement in care (including PrEP prescription and viral suppression). 
Endpoint:  
o Self-reported data related to autonomy support, social support, stigma, barriers to 
healthcare, individual agency (Source: Cross-sectional assessment in sample of 
HHI MSM at PHASE HCFs [questionnaires]) 
o Any PrEP prescription in last 12 months for HHI MSM not living with HIV 
(Source: Cross-sectional assessment in sample of HHI MSM at PHASE HCFs 
[case report forms]) 
o Viral load suppression and retention in care in last 12 months in HHI MSM living 
with HIV (Source: Cross-sectional assessment in sample of HHI MSM at PHASE 
HCFs [case report forms]). 
13.3 Considerations for Power  
For five study communities, the number of HCFs for assessing power for each objective is fixed: 
60 in total, with 20 PHASE HIV treatment HCFs and 40 PHASE HIV prevention HCFs. We 
assess the effect sizes for which we have 80% power to detect for each objective, under a range 
of assumptions. The power assessments for the primary objectives are performed for an 
interrupted time series (ITS) design through simulations, the details of which are given below. 
13.3.1 Simulation for Number of Clients at a Healthcare Facility (HCF) 
The simulations evaluating the power for the endpoint of number of HHI MSM visiting the 
PHASE (both HIV prevention and HIV treatment) HCFs were performed under the interrupted 
time series (ITS) design. The number of clients visiting the 𝑖𝑡ℎ clinic (𝑖= 1, . . , 𝑁) during the 
assessment timepoint 𝑇𝑗 was generated as a Poisson random variable with mean:  
𝐸(𝑛𝑖𝑗) = exp(𝜆𝑖0 + 𝜆𝑖1𝑇𝑗+ 𝜆𝑖2(𝑇𝑗−𝑇0)𝐼[𝑇𝑗> 𝑇0] + 𝜆𝑖3𝐹𝑖+ 𝑒𝑖𝑗) , 

 
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Where 𝑇0 is the baseline time period, expit(𝑥) =
1
1+𝑒−𝑥, 𝐹𝑖 indicates whether the 𝑖𝑡ℎ HCF is a 
HIV prevention facility or not, and (𝜆𝑖0, 𝜆𝑖1, 𝜆𝑖2) is a vector of random coefficients that was 
simulated as a multivariate normal random variable with mean (𝜆00, 𝜆01, 𝜆02) and variance 𝛴𝜆.  
Here exp(𝜆02) is the intervention effect, the relative increase in the average number of HHI 
MSM presenting for service at the PHASE HCFs per year during the intervention periods and 
exp(𝜆03) is the ratio of the number of HHI MSM at PHASE HIV prevention HCFs versus 
PHASE HIV treatment HCFs. Also, 𝑒𝑖1, … , 𝑒𝑖𝑡 are normally distributed and correlated random 
variables with mean zero that were generated such that 𝑒𝑖𝑗= 𝜌𝑒𝑖𝑗−1 + 𝑣𝑖𝑗 (𝑗= 2, … , 𝑡) with 
𝑒𝑖1~𝑁(0, 𝜎𝑒
2) and 𝑣𝑖𝑗~𝑁(0, 𝜎𝑣
2). Here 𝜌= 0.25, 𝜎𝑒
2 = 0.0025, 𝜎𝑣
2 = 0.0025. 
The power assessment was based on a Wald test (testing 𝜆02 = 0) using a generalized estimating 
equation (GEE) modification of the segmented Poisson model with the log link function and 
facilities as clusters and assuming an AR-1 correlation structure. The following additional 
assumptions were made: 
• There were 4 evaluation time periods (𝑇𝑗 , 𝑗= −1, 0, 1, 2) with 𝑇−1 and 𝑇0 being the 
pre-baseline and baseline time periods, respectively. 
• The number of PHASE HIV prevention HCFs was 40. 
• The number of PHASE HIV treatment HCFs was 20. 
• No pre-intervention secular time trend: 𝜆01 = 0. 
• The average number of HHI MSM at PHASE HIV treatment HCFs at baseline was 
assumed to be 30, 50, 90 and 120 at baseline (𝜆00 =
log(30) , log(50) , log(90) , log (120)). This was based on the average number of 
HHI MSM living with HIV and receiving HIV care at HIV treatment HCFs in 
Atlanta, Birmingham, Memphis, Mobile and Montgomery, which was used as a 
proxy for potential PHASE treatment HCFs. This average number was 89 based on 
the CDC 2020 estimates of facility-level number of HHI MSM, aged 13 years or 
older receiving HIV medical care at this set of facilities. 
• The average number of HHI MSM not living with HIV at the PHASE HIV prevention 
HCFs was assumed to be smaller than the average number of HHI MSM at HIV 
treatment HCFs at baseline. In particular, it is assumed that the average number of 
HHI MSM clients at the PHASE HIV prevention HCFs at baseline was 60% of that at 
PHASE HIV treatment HCFs at baseline (𝜆𝑖3 = −0.5): 18, 30, 54,72.  
• The variability of the number of HHI MSM at PHASE HCFs varies from low 
(diag(𝛴𝜆) = (0.01, 0.001, 0.001)), medium (diag(𝛴𝜆) = (0.025, 0.0025, 0.0025)), and 
high (diag(𝛴𝜆) = (0.1, 0.005, 0.005)), 
• Type I error rate = 5% (two-sided). 
• The number of simulation replicates for each scenario was 1000. 
13.3.2 Simulation of Retention in Care and PrEP Prescription  
The number of HHI MSM client/patients visiting the 𝑖𝑡ℎ PHASE HCF during the baseline period 
(𝑛𝑖0) was generated as a Poisson random variable with mean exp (𝛼𝑖0), where 𝛼𝑖0 ~ 𝑁(𝛼00, 𝜎𝛼
2). 

 
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The outcome of interest (PrEP prescription or retention) for a participant visiting the 𝑖𝑡ℎ clinic 
during the time period 𝑇𝑗 was simulated based on the following model: 
𝐸(𝑌𝑖𝑗𝑘) = expit(𝛽𝑖0 + 𝛽𝑖1𝑇𝑗+ 𝛽𝑖2(𝑇𝑗−𝑇0)𝐼[𝑇𝑗> 𝑇0] + 𝑒𝑖𝑗), 
where 𝑇0 is the baseline time period, expit(𝑥) =
1
1+𝑒−𝑥, (𝛽𝑖0, 𝛽𝑖1, 𝛽𝑖2) is a vector of random 
coefficients that was simulated as a multivariate normal random variable with mean 
(𝛽00, 𝛽01, 𝛽02) and variance 𝛴𝛽. 𝛽02, the change in slope during the intervention period, is the 
intervention effect. Here expit(𝛽00 + 𝛽01) is the PrEP prescription (retention) proportion at the 
first assessment time period, 𝛽01 is the slope of the logit-transformed PrEP prescription 
(retention) proportion pre-intervention (before baseline) and 𝛽02 represents the change in slope 
during the intervention period. As before, 𝑒𝑖1, … , 𝑒𝑖𝑡 are normally distributed and correlated 
random variables with mean zero that were generated such that 𝑒𝑖𝑗= 𝜌𝑒𝑖𝑗−1 + 𝑣𝑖𝑗 (j=2,…,t) with 
𝑒𝑖1~𝑁(0, 𝜎𝑒
2) and 𝑣𝑖𝑗~𝑁(0, 𝜎𝑣
2). Here 𝜌= 0.25, 𝜎𝑒
2 = 0.0025, 𝜎𝑣
2 = 0.0025, and 𝜎𝛼
2 = 0.01. It 
is worth mentioning that retention in care and PrEP prescription were modeled separately in the 
simulations based on the model given above. Moreover, the simulations were performed 
separately for the retention in HIV care and PrEP prescription endpoints. Also, the intervention 
effects on retention in care and PrEP prescription are not expected to be the same. 
PrEP prescription (retention) proportion at the 𝑖𝑡ℎ facility and time period 𝑇𝑗 was calculated as  
𝑝𝑖𝑗= ∑𝑦𝑖𝑗𝑘
𝑘
/𝑛𝑖𝑗 
where 𝑛𝑖𝑗 is the number of HHI MSM visiting the ith PHASE HCF during the assessment time 
period. For the power simulation no increase in client/patient volume was assumed, (i.e. 𝑛𝑖𝑗 = 
𝑛𝑖0). The power calculation for the intervention effect under the ITS design was based on a Wald 
test: testing for no change in slope in post-intervention PrEP prescription proportion (or 
retention), that is, 𝛽02 = 0, using a generalized estimating equation (GEE) model for the logit-
transformed proportions 𝑝𝑖𝑗 with the identity link function, facilities as clusters and assuming an 
AR-1 correlation structure for repeated facility observations. The following additional 
assumptions were made: 
• All time periods had a duration of a calendar year, with the baseline period the year 
before the intervention implementation. 
• There were 4 evaluation time periods (𝑇𝑗 , 𝑗= −1, 0, 1, 2) with 𝑇−1 and 𝑇0 being the 
pre-baseline and baseline timepoint (pre-intervention), respectively. 
• The number of PHASE HIV prevention HCFs was 40. 
• The number of PHASE HIV treatment HCFs was 20. 
• The average number of patients at PHASE HIV treatment HCFs was 𝑒𝑥𝑝(𝛼00) =
30, 50, 90, 120 at each time period. 
• The average number of clients at PHASE HIV prevention HCFs was 𝑒𝑥𝑝(𝛼00) =
18, 30, 54, 72 at each time period. 

 
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• The average PrEP prescription proportion at baseline was 18% (𝛽00 = −1.5). This 
assumption was based on the HPTN 096 pilot study data. The average proportion of 
Self-reported current use of PrEP among HHI MSM in the four study communities 
(Houston, Dallas, Greenville and Montgomery) was 21.5% with much smaller 
proportions from the two smaller communities (13% and 17.5%, respectively for 
Greenville and Montgomery) when compared with the larger communities (Dallas 
and Houston). It is expected that several PHASE HIV prevention HCFs will be from 
small communities, and it is possible that the baseline proportion of PrEP 
prescriptions for HHI MSM at the PHASE HIV prevention HCFs would be smaller 
than the observed 21.5% of PrEP use in the sample of HHI MSM from the four 
communities in the pilot study.  
• The average retention proportion at baseline was 77% (𝛽00 = 1.2). This was based on 
the HRSA Ryan White HIV/AIDS program services reports 2020 (Table 12b) and 
2021 (Table 12b) showing overall retention proportions of 77.7% and 75.6% for 2020 
and 2021, respectively for HHI MSM aged 13 years or older receiving HIV care at 
Ryan and White HIV care clinics. 
• The time trend for PrEP prescription pre-intervention varies from no-trend (𝛽01 = 0), 
small trend (𝛽01 = 0.1), moderate trend (𝛽01 = 0.2) and substantial trend (𝛽01 =
0.3). 
• The time trend for retention varies from no-trend (𝛽01 = 0), small trend (𝛽01 =
0.05), moderate trend (𝛽01 = 0.1) and substantial trend (𝛽01 = 0.15). 
• The between-clinic variability varies from low (diag(𝛴𝛽) = (0.01, 0.001, 0.001)), 
medium (diag(𝛴𝛽) = (0.25, 0.025, 0.025)) and high (diag(𝛴𝛽) = (0.5, 0.05, 0.05)). 
• Type I error rate = 5% (two-sided). 
• The number of simulation replicates for each scenario was 1000. 
13.3.3 Power for Primary Endpoints 
Simulation-based power results are provided in Table 6 for the endpoint of number of HHI MSM 
clients at the PHASE HCFs, Table 7 for the retention in care endpoint and Table 8 for the PrEP 
prescription endpoint. The following power statements are derived from the results displayed in 
the tables: 
If the PHASE HIV treatment HCFs served an average of 90 HHI MSM and the PHASE HIV 
prevention HCFs served an average of 54 HHI MSM, with medium variability in number of 
clients between HCFs and assuming no background trend in client volume, we would have 80% 
power to see a relative increase of 17.4% in patient numbers between the baseline period and the 
second year of the intervention.  
If the PHASE HIV treatment HCFs served an average of 90 HHI MSM and average retention in 
care during the baseline period is 77% with a medium variability in retention proportion between 
HCFs and a background improvement in retention of 1% in the absence of an intervention, we 
would have 80% power to see a relative increase of 15% [(expit(𝛽00 + 2𝛽01 + 2𝛽02)/ 
expit(𝛽00) = 1.15] in retention, translating to a 11.6% increase (from 77.0% during the baseline 

 
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period to 88.5% during the last year of the intervention) as a result of the intervention, compared 
to 1.7% increase (from 77.0% to 78.7%) in the absence of an intervention.   
If the PHASE HIV prevention HCFs served an average of 54 HHI MSM, and we assume a 
medium variability in PrEP prescription proportion between HCFs and a 9% background relative 
increase in PrEP prescriptions in the absence of an intervention, we would have 80% power to 
see a relative increase of 120% (expit(𝛽00 + 2𝛽01 + 2𝛽02)/ expit(𝛽00) = 2.2 ) in PrEP 
prescriptions, translating to a 22% increase (from 18.0% during the baseline period to 40% 
during the last year of the intervention) as a result of the intervention, compared to 3.2% increase 
(from 18.0% to 21.2%) in the absence of an intervention.  
Table 6. Power simulations for Objective 1. Relative increase from baseline (Alt. Hypothesis) in 
number of HHI MSM presenting at the PHASE HIV treatment HCFs and PHASE HIV 
prevention HCFs with 80% power over the two years of the implementation of the intervention 
based on a Wald test using a segmented generalized estimating equations (GEE) model for count 
data with the log-link function, assuming an AR-1 correlation structure, alpha=0.05 (two-sided) 
and no underlying time trend (before the start of the intervention). The evaluation assumes 60 
HCFs: 20 PHASE HIV treatment HCFs and 40 PHASE HIV prevention HCFs. 
Size of 
PHASE 
HIV 
treatment 
HCF1 
Size of 
PHASE 
HIV 
prevention 
HCFs2 
SD_btwf3 
SD_total4 SD_care_bsl5 SD_prep_bsl6 Intervention effect 
(𝝀𝟎𝟐)7 
Relative increase8 
Variability of the number of HHI MSM at PHASE HCFs = Low 
30 
18 
2.54 
5.94 
6.36 
4.66 
0.140 
1.323 
50 
30 
4.21 
8.17 
8.80 
6.39 
0.110 
1.246 
90 
54 
7.46 
12.26 
13.51 
9.41 
0.080 
1.174 
120 
72 
9.89 
15.27 
16.89 
11.49 
0.075 
1.162 
Variability of the number of HHI MSM at PHASE HCFs = Medium 
30 
18 
4.13 
7.08 
7.37 
5.21 
0.140 
1.323 
50 
30 
6.73 
10.18 
10.88 
7.44 
0.105 
1.234 
90 
54 
11.91 
16.25 
17.66 
11.62 
0.080 
1.174 
120 
72 
15.70 
20.68 
22.64 
14.69 
0.070 
1.150 
Variability of the number of HHI MSM at PHASE HCFs = High 
30 
18 
8.67 
10.83 
11.75 
7.58 
0.130 
1.297 
50 
30 
14.15 
16.78 
18.60 
11.76 
0.105 
1.234 
90 
54 
24.89 
28.36 
32.31 
20.08 
0.075 
1.162 
120 
72 
32.96 
37.06 
42.71 
26.27 
0.065 
1.139 
1Size of PHASE HIV treatment HCF is the average number of HHI MSM presenting at the PHASE HIV treatment HCFs during 
the baseline period. 
2Size of PHASE HIV prevention HCF is the average number of HHI MSM presenting at the PHASE HIV prevention HCFs 
during the baseline period. 
3SD_btw is the between facility standard deviation of the number of HHI MSM presenting at the PHASE HCFs. 
4SD_total is the square root of the total variance (between facility variance + within facility variance) of the number of HHI 
MSM presenting at the PHASE HCFs. 
5 SD_care_bsl is the standard deviation of the number of HHI MSM with HIV presenting at the PHASE HIV treatment HCFs 
during the baseline period. 
6SD_prep_bsl is the standard deviation of the number of HHI MSM without HIV presenting at the PHASE HIV prevention HCFs 
during the baseline period. 
7Intervention effect is the effect size., which is 𝝀𝟎𝟐. 
8Relative increase is the relative increase from baseline in the number of HHI MSM presenting at the PHASE HCFs at the end of 
the study. This was obtained as 𝑒𝑥𝑝(2𝜆02). 

 
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Table 7. Power simulations for Primary Objective 2. Increase in retention in care proportion at 
the end of the implementation of the intervention for which we have 80% power based on a 
Wald test using a segmented GEE model for the logit transformation of the retention in care 
proportion, assuming an AR-1 correlation structure and alpha=0.05 (two-sided). The number of 
PHASE HIV treatment HCFs was fixed at 20. The baseline retention in care proportion is 
assumed to be 77%. 

 
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1Size is the average number of HHI MSM at the PHASE HIV treatment HCFs during baseline period. 
2Intervention effect (𝛽02) detectable with 80% power 
3 Increase in the retention proportion at the end of the study with the intervention from baseline. This was calculated 
as expit(𝛽00 + 2𝛽01 + 2𝛽02)- expit(𝛽00). 
Size1 
Time 
trend(𝜷𝟎𝟏) 
Relative increase 
(background) from 
baseline of 77% 
Intervention 
effect(𝜷𝟎𝟐)2 
Total increase3 
under alternative 
Total 
increase4 
under null 
Increase due to the 
intervention only5 
Variability of retention in care proportion across PHASE HIV treatment HCF = Low 
30 
0 
1 
0.65 
15.6% 
0.0% 
15.6% 
 
0.05 
1.01 
0.64 
16.1% 
1.7% 
14.4% 
 
0.1 
1.02 
0.63 
16.6% 
3.4% 
13.2% 
 
0.15 
1.04 
0.62 
17.1% 
4.9% 
12.2% 
50 
0 
1 
0.46 
12.4% 
0.0% 
12.4% 
 
0.05 
1.01 
0.46 
13.4% 
1.7% 
11.6% 
 
0.1 
1.02 
0.46 
14.2% 
3.4% 
10.8% 
 
0.15 
1.04 
0.47 
15.1% 
4.9% 
10.2% 
90 
0 
1 
0.33 
9.7% 
0.0% 
9.7% 
 
0.05 
1.01 
0.33 
10.8% 
1.7% 
9.1% 
 
0.1 
1.02 
0.33 
11.8% 
3.4% 
8.5% 
 
0.15 
1.04 
0.33 
12.8% 
4.9% 
7.9% 
120 
0 
1 
0.29 
8.7% 
0.0% 
8.7% 
 
0.05 
1.01 
0.3 
10.1% 
1.7% 
8.4% 
 
0.1 
1.02 
0.29 
11.0% 
3.4% 
7.6% 
 
0.15 
1.04 
0.3 
12.2% 
4.9% 
7.3% 
Variability of retention in care proportion across PHASE HIV treatment HCF = Medium 
30 
0 
1 
0.72 
16.5% 
0.0% 
16.5% 
 
0.05 
1.01 
0.71 
17.0% 
1.7% 
15.2% 
 
0.1 
1.02 
0.69 
17.3% 
3.4% 
13.9% 
 
0.15 
1.04 
0.68 
17.7% 
4.9% 
12.8% 
50 
0 
1 
0.48 
12.8% 
0.0% 
12.8% 
 
0.05 
1.01 
0.48 
13.7% 
1.7% 
12.0% 
 
0.1 
1.02 
0.48 
14.5% 
3.4% 
11.2% 
 
0.15 
1.04 
0.47 
15.1% 
4.9% 
10.2% 
90 
0 
1 
0.37 
10.6% 
0.0% 
10.6% 
 
0.05 
1.01 
0.37 
11.6% 
1.7% 
9.9% 
 
0.1 
1.02 
0.37 
12.6% 
3.4% 
9.3% 
 
0.15 
1.04 
0.37 
13.5% 
4.9% 
8.6% 
120 
0 
1 
0.33 
9.7% 
0.0% 
9.7% 
 
0.05 
1.01 
0.33 
10.8% 
1.7% 
9.1% 
 
0.1 
1.02 
0.33 
11.8% 
3.4% 
8.5% 
 
0.15 
1.04 
0.32 
12.6% 
4.9% 
7.7% 
Variability of retention in care proportion across PHASE HIV treatment HCF = High 
30 
0 
1 
0.83 
17.7% 
0.0% 
17.7% 
 
0.05 
1.01 
0.81 
18.0% 
1.7% 
16.3% 
 
0.1 
1.02 
0.81 
18.5% 
3.4% 
15.1% 
 
0.15 
1.04 
0.79 
18.8% 
4.9% 
13.8% 
50 
0 
1 
0.53 
13.7% 
0.0% 
13.7% 
 
0.05 
1.01 
0.52 
14.4% 
1.7% 
12.6% 
 
0.1 
1.02 
0.51 
15.0% 
3.4% 
11.6% 
 
0.15 
1.04 
0.51 
15.7% 
4.9% 
10.8% 
90 
0 
1 
0.38 
10.8% 
0.0% 
10.8% 
 
0.05 
1.01 
0.38 
11.8% 
1.7% 
10.1% 
 
0.1 
1.02 
0.38 
12.8% 
3.4% 
9.4% 
 
0.15 
1.04 
0.38 
13.7% 
4.9% 
8.8% 
120 
0 
1 
0.36 
10.4% 
0.0% 
10.4% 
 
0.05 
1.01 
0.35 
11.2% 
1.7% 
9.5% 
 
0.1 
1.02 
0.36 
12.4% 
3.4% 
9.1% 
 
0.15 
1.04 
0.35 
13.2% 
4.9% 
8.3% 

 
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4Projected increase in the retention proportion at the end of the study without the intervention from baseline. This 
was calculated as expit(𝛽00 + 2𝛽01)- expit(𝛽00). 
5Difference between the increase in the retention proportion at the end of the study with the intervention and the 
projected increase in the retention proportion at the end of the study without the intervention. This was calculated as 
expit(𝛽00 + 2𝛽01 + 2𝛽02) - expit(𝛽00 + 2𝛽01). 
 
Table 8. Power simulations for Primary Objective 3. Increase in proportion with PrEP 
prescription at the end of the implementation detectable with 80% power, based a Wald test 
using a segmented GEE model for the logit-transformation of the PrEP prescription proportion 
with the identity link function, assuming an AR-1 correlation structure and alpha=0.05 (two-
sided). The number of PHASE HIV prevention HCFs was fixed at 40. The baseline PrEP 
prescription proportion is assumed to be 18%. 
Size1 
Time 
trend(𝜷𝟎𝟏) 
Relative 
increase 
(background) 
from baseline of 
18% 
Intervention 
effect(𝜷𝟎𝟐)2 
Total increase3 under 
alternative 
Total increase4 under 
null 
Increase due 
to the 
intervention 
only5 
Variability of PrEP prescription proportion across PHASE HIV prevention HCF = Low 
18 
0 
1 
1.05 
46.3% 
0.0% 
46.3% 
 
0.1 
1.09 
1.14 
54.5% 
3.2% 
51.3% 
 
0.2 
1.18 
1.20 
60.3% 
6.7% 
53.6% 
 
0.3 
1.29 
1.25 
65.0% 
10.7% 
54.3.% 
30 
0 
1 
0.61 
24.8% 
0.0% 
24.8% 
 
0.1 
1.09 
0.68 
33.3% 
3.2% 
30.1% 
 
0.2 
1.18 
0.75 
41.6% 
6.7% 
34.9% 
 
0.3 
1.29 
0.81 
49.0% 
10.7% 
38.4% 
54 
0 
1 
0.33 
11.9% 
0.0% 
11.9% 
 
0.1 
1.09 
0.34 
16.7% 
3.2% 
13.6% 
 
0.2 
1.18 
0.35 
21.9% 
6.7% 
15.2% 
 
0.3 
1.29 
0.39 
28.8% 
10.7% 
18.1% 
72 
0 
1 
0.28 
9.8% 
0.0% 
9.8% 
 
0.1 
1.09 
0.28 
14.1% 
3.2% 
10.9% 
 
0.2 
1.18 
0.29 
19.0% 
6.7% 
12.3% 
 
0.3 
1.29 
0.30 
24.3% 
10.7% 
13.7% 
Variability of PrEP prescription proportion across PHASE HIV prevention HCF = Medium 
18 
0 
1 
1.09 
48.1% 
0.0% 
48.1% 
 
0.1 
1.09 
1.16 
55.3% 
3.2% 
52.1% 
 
0.2 
1.18 
1.20 
60.3% 
6.7% 
53.6% 
 
0.3 
1.29 
1.22 
64.1% 
10.7% 
53.4% 
30 
0 
1 
0.74 
31.3% 
0.0% 
31.3% 
 
0.1 
1.09 
0.80 
39.2% 
3.2% 
36% 
 
0.2 
1.18 
0.87 
47.2% 
6.7% 
40.5% 
 
0.3 
1.28 
0.94 
54.5% 
10.7% 
43.8% 
54 
0 
1 
0.42 
15.8% 
0.0% 
15.8% 
 
0.1 
1.09 
0.45 
21.9% 
3.2% 
18.7% 
 
0.2 
1.18 
0.49 
28.8% 
6.7% 
22% 
 
0.3 
1.29 
0.55 
36.7% 
10.7% 
26.1% 
72 
0 
1 
0.33 
11.9% 
0.0% 
11.9% 
 
0.1 
1.09 
0.34 
16.7% 
3.2% 
13.6% 
 
0.2 
1.18 
0.35 
21.9% 
6.7% 
15.2% 
 
0.3 
1.29 
0.37 
27.8% 
10.7% 
17.1% 
Variability of PrEP prescription proportion across PHASE HIV prevention HCF = High 
18 
0 
1 
1.10 
48.6% 
0.0% 
48.6% 
 
0.1 
1.09 
1.15 
54.9% 
3.2% 
51.7% 
 
0.2 
1.18 
1.20 
60.3% 
6.7% 
53.6% 

 
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1Size is the average number of HHI MSM at the PHASE HIV prevention HCFs at baseline. 
2Intervention effect means effect size (𝛽02) detectable with 80% power. 
3Total increase in proportion of PrEP prescription at the end of the study with the intervention from baseline. This was calculated 
as expit(𝛽00 + 2𝛽01 + 2𝛽02)- expit(𝛽00). 
4Projected increase in proportion of PrEP prescription at the end of the study without the intervention from baseline. This was 
calculated as expit(𝛽00 + 2𝛽01)- expit(𝛽00). 
5Difference between the increase in the retention proportion at the end of the study with the intervention and the projected 
increase in the retention proportion at the end of the study without the intervention. This was calculated as expit(𝛽00 + 2𝛽01 +
2𝛽02) − expit(𝛽00 + 2𝛽01). 
 
A simulation study was also performed to evaluate the type 1 error rates of the tests assessing the 
intervention effects on the primary endpoints under the ITS design. The data generation in the 
simulations was done similarly as for the power assessment for each endpoint except that this 
was done under the null hypothesis of no intervention effect. The simulations results indicated 
non-substantially inflated type 1 error rates for the endpoints ranging between 0.036 and 0.088 
with the assumed nominal significance level of 0.05 under the different scenarios that were 
considered. 
 
For a minimum of three communities and 36 HCFs (12 PHASE HIV treatment and 24 PHASE 
HIV prevention HCFs), using similar methods, there would be 80% power to detect the 
following differences: for the number of HHI MSM clients at all PHASE HCFs, a relative 
increase of 23.4%; for retention in care (PHASE HIV treatment HCFs), a relative increase of 
18% (absolute change of 13.7%, from 77% at baseline to 90.7% at end of intervention); for PrEP 
prescription (PHASE HIV prevention HCFs), a relative increase of 136% (absolute change of 
25%, from 18.0% at baseline to 43% at end of intervention). 
13.4 Accrual and Retention 
Primary outcomes will be measured over different time periods in this study using facility level 
evaluations based on electronic medical record data from approximately 40 PHASE HIV 
prevention HCFs providing HIV prevention services and approximately 20 PHASE HIV 
treatment HCFs providing HIV treatment services across these five study communities. Given 
that primary data collection will rely on cross-sectional facility level evaluations (obtained from 
Size1 
Time 
trend(𝜷𝟎𝟏) 
Relative 
increase 
(background) 
from baseline of 
18% 
Intervention 
effect(𝜷𝟎𝟐)2 
Total increase3 under 
alternative 
Total increase4 under 
null 
Increase due 
to the 
intervention 
only5 
 
0.3 
1.29 
1.22 
64.1% 
10.7% 
53.4% 
30 
0 
1 
0.84 
36.2% 
0.0% 
36.2% 
 
0.1 
1.09 
0.87 
42.6% 
3.2% 
39.4% 
 
0.2 
1.18 
0.95 
50.8% 
6.7% 
44% 
 
0.3 
1.29 
1.01 
57.2% 
10.7% 
46.5% 
54 
0 
1 
0.51 
20.0% 
0.0% 
20% 
 
0.1 
1.09 
0.55 
26.8% 
3.2% 
23.6% 
 
0.2 
1.18 
0.59 
33.8% 
6.7% 
27% 
 
0.3 
1.29 
0.64 
41.1% 
10.7% 
30.5% 
72 
0 
1 
0.39 
14.5% 
0.0% 
14.5% 
 
0.1 
1.09 
0.42 
20.5% 
3.2% 
17.3% 
 
0.2 
1.18 
0.44 
26.3% 
6.7% 
19.5% 
 
0.3 
1.29 
0.50 
34.3% 
10.7% 
23.6% 

 
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the EMRs), no consideration for accrual and retention of participants is necessary for these 
endpoints. 
On the other hand, there are secondary study endpoints that are based on recruitment into the 
cross-sectional assessment data collected from a subset of HHI MSM at baseline, after one year 
(midpoint) and at the end of the two-year implementation of the integrated strategy (post-
intervention); a subset of these participants will be invited to participate in qualitative interviews. 
For the cross-sectional assessment, it is generally expected that potential participants will be 
recruited, screened, enrolled, and complete their questionnaire all in the same visit. Each PHASE 
HCF will be assigned a target accrual number for each stratification category during each 
sampling timeframe (see Section 4.3.2.1 for stratification), and study coordinators will be 
expected to locally track enrollment and stratification of each participant. Accrual by 
stratification status will also be monitored across PHASE HCFs through the study database once 
data elements are entered from the medical record for each participant. Accrual targets may be 
adjusted across PHASE HCFs based on actual enrollment.  
13.5 Data and Feasibility Monitoring and Interim Analyses 
A multi-tiered data and feasibility monitoring approach will be followed for the duration of this 
study. Data and Safety Monitoring Board oversight is not planned for this study. The monitoring 
approach will include 1) regular ongoing oversight of study implementation activities by 
component-specific and cross-cutting working groups comprised of protocol co-chairs, 
statisticians, key LOC and SDMC staff members, sub-groups of protocol team members, 
implementing partners, and NIH representatives; 2) monthly protocol leadership oversight with 
key members of the protocol leadership team and NIH representatives; and 3) HPTN SMC 
review. The HPTN SMC will conduct interim reviews of study progress, including tracking of 
PHASE HCF participation and EMR data transfer, rates of participant accrual for cross-sectional 
assessments, measures of integrated strategy delivery and uptake (i.e., process measure data), 
and completion of primary and secondary endpoint collection. The frequency and content of 
protocol leadership oversight and HPTN SMC reviews will be determined prior to the start of the 
study as outlined in the HPTN Manual of Operations (MOP) (Section 15.5 Study Monitoring 
Committee (SMC) Oversight) and the Study-Specific Monitoring Plan. The Study-Specific 
Monitoring Plan will outline the key parameters and performance standards that will be 
monitored for both monthly protocol leadership oversight and SMC review.  
Implementation of the intervention is a critical component of protocol leadership oversight and 
HPTN SMC review for this study. Standards for implementation of each of the four components 
will be outlined in the Study-Specific Monitoring Plan with key parameters and performance 
standards to be developed in collaboration with the SMC and NIH representatives. The 
implementation metrics available for each component are described in Protocol Sections 5.3 and 
5.4 (for health access coalitions), 6.3 and 6.4 (for social media), 7.3 and 7.4 (for PHASE) and 8.7 
and 8.8 (for peer support). If the study team is not meeting the agreed upon standards, the study 
team would undergo a remediation/modification process with the SMC and NIH, including the 
potential to stop the study if the implementation of the intervention is so poor that it is judged 
improbable that it could result in substantive change in any of the primary study endpoints. 

 
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13.6 Statistical Analysis 
This section briefly describes the statistical analyses of the primary objectives. Detailed technical 
specifications of the statistical analyses, including secondary objectives will be described in a 
separate Statistical Analysis Plan. 
13.6.1 Primary Analyses 
This trial is designed to assess the effect of the integrated intervention on the following endpoints 
(i) number of HHI MSM clients established in care at these healthcare facilities, (ii) retention in 
care in HHI MSM living with HIV, and (iii) PrEP uptake in HHI MSM not living with HIV. 
Note that although the primary endpoints of number of clients, retention in care, and PrEP uptake 
will be measured among HHI MSM clients, we have also included analogs of these endpoints 
(supportive endpoints) that will be measured among all men with the same demographic 
characteristics as HHI MSM except for sexual orientation and/or sexual behavior who are clients 
at the facilities. Given this is an implementation project, the primary endpoints may be 
influenced by the quality of the data that will be used to identify HHI MSM within the client 
population. Thus, in the scenario that the primary endpoints are limited by data availability and 
completeness (regarding MSM status), the supportive analyses will help for interpretation and 
understanding of the effect of the intervention on the endpoints. 
13.6.1.1 Interrupted Time series (ITS) Model 
All three primary endpoints will be measured over four distinct time periods in this study. Of 
these, two will be pre-intervention measures, collected before the start of the intervention, and 
two will be post-intervention measures, collected in the period between the start of the 
intervention and its conclusion after two years. For notational ease, we define the two-year long 
integrated intervention to be Year 1 and Year 2, starting after the baseline (Year 0), and 
continuing up through the end of Year 2. One of the pre-intervention measures will be the 
baseline period, that is, prior to the start of the integrated intervention, named Year 0. We will 
have another (retrospective) one year pre-baseline period, namely Year -1. Each year will rely on 
EMR data accumulated in the 12-month period. The definition of the end of the baseline year 
will be defined during the first intervention year and may vary by facility but will pre-date 
conducting any PHASE training at the facility.  
The repeated evaluation of the endpoints at these participating PHASE HCFs, including multiple 
pre-intervention and during-intervention measurements, will allow us to implement the 
interrupted time series design [213, 237-239] to assess intervention effect. The pre-intervention 
timepoints will establish a background level and trend. This trend will be interrupted by the study 
intervention and the subsequent two years of observation during the intervention period will 
determine if the integrated strategy has changed the expected trend.  
HPTN 096 is a quasi-experimental study. Quasi experimental designs (QEDs) are non-
randomized designs used for evaluating the effect of interventions, implemented in scenarios 
when randomization is not feasible, as in HPTN 096. The interrupted time series (ITS) design is 
considered the strongest among QEDs and a powerful tool for evaluating the impact of 
interventions implemented in healthcare [237]. Under the ITS design, endpoints are measured at 

 
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different time points before and after implementing an intervention, allowing the change in level 
and trend of endpoints to be compared, to evaluate the intervention effect. Note that the ITS 
design has internal validity even in the presence of a secular time-trend. That is, if there is a 
background rate of improvement of the endpoints even without the intervention the ITS design 
allows modelling background trend (based on the 2 pre-intervention years) separately from the 
intervention effect, so that background changes are not falsely attributed to the intervention 
itself. This design can correctly estimate the intervention effect even in the presence of a 
background time trend, i.e. to detect if the intervention has an additional effect than the 
underlying trend. One necessary assumption of the ITS design is that the temporal trend 
observed in the endpoint in the pre-intervention period would remain the same if the intervention 
is not implemented. 
13.6.1.2 Impact Model for the Interrupted Time Series (ITS) Design 
One important step in an ITS analysis is the selection of the intervention-impact model, that is, to 
hypothesize how the intervention will impact the endpoints if it were effective. Examples of 
some possible impact models are given below (illustration taken from Bernal et al. 2017 – see 
Figure 11 in [238], for (a) level change; (b) slope change; (c) level and slope change; (d) slope 
change following a lag; (e) temporary level change; (f) temporary slope change leading to a level 
change. 
Figure 11. Slope and Level Changes 
 
It is usually recommended that the impact model is selected a priori based on existing literature 
and knowledge of the intervention and the mechanism by which it is expected to act on the 
endpoints. Based on our knowledge of the study setting and implementation process of the 
integrated intervention in HPTN 096, we do not expect any sudden level change in these 

 
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endpoints just following start of the intervention or anytime later, rather we expect the 
intervention to slowly show its impact on these endpoints over time. Hence, impact model (b) 
slope change (from the above figure) is deemed most appropriate for analysis of the HPTN 096 
data, and this model will be implemented in analysis of all three endpoints. 
Endpoint measures from a participating facility will be correlated over time. This correlation is 
due to (i) facility-wise random effect: random fluctuation of these endpoints due to facility-
specific practices, clients, and a varying degree of implementation of the intervention at a given 
facility, and (ii) autocorrelation: consecutive measurement of the endpoints may be more similar 
to one another than measurements that are further apart. 
13.6.1.3 Number of HHI MSM Served at PHASE HCFs 
Our primary measure of the number of HHI MSM at PHASE HCFs will be based on electronic 
medical record (EMR) data (containing the number of clients and visit information) from 
approximately 20 PHASE HCFs that provide HIV treatment services and 40 PHASE HCFs that 
provide HIV prevention services across the five intervention communities. The number of HHI 
MSM will be measured for each participating PHASE (HIV treatment or prevention) HCF at 
each of the four assessment timepoint (pre-baseline, baseline, midpoint and postintervention) as 
the number of HHI MSM with a visit at the HCF in the previous 12 months.  
The primary interest lies in the estimation of the average effect of the implementation of the 
package of interventions on the number of HHI MSM across the HCFs. We will fit the following 
segmented regression model, assuming no immediate level-change, using Generalized 
Estimating Equations (GEE) with autoregressive order 1 (AR-1) correlation structure, clustering 
at the health facility level to estimate and test for the intervention effect: 
                              𝐸(𝑛𝑖𝑗) = exp(𝛾0 + 𝛾1𝑇𝑗+ 𝛾2(𝑇𝑗−𝑇0)𝐼[𝑇𝑗> 𝑇0] + 𝛾3𝐹𝑖)                         (1)      
where 𝑛𝑖𝑗 be the number of clients evaluated at facility 𝑖, 𝑖= 1, … , 𝑁, at time periods 𝑇𝑗, 𝑗∈
{−1,0,1,2} . 𝑁 (𝑎𝑝𝑝𝑟𝑜𝑥𝑖𝑚𝑎𝑡𝑒𝑙𝑦 60) is the total number of participating PHASE HCFs (20 
PHASE HIV treatment HCFs and 40 PHASE HIV prevention HCFs). 𝑇−1 and 𝑇0 are pre-
baseline and baseline, Years -1 and 0, respectively; 𝑇1 and 𝑇2 are intervention, Years 1 and 2, 
respectively. Note that 𝑇0 is the time when the intervention is implemented. 𝐹𝑖 indicates the 
facility type for the 𝑖𝑡ℎ HCF, that is, 𝐹𝑖= 1 if it is a PHASE HIV prevention HCF and 𝐹𝑖= 0 if 
it is a PHASE HIV treatment HCF. exp (𝛾0) is the mean number of HHI MSM clients with at 
least one visit at baseline, 𝛾1is the coefficient associated with the effect of secular (time) trend on 
the logarithm of the number of HHI MSM clients seen at a facility (slope), and 𝛾2 is the 
coefficient associated with the slope change due to the intervention, and hence is the intervention 
effect on the logarithm of the average number of HHI MSM visiting any PHASE HCF, and 
exp (𝛾3) is the ratio of the average number of HHI MSM with a visit at PHASE HIV prevention 
HCFs divided by the average number of HHI MSM with a visit at PHASE HIV treatment HCFs. 
From model (1), we will provide a 95% CI for the intervention effect 𝛾2 and a p-value for testing 
the hypothesis 𝐻0: 𝛾2 = 0 using 𝛼 = 0.05 (two-sided). We will also provide model-based 
estimates for the number of HHI MSM seen at a PHASE HCF (separately for HIV treatment and 
HIV prevention HCFs) and their CI at each time point under the intervention and under the 

 
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counterfactual condition of no intervention. This will facilitate interpretation of the impact of the 
intervention on the number of clients. We will use 𝛾2, the intervention effect in the transformed 
scale, to estimate a total intervention effect (given as Δ) and its 95% CI for each type of PHASE 
HCF, as the difference between the estimated number of HHI MSM clients seen at a given type 
of PHASE HCF at the post-intervention timepoint Year 2 (end of intervention) and model 
predicted estimates at that timepoint under the counterfactual condition of no intervention: 
ΔPrEP =  𝐸(𝑛𝑖2|intervention, HIV prevention HCF) −
𝐸(𝑛𝑖2|no intervention, HIV prevention HCF)  
   = exp(𝛾0 + 𝛾1𝑇2 + 𝛾2(𝑇2 −𝑇0) + 𝛾3) −exp(𝛾0 + 𝛾1𝑇2 + 𝛾3) 
ΔHIV =  𝐸(𝑛𝑖2|intervention, HIV treatment HCF) −𝐸(𝑛𝑖2|no intervention, HIV treatment HCF)  
   = exp(𝛾0 + 𝛾1𝑇2 + 𝛾2(𝑇2 −𝑇0)) −exp(𝛾0 + 𝛾1𝑇2) 
As a sensitivity analysis, we will also repeat the above analyses after adjusting for potential 
confounders in the segmented regression model (1), including the HCF size, and characteristics 
(such as average age) of HHI MSM at any PHASE HCF at baseline. 
13.6.1.4 Retention in Care 
Our primary measure of retention in care among HHI MSM living with HIV will be measured as 
the number of HHI MSM living with HIV with at least two HIV medical visits to the PHASE 
HIV treatment HCFs at least 90 days apart within the previous 12 months at each assessment 
timepoint based on EMR data containing HIV medical visit information from approximately 20 
PHASE HIV treatment HCFs that provide HIV care services across the five intervention 
communities.  
The proportion of HHI MSM living with HIV who are retained in care will be measured for all 
participating PHASE HIV treatment HCFs at each of the four measurement windows (Year -1, 
Year 0, Year 1 and Year 2). The primary interest is in estimating the average intervention effect 
on the retention in care proportion across the PHASE HIV treatment HCFs. We will use a 
segmented GEE model for the logit-transformation of the retention in care proportion using the 
identity link function, assuming no immediate level-change, an AR-1 correlation structure and 
clustering at the healthcare facility-level to test for the intervention effect on the retention in care 
proportion. The GEE model is formulated as follows. 
                           (logit(E(𝑟𝑖𝑗)) = 𝛼0 + 𝛼1𝑇𝑗+ 𝛼2(𝑇𝑗−𝑇0)𝐼[𝑇𝑗> 𝑇0],                                   (2) 
where 𝑟𝑖𝑗 is the retention in care proportion for HIV care facility i at the assessment timepoint 𝑇𝑗 
which is defined similarly as in model (1) for 𝑗= −1, … ,2; and 𝑙𝑜𝑔𝑖𝑡(𝑥) = log (𝑥/(1 −𝑥). 
Also, average of the logit-transformed retention proportion at baseline, 𝛼1is the coefficient 
associated with the effect of secular (time) trend on the logit-transformation of the retention in 
care rate (slope), and 𝛼2 is the coefficient associated with the slope change due to the 
intervention, and hence is the intervention effect on the logit-transformed retention in care. 

 
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From model (2), we will provide a 95% CI for the intervention effect 𝛼2 and a p-value for testing 
the hypothesis 𝐻0: 𝛼2 = 0 using 𝛼 = 0.05 (two-sided). We will also provide model-based 
estimates for retention in care rates and their CI at each time point under the intervention and 
under the counterfactual condition of no intervention. This will help us understand how the 
retention in care rates have been impacted by the background trend as well as the intervention 
over the period of the study. Using large sample approximation for asymptotic behavior of 
functions (that is, the delta method), we can use 𝛼2, the intervention effect, to estimate a total 
intervention effect (given as Δ), as the difference between the estimated retention rates at Year 2 
(end of intervention) and model predicted rates at Year 2 under the counterfactual condition of 
no intervention: 
Δ =  𝐸(𝑟𝑖2|intervention) −𝐸(𝑟𝑖2|no intervention)  
   = expit(𝛼0 + 𝛼1𝑇2 + 𝛼2(𝑇2 −𝑇0)) −expit(𝛼0 + 𝛼1𝑇2), 
As a supportive analysis, we will also repeat the above analyses after adjusting for potential 
confounders in the regression model, including HCF size, and characteristic (such as average 
age) of HHI MSM living with HIV at the PHASE HIV treatment HCFs at baseline. 
13.6.1.5 PrEP Prescription 
Our primary measure of PrEP prescription among HHI MSM living without HIV will be 
measured based on EMR data containing visit, STI diagnosis and PrEP prescription information 
from approximately 40 PHASE HIV prevention HCFs that provide PrEP services across the five 
intervention communities.  
PrEP prescriptions issued will be assessed in HHI MSM living without HIV seen at each PHASE 
HIV prevention HCF. Evaluations will be based on visit history and PrEP prescriptions recorded 
in the EMR of these facilities. PrEP prescription proportion at a facility will be defined as the 
proportion of HHI MSM living without HIV with at least one visit in the past 12 months with a 
PrEP prescription.  
PrEP prescription proportion will be measured for all participating PHASE HIV prevention 
HCFs at each of the four measurement windows (Year -1, Year 0, Year 1 and Year 2). The 
primary interest is in estimating the average intervention effect on the PrEP prescription 
proportion across the HIV prevention health facilities. We will use a segmented GEE model, 
similar to model (2) for the logit-transformation of the PrEP prescription proportion, using the 
identity link function, assuming no immediate level-change, an AR-1 correlation structure and 
clustering at the healthcare facility-level to test for the intervention effect on the PrEP 
prescription proportion. The GEE model is formulated as follows. 
                          𝐸(logit(𝑝𝑖𝑗)) = (𝛽0 + 𝛽1𝑇𝑗+ 𝛽2(𝑇𝑗−𝑇0)𝐼[𝑇𝑗> 𝑇0]),                              (3) 
where 𝑝𝑖𝑗 is the PrEP prescription proportion for PHASE HIV prevention HCF i at the 
assessment timepoint 𝑇𝑗 which is defined similarly as in model (1) for 𝑗= −1, …,2. Also, 𝛽0 is 
the average of the logit-transformed PrEP prescription proportion at baseline, 𝛽1is the coefficient 
associated with the effect of secular (time) trend on the logit-transformed PrEP prescription 

 
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(slope), and 𝛽2 is the coefficient associated with the slope change due to the intervention, and 
hence is the intervention effect on the logit-transformed PrEP prescription proportion.  
After fitting model (3), we will provide a 95% CI for the intervention effect 𝛽2 and a p-value for 
testing the hypothesis 𝐻0: 𝛽2 = 0 using 𝛼 = 0.05 (two-sided). We will also provide model-based 
estimates for PrEP prescription proportion and their CI at each timepoint under the intervention 
and also under the counterfactual condition of no intervention. This will help us understand how 
the PrEP prescription proportions have been impacted by the background trend as well as the 
intervention over the period of the study. Similarly, as for retention, we can use the estimate of  
𝛾2, the intervention effect (for PrEP prescription proportion), we will estimate the total 
intervention effect (given as Δ) as the difference between the estimated PrEP prescription at Year 
2 (end of intervention) and model predicted proportion at Year 2 under the counterfactual 
condition of no intervention, and will be evaluated as the following: 
Δ =  𝐸(𝑝𝑖2|intervention) −𝐸(𝑝𝑖2|no intervention)  
    = expit(𝛽0 + 𝛽1𝑇2 + 𝛽2(𝑇2 −𝑇0)) −expit(𝛽0 + 𝛽1𝑇2) 
As a supportive analysis, we will also repeat the above analyses after adjusting for potential 
confounders in the regression model, including HCF size, and characteristic (such as average 
age) of HHI MSM at the PHASE HIV prevention HCFs, and level of completeness of sexual 
behavior and sexual orientation information at baseline. 
13.6.2 Secondary Analyses 
Details of the analysis plan for the secondary endpoints will be provided in the separate 
Statistical Analysis Plan.  
14 SOCIAL HARMS REPORTING 
It is possible that some elements of the study may result in a social harm. A social harm is 
defined as an undesired change in a person’s relationships, experiences, interactions, rights 
and/or community status that occurs as a direct result of participating in a research study. 
Participants will be enrolled into the peer support component, as well as the cross-sectional 
assessment and qualitative data collection activities that will take place at PHASE HCFs. It is 
possible that those enrolled into these parts of the study may experience social harms, 
particularly if there is a breach of confidentiality. For these aspects of the study, social harms 
will be reported by participant identification number to the study database. 
Individuals who participate in other PHASE, health access coalitions and social media 
component activities may also experience negative impacts. For example, the PHASE 
component is designed to increase the level of sexual orientation data collected in medical 
records, which may lead to social harms due to clinic staff having access to this information. In 
addition, social harms may also occur to implementers of the integrated strategy components. 
For example, social media content that is developed for the purposes of the study may cause the 
content creators to be negatively targeted or bullied by members of the online community. The 
study team will be vigilant for evidence of such incidents and will report them to the study 

 
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database in association with the relevant intervention component. Implementers will also be 
instructed on how to report such incidents to the study team – for either themselves or on behalf 
of others who may have been negatively impacted by the study activities – for documentation in 
the study database.  
A summary of all social harms will be reported to the single institutional review board (sIRB) 
and the SMC at least annually. The protocol team and SMC will review the social harms and 
watch for any trends. If needed, adjustments will be made to study conduct. In addition, the 
study’s CAG may be consulted to help minimize the potential occurrence of specific types of 
social harms if trends are discovered.  
15 HUMAN SUBJECTS CONSIDERATIONS 
15.1 Ethical Review 
This protocol will be reviewed and approved by the HPTN Scientific Review Committee and 
NIAID Prevention Science Review Committee with respect to scientific content and compliance 
with applicable research and human subjects regulations.  
The protocol, participant education and recruitment materials (including electronic and verbal 
consent language), and other requested documents — and any subsequent modifications — also 
will be reviewed and approved by the HPTN single IRB (sIRB), as the IRB responsible for 
oversight of this research study.  
The HPTN Leadership and Operations Center (LOC) will make progress reports to the sIRB as 
needed and within three months of study termination or completion. All changes in research and 
all unanticipated problems involving risks to human subjects or others will also be provided to 
the NIH and sIRB.  
15.2 Orientation to the Human Subjects Consideration Section 
Human subjects considerations for each component of the integrated strategy and the data 
collection activities are detailed in the sub-sections below separately for each activity.  
15.3 Health Access Coalition Component Human Subjects Considerations 
In general, data collection activities for the health access coalition component are limited to 
descriptive, aggregate organizational and activity information about coalitions in each 
community and do not include collection of data or private identifiable information on any 
individual coalition members. Coalition members are not considered study participants. 
However, coalition members will be expected to complete periodic anonymous coalition 
effectiveness inventory surveys to self-report the effectiveness of their coalition. These surveys 
are considered to be human subjects research, but in this case, they are expected to meet the 
definition for exempt under 45 CFR 46.104(d)(2)(i), as data will be collected anonymously. 

 
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15.3.1 Health Access Coalition Component Informed Consent 
As the health access coalition component is expected to be exempt under 45 CFR 46(d)(2)(i), 
written informed consent will not be collected. However, as part of standardized coalition 
training, all coalitions members will be informed that their participation in the coalition is part of 
a research study. The training will also cover the kind of information that will be collected and 
reported about their coalition and its activities, as well as the coalition effectiveness inventory 
survey. Members will also be informed that no data or identifiable information about individual 
members will be stored by the HPTN 096 study team, analyzed, or included in any publication.  
15.3.2 Health Access Coalition Component Risks 
Though not considered study participants, coalition members involved in HPTN 096 study 
activities may face some risks. These include possible social harms, stigmatization, or risks 
related to unwanted disclosure of HIV status or sexual orientation due to association with an 
HIV- and MSM-related research study. To minimize these risks, no personal identifying 
information about individual coalition members will be stored as study data, analyzed, or 
included in any HPTN 096 publications. All social harms will be reported and monitored as 
described in Section 14.  
15.3.3 Health Access Coalition Component Benefits 
Coalition members and communities may benefit from involvement in this study. Coalition 
activities may change social norms around HIV and foster collective efficacy of local 
organizations to improve the social and healthcare environments in which individuals exist and 
receive HIV care and preventive services. Coalition members may also benefit from an increase 
in knowledge and awareness related to HIV prevention and treatment, as well as from capacity-
building and professional networking that may result from coalition participation.  
15.3.4 Health Access Coalition Component Incentives  
Coalition members will be compensated for their time spent towards coalition activities. 
Coalition member compensation structures will be equal across all communities, determined by 
the study team at rates assessed to be comparable to market value, and transparently 
communicated to all coalition members.  
15.4 Social Media Component Human Subjects Consideration 
This section addresses only educational social media content created, posted and advertised as 
part of the social media component intervention and does not address social media used for 
recruitment purposes for the peer support component (this is addressed in the peer support 
human subjects section).  
Data will be collected from a subset of individuals exposed to social media content to determine 
if the social media content is reaching the intended audience of HHI MSM. These data will be 
collected via:  
• anonymous and/or confidential pop-up questions or surveys (with or without incentives) 

 
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• individual interviews 
• focus groups 
Surveys and interviews are considered to be human subjects research, but in this case, they are 
expected to meet the definition for exemption under 45 CFR 46.104(d)(2)(i) (because the data 
are collected anonymously) or 45 CFR 46.104(d)(2)(iii) (because there are adequate provisions 
to protect the privacy of subjects and maintain the confidentiality of data).  
If incentives are used for pop-up question or survey completion, limited identifying information 
(for example, an email address) will be collected and a unique code will be used to prevent 
someone from completing the surveys or interviews more than once for fraud prevention 
purposes. Measures will be taken to protect the privacy and confidentiality of contact 
information and the data collected. Each survey will be authenticated by a unique code that 
participants must use to begin the survey and request their incentive. If collected, limited contact 
information to receive the incentive will be stored separately from the data. Those who complete 
these incentivized pop-up questions or surveys will be informed that their limited contact 
information will only be used to provide the incentive. This limited contact information will not 
be able to be linked to survey data.  
For individual interviews and focus groups, limited identifying information (name, address, 
phone, email) will be collected to set up the interview/focus group session and to provide 
incentives. A link-log will be maintained to provide a unique identifier for each participant and 
to ensure that no one participates in the interviews or focus groups more than once. Interviews 
and focus groups will be recorded and transcribed using the unique identifier; once an accurate 
transcription is obtained, the recording will be destroyed. Names and other identifying 
information will be redacted from transcripts. Once all interviews and focus groups are complete 
and accurately transcribed, the link-log will be destroyed.  
All social media data collection tools, including pop-up questions, surveys and individual 
interview and focus group guides will be submitted and approved by the sIRB prior to use.  
15.4.1 Social Media Component Informed Consent 
As the social media component is expected to be exempt under 45 CFR 46.104(d)(2)(i) or 45 
CFR 46.104(d)(2)(iii), written informed consent will not be collected. However, individuals 
completing pop-up questions or surveys, and participating in interviews or focus groups, will be 
informed that they are providing information for a research study.  
15.4.2 Social Media Component Risks 
While measures will be taken to protect the privacy and confidentiality of contact information 
and the data collected from individuals taking part in social media data collection activities, it is 
possible that the data could be linked to the contact information. In addition, it is possible that 
individuals may experience social harm by participating in the social media campaign, for 
example if people recognize them in a social media post or ad and harass them for assumptions 
made about their sexual orientation or HIV status. All social harms will be reported and 
monitored as described in Section 14.  

 
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15.4.3 Social Media Component Benefits 
There may be no direct benefits to individuals exposed to social media content as part of this 
study or participating in social media data collection activities. However, individuals who see the 
messaging may benefit from learning HIV-related information and acting on it. The information 
learned from the study may also improve how HIV-related social media messaging reaches and 
appeals to HHI MSM.   
15.4.4 Social Media Component Incentives 
Compensation will not be provided to any individual social media users for viewing the content 
distributed for the study. However, appropriate compensation will be provided, pending sIRB 
approval, for pop-up questions (if incentivized), surveys (if incentivized), interviews and focus 
groups used to determine if the social media content is reaching HHI MSM.  
15.5 Peer Support Component Human Subjects Considerations 
Participants enrolled in the peer support component will not be followed as in a typical clinical 
trial. Once enrolled, participation in the peer support component can continue until the study 
ends, in that peer support participants are eligible to contact peer supporters and receive peer 
support services at their desired frequency throughout the duration of the study. Data will be 
collected on individual participants and their use of the program, and as such, participant-level 
data collection activities constitute non-exempt human subjects research, and 45 CFR 46 applies. 
All peer support recruitment materials, including content to be utilized via social media as 
appropriate and print materials, will undergo sIRB review and approval.  
Adolescents aged 15 to 17 years of age are eligible to participate in the peer support component. 
Per the US Code of Federal Regulations (CFR), the HPTN sIRB must consider the potential risks 
and benefits to these participants as described in 45 CFR 46 Subpart D. With respect to 45 CFR 
46 Subpart D, the specifications of 45 CFR 46.404 are expected to apply to adolescent 
participants not of legal age to consent in the peer support component. The study involves no 
more than minimal risk to any participant. 
Personal information (such as place of residence, name, age, contact information, etc.) will be 
obtained from participants to determine program eligibility and to link the participant with a peer 
supporter. This information will be maintained confidentially and stored securely in a separate 
area of the database from where data for analysis is stored. As necessary, implementers including 
peer supporters will have the names and contact information of participants to identify them and 
provide appropriate support services. The peer supporters, in collaboration with the study team 
and the local organizations, will implement confidentiality protections and identify potential 
confidentiality issues and strategies to address them. Training will also emphasize the 
importance of protecting the confidentiality of participants and the data collected about the 
participants. Peer support sessions may be conducted virtually and/or in person. The platform by 
which the peer supporter will conduct virtual support sessions with the participants will allow 
secure two-way messaging (for text) and audio and/or video calling. All communication between 
the participant and the peer supporter will be conducted privately, and every effort will be made 
to protect participant’s privacy and confidentiality to the extent possible. 

 
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Study data in the form of surveys and assessments will be completed by participants following 
peer support sessions. This data will be identified by a coded number to maintain client 
confidentiality. All participants will be authenticated and assigned a study identification number 
within the study database; thus, no linkage log will be maintained. All reports summarizing peer 
support process data will include aggregate data only and will not include any participant 
identifying information. For individual interviews and/or focus groups, limited identifying 
information (such as name, contact information) will be captured to coordinate the 
interview/focus group session and to provide reimbursement for participation. These sessions 
will be recorded and transcribed; and any identifying information will be redacted from 
transcripts to protect participant identity. All tools and guides used in the conduct of any 
interviews and/or focus groups will be submitted and approved by the sIRB prior to use.  
Participants’ information will not be released without their written permission, except as 
necessary for study review, monitoring, and/or auditing purposes.  
15.5.1 Peer Support Component Informed Consent 
Per 45 CFR 46.117, participation in the peer support component poses no more than minimal 
risk of harm to participants because the peer support activities are low risk, involve no 
procedures for which written consent is normally required outside of the research context, and 
participants would not be deprived of any clinical care for which they would otherwise be 
entitled. Therefore, a waiver of documented written consent will be requested for all participants. 
However, all potential participants will review the consent text (electronically) prior to enrolling 
in the peer support component. The consent text will include a checkbox where the participant 
must acknowledge their willingness to participate in the peer support component. All participants 
will be offered the ability to download a copy of the consent text for their records. The consent 
language will be submitted to and approved by the sIRB prior to implementation. All peer 
supporters will be trained to properly conduct and ensure the integrity of the informed consent 
process. Participants requested to participate in an interview and/or focus group will be reminded 
that they are participating in these sessions as part of a research study and their permission to 
participate will be documented.  
Per 45 CFR 46.408(a), it is expected that adolescents participating in this study would be deemed 
capable of providing assent, as all participants will be at least 15 years of age. However, per 45 
CFR 46.408(e), a waiver of documented assent will be requested in accordance with the same 
criteria for adult participants given that the study is low risk. Additionally, a waiver of 
parental/guardian permission will be requested for these adolescents per 45 CFR 46.408(c). This 
is because the study is designed for a population for which parental or guardian permission is not 
a reasonable requirement to protect the study participants. There is concern that parent/guardian 
knowledge of a participant’s involvement in the study may pose significant risk to participant’s 
privacy and confidentiality, particularly for those whose parents are not aware or supportive of 
their sexual orientation, and stigma may prevent these adolescents from participating in the 
study.  
It is the responsibility of the HPTN sIRB to determine the level of risk to adolescents in the 
categories specified in 45 CFR 46.404-407. The risk category assigned by the sIRB will 
ultimately determine the parental informed consent and assent requirements for the study. 

 
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Additionally, it will be the responsibility of the sIRB to require any additional mechanisms to 
protect adolescent participants in lieu of parent/guardian permission, per the DAIDS Site Clinical 
Operations and Research Essentials (SCORE) Manual: Informed Consent of Participants: 
https://www.niaid.nih.gov/sites/default/files/score-informed-consent.pdf.  
15.5.2 Peer Support Component Risks 
It is not expected that this study component will expose human subjects to unreasonable risk. 
Participation in this research includes the risks associated with the loss of confidentiality and 
discomfort with the nature of topics when discussing sexual behaviors and other practices. 
Discussion topics covered during support sessions may cause program participants discomfort 
given their personal nature. Feelings of embarrassment may arise from thinking or talking about 
one’s own behavior or attitudes on sensitive topics, such as discussing one’s sexual behavior and 
ways to protect against or manage HIV. Disclosure of one’s HIV and STI status may cause 
worry, sadness, or depression. Trained peer supporters and a mental health professional will be 
available to help participants deal with these feelings and answer any questions the participants 
may have.  
Although the study team will make every effort to protect participant privacy and confidentiality, 
it is possible that participants' involvement in the study could become known to others, and that 
social harms may result. For example, participants may experience stigma and could be treated 
unfairly or discriminated against or could have problems being accepted by their families and/or 
communities because they assume that they have HIV, or their sexual orientation is assumed, by 
taking part in the study. All social harms will be reported and monitored as described in Section 
14.  
Support sessions may take place in person or via the participant’s personal device (cell phone, 
computer, etc.). There is a possibility that the participant may exceed their data plan limit on 
their personal device if used to access the program. 
15.5.3 Peer Support Component Benefits 
There may be no direct benefits to program participants in this study, however, program 
participants will be able to engage with peers who possess similar lived experience and talk 
about what they are going through or why support is being sought. Additionally, participants and 
others may benefit in the future from information learned from this study. Specifically, 
information learned in this study may lead to the development of effective prevention programs 
improving HIV prevention, care and support services for HHI men. Participants also may 
appreciate the opportunity to contribute to the field of HIV prevention research. 
15.5.4 Peer Support Component Incentives 
Pending sIRB approval, peer support component participants will be compensated for their time 
and effort in the study. They will be compensated for taking part in an initial support session, for 
responding to brief surveys about their experiences obtaining peer support and for taking part in 

 
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any interviews and/or focus group sessions. Specific reimbursement amounts will be outlined in 
the study informed consent text and information sheet and will be explained to participants.  
15.6 PHASE Component Human Subjects Considerations 
The PHASE component of the integrated strategy involves intervening on healthcare facilities 
and their staff, and will include collection of various types of data, each of which have different 
human subjects’ considerations:  
1. Pre-/post-training assessments for Foundation and ECHO: Surveys to assess 
knowledge and attitude change related to healthcare provision to HHI MSM will be 
implemented with HCF staff pre- and post-training for the Foundation workshops as well 
as the ECHO sessions. These assessments are considered to be human subjects research, 
but they are expected to meet the definition for exemption under 45 CFR 46.104(d)(2)(i), 
as data will be collected anonymously. Pre and post responses will be linked via a 
participant-created unique code that will be known only to the participant and will not be 
retained on a link-log. All participants are expected to be of legal age to provide consent.  
2. Participant experience training evaluations: Participant evaluations will be 
administered after the Foundation workshops and ECHO sessions. As these evaluations 
are for internal quality assurance and improvement purposes, they do not meet the 
definition of human subjects research under 45 CFR 46.102(l).   
3. Quality Improvement (QI) data: QI clinical, client/patient, and provider data are 
collected (as described in Section 8.2.5) by each HCF for QI purposes only and are not 
collected in the study database or systematically analyzed for this study. As these data 
collection activities are for each HCF’s quality improvement purposes, they do not meet 
the definition of human subjects research under 45 CFR 46.102(l), which is defined as 
“…a systematic investigation, including research development, testing and evaluation, 
designed to develop or contribute to generalizable knowledge…”    
15.6.1 PHASE Component Informed Consent 
The pre-/post-training assessments are the only activities considered human subjects research as 
a part of the PHASE intervention. As they are expected to meet the definition for exemption 
under 45 CFR 46.104(d)(2)(i), informed consent will not be collected. However, HCF staff 
participating in the trainings will be shown a brief online informational form within which they 
must acknowledge their agreement to participate in the assessment prior to entering the web-
based assessment and will be permitted to opt out of the assessments.  
Additionally, in the interest of transparency, all HCF staff participating in PHASE activities will 
be informed of the nature of their clinic participation as part of a research study. Individual HCF 
staff will not be required to participate in any specific activities of PHASE and are permitted to 
opt out.  

 
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15.6.2 PHASE Component Risks 
It is not expected that PHASE participation will expose HCF staff to unreasonable risk. 
However, participants may feel uncomfortable, worried, sad, or anxious when discussing stigma 
and discrimination or experience other types of social harms because they provide services to 
HHI MSM related to HIV. The PHASE training team will be available to help address these 
feelings as they come up in trainings. All social harms will be reported and monitored as 
described in Section 14.  
15.6.3 PHASE Component Benefits 
There may be a wide range of benefits from PHASE participation. Preventing or reducing 
intersectional stigma and changing organizational norms around providing HIV services can 
improve the social and healthcare environments in which individuals exist and receive HIV care 
and preventive services. Staff members may benefit from an increase in knowledge and 
awareness related to service provision to HHI MSM, as well as from capacity-building and 
professional networking that may result from PHASE participation. 
15.6.4 PHASE Component Incentives 
HCFs will be provided with a small compensation package that is intended to offset, but not 
entirely compensate for, any revenue loss or staff time expended as a result of participation in 
PHASE activities. Individual staff members will not be compensated for participation in PHASE 
activities or for completion of PHASE training assessment surveys or evaluations.  
15.7 Cross-Sectional HHI MSM Assessment Human Subjects Considerations 
The cross-sectional HHI MSM client assessment is considered human subjects research and 45 
CFR 46 Subpart A applies. Individuals participating in the cross-sectional assessment will be 
considered study participants and will be enrolled into the study. Cross-sectional assessment 
participation will include completion of a behavioral questionnaire by the participant as well as 
collection of limited medical record information abstracted from the participant’s medical chart 
and submitted via case report form to the study database to be linked with questionnaire data. 
Study participation will not involve investigational drugs or devices, nor will directly identifying 
data be collected; thus, the cross-sectional HHI MSM client assessment involves no more than 
minimal risk to any participant. 
15.7.1 Cross-Sectional Assessment Informed Consent and Authorization to Use Protected 
Health Information 
A waiver of written informed consent will be requested under 45 CRF 46.117(c)(1)(ii) as this 
study activity presents no more than minimal risk to participants. Prior to enrolling in the study, a 
study information sheet will be reviewed with each participant as part of the recruitment process 
and participants will be offered a copy. The information sheet will be submitted to and reviewed 
by the sIRB. Potential participants deemed eligible who agree to participate will be required to 
review a brief electronic consent form and enter their agreement to participate into the electronic 
consent form prior to proceeding to the survey. The consent language will be submitted to and 
approved by the sIRB prior to implementation along with the survey tool.  

 
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As data collection involves abstraction of medical record information that is considered protected 
health information (PHI), such as medical visit and diagnosis dates, a Health Insurance 
Portability and Accountability Act (HIPAA) authorization will be obtained from each participant 
prior to enrollment. The HIPAA authorization will be captured on an sIRB-approved form that 
meets requirements of 45 CFR 164.508.  
15.7.2 Cross-Sectional Assessment Risks 
It is not expected that this study activity will expose participants to unreasonable risk. 
Participation in the cross-sectional assessment includes the risks associated with the loss of 
confidentiality and discomfort with the nature of topics when answering questions related sexual 
behaviors, barriers to healthcare, and HIV and other STIs. 
Although the study team will make every effort to protect participant privacy and confidentiality, 
it is possible that participants' involvement in the study could become known to others, and that 
social harms may result. For example, participants may experience stigma and could be treated 
unfairly or discriminated against or could have problems being accepted by their families and/or 
communities because their HIV status or sexual orientation may be assumed by taking part in the 
study. All social harms will be reported and monitored as described in Section 14.  
15.7.3 Cross-Sectional Assessment Benefits 
There may be no direct benefits to participants in this study. However, participants may benefit 
indirectly. The information gathered from the assessment may show how healthcare services can 
be provided more successfully to HHI MSM, which may impact healthcare provision to 
participants and other members of their community.   
15.7.4 Cross-Sectional Assessment Incentives 
Pending sIRB approval, participants will be offered compensation for their time and effort in this 
study activity. Specific information regarding compensation, including how compensation will 
be provided and the amount, will be specified in the electronic consent text and explained to 
participants.  
15.8 EMR Data Collection Considerations 
Collection of EMR data at PHASE HCFs for study endpoint assessment is expected to meet the 
definition for human subjects research because such data may include identifiable private 
information. Data collected will be limited to information collected as part of the medical record 
for client care and will not be generated specifically for this study. This activity is expected to 
meet the criteria for exemption under 45 CFR 46.104(d)(4)(ii), in that it involves only secondary 
research using identifiable private information that will be recorded in such a manner that the 
identity of the human subjects cannot readily be ascertained directly or through linked identifiers, 
human subjects will not be contacted through the use of this data or because of their affiliation 
with the dataset, nor will they be re-identified.  
Any information available to the SDMC in the central database will first be stripped of client 
identifiers and identified only by a unique study code. However, as visit and laboratory test dates 

 
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will be retained in the study database, the data is considered a limited data set [240] under the 
HIPAA Privacy Rule per 45 CFR 164.514e, meaning that it would not be considered fully 
deidentified. Only the minimum necessary information needed to assess study endpoints will be 
extracted from the medical record and used to generate the limited dataset for analysis. It is 
expected that use of the limited data set will meet requirements for a waiver of individual 
authorization under the Privacy Rule per 45 CFR 164.512(i) [241]. 
Specifically, the use of the data involves no more than minimal risk; the transmitted data will be 
stripped of all direct identifiers and plans will be in place with the participating HCFs both to 
protect the identifiers and destroy them after the study; the dataset provided to the HPTN SDMC 
will not be reused or disclosed to any other person or entity outside of the use for this research 
study except as required by law; the research could not practicably be conducted without this 
waiver as assessment of study endpoints necessitates a complete set of data on all HHI MSM and 
men with the same demographic characteristics except for sexual orientation and/or sexual 
behavior who are clients at the participating HCFs, and this may not be possible to obtain if 
individual authorization were required; and the study design requires this limited data set of 
identified elements from the medical record in order to assess study endpoints.  
The third-party vendor will be responsible for retaining a link-log in order to link client-level 
deidentified data across all study timepoints; however, the HPTN SDMC, as receiver of the data, 
will never have access to this link-log. As such, the identity of clients will not be readily 
ascertained by the investigators through the link-log. Agreements will be established between 
each participating HCF and the third-party vendor.  These agreements will meet the standards 
specified in the Privacy Rule under HIPAA.  
15.8.1 EMR Data Collection Informed Consent 
As collection of EMR data for this study activity is expected to be exempt under 45 CFR 
46.104(d)(4)(ii), written informed consent will not be collected. 
15.8.2 EMR Data Collection Risks 
All efforts will be made to protect the privacy, security and confidentiality of medical record data 
obtained for the study; however, there is a small risk that a privacy or security breach may occur 
when de-identifying medical record information. Data systems and data handling procedures for 
capturing, transferring, and storing electronic data obtained from EMRs by the third-party vendor 
have been developed to preserve client confidentiality, privacy, and security. However, if a 
privacy or security breach does occur, it will be captured as a social harm. All social harms will 
be reported and monitored as described in Section 14. 
15.8.3 EMR Data Collection Benefits 
There may be no direct benefits to clients/patients whose data are used for this research study. 
However, clients whose data are used in this study may benefit indirectly, as well as future 
clients/patients. The information learned from the study may positively impact how healthcare 
services are provided to HHI MSM.   

 
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15.8.4 EMR Data Collection Incentives 
Clients whose medical records are accessed for this study will receive no compensation.  
15.9 Qualitative Data Collection Considerations 
Qualitative data collection activities (specifically, IDIs) with PHASE staff members and PHASE 
healthcare facility clients/patients are considered human subjects research, and 45 CFR 46 
Subpart A applies. For PHASE clients/patients, a subset of individuals who participated in the 
cross-sectional HHI MSM client assessment will be selected for interviews; they will already be 
considered study participants and will be enrolled in the study. Contact information for cross-
sectional participants who agree to be contacted about qualitative interviews will be stored in a 
separate database from assessment data and will not be linked to assessment data. 
15.9.1 Qualitative Data Collection Informed Consent 
A waiver of written informed consent will be requested under 45 CFR 46.117 (c)(1)(ii), as 
participation in qualitative interviews presents no more than minimal risk to participants. 
Additionally, for staff members, 45 CFR 46.117(c)(1)(i) applies, as a signed informed consent 
document would be the only information linking the participant to the research. Before 
proceeding with interviews, participants will be verbally informed about the study and provide 
oral consent. The oral consent language will be submitted for sIRB review with the drafted 
interview guide. 
Adolescents participating in this study would be deemed capable of providing assent as 
described in 45 CFR 46.408(a). A waiver of parental/guardian consent will be requested for 
those not of legal age to consent, per 45 CFR 46.408(c). This study is designed for a population 
(HHI MSM in the southern US) for which parental or guardian permission is not a reasonable 
requirement to protect the study participants. There is concern that parent/guardian knowledge of 
a participant’s involvement in the study may pose a significant risk to participant’s privacy and 
confidentiality, particularly for those whose parents are not aware or supportive of their sexual 
orientation, and stigma may prevent these adolescents from participating in the study.   
Per 45 CFR 46.408(e), the sIRB will be requested to waive documented assent in accordance 
with the same criteria for adult participants. 
15.9.2 Qualitative Data Collection Risks 
Participants may feel uncomfortable or embarrassed by some of the questions asked in 
interviews; however, they can refuse to answer any question or leave the discussion at any time. 
15.9.3 Qualitative Data Collection Benefits 
There may be no direct benefits to participants in this study. However, participants (both 
clients/patients and staff), other clients/patients, and other healthcare organizations may benefit 
from the information learned about stigma and providing care for HHI MSM through the 
interviews.  

 
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15.9.4 Qualitative Data Collection Incentives 
Pending sIRB approval, participants will be compensated for their time and effort participating in 
the qualitative data collection activities. Reimbursement amounts will be specified in the verbal 
consent text and explained to participants.  
15.10 Confidentiality for all Study Activities 
All study-related information will be stored securely. Electronic documents will be stored using 
appropriate computer security protections. All other participant information such as forms, lists, 
logbooks, appointment books, and any other listings that link participant ID numbers to other 
identifying information will be stored in a separate, locked file in an area with limited access to 
study staff. All reports, study data collection, process, and administrative forms will be identified 
by a coded number to maintain participant confidentiality. All databases will be secured with 
password-protected access systems.  
Interviews and focus groups will be conducted in a private location or through a video 
conferencing platform. Interviews and focus groups will be recorded and then transcribed by 
qualified personnel. All participant identifiers will be removed from transcripts, and all reports 
and publications will be carefully redacted to ensure that identification of interview or focus 
group participants is not possible.  
Reports and public use datasets produced from data collected will present only completely 
deidentified data in compliance with HIPAA Safe Harbor standards [242] for de-identification of 
data. 
15.11 Study Discontinuation 
The study may be discontinued at any time by NIAID, the HPTN, and/or the sIRB.  
16 ADMINISTRATIVE PROCEDURES 
16.1 Source Documentation and Direct Data Entry 
Direct data entry or direct data capture of study data into the study database is only allowed 
when capturing information directly from the participant (participant self-report). Other study 
data will be sourced from electronic or paper source documents prior to being entered into the 
database. Source documentation tables will be finalized prior to implementation. 
16.2 Protocol Registration 
There will be no protocol registration requirements for this study because it does not include an 
investigational agent and there are no informed consent forms. There will also be no safety or 
medically related adverse event data collection and participating organization (e.g., PHASE 
HCFs) will not undergo traditional monitoring. 

 
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16.3 Study Activation 
For the integrated strategy components, a formal study activation process will not be followed. 
However, for any given study component, operational feasibility conditions will be met prior to 
the start of implementation of that component. For example, health access coalitions, CLOs, and 
peer support implementing partners must complete study-specific training prior to study 
activities. Further, financial agreements with any implementing partners must be in place prior to 
the initiation of study activities. Given that PHASE HCFs will be involved in data collection for 
endpoint assessment, these organizations must undergo a training and activation process prior to 
implementation. Specific operational and fiscal tasks required prior to initiation of integrated 
strategy intervention implementation and data collection activities will be determined and 
monitored by HPTN LOC staff and documented internally.  
16.4 Study Coordination 
Study implementation will be directed by this protocol as well as the implementation manuals 
specific to each component of the integrated strategy and data collection activities. The 
implementation manuals will outline study procedures; how data will be captured and processed; 
management and reporting; intervention oversight and monitoring; and other study operations. 
For the data collection activities, including EMR data extraction, study electronic case report 
form (eCRF) completion, questionnaire administration, qualitative data collection and other 
study instruments, instructions will be developed by the protocol team and HPTN SDMC. Data 
will be submitted to the HPTN SDMC or the HPTN LOC, as appropriate, for cleaning, reporting 
and analysis. Quality control data queries will be generated on a routine schedule for verification 
and resolution by local data management staff. 
Close coordination between protocol team members will be necessary to track study progress, 
respond to queries about proper study implementation, and address other issues in a timely 
manner.  
16.5 Study Monitoring 
Because there will be minimal data collected via eCRFs, no signed informed consent forms, no 
long-term follow-up of individual participants, and the components of the integrated strategy are 
all expected to be deemed low risk, no traditional on-site study monitoring will take place for the 
study. However, oversight will be provided for each component, including, but not limited to, 
monitoring the process measures, routine protocol team monitoring of component engagement, 
and HPTN SMC review. The HPTN LOC, HPTN SDMC, DAIDS and their designees may visit 
the implementing partner organizations and PHASE HCF sites. Site visits may be used to:  
• verify compliance with human subjects and other research regulations and guidelines; 
• assess adherence to the study protocol and procedural manuals;  
• inspect study-related documentation; and 
• confirm the quality and accuracy of information collected at the site and entered into the 
study database.  

 
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16.6 Protocol Compliance 
The study will be conducted in full compliance with the protocol. The protocol will not be 
amended without prior written approval by the Protocol Chairs and DAIDS Medical Officer. All 
protocol amendments must be submitted to and approved by the sIRB and the DAIDS 
Regulatory Support Center prior to implementing the amendment. 
16.7 Study Records 
All study records will be maintained and stored in a secure, complete and accurate manner 
throughout the study. The responsible parties are outlined below: 
• sIRB-related documentation and approval: HPTN LOC 
• Health access coalitions component: HPTN LOC Coalition Managers, CLO 
• Social media component: HPTN LOC 
• PHASE component: HPTN LOC, implementing partners and interventionists, and the 
participating HCFs 
• Peer support component: HPTN LOC, HPTN SDMC and implementing partners 
• Data collection activities at PHASE HCFs: HPTN LOC, HPTN SDMC and PHASE 
HCFs 
Under the US DHHS regulations, the responsible parties are required to retain all study records 
relating to research for at least three [3] years after completion of the research, or longer if 
needed to comply with local regulations.  
Completion of a clinical research study occurs when the following activities have been 
completed: 
• All research-related interventions or interactions with human subjects (e.g., when all 
subjects are off study). 
• All protocol-required data collection of identifiable private information described in the 
sIRB-approved research plan. 
• All analysis of identifiable private information described in the sIRB-approved research 
plan. 
• Primary analysis of either identifiable private or de-identified information.  
Study records include administrative documentation — including all reports and correspondence 
relating to the study — as well as documentation related to each participant screened and/or 
enrolled in the study — including locator forms, eCRFs, notations of all contacts with the 
participant, and all other source documents. 
All study records (including participant records) may be reviewed by study staff and other staff 
employed by the HPTN, NIH, sIRB, and the US Office for Human Research Protections.  

 
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16.8 Use of Information and Publications 
Publication of the results of this study will be governed by the HPTN MOP (Section 21 
Publications and Data Sharing Policy). Any presentation, abstract, or manuscript will undergo 
review by the HPTN Manuscript Review Committee and DAIDS prior to submission. 
16.9 ClinicalTrials.gov 
This protocol is not subject to the Food and Drug Administration Amendments Act of 2007.  
However, it will be registered in ClinicalTrials.gov to meet International Committee of Medical 
Journal Editors requirements and as a requirement of the sponsor (NIH). 

 
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APPENDIX I: SCHEDULE OF EVALUATIONS FOR DATA COLLECTION 
ACTIVITIES AT PHASE HCF 
Administrative and 
Behavioral Procedures 
1-4 months 
(Baseline) 
12-15 
months 
(Midpoint) 
18-23 months 
(prior to study 
conclusion) 
24-27 months 
(Post-
Intervention) 
Screening/Confirmation of 
eligibility and 
stratification 
X 
X 
 
X 
Electronic (checkbox) 
consent 
X 
X 
 
X 
Completion of 
questionnaire 
X 
X 
 
X 
Chart abstraction/eCRF 
data entry1 
X 
X 
 
X 
Qualitative Interviews 
(HHI MSM clients)2 
 
X3 
 
(X)4 
Qualitative Interviews 
(HCF staff) 
 
 
X 
 
1eCRF data must be entered within seven days of questionnaire completion. Completed for participants of the cross-sectional 
HHI MSM client assessment only.  
2Recruitment for qualitative interviews will take place at a subset of HCF only with a subset of HHI MSM; at these selected 
HCFs, participants will be invited to participate upon completion of the questionnaire. Those who agree will be contacted for an 
interview at a later date. 
3Midpoint qualitative interviews with HHI MSM clients will take place through 18 months. 
4Recruitment for HHI MSM qualitative interviews will continue into the post-intervention sampling timeframe if qualitative 
accrual targets are not met at midpoint.