Texting in Community Health Center Dental Clinics to Reduce HIV Risk
Phase: NA
Conditions: HIV Infections
Sponsor: Boston University

 
 
 
 
 
Texting in Community Health Center Dental 
Clinics to Reduce HIV Risk: RCT 
 
NCT Number: NCT06088277 
NIDCR Grant Number:  UG3DE031249 
BU GDSM Protocol Number: H-43228 
Principal Investigators:  Michelle Henshaw DDS, MPH 
Curt Beckwith MD, FACP, FIDSA 
NIDCR Program Official: Hongen Yin MD, PhD, MHSc 
NIDCR Project Scientist: William Elwood, PhD 
 
 
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STATEMENT OF COMPLIANCE 
The study will be conducted in accordance with the International Conference on 
Harmonization guidelines for Good Clinical Practice (ICH E6), the Code of Federal 
Regulations on the Protection of Human Subjects (45 CFR Part 46), and the NIDCR 
Clinical Terms of Award. All personnel involved in the conduct of this study have 
completed human subjects’ protection training. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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SIGNATURE PAGE 
The signature below constitutes the approval of this protocol and the attachments and 
provides the necessary assurances that this trial will be conducted according to all 
stipulations of the protocol, including all statements regarding confidentiality, and 
according to local legal and regulatory requirements and applicable US federal 
regulations and ICH guidelines. 
 
 
Multiple Principal Investigators (MPI): 
 
Signature:  
Date:  
 
Dr. Michelle Henshaw 
 
DD – MMM – YYYY 
 
Signature:  
Date:  
 
Dr. Curt Beckwith 
 
DD – MMM – YYYY 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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TABLE OF CONTENTS 
HEADING                                                                                                                                  PAGE 
STATEMENT OF COMPLIANCE ................................................................................................ 2 
SIGNATURE PAGE .................................................................................................................... 3 
TABLE OF CONTENTS .............................................................................................................. 4 
LIST OF ABBREVIATIONS ......................................................................................................... 7 
PROTOCOL SUMMARY ............................................................................................................. 9 
SCHEMATIC OF STUDY DESIGN ........................................................................................... 11 
1 
KEY ROLES AND CONTACT INFORMATION ................................................................. 12 
2 
INTRODUCTION: BACKGROUND INFORMATION AND SCIENTIFIC RATIONALE ....... 14 
2.1 
Background Information ........................................................................................ 14 
2.2 
Rationale .............................................................................................................. 15 
2.3 
Potential Risks and Benefits ................................................................................. 15 
2.4 
Potential Risks ...................................................................................................... 15 
2.4.1 Potential Benefits ...................................................................................... 16 
3 
OBJECTIVES ................................................................................................................... 17 
3.1 
General Study Objective ....................................................................................... 17 
3.2 
Study Objectives and Outcome Measures ............................................................ 17 
3.2.1 Primary ...................................................................................................... 17 
3.2.2 Secondary ................................................................................................. 17 
4 
STUDY DESIGN .............................................................................................................. 19 
5 
STUDY ENROLLMENT AND WITHDRAWAL .................................................................. 20 
5.1 
Inclusion Criteria ................................................................................................... 20 
5.2 
Exclusion Criteria .................................................................................................. 20 
5.3 
Recruitment and Retention Strategies .................................................................. 21 
5.3.1 Retention Procedures ................................................................................ 22 
5.4 
Treatment Assignment Procedures ....................................................................... 23 
5.4.1 Randomization Procedures ....................................................................... 23 
5.4.2 Masking Procedures .................................................................................. 23 
5.5 
Subject Withdrawal ............................................................................................... 24 
5.5.1 Reasons for Withdrawal ............................................................................ 24 
5.5.2 Handling of Subject Withdrawals or Subject Discontinuation of Study 
Intervention ............................................................................................... 25 
5.6 
Premature Termination or Suspension of Study .................................................... 25 
6 
STUDY INTERVENTION .................................................................................................. 26 
6.1 
Study Behavioral or Social Intervention(s) Description .......................................... 26 
6.2 
Administration of Intervention ................................................................................ 27 
6.2.1 Intervention Fidelity ................................................................................... 27 
6.2.2 Assessment of Subject Compliance with Study Intervention ...................... 27 
7 
STUDY SCHEDULE ......................................................................................................... 28 
7.1 
Screening (Day -1 to -30) ...................................................................................... 28 
7.2 
Baseline & Enrollment (Day -1 to -30) ................................................................... 28 
7.3 
Intervention initiation (Day 0) ................................................................................ 28 
7.4 
3-month assessments (90 days ± 30 days): .......................................................... 29 

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7.5 
End of intervention (Last day of week 24). ............................................................ 29 
7.6 
6-month assessments (180 days ± 60 days): ........................................................ 29 
7.7 
Final Study assessment & End of Study Instructions (365 days ± 60 days) .......... 29 
7.8 
Special situations during Screening, Baseline, and other assessments ................ 29 
7.8.1 Participant request in-person or phone interview. ...................................... 29 
7.8.2 Procedure or assessment interruption ....................................................... 29 
7.9 
Lost to Follow-up .................................................................................................. 29 
7.10 
Early Termination Visit .......................................................................................... 30 
7.11 
Unscheduled Contact............................................................................................ 30 
8 
STUDY PROCEDURES /EVALUATIONS ........................................................................ 31 
8.1.1 Screening .................................................................................................. 31 
8.1.2 Baseline .................................................................................................... 31 
8.1.1 Randomization .......................................................................................... 33 
8.1.2 Intervention Initiation ................................................................................. 33 
8.1.3 3- and 6-month questionnaires .................................................................. 33 
8.1.4 12-month/final questionnaire ..................................................................... 34 
8.2 
Text Message Delivery ......................................................................................... 35 
8.3 
Intervention Dose and Engagement: ..................................................................... 35 
9 
ASSESSMENT OF SAFETY ............................................................................................ 36 
9.1 
Specification of Safety Parameters ....................................................................... 36 
9.1.1 Unanticipated Problems ............................................................................ 36 
9.1.2 Adverse Events ......................................................................................... 36 
9.1.3 Serious Adverse Events ............................................................................ 36 
9.2 
Time Period and Frequency for Event Assessment and Follow-Up ....................... 37 
9.3 
Characteristics of an Adverse Event ..................................................................... 37 
9.3.1 Relationship to Study Intervention ............................................................. 37 
9.3.2 Expectedness of SAEs .............................................................................. 37 
9.3.3 Severity of Event ....................................................................................... 37 
9.4 
Reporting Procedures ........................................................................................... 38 
9.4.1 Unanticipated Problem Reporting to IRB and NIDCR ................................ 38 
9.4.2 Serious Adverse Event Reporting to NIDCR.............................................. 39 
9.5 
Halting Rules ........................................................................................................ 39 
10 
STUDY OVERSIGHT ....................................................................................................... 40 
11 
CLINICAL SITE MONITORING ........................................................................................ 41 
12 
STATISTICAL CONSIDERATIONS .................................................................................. 42 
12.1 
Study Hypotheses ................................................................................................. 42 
12.2 
Sample Size Considerations ................................................................................. 42 
12.3 
Final Analysis Plan ............................................................................................... 42 
13 
SOURCE DOCUMENTS AND ACCESS TO SOURCE DATA/DOCUMENTS .................. 44 
14 
QUALITY CONTROL AND QUALITY ASSURANCE ........................................................ 45 
15 
ETHICS/PROTECTION OF HUMAN SUBJECTS ............................................................. 46 
15.1 
Ethical Standard ................................................................................................... 46 
15.2 
Institutional Review Board .................................................................................... 46 
15.3 
Informed Consent Process ................................................................................... 46 

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15.4 
The consent process will be documented via REDCap. ........................................ 46 
15.5 
Exclusion of Women, Minorities, and Children (Special Populations) .................... 47 
15.6 
Subject Confidentiality .......................................................................................... 47 
15.7 
Certificate of Confidentiality .................................................................................. 47 
16 
DATA HANDLING AND RECORD KEEPING ................................................................... 48 
16.1 
Data Management Responsibilities ....................................................................... 48 
16.2 
Data Capture Methods .......................................................................................... 48 
16.3 
Types of Data ....................................................................................................... 49 
16.4 
Schedule and Content of Reports ......................................................................... 49 
16.5 
Study Records Retention ...................................................................................... 49 
16.6 
Protocol Deviations ............................................................................................... 49 
17 
PUBLICATION/DATA SHARING POLICY ........................................................................ 51 
REFERENCES ......................................................................................................................... 52 
APPENDIX A ............................................................................................................................ 55 

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LIST OF ABBREVIATIONS 
ABBREVIATION DEFINITION 
AE Adverse Event/Adverse Experience 
BEDAC Biostatistics and Epidemiology Data Analytics Center 
BMFVP Behavioral Model for Vulnerable Populations 
C-CERC CFAR Community Engaged Research Council 
CFAR Center for AIDS Research 
CFR Code of Federal Regulations 
CHC Community Health Center 
CRF Case Report Form 
CRO Contract Research Organization 
CSOC Clinical Study Oversight Committee 
DCC Data Coordinating Center 
DSMB Data and Safety Monitoring Board 
eCRF Electronic Case Report Form 
EtHE Ending the HIV Epidemic 
GCP Good Clinical Practice 
GSDM Goldman School of Dental Medicine (Boston University) 
HIPAA Health Insurance Portability and Accountability Act 
HIV Human Immunodeficiency Virus 
ICF Informed Consent Form 
ICH International Conference on Harmonization 
ICMJE International Committee of Medical Journal Editors 
IRB Institutional Review Board 
ISM Independent Safety Monitor 

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MOP Manual of Procedures 
MPI Multiple Principal Investigator 
N Number (typically refers to subjects) 
NIDCR National Institute of Dental and Craniofacial Research, NIH, DHHS 
NIH National Institutes of Health 
OCTOM Office of Clinical Trials Operations and Management, NIDCR, NIH 
OHRP Office for Human Research Protections 
PHI Protected Health Information 
PI Principal Investigator 
QA Quality Assurance 
QC Quality Control 
RA Research Assistant 
SAE Serious Adverse Event/Serious Adverse Experience 
SOP Standard Operating Procedure 
TM Text Message 
TM HIV Text Messages regarding HIV 
TM HL Text Messages regarding Heathy Living 
UP Unanticipated Problem 
US United States 
 
 
 
 
 
 
 

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PROTOCOL SUMMARY 
Title: Texting in Community Health Center Dental Clinics 
to Reduce HIV Risk 
Précis: This is a text message-based intervention among 
individuals with at least one risk factor for HIV from 
targeted community health center dental clinics. The 
purpose of the intervention is to reduce HIV risk 
factors and promote HIV testing. This will be 
accomplished through delivering the text message 
program to English and Spanish-speaking dental 
patients (n=266) who are 18 years or older. Patients 
across all sites will be randomized to receive either 
text messages regarding HIV Risk Reduction (TM 
HIV) or healthy living (TM HL) over the course of 6 -
months (24 -weeks). The outcome will be measured 
using questionnaires at 90, 180 and 365 days. 
Objectives: To determine if HIV related text messages could 
decrease the risk of acquiring HIV by increasing the 
utilization of HIV prevention services (e.g., repeat 
HIV testing, PrEP uptake, etcetera) and behavioral 
change when compared to the control text 
messages. To assess the mechanisms through 
which the intervention effects occur (mediation). 
Population: The target population is adult dental patients at 
Community Health Centers (CHC) in Suffolk County, 
Massachusetts. 
Number of Sites: The study sites will include Codman Square CHC, 
South End CHC (part of East Boston CHC), East 
Boston CHC, Geiger Gibson CHC, and Uphams 
Corner CHC. All clinics are in the Greater Boston 
Area. The clinics serve an urban, ethnically diverse, 
and low-income population and have a primary 
affiliation with Boston Medical Center (BMC), the 
primary teaching affiliate of Boston University (BU).  

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Description of Intervention: Patients will be recruited and enrolled into the trial. 
Baseline and follow-up questionnaires will be 
completed at the beginning, midway, end of 
treatment and end of the study. Patients will be 
randomized into either the intervention group 
receiving the HIV prevention TM intervention (TM 
HIV) or the comparison group receiving the TM 
intervention focused on achieving a healthy lifestyle 
(TM HL). All participants will receive the respective 
text message intervention over 24-weeks.  
Study Duration: 36-months 
Subject Participation 
Duration: 
12-months 
Estimated Time to Complete 
Enrollment: 
24-months 

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SCHEMATIC OF STUDY DESIGN  
 
 
 

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1 KEY ROLES AND CONTACT INFORMATION 
Multiple PI:  Michelle Henshaw, DDS, MPH 
Professor of Health Policy and Health Services Research  
Boston University Goldman School of Dental Medicine 
Co-Leader - HIV & Oral Health Scientific Working Group, Providence/Boston Center for AIDS Research  
• Address: 560 Harrison Avenue, Boston, MA 02118. 
• Phone: (617) 358-6111 
• Fax: (617) 358-6381 
• Email: mhenshaw@bu.edu 
 
Curt Beckwith, MD, FACP, FIDSA 
Professor of Medicine, Division of Infectious Diseases 
The Miriam Hospital/Rhode Island Hospital 
Alpert Medical School of Brown University 
Associate Director, Providence/Boston Center for AIDS Research  
Co-Leader - HIV & Oral Health Scientific Working Group, Providence/Boston Center for AIDS Research 
• Address: The Miriam Hospital, 164 Summit Ave, Providence, RI, 02906. 
• Phone: (401) 793-4397 
• Fax: (401) 793-4709 
• Email: CBeckwith@Lifespan.org 
 
 
Institutions: Boston University Goldman School of Dental Medicine 
• Address: 100 East Newton Street, Boston, MA 02118. 
 
The Miriam Hospital  
• Address: 1 Hoppin Street, Providence, RI 02903. 

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NIDCR Program Official:  Hongen Yin M.D., Ph.D., MHSc. 
Director 
HIV/AIDS & Oral Health Research Program 
National Institute of Health, National Institute of Dental and Craniofacial Research 
• Address: Democracy One, Room 640, 6701 Democracy Blvd, Bethesda, MD 20892-4878. 
• Phone: (301) 496-0525 
• Email: hongen.yin@nih.gov 
 
 
NIDCR Project Scientist: William (Bill) Elwood, PhD 
OppNet/Health Scientist Administrator 
National Institute of Health, Office of Behavioral and Social Sciences Research 
• Address: 31 Center Drive, Building 31, Room B1C19, Bethesda, MD 20892. 
• Phone: (301) 402-0116 
• Email: william.elwood@nih.gov  
 
 
Co-investigators: Matthew Mara, BS, DMD, EdM, AEGD 
Boston University Goldman School of Dental Medicine 
• Address: 560 Harrison Avenue, Boston, MA 02118. 
• Phone: (617) 358-6385 
• Fax: (617) 358-6381 
• Email: maramb@bu.edu 
 
Sara Lodi, BA, MSc, PhD 
Boston University School of Public Health 
Crosstown Building 
• Address: 801 Massachusetts Avenue 3rd Floor Boston, MA 02118. 
• Phone: (617) 358-2705 
• Email: slodi@bu.edu 
 
 

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2 INTRODUCTION: BACKGROUND INFORMATION AND SCIENTIFIC RATIONALE  
2.1 
Background Information 
Fourteen percent of people living with HIV (PLWH) do not know they are infected, so 
they do not benefit from antiretroviral therapy (ART) and may spread the virus.1,2 To 
reach these individuals, the CDC recommends incorporating HIV testing into all aspects 
of primary health care, including dental care.3 Dentists are already trained to detect and 
monitor medical conditions and, therefore, are “well-positioned to be the first line of 
screening” for multiple health conditions4 including HIV infection.5 HIV interventions in 
dental clinics have the potential to play a key role in the Ending the HIV Epidemic 
(EtHE) initiative because 25% of adults do not seek medical care annually, but 23% of 
these individuals do receive dental care.6 Since rapid HIV tests (RHT) use oral fluid 
specimens, both dental providers and patients feel that dental clinics are logical sites for 
HIV prevention and testing efforts.5 Given this, delivering HIV interventions as part of 
routine dental care has the potential to make important contributions to EtHE. 
CHCs in the U.S. provide coordinated medical and dental health care to an estimated 
30 million people, two-thirds of whom are from racial and ethnic minority groups who 
experience a disproportionate burden of HIV infection.7,8 However, the use of text 
messaging (TM) to support HIV prevention in CHC dental clinics has not been studied. 
In response, this study will evaluate TM ability to support HIV prevention for dental clinic 
patients to address the prevention pillar of EtHE. Specifically, the hypothesis we are 
testing is: H1: Participants randomized to receive the HIV prevention TM intervention 
(TM HIV) will have higher proportion of repeat HIV testing within 12-months compared 
to the participants who receive the TM control condition, which is a TM intervention 
focused on achieving a healthy lifestyle (TM HL). H2: Participants randomized to receive 
TM HIV will have higher proportion of HIV pre-exposure prophylaxis (PrEP) uptake and 
condom use within the past 6-months compared to the participants who receive the TM 
HL.  
This study will rely on a conceptual framework informed by the Behavioral Model for 
Vulnerable Populations (BMVP), an adaption of Anderson’s Behavioral Model of Health 
Care Utilization, which has been used extensively to examine the multi-faceted and 
multi-level factors that affect health behaviors, use of health services, and health 
outcomes among vulnerable populations.12-14 The model posits that a series of 
individual, social, and structural predisposing factors, in addition to enabling or impeding 
factors and need factors, collectively influence health behaviors and the use of health 
services, which in turn produce health outcomes.15 Individual and structural 
vulnerabilities may affect individuals’ utilization of HIV testing services, uptake of PrEP, 
and health-promoting behaviors. Predisposing (sociodemographic variables, community 
norms), enabling (personal, clinic, and community resources), and perceived need 
(perceived risks and community burden) factors are hypothesized to influence health-
promoting behaviors and linkage and access to HIV testing and PrEP. We will augment 
this model by utilizing Social Cognitive Theory (SCT) to support individual behavior 

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change and uptake of HIV prevention services through our TM intervention. SCT has 
been used successfully to achieve sustained behavior change and improve outcomes 
for many conditions, including HIV risk reduction).16 SCT posits that goal setting, 
feedback on progress, and rewards increase self-efficacy (perceived capability of 
performing the behavior) and outcome expectations (belief that performing the behavior 
will result in a positive outcome), which leads to increased motivation, attempts to 
change, and positive health behavior outcomes.17-19 In this project, we propose that 
enhancing self-efficacy and outcomes expectations through TM in those individuals with 
perceived need will foster behavior changes such as HIV testing, PrEP uptake, and risk 
reduction, including condom use.  
2.2 
Rationale 
Dentists and dental clinics can play an important role in expanding HIV testing and 
facilitating access to HIV prevention services for at-risk populations in highly impacted 
areas. This study will test an interactive text messaging intervention to reduce HIV risk 
and promote testing: supporting both the diagnosis and prevention pillars of the Ending 
the HIV Epidemic initiative. If successful, this model which targets dental patients in 
community health centers in Suffolk County, MA, a designated hotspot, can be 
replicated at low cost within other high-risk communities.  
2.3 
Potential Risks and Benefits 
2.4 
Potential Risks 
This study poses minimal risk to the participant. Listed below are the risks:  
• It is possible that some aspects of the assessments (e.g., answering questions 
about HIV risk) or text messages may be uncomfortable or embarrassing. To 
address this risk, participants will be clearly informed of the topics to be 
addressed when completing questionnaires or during text message delivery. 
Also, participants will be told that they are free to skip any question they prefer 
not to answer. 
• There are two potential consequences of text messaging: accidents and thumb 
and joint pain. Texting while driving or walking could increase the risk of 
accidents. Research subjects will be cautioned about reading and responding to 
texts while engaging in such activities. Additionally, research subjects will be 
instructed on Massachusetts’ “Hands-Free” and “Comparative Negligence” Laws. 
Frequent texting may increase the risk of thumb and joint pain. The number of 
texts involved in this study is unlikely to result in thumb and joint pain. 
• Loss of privacy 
o “Agile Health” is the health communications company that will be 
programming our text messages. Their database will contain the text 
messaging system, including information on what text messages each 
participant has received, which text messages participants have 

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responded to, their actual responses, and feedback about individual 
messages. This database is HIPAA compliant.  
o For all data collected, confidentiality will be maintained by numerically 
coding all data with a unique identifier. All electronic data will be stored in 
password-protected, secured computer systems. Data will be collected 
through 1) secure web-based REDCap, 2) paper and pencil 
questionnaires (in the event of REDCap failure), and 3) the Agile Health 
database, which is HIPAA compliant. Paper forms may be used for any 
eCRF if electronic versions are unavailable (e.g., REDCap is down). Only 
the participant’s study identification number will appear on any paper data 
or transcripts. Any paper data will be stored in a secured-locked filing 
cabinet at the Research Project Director's office at GSDM’s Department of 
Health Policy and Health Services Research at 560 Harrison Ave. in 
Boston, Massachusetts. Only the Principal Investigators and the Research 
Project Director will have access to the locked cabinets.  An electronic file 
will be maintained that associates the participant’s name with that 
participant's study identification number. This file will be kept in a secure, 
locked, and password-protected location, separate from the actual study 
data (e.g., screener and questionnaire data).  
o Participant information will be accessible only to research staff. Study data 
will be kept secured for 7 years after the study ends and then will be 
destroyed.   
2.4.1 
Potential Benefits 
Participants may not receive any direct benefit from participating in this study; 
however, participants may learn more about HIV prevention, health, and wellness. 
Participants could also have the satisfaction of helping the scientific community to 
learn more about how to use text messaging programs: (1) to prevent new HIV 
infection or (2) to foster the adoption of health-conscious lifestyle decisions and/or 
behaviors. 
 

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3 OBJECTIVES 
3.1 
General Study Objective 
• To determine if HIV related text messages could decrease the risk of acquiring 
HIV by increasing the utilization of HIV prevention services and behavioral 
change when compared to the control text messages. 
• To assess the mechanisms through which the intervention effects occur 
(mediation). 
3.2 
Study Objectives and Outcome Measures 
3.2.1 
Primary 
 
HIV Testing: To compare the proportion of participants in the active (TM HIV) arm and 
control (TM HL) arm reporting HIV testing at month 3, 6, & 12.  
• Assessment tool -> HIV/HCV Testing Domains Measure 33, 34 
o “Have you ever been tested for HIV?  
▪ 
Yes  
▪ 
No” 
3.2.2 
Secondary  
 
PrEP Adherence: To compare the proportion of participants in the active (TM HIV) arm and 
control (TM HL) arm who reported PrEP adherence at month 3, 6, & 12.  
• Assessment tool -> PrEP Adherence Self-Efficacy Scale 24 
o “What is your experience in using PrEP? 
▪ 
I’ve never used PrEP. 
▪ 
I used PrEP over a year ago but I’m not currently taking it. 
▪ 
I have a prescription for PrEP but don’t take it every day. 
▪ 
I take my PrEP medicine every day. 
▪ 
Prefer not to answer.” 
 
PrEP Uptake: To compare the proportion of participants in the active (TM HIV) arm and 
control (TM HL) arm who started PrEP at month 3, 6, & 12.  
• Assessment tool -> PrEP Adherence Self-Efficacy Scale 24 
o “What is your experience in using PrEP? 
▪ 
I’ve never used PrEP. 
▪ 
I used PrEP over a year ago but I’m not currently taking it. 
▪ 
I have a prescription for PrEP but don’t take it every day. 
▪ 
I take my PrEP medicine every day. 
▪ 
Prefer not to answer.” 
 
Condom Use: To compare the proportion of participants in the active (TM HIV) arm and 
control (TM HL) arm who used condoms at their last sexual encounter at month 3, 6, & 12.  
• Assessment tool -> AIDS Risk Behavior Assessment 21 

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o “The last time you had … sex …, did you or your partner use condoms/latex 
protection? 
▪ 
Yes 
▪ 
No 
▪ 
Don’t know 
▪ 
Prefer not to answer” 
 
Injection Drug use: To compare the proportion of participants in the active (TM HIV) arm 
and control (TM HL) that reported intravenous drug injection at month 3, 6, & 12. And 
among these individuals the proportion that reported using clean needles, and clean 
“works”.  
• Assessment tool -> TCU HIV/AIDS Risk Assessment 20 
o "In the past … did you injected drugs with a needle? 
▪ 
Yes 
▪ 
No 
▪ 
Prefer not to answer”
 
Self-Efficacy: To compare the participants’ self-efficacy to obtain HIV tests, to use 
condoms, and to start/ adhere to PrEP in the active (TM HIV) intervention arm and control 
(TM HL) arm at month 3, 6, & 12.  
• 
Assessment tool -> Confidence Assessment 35 
o “How confident are you that you … next time you have sex? 
▪ 
1- Not at all 
▪ 
2 
▪ 
3 
▪ 
4 
▪ 
5 - Very much 
▪ 
Prefer not to answer” 
 
Motivation: To compare the participants’ motivation to obtain HIV tests, to use condoms, 
and to start/ adhere to PrEP in the active (TM HIV) intervention arm and control (TM HL) arm 
at month 3, 6, & 12.  
• 
Assessment tool -> Confidence Assessment 35 
o “How motivated are you … next time you have sex? 
▪ 
1- Not at all 
▪ 
2 
▪ 
3 
▪ 
4 
▪ 
5 - Very much 
▪ 
Prefer not to answer” 
 
Outcome Expectations: To compare the participants’ perception in the preventing 
effects of obtaining HIV tests, using condoms, and starting/ adhering to PrEP will be 
successful at preventing HIV at month 3, 6, & 12. 
• Assessment tool -> Confidence Assessment 35 
o How much do you believe that … will prevent you from getting HIV? 
▪ 
1- Not at all 
▪ 
2 
▪ 
3 
▪ 
4 
▪ 
5 - Very much 
▪ 
Prefer not to answer” 
 
For more information on the assessments tools please see document tittle “Assessment 
Compendium”.

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4 STUDY DESIGN 
This is a single-masked, randomized control trial (RCT) designed (1) to reduce the risk 
of acquiring HIV and (2) to promote HIV testing. The target population consists of dental 
clinic patients who are 18 years of age or older with at least one HIV risk factor. The 
participating dental clinics are in urban, ethnically diverse, and low-income areas. The 
RCT has been informed by the initial phases of the UG2-funded study (patient and 
provider interviews, advisory board meetings). 
 
The study will be conducted with participants recruited at 5 CHC dental clinics. We will 
recruit 266 participants (n= 266) over a 24-month period with an expected drop-out rate 
of 30% for a final sample of 186 participants. Participants will be recruited in the dental 
clinic waiting area and if there is time, they will be screened for eligibility at the clinic, 
and if they are eligible and interested, they will be guided through the informed consent 
process. Participants will then complete a baseline questionnaire, after which they will 
be randomized to receive either TM HIV or TM HL messages.  
 
The intervention will last 6 -months. Participants will receive 5 messages per week for 
the first 3 months and 3 -messages per week for the last 3 -months of the intervention. 
Participants will be able to choose different blocks of time in which they could receive 
texts (e.g., morning, afternoon, evening). The text messages will be delivered using an 
automated system; at least one message per week will be interactive (require answers 
or clicking on a link for more information) and will be customized to participants based 
on their answers on the baseline questionnaire (language, gender identity, IDU use and 
PREP use).   
 
Participant assessments will be completed through follow-up questionnaire accessed 
through text message links that will be sent at 3-, 6-, and 12-month. In addition, 
participants will receive a monthly set of TMs with Yes or No, or 5-Likert scale questions 
to assess: 1) motivation, 2) self-efficacy as it relates to outcome expectations related to 
condom use PrEP use and HIV testing. Assessments will be completed using the same 
assessment tools utilized in the baseline questionnaire. If requested by participants, the 
assessment links could be sent by email. 
 
 
 
 
 
 
 
 

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5 STUDY ENROLLMENT AND WITHDRAWAL 
5.1 
Inclusion Criteria 
To be eligible to participate in this study, an individual must meet all the following 
criteria: 
• Be 18 years of age or older. 
• Be able to read in English or Spanish. 
• Be a registered dental patient at one of the participating community health 
centers. 
• Be able to give written informed consent by signing and dating the study’s 
informed consent form in REDCap. 
• Be willing to comply with all study procedures and able to participate in the study 
for its entire duration. 
• Have unlimited Text Message on their mobile phone plan or be willing to pay for 
data consumption for the text messages that are sent or received. 
• Have used any type of text messaging at least once in the past. 
• Has at least one self-reported risk factor for HIV including any of the following:  
o Be a sexually active Man who has sex with men within the past 12 
months.  
o Multiple sex partners within the past 12 months independent of gender or 
sex. 
o Intravenous drug injection within the past 12 months. 
o At least one current sexual partner within the past 12 months and 
inconsistent or no condom use. 
o Within the past five years, history of being sexually active and no history of 
HIV testing, where sexual activity is defined as:  
▪ Insertion of a penis into a vagina or anus. 
▪ Cunnilingus 
▪ Fellatio. 
5.2 
Exclusion Criteria 
An individual who meets any of the following criteria will be excluded from participation 
in this study: 
• Self-report HIV infection at the time screening. * 
• Participating in another HIV study or another text message study. 

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• A woman who reports having sex exclusively with women. 
• Does not have a mobile phone or other device which can receive text messages 
from Agile Health. 
* Note: Data from individuals who develop HIV while on the study will be kept and 
analyzed using the intention to treat principle. 
5.3 
Recruitment and Retention Strategies 
The target population is dental clinic patients (>18 years old) at one of the four 
participating community health centers with 5 dental clinics (Codman, Geiger Gibson, 
Uphams, East Boston (East Boston and South End locations) with at least one risk 
factor for HIV. 
 
The primary recruitment method will be RAs, or other trained study 
personnel, approaching all patients in the dental clinic waiting rooms (and other clinic 
spaces deemed appropriate by clinic partners) who appear to be over age 18.  The 
eligibility screener would include age as the first question so if the person approached is 
not 18 years of age or older, the screening will immediately cease. 
 
Other strategies to identify potentially eligible participants may include: (1)  CHC 
staff informing patients about the study and directing them to a RA (if the RA isn’t 
present, the clinician will give the potential participant a study flyer with information on 
how to contact the study team and will ask the potential participant to complete a 
consent to contact form so the study team can contact the potential participant at a later 
time). Completed consent to contact forms will be placed in a locked drop box at the 
site; (2) bilingual study advertising, with RA contact information, will be on display in 
study clinics (flyers); and (3) distributing recruitment materials (flyers) at other clinics 
within the CHCs so potential participants can contact the study team via the study 
phone number listed on the flyer.  
 
Each participating site has designated its own secure location for locked boxes in which 
completed permission to contact forms will be stored on site until a member of the study 
staff is able to collect them. Only the study team has keys to the lock boxes. After 
collection, study staff will attempt to contact all potential participants to tell them more 
about the study. After successfully or unsuccessfully attempting to contact the potential 
participant, all completed permission to contact forms will be stored in a locked filing 
cabinet in the Research Project Director's office. 
 
For all consent to contact forms received by the study staff, the study staff will contact 
the participant a maximum of 5 times over a 3-week period, using the participants 
preferred modes of contact.  If no contact has been made after 5 attempts, no further 
contacts will be attempted and the consent to contact form will be destroyed. 
 
An informational letter may be sent from the CHC dental clinic directors that will inform 
patients that the health center is partnering with Boston University to study the 
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contact information will also be included in the letter, should a patient be interested in 
assessing eligibility or asking questions about the study. 
5.3.1 
Retention Procedures 
To maximize completion of the follow-up study questionnaires, participants will receive a 
TM with the link to the 3-month and 6-month questionnaires 85 days and 175 days, 
respectively, after the first day of the TM intervention. If the participant does not 
complete the 3-month questionnaire after receiving the first link, subsequent reminder 
TMs will be sent 4 and 9 days later. If not completed by day 8, the RA will make 
additional attempts to contact the participant via email and phone between days 8 and 
10.  For the 6- and 12-month questionnaires, the link will be resent 5, 10 and 15 days 
after the initial email.  The RA will make an additional contact via email or phone 
between day 15 and 25. A postcard (questionnaire reminder) will be placed in an 
envelope and mailed to participants on an as-needed basis to remind participants to 
complete their 3-, 6- or 12-month follow-up questionnaires if other forms of outreach 
have proven unsuccessful.   
In addition, if we are unable to contact hard-to-reach participants, we will use the White 
Pages, a paid online directory or people search engine to verify or update participant 
contact information. Data that are accessible with a paid membership include: mobile 
phone numbers, previous and current street addresses, landline phone numbers, 
previous cities of residence, relatives, and associates. Hard-to-reach participants may 
include those who we discover have incorrect contact information and study staff 
attempts to use alternate means have been exhausted. For example, study staff may 
reach out to a participant’s listed cell phone number and discover the phone number 
has been disconnected or now belongs to a different person, or participants may have a 
change of address during the conduct of the study. When these changes are identified, 
staff will attempt to contact the participant via newly obtained contact information (e.g., 
phone number, email, letter, or alternate contact). If these methods prove to be 
unsuccessful, study staff would then utilize an online directory or people search engine 
to find updated contact information.  
If a potential match is found through an online directory or people search engine, study 
staff will reach out and confirm the participant’s identity by having the participant confirm 
their birthdate or the home address on file. Once determined that the individual is a 
participant, their contact information will be updated directly into REDCap. To retain 
participants during the study, we will provide compensation for their time and effort 
spent completing the baseline and follow-up questionnaires. It is anticipated that most 
individuals will complete the questionnaire in 45 – 60 minutes. 
Participant Compensation is as follows: 
• A $60.00 gift card after ‘opting’ into the text message program by replying to an 
initial text and completing the first questionnaire. 
• A $60.00 gift card after completing questionnaires at 90-, 180- and 365-day 
timepoints (potential compensation of $180 in total).  

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• If all questionnaires are completed participants will receive a bonus $60 gift card.  
• The total possible compensation participants may receive is $300.00 in gift cards. 
During the text message program, participants will be asked assessment questions that 
have a “$” sign. Each time they provide an answer to these questions, their name will be 
entered into a monthly raffle for a $100.00 gift card. The number of $ questions will 
range from 1-4 questions each month. After the name is randomly drawn by the study 
team for that month, a new month will begin, and all previous entries will be cleared. 
Because text messages are received over the course of 6-months, they will have the 
opportunity to earn entries in 6 monthly raffles.    
If participants are not responding to the text message program, we will contact them to 
check in with them to problem-solve any technical issues and discuss their satisfaction 
with the program.  A postcard will be sent if we are unable to reach a participant via 
email or text. 
5.4 
Treatment Assignment Procedures 
5.4.1 
Randomization Procedures  
To randomly assign participants to treatment groups at baseline, we will use a permuted 
randomized block design (random-sized blocks of 2 or 4 participants), stratified by study 
site [Codman Square, Geiger Gibson, Uphams Corner, South End (part of East Boston), 
and East Boston Community Health Centers] and preferred language (English or 
Spanish) of the patient to yield 10 strata. The randomization list will be created using 
REDCap. Participants will be randomized by the web-based REDCap randomization 
module. Once the baseline questionnaire is completed, REDCap will automatically 
randomize participants into TM HIV or TM HL, and this code, as well as the TM 
personalization options from the baseline questionnaire, will be transferred via secure 
API to the Agile Health system so the first TM (HIV or HL) will occur within 24 hours 
after randomization. 
The randomization list will be maintained by the BEDAC group, and the study staff will 
not have access to that data until the conclusion of the data collection. 
5.4.2 
Masking Procedures  
The Project Directors are the only research staff members who will be interacting with 
the text messages; consequently, they will be the only study staff members that will be 
unmasked. All study staff collecting data, including the RAs, will be masked to treatment 
condition as will the MPIs and study statistician. The data collection procedures will be 
identical across treatment conditions, and the study staff collecting data will not be privy 
to participant condition group (TM HIV or TM HL) assignment. It is possible that a 
participant could reveal the content of their study text messages during follow-up 
questionnaires if the RA is assisting the participant in assessment. However, to 
encourage maintenance of the study masking, participants will be instructed during the 
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activities with the RAs at follow-ups. Additionally, RA will remind participants to refrain 
from disclosing the content of their TM prior to providing them assistance if requested. If 
the study arm assignment of a participant becomes known by an RA, that RA will not be 
involved with subsequent assessment activities for that participant.  
Since the intervention is a text messaging intervention, we do not anticipate a need for 
unmasking. However, if it becomes necessary to unmask an enrollee, the Research 
Project Director will have the ability to unmask an enrollee by disclosing the status of 
the participant’s randomization after approval by the MPIs.  
5.5 
Subject Withdrawal 
Subjects are free to withdraw from the study at any time. During the TM program, the 
participant can text ‘stop’ at any time, and the messages will cease. If they request that 
the TM be stopped, then the research team will contact the participant to see if they 
want to continue in the study and complete follow-up questionnaires. To avoid silent 
withdrawal, the project director will measure participants engagement through their 
interactions with the TM (e.g., Responses to TM that ask questions). Participants that 
had been inactive for more than two weeks without interacting with the TM will be follow 
up with a phone call or email to rule-out silent withdrawal. 
Subjects who want to withdraw from the study after ending the intervention, but before 
the final assessment, would be able to do it by contacting the study staff through e-mail, 
phone call, or text. After the TM program is finished, participants can e-mail, call, or text 
study staff to state that they want to withdraw from the program. If a study subject 
requests to be withdrawn from the study through either of these procedures, the 
research team will attempt to ascertain the reason for withdrawal. The Principal 
Investigators will also have the option to withdraw a participant if continued participation 
is not in the best interest of the participant. 
5.5.1 
Reasons for Withdrawal 
Subjects are free to withdraw from participation in the study at any time upon request. 
We anticipate that reasons for a subject’s withdrawal may include one or more of 
the following:  
● Does not have time to participate.  
● Does not want to receive TMs.  
● Does not feel the need for health information.  
A study subject may be withdrawn from study participation by the investigative team if: 
● Any clinical adverse event (AE), laboratory abnormality, or other medical 
condition or situation occurs such that continued participation in the study 
would not be in the best interest of the subject. 
● The subject meets an exclusion criterion (either newly developed or not 
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determined by the MPIs. All collected data pertaining to randomized 
participants will be analyzed. 
5.5.2 
Handling of Subject Withdrawals or Subject Discontinuation of Study 
Intervention 
Participants can stop the text message program at any time by typing in the keyword 
“stop.” They can also withdraw from the program by calling or emailing program staff. If 
a participant wants to withdraw from the text message program, we will ask them if they 
would still like to complete the questionnaires at the time when their text message 
program would have ended if they did not withdraw (to be consistent with other 
participants). If they do not want to complete the questionnaire, we will withdraw them 
from the study. We will ascertain all reasons for withdrawal—whether from the text 
message program, from questionnaire completion, or both. All data collected while the 
participant was enrolled in the study will be retained and analyzed. 
5.6 
Premature Termination or Suspension of Study 
This study may be suspended or prematurely terminated if there is sufficient reasonable 
cause. Written notification documenting the reason for study suspension or termination 
will be provided by the suspending or terminating party to the PI, funding agency, and 
regulatory authorities. If the study is prematurely terminated or suspended, the PI will 
promptly inform the IRB and will provide the reason(s) for the termination or suspension.  
Circumstances that may warrant termination include, but are not limited to: 
• Determination of unexpected, significant, or unacceptable risk to subjects. 
• Insufficient adherence to protocol requirements. 
• Data that are not sufficiently complete and/or evaluable.  
• Determination of futility. 

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6 STUDY INTERVENTION 
6.1 
Study Behavioral or Social Intervention(s) Description 
The intervention is a theory-based, dose-matched, interactive, and automatic text 
messages system aimed to reduce HIV risk factors in dental patients from community 
health centers located in areas with high HIV prevalence (e.g., Suffolk County, MA). The 
intervention will be delivered through a secure messaging engine (Agile Health). Agile 
Health platform uses data-driven algorithms and personalization rules to automate 
much of the member experience, while queuing up digital coaches for live member 
support, when needed 36. Agile Health will not collect personal health or personal 
identifiable information, except for subjects’ phone number, which will be used to deliver 
the intervention. For more information on Agile Health Privacy policies. 
 
All qualifying subjects, that had accepted to participate in the study, will be randomized 
and enrolled through the Agile Health platform in either the active group treatment 
(AGT) or control group treatment (CGT) text message curriculum. Agile Health will start 
sending text messages within 24 hours of randomization. The intervention will last 6-
months and will consist of text messages sent to participants cell phones addressing 
HIV prevention (active group) or having a healthy lifestyle (control group). Participants 
will choose the time at which they expect the text message delivery during baseline. 
AGT and CGT will be match in the number of the topics, engagement strategies, and 
program features. 
 
Agile Health will deliver four types of messages: 
• 
Introduction Messages: Present the program to participants and explain how the 
member can earn raffle entries and a gift card. This message will be sent in week 1 
after randomization. 
• 
Core Messages: These messages are designed to educate participants on HIV 
prevention (AGT) or wellness (CGT), and they will be delivered in questions or 
simple statement format. They will be sent from week 2-12 on Monday, Tuesday, 
Friday, and Saturday, and from week 13-24 on Mondays, Wednesday, and Friday. 
They will present information or ask questions related to five core topics of each 
study arm. The five core topics for each study arm are: 
o AGT: HIV testing, condom use, PrEP, partner communication strategies, and 
substance use. 
o CGT: physical activity, nutrition, stress management, sleep habits, and 
general wellness. 
• 
Assessment Messages: Sent on Saturday of weeks 4, 8, 12, 16, 20, and 24, and 
will cover core topics and mediators for motivation, self-efficacy, and outcome 
expectations.  

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• 
Check-in Messages: Sent on Wednesday of each week and will ask participants 
open ended questions related to core topics (e.g., HIV testing, condom use, healthy 
eating, and physical activity). 
6.2 
Administration of Intervention 
The TM intervention is automated and interactive. The program will begin sending TMs 
within 24 hours of randomization. Both arms will be 6-months in duration. The TMs will 
be delivered 5 times per week for the first 3-months and 3 messages per week for the 
last 3-months (exclusive of brief assessment questions, which occur once per month). 
The number of texts, dose, and duration will be equivalent between the two groups. 
Participants in both groups will be assessed monthly via TM on core topics (testing for 
TM HIV or physical activity for TM HL) and mediators (motivation, self-efficacy, and 
outcome expectations). 
6.2.1 
Intervention Fidelity 
The TM interventions will not use human providers. They will be delivered by a text 
message engine exactly as designed. The aforesaid allow us to anticipate a 100% 
reliable intervention and give us confidence that intervention will be delivered as 
expected. All subject responses that are not recognized by the system will be flagged 
for the project manager to evaluate and respond to if required. Because of this, a 
designated member of the study staff will review a portion of the project director's 
responses to ensure there is no treatment contamination.  
6.2.2 
Assessment of Subject Compliance with Study Intervention 
Agile Health platform keeps track of all text messages (sent and received), including 
both unprompted responses and expected responses from participants. This includes 
responses to assessment questions (e.g., motivation) and responses to the interactive 
intervention features of the text message programs.  
Agile Health will send monthly reports to the study team. The monthly reports will 
contain the following numbers for the AGT and CGT: 1) participants enrolled in the TM 
program, 2) participants status, 3) number of text messages sent by system, 4) number 
of text messages received by system stratified by expected responses or unprompted 
engagement, 5) key words text by participants, 6) expected response rate and program 
engagement. The study team will review the reports to make sure subjects had not 
silently withdraw from the study.   
 
 
 

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7 STUDY SCHEDULE 
The study schedule of event is outlined in appendix A, table 1. Participant will receive 
the assessment questionnaire through email or text message unless participant request 
to have an in-person or phone interview. 
7.1 
Screening (Day -1 to -30) 
Subjects will be recruited at the participating community health centers (more 
information in manual of procedure). A designated study staff member will obtain verbal 
consent to start eligibility screening. If the participant screens eligible, the RA will enter 
the participants phone number into the Agile Health (AH) portal to generate a test text to 
ensure the participant will be able to receive the intervention. Phone numbers are not 
saved by Agile Health system during this process. Participants who cannot receive the 
intervention will be set as ineligible until they are able to receive text messages.  
The screening process will end with one of three options: 
• Exclusion: Participant did not meet the eligibility criteria. 
• Declination: Participant met the eligibility criteria but declined to participate. 
• Informed Consent Form (ICF) Signature: Participant met the eligibility criteria and 
accepted to voluntarily participate in the study after: 
o Having read and discussed ICF with a qualified study staff. 
o Asked question (if any) and have those being answered to their 
satisfaction. 
o Voluntarily signed the ICF. 
o Have received a copy of the signed ICF. 
For more information on the tools used to collect the screening information, please see 
section 8.1.1 Screening. 
7.2 
Baseline & Enrollment (Day -1 to -30) 
Participants who consent to be in the study will complete the contact form and the 
baseline questionnaire. Only subjects completing the baseline questionnaire will be 
randomized. A copy of the participant’s informed consent form (signed and dated) will 
be provided to the participant via email or text, depending upon the participant’s 
preference. Participants who complete the baseline questionnaire will be randomized to 
one of two arms (HIV prevention or Healthy Lifestyle). 
For more information on the tools used to collect baseline information, please see 
section 8.1.2 Baseline. 
7.3 
Intervention initiation (Day 0) 
The intervention will start within 24 hours of randomization. The first day of the 
intervention is day 0. 

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7.4 
3-month assessments (90 days ± 30 days):  
The 3-month assessment target date is 90 days after the start of the TM program with a 
window of plus or minus 30 days from that target date. For more information on tools 
used to collect information, please see section 8.1.5 3- and 6-Months Questionnaires. 
7.5 
End of intervention (Last day of week 24). 
The intervention will last 6-months, each “month” consists of 28 days, which is a 
cumulative total of 168 days (24 weeks). 
7.6 
6-month assessments (180 days ± 60 days): 
The 6-month assessment target date is 180 days after the start of the TM program with 
a window of plus or minus 60 days from that target date. For more information on tools 
used to collect information, please see section 8.1.5 3- and 6-Months Questionnaires. 
7.7 
Final Study assessment & End of Study Instructions (365 days ± 60 days) 
The final study assessment target date is 365 days after the start of the TM program 
with a window of plus or minus 60 days from that target date. End of Study Instructions 
will be delivered to the subject using text message, phone call or email. For more 
information on tools used to collect information, please see section 8.1.6 12-Months/ 
Final Questionnaire. 
7.8 
Special situations during Screening, Baseline, and other assessments 
7.8.1 
Participant request in-person or phone interview. 
Participants that request assessment via phone interview or in person will have the 
assessment done as requested. RAs or designated research staff will contact the 
participant to arrange an in person or phone appointment to administer the 
corresponding assessment questionnaire. The data gathered during the in-person or 
phone assessment will be entered into REDCap. 
7.8.2 
Procedure or assessment interruption 
Participants that are unable to complete the screening process or informed consent 
process, due to any logistical reason (e.g., participant was called to his dental 
appointment) will be asked to complete a consent to contact form. Study team will 
contact the individual to complete the screening and informed consent at a future date 
using the contact form information. 
7.9 
Lost to Follow-up  
RAs will make a maximum of 5 attempts to contact the study participant before they are 
considered lost to follow-up. For more information see Manual of Procedures. 

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7.10 
Early Termination Visit  
Not applicable. 
7.11 
Unscheduled Contact  
An unscheduled visit would be considered to occur if a study subject was in contact with 
a member of the study team regarding HIV risk, attitudes, or practices if the contact was 
not: 1) part of standard texting procedures; 2) part of normal follow up for questionnaire 
completion or retention activities; or 3) related to the occurrence of adverse events or 
unanticipated problems. All unscheduled visits will be documented via a note to file and 
included in the participants’ research record. 

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8 STUDY PROCEDURES /EVALUATIONS 
All study assessment points include the completion of questionnaires by participants to 
assess each of the outcome measures described in section four of this protocol. All 
questionnaires and assessments will be recorded using Electronic Data Capture (EDC) 
system, REDCap (for more information on REDCap, please see the Manual of 
Procedures). All assessment tools used for this study will be listed and explained in the 
Assessment Compendium. 
8.1.1 
Screening  
 
Screening will occur between day -30 to day -1. A study staff will screen all potential 
participants in person at the screening site. Screening will start after verbal consent has 
been granted by participants. The Screening process will be divided into 5-stages, 
which are: 
• Brief Screening Agreement 
o RA introduce themselves in the waiting room and requests permission to 
present the study. 
o Collection of the following information: 1) Participants language, 2) Site 
identification, 3) Screening date, 4) Consent to contact, and 5) Participants 
age. 
o Study presentation to participant.  
• Screener 
o Collection of demographic and risk factors necessary to determine 
participants’ eligibility (e.g., sex, HIV status, condom use, etcetera). 
• Agile Health Phone Verification 
o Process done to ensure that participants can receive text message from 
the Agile Health system.  
o No data are saved in the Agile Health system during the test text. 
• Eligibility determination 
o Will be determined by REDCap. 
o RA will confirm the eligibility. 
• Informed Consent 
o A qualified study staff will go over the informed consent process with the 
participant.  
o The informed consent form will be collected electronically using REDCap. 
o A copy of the signed informed consent form will be delivered electronically 
through email to the participant. 
8.1.2 
Baseline 
 
The baseline will occur at day 0. It will be divided in two stages. In the first stage, a 
trained research staff member will obtain the participant’s contact information by filling 
the Contact Form.  
 

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The second stage of the baseline may be conducted in person using EDC at the dental 
clinic in a private space or by phone. When not possible, participants will be able to 
complete the questionnaire via a secure website on their personal electronic device 
(e.g., laptop, tablet, or smartphone), or over the phone with the study team's assistance. 
 
The following questionnaires and activities will occur at baseline assessment: 
• First stage 
o Contact Form 
 
▪ It will be completed by a designated and qualified study staff. 
▪ It should be completed on the same day that the participant signs 
the Informed Consent Form. 
• Second stage 
o Demographics 
o Behavioral Health History 
▪ Generalized Anxiety Disorder 7-item scale (GAD-7) 
▪ Center for Epidemiologic Studies - Depression 20 Item Scale (CES-D 
20) 
o HIV Testing History assessment 
▪ HIV/HCV Testing Domains Measures 
▪ KAP Survey Questionnaire 
▪ Perceived Risk of HIV Scale (PRHS) 
▪ HIV Testing Self-Efficacy 
o PrEP related assessment 
▪ PrEP Knowledge 
▪ PrEP Stigma 
▪ PrEP Subjective Norms 
▪ PrEP Descriptive Norms 
▪ PrEP Experience 
▪ PrEP Adherence Self-Efficacy Scale (PrEP-ASES) 
▪ PrEP Uptake Self-Efficacy (IBM Model for PrEP Use) 
▪ PrEP Intentions 
o Condoms related assessments 
▪ Condom Use Self-Efficacy Scale (CUSES) 
▪ AIDS Risk Behavior Assessment (ARBA) 
o General substance uses assessment 
▪ Addiction Severity Index Lite (ASI-Lite) 
o Injectable drug use assessment 
▪ TCU HIV/AIDS Risk Assessment (TCU) 
o Confidence assessment 
▪ Confident, Motivation and Outcome Scales (SCT Mediators) 
o Social Support and Stigma assessment 
▪ Intersectional Discrimination Index - Anticipated (InDI-A) 
▪ Intersectional Discrimination Index - Day-to-Day (InDI-D) 
▪ Medical Outcomes Study Social Support Survey (mMOS-SS) 
 

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8.1.1 
Randomization 
Randomization will be completed automatically by REDCap when the participant 
finishes the baseline questionnaires. For more information, please see section 5.4.1 
Randomization Procedure. 
8.1.2 
Intervention Initiation 
The intervention will start after the participant had been randomized and had opt-in to 
received message from Agile Health. The day the intervention initiates will be 
considered day 0. For information, please see section 6. Study Intervention. 
8.1.3 
3- and 6-month questionnaires 
The 3-month assessment target date is 90 days after the start of the TM program with a 
window of plus or minus 30 days from that target date. While the 6-month assessment 
target date is 180 days after the start of the TM program with a window of plus or minus 
60 days from that target date.  
The participants will receive a link on their assessment target day. This link will take 
them to a secure website where they will fill the assessment that correspond to the 
endpoint in which they are being evaluated. Participants will be able to access the link 
using a personal computer, a laptop, a tablet, or a smartphone. A designated study staff 
can assist the participant with the evaluation if they request it. 
The following questionnaires and activities will occur at 3- and 6- months assessment: 
● HIV Testing History assessment 
o HIV/HCV Testing Domains Measures 
o KAP Survey Questionnaire 
o Perceived Risk of HIV Scale (PRHS) 
o HIV Testing Self-Efficacy 
● PrEP related assessment 
o PrEP Knowledge 
o PrEP Stigma 
o PrEP Subjective Norms 
o PrEP Descriptive Norms 
o PrEP Experience 
o PrEP Adherence Self-Efficacy Scale (PrEP-ASES) 
o PrEP Uptake Self-Efficacy (IBM Model for PrEP Use) 
o PrEP Intentions 
● Condoms related assessments 
o Condom Use Self-Efficacy Scale (CUSES) 
o AIDS Risk Behavior Assessment (ARBA) 
● Injectable drug uses assessment 
o TCU HIV/AIDS Risk Assessment (TCU) 
● Confidence assessment 
o Confident, Motivation and Outcome Scales (SCT Mediators) 
● Social Support and Stigma assessment 
o Intersectional Discrimination Index - Anticipated (InDI-A) 

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o Intersectional Discrimination Index - Day-to-Day (InDI-D) 
o Medical Outcomes Study Social Support Survey (mMOS-SS) 
● Text Messaging Program Satisfaction questionnaire 
8.1.4 
12-month/final questionnaire 
The final study assessment target date is 365 days after the start of the TM program 
with a window of plus or minus 60 days from that target date. The participant will do the 
following assessments: HIV Testing History, PrEP, Condoms, Injection Drug Use,  
Confidence, Social Support and Stigma, and Text Messaging Program Satisfaction 
questionnaire (assessment listed below). Participants will complete the questionnaire 
via a secure website using a personal computer, a laptop, tablet, smartphone, or over 
the phone with the study team's assistance.  
 The following questionnaires and activities will occur at the final study assessment: 
• First Stage 
o HIV Testing History assessment 
▪ HIV/HCV Testing Domains Measures 
▪ KAP Survey Questionnaire 
▪ Perceived Risk of HIV Scale (PRHS) 
▪ HIV Testing Self-Efficacy 
o PrEP related assessment 
▪ PrEP Knowledge 
▪ PrEP Stigma 
▪ PrEP Subjective Norms 
▪ PrEP Descriptive Norms 
▪ PrEP Experience 
▪ PrEP Adherence Self-Efficacy Scale (PrEP-ASES) 
▪ PrEP Uptake Self-Efficacy (IBM Model for PrEP Use) 
▪ PrEP Intentions 
o Condoms related assessments 
▪ Condom Use Self-Efficacy Scale (CUSES) 
▪ AIDS Risk Behavior Assessment (ARBA) 
o Injectable Drug Use assessment 
▪ TCU HIV/AIDS Risk Assessment (TCU) 
o Confidence assessment 
▪ Confident, Motivation and Outcome Scales (SCT Mediators) 
o Social Support and Stigma assessment 
▪ Intersectional Discrimination Index - Anticipated (InDI-A) 
▪ Intersectional Discrimination Index - Day-to-Day (InDI-D) 
▪ Medical Outcomes Study Social Support Survey (mMOS-SS) 
o Text Messaging Program Satisfaction questionnaire 
 

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8.2 
Text Message Delivery 
The intervention will be delivered to participants via the Agile Health TM platform for 6-
months. Participants will receive 5-intervention messages per week for the first 3-
months and 3-messages per week for the last 3-months of the intervention. Participants 
will be able to choose different blocks of time in which they could receive texts (e.g., 
morning, afternoon, evening). The text messages (TM) will be generated from an 
automated system. The text messages are customized to the participant based on their 
characteristics and answers to the baseline questionnaire and text messages. If the 
participant texts back a response that is not recognized by our automated system, the 
system will alert the project director, who will be able to respond to the participant from 
either her desktop computer or phone. The project director is not masked to treatment 
condition because of this. However, they will not be administering participant 
assessments, so the lack of masking will have no impact on study outcomes. In addition 
to the interventional text messages, participants will receive monthly text messages 
assessing outcome expectation, motivation, and HIV risk behaviors. 
8.3 
Intervention Dose and Engagement:  
Intervention dose: The participants will automatically receive messages for 6 months.  
For the first three months they will receive 5 TM per week regarding either HIV risk 
reduction or healthy lifestyle and 3 TM per week for the last 3-months.  
 
Engagement:  Agile Health will send regularly scheduled reports which will include data 
regarding 1) number of texts sent, 2) percent of texts responded to, 3) number 
prompted responses.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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9 ASSESSMENT OF SAFETY 
9.1 
Specification of Safety Parameters 
Safety monitoring for this study will focus on unanticipated problems involving risks to 
participants, including unanticipated problems that meet the definition of a serious 
adverse event.  
9.1.1 
Unanticipated Problems 
The Office for Human Research Protections (OHRP) considers unanticipated problems 
involving risks to subjects or others to include, in general, any incident, experience, or 
outcome that meets all the following criteria: 
• unexpected in terms of nature, severity, or frequency given (a) the research 
procedures that are described in the protocol-related documents, such as the 
IRB-approved research protocol and informed consent document; and (b) the 
characteristics of the subject population being studied. 
• related or possibly related to participation in the research (“possibly related” 
means there is a reasonable possibility that the incident, experience, or outcome 
may have been caused by the procedures involved in the research); and 
• suggests that the research places subjects or others at a greater risk of harm 
(including physical, psychological, economic, or social harm) than was previously 
known or recognized. 
9.1.2 
Adverse Events 
An adverse event is any untoward or unfavorable medical occurrence in a human 
subject, including any abnormal sign (for example, abnormal physical exam or 
laboratory finding), symptom, or disease, temporally associated with the subject’s 
participation in the research, whether or not considered related to the subject’s 
participation in the research. 
9.1.3 
Serious Adverse Events 
A serious adverse event (SAE) is one that meets one or more of the following criteria: 
• Results in death 
• Is life-threatening (places the subject at immediate risk of death from the event 
as it occurred) 
• Results in inpatient hospitalization or prolongation of existing hospitalization 
• Results in a persistent or significant disability or incapacity 
• Results in a congenital anomaly or birth defect  

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• An important medical event that may not result in death, be life-threatening, or 
require hospitalization may be considered an SAE when, based upon appropriate 
medical judgment, the event may jeopardize the subject and may require medical 
or surgical intervention to prevent one of the outcomes listed in this definition. 
9.2 
Time Period and Frequency for Event Assessment and Follow-Up 
Unanticipated problems will be recorded in the data collection system throughout the 
study.  
The PI will record all reportable events with start dates occurring any time after informed 
consent is obtained until 7 days (for non-serious AEs) or 30 days (for SAEs) after the 
last day of study participation. Events will be followed for outcome information until 
resolution or stabilization. 
9.3 
Characteristics of an Adverse Event 
9.3.1 
Relationship to Study Intervention 
To assess the relationship of an event to study intervention, the following guidelines are 
used: 
1. Related (Possible, Probable, Definite) 
a. The event is known to occur with the study intervention. 
b. There is a temporal relationship between the intervention and event onset. 
c. The event abates when the intervention is discontinued. 
d. The event reappears upon a re-challenge with the intervention. 
2. Not Related (Unlikely, Not Related) 
a. There is no temporal relationship between the intervention and event 
onset. 
b. An alternate etiology has been established. 
9.3.2 
Expectedness of SAEs 
The NIDCR Medical Monitor and the Study PI will be responsible for determining 
whether an SAE is expected or unexpected. An adverse event will be considered 
unexpected if the nature, severity, or frequency of the event is not consistent with the 
risk information previously described for the intervention.  
9.3.3 
Severity of Event 
The following scale will be used to grade adverse events: 

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1. Mild: no intervention required; no impact on activities of daily living (ADL) 
2. Moderate: minimal, local, or non-invasive intervention indicated; moderate impact 
on ADL 
3. Severe: significant symptoms requiring invasive intervention; subject seeks 
medical attention, needs major assistance with ADL 
9.4 
 Reporting Procedures 
9.4.1 
Unanticipated Problem Reporting to IRB and NIDCR 
Incidents or events that meet the OHRP criteria for unanticipated problems require the 
creation and completion of an unanticipated problem report form. OHRP recommends 
that investigators include the following information when reporting an adverse event, or 
any other incident, experience, or outcome as an unanticipated problem to the IRB: 
• Appropriate identifying information for the research protocol, such as the title, 
investigator’s name, and the IRB project number. 
• A detailed description of the adverse event, incident, experience, or outcome.  
• An explanation of the basis for determining that the adverse event, incident, 
experience, or outcome represents an unanticipated problem.  
• A description of any changes to the protocol or other corrective actions that have 
been taken or are proposed in response to the unanticipated problem. 
To satisfy the requirement for prompt reporting, unanticipated problems will be reported 
using the following timeline:  
• Unanticipated problems that are serious adverse events will be reported to the 
IRB and to NIDCR as soon as possible or within 1 week of the investigator 
becoming aware of the event.  
• Any other unanticipated problem will be reported to the IRB and to NIDCR within 
2 weeks of the investigator becoming aware of the problem.  
• All unanticipated problems should be reported to appropriate institutional officials 
(as required by an institution’s written reporting procedures), the supporting 
agency head (or designee), and OHRP within one month of the IRB’s receipt of 
the report of the problem from the investigator. 
All unanticipated problems will be reported to NIDCR concurrently with reporting to the 
IRB. These reports will be made to NIDCR’s centralized reporting system via the 
Clinical Research Operations and Management Support (CROMS) contractor, Rho 
Product Safety: 
• Product Safety Fax Line (US): 1-888-746-3293 
• Product Safety Fax Line (International): 919-287-3998 

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• Product Safety Email: rho_productsafety@rhoworld.com  
General questions about SAE reporting can be directed to the Rho Product Safety Help 
Line (available 8:00AM – 5:00PM Eastern Time):  
• US: 1-888-746-7231 
• International: 919-595-6486 
9.4.2 
Serious Adverse Event Reporting to NIDCR 
Any AE meeting the specified Serious Adverse Event criteria will be submitted on an 
SAE form to NIDCR’s centralized safety system via Rho Product Safety. This report 
may be sent by fax or email. Once submitted, Rho Product Safety will send a 
confirmation email to the investigator within 1 business day. The investigator should 
contact Rho Product Safety if this confirmation is not received. This process applies to 
both initial and follow-up SAE reports. 
SAE Reporting Contact Information: 
• Product Safety Fax Line (US): 1-888-746-3293 
• Product Safety Fax Line (International): 919-287-3998 
• Product Safety Email: rho_productsafety@rhoworld.com  
General questions about SAE reporting can be directed to the Rho Product Safety Help 
Line (available 8:00AM – 5:00PM Eastern Time):  
• US: 1-888-746-7231 
• International: 919-595-6486 
The study clinician will complete a Serious Adverse Event Form and submit via fax or 
email within the following timelines:  
• All deaths and immediately life-threatening events, whether related or unrelated, 
will be recorded on the Serious Adverse Event Form and submitted to Product 
Safety within 24 hours of site awareness.  
• Serious adverse events other than death and immediately life-threatening events, 
regardless of relationship, will be reported by fax within 72 hours of site 
awareness.  
All SAEs will be followed until resolution or stabilization.  
9.5 
 Halting Rules 
There are no halting rules for the RCT. 
 

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10 STUDY OVERSIGHT 
The PIs, Dr. Henshaw and Dr. Beckwith, will be responsible for study oversight, 
including monitoring safety, ensuring that the study is conducted according to the 
protocol and ensuring data integrity. 
In addition to the PI’s responsibility for oversight, study oversight will be under the 
direction of the NIDCR Program Official. The PIs typically meet bi-monthly with the 
NIDCR program official. At these meetings, the study team will report data regarding 
enrollment and retention, unanticipated problems and protocol deviations, outcome 
measures, quality management findings, and other relevant parameters. If necessary, 
additional steps may be taken to ensure data integrity and protocol compliance.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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11 CLINICAL SITE MONITORING 
No outside clinical site monitoring will be employed for this study. The PIs and staff will 
closely monitor the subjects as they progress through the study. They will monitor and 
evaluate study processes and documentation based on the International Council for 
Harmonization (ICH), E6: Good Clinical Practice guidelines (GCP), and internal quality 
management plans. The NIDCR reserves the right to conduct independent clinical site 
monitoring as necessary. 
 
 
 
 
 
 
 
 
 
 
 

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12 STATISTICAL CONSIDERATIONS 
12.1 
Study Hypotheses 
• H1: Participants randomized to receive the HIV prevention TM intervention (TM 
HIV) will have higher proportion of HIV testing within 12-months compared to the 
participants who receive the TM control condition, which is a TM intervention 
focused on achieving a healthy lifestyle (TM HL).  
• H2: Participants randomized to receive TM HIV will have higher proportion of 
PrEP uptake and condom use within the past 6-months compared to the 
participants who receive the TM HL. 
12.2 
Sample Size Considerations 
With 266 enrolled participants (133 participants per arm), assuming 30% loss to follow-
up during the follow-up period, we anticipate that 186 participants will complete the 
baseline and 12-month study assessments. For a 2-sided chi-square test with continuity 
correction and a significance level of 0.05, this sample size gives our study an 80% 
power to detect a 20% absolute difference in proportions who completed HIV testing 
between participants randomized to the TM HIV versus TM HL, assuming proportions of 
HIV testing of 50% and 30% for the TM HIV and TM HL groups, respectively.26-29    
12.3 
Final Analysis Plan 
We will compute descriptive statistics on baseline variables overall and by randomization 
group to characterize the study population and to detect any baseline imbalance. For 
continuous measures, we will report the mean, standard deviation, median, interquartile 
range, and the minimum and maximum. For categorical data, we will report counts and 
percentages. For the primary outcome (at least one HIV test within 12-months), we will 
estimate the intention-to-treat effect by including all participants according to their 
randomized intervention. We will use multiple logistic regression models to determine the 
proportion of participants who tested for HIV where the main independent variable is a 
binary indicator representing assignment to the TM intervention (yes versus no). The 
models will be adjusted for the randomization stratification factors (clinic and self-reported 
primary risk factor) to improve efficiency. We will also adjust for baseline characteristics 
that differ by study arm despite randomization. We will use similar methods for other 
binary secondary outcomes (initiation of PrEP, condom use).  
Missing data: To determine whether there is a potential for selection bias due to loss of 
follow-up, we will compare participants lost to follow-up and those who complete the 
study, using their baseline assessment, using the 2 independent samples t-test and 
Fisher’s exact test, comparing characteristics such as age, sex, study site, and recent 
HIV. If either of these groups differs from those, we were able to follow, we will use inverse 
probability weighing to calibrate our estimates to the original group and compare these 
results to the main analyses. In addition, we will compare the data collected to the point 
of lost to follow-up to the data of those who complete the study, to examine missing data 
mechanisms. In situations where missing data occur, we will examine the reasons for the 

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missing data whenever possible. If it is reasonable to assume that data are missing at 
random, we will use multiple model-based imputation methods. 
We will examine the mechanism of intervention effects of the TM intervention on HIV 
testing through mediation analysis.  We hypothesize that HIV TM will lead to improved 
self-efficacy at 2 months (mid-treatment), which in turn will be associated with better 
proximal outcomes (increased motivation and positive behavior) at the end of treatment, 
4 months. We will also assess changes in mediators over the course of treatment and 
their mediational effect on the primary outcome (HIV testing at 12-months). To this end, 
we will use methods for mediation analysis based on the counterfactual framework, which 
advanced mediation analysis beyond previous methods, to derive the direct and indirect 
effects for each of these mediators on the rate of HIV testing while accounting for potential 
interactions between the intervention and the mediator and adjusting for potential 
confounding between the mediator and the outcome. We will use the method proposed 
by Imai et al30 and implemented in the R mediation package.31 We will use generalized 
estimating equations to accommodate for the time-dependent exposure and mediator 
variables.32 For each mediator, we will express the results of these analyses in terms of 
the proportion of the total effect of the intervention group on HIV testing that is explained 
by the mediator. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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13 SOURCE DOCUMENTS AND ACCESS TO SOURCE DATA/DOCUMENTS 
Study staff will maintain appropriate research records for this study in compliance with 
ICH E6, Section 4.9, and regulatory and institutional requirements for the protection of 
the confidentiality of subjects. Study staff will permit authorized representatives of 
NIDCR and regulatory agencies to examine (and when required by applicable law, to 
copy) research records for the purposes of quality assurance reviews, audits, and 
evaluation of the study safety, progress, and data validity.  
Source documents for this study include: 
• Screening forms (eCRF): Subject's eligibility will be determined via a 
questionnaire in REDCap. This data will be collected in the BU REDCap system 
and managed by BEDAC. 
• Informed Consent documents (eCRF): The informed consent process will be 
documented and stored within the REDCap system and managed by BEDAC.  
• Contact Information (eCRF): Contact information will be documented and stored 
within the REDCap system and managed by BEDAC. Research staff will have 
access to this information to contact participants. 
• TMs sent: TM sent will be documented and maintained in the Agile Health 
platform. 
• TMs responses: All TM responses will be recorded and maintained in the Agile 
Health platform. Unrecognized texts will also be included in the project 
dashboard so that the project director can respond. 
Questionnaire responses (baseline, 3-, 6-, and 12-months) (eCRF) will be collected via 
REDCap. The data will be stored and managed by BEDAC.  
Qualitative logs of procedural issues identified by the research staff will be collected and 
documented by the project director and stored on a password-protected computer. 
It is expected that for all of the eCRFs listed above, data will be directly entered into the 
REDCap system, so this will be the primary data source. In the rare instances when a 
paper form is used instead of the eCRF, the paper form will be the primary data source. 
 
 

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14 QUALITY CONTROL AND QUALITY ASSURANCE 
Ultimate responsibility for implementing and maintaining quality assurance (QA) and 
quality control (QC) systems with written operating procedures to ensure that the trial is 
conducted, and data are generated, documented, and reported in compliance with the 
protocol resides with the principal investigators of the study. The project director, 
BEDAC, and Agile Health will provide regular reports on the fidelity and administration 
of the intervention to the MPIs. These processes are outlined in the study’s Quality 
Management Plan.  
In addition to the reports, all eCRFs will use standard procedures to ensure data quality, 
such as required responses and maximum and minimum data ranges.  
All staff will undergo required trainings for each task for which they assume 
responsibility. Trainings for responsibilities such as administration of questionnaires, 
recruitment, or obtaining informed consent will require the staff member to review the 
administration procedures with one of the MPIs or the project director and then 
successfully administer a minimum of three mock questionnaires with study staff or 
other department members. These mock administrations will be audio recorded and 
reviewed with the PIs or Project Director to ascertain if competency was met on that 
administration. All trainings will be documented on a training log. All assigned tasks will 
be tracked on a delegation of responsibility log. 
For more information on the study’s QA and QC, please see the Quality Management 
Plan. 
 
 
 
 
 
 
 
 
 
 
 
 
 

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15 ETHICS/PROTECTION OF HUMAN SUBJECTS 
15.1 
Ethical Standard 
The PIs will ensure that this study is conducted in full conformity with the principles set 
forth in The Belmont Report: Ethical Principles and Guidelines for the Protection of 
Human Subjects of Research, as drafted by the US National Commission for the 
Protection of Human Subjects of Biomedical and Behavioral Research (April 18, 1979) 
and codified in 45 CFR Part 46 and/or the ICH E6.  
15.2 
Institutional Review Board 
The protocol, informed consent form(s), recruitment materials, and all subject materials 
will be submitted to the IRB for review and approval. Approval of both the protocol and 
the consent form must be obtained before any subject is enrolled. Any amendment to 
the protocol will require review and approval by the IRB before the changes are 
implemented in the study.  
15.3 
Informed Consent Process 
Informed consent is a process that is initiated prior to the individual agreeing to 
participate in the study and continues throughout study participation. Extensive 
discussion of risks and possible benefits of study participation will be provided to 
subjects. A consent form describing in detail the study procedures and risks will be 
given to the subject either in hard or electronic copy. Consent forms will be IRB-
approved, and the subject is required to read and review the document or have the 
document read to them.  
The investigator or designee will explain the research study to the subject and answer 
any questions that may arise. The subject will sign the informed consent document prior 
to any study-related assessments or procedures. Subjects will be given the opportunity 
to discuss the study with their surrogates or think about it prior to agreeing to 
participate. They may withdraw consent at any time throughout the course of the study. 
A copy of the signed informed consent document will be given to subjects for their 
records either via text or email. The rights and welfare of the subjects will be protected 
by emphasizing to them that the quality of their clinical care will not be adversely 
affected if they decline to participate in this study. 
15.4 
The consent process will be documented via REDCap.  
For subjects who speak Spanish, a Spanish version of the consent form will be used 
that was translated from the English version and then back translated into English. A 
bilingual (English and Spanish) study staff will administer the consent process with 
individuals in the language of their choice. All processes are identical to those described 
for English speakers. 
 

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15.5 
Exclusion of Women, Minorities, and Children (Special Populations) 
Individuals of any gender or racial/ethnic group may participate. Our eligibility criteria 
include a minimum age of 18 years based on the demographic profile of patients at the 
community health center adult dental clinics; this also reflects the age of majority in 
Massachusetts. Some participants enrolled in this research may be between the ages of 
18-21, and those individuals will meet the NIH definition of children. We will not seek nor 
obtain parental consent for these subjects’ participation in research, given that they no 
longer meet the legal definition of minors. 
15.6 
Subject Confidentiality 
Subject confidentiality is strictly held in trust by the investigators, study staff, and the 
sponsor(s) and their agents. This confidentiality is extended to any study information 
relating to subjects. 
The study protocol, documentation, data, and all other information generated will be 
held in strict confidence. No information concerning the study, or the data will be 
released to any unauthorized third party without the prior written approval of the 
sponsor. 
The study monitor or other authorized representatives of the sponsor may inspect all 
study documents and records required to be maintained by the investigator, including 
but not limited to medical records (office, clinic, or hospital) for the study subjects. The 
clinical study site will permit access to such records. 
15.7 
Certificate of Confidentiality  
To further protect the privacy of study subjects, a Certificate of Confidentiality will be 
obtained from the NIH. This certificate protects identifiable research information from 
forced disclosure. It allows the investigator and others who have access to research 
records to refuse to disclose identifying information on research participation in any civil, 
civil, criminal, administrative, legislative, or other proceedings, whether at the federal, 
state, or local level. By protecting researchers and institutions from being compelled to 
disclose information that would identify research subjects, Certificates of Confidentiality 
help achieve the research objectives and promote participation in studies by helping 
assure confidentiality and privacy to the subjects.  
 
 
 
 
 

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16 DATA HANDLING AND RECORD KEEPING 
The investigators are responsible for ensuring the accuracy, completeness, legibility, 
and timeliness of the data reported. The investigators will maintain adequate case 
histories of study subjects, including accurate case report forms (CRFs) and source 
documentation, in collaboration with Agile Health and Biostatics and Epidemiology Data 
Analytics Center (BEDAC). 
16.1 
Data Management Responsibilities 
BEDAC at Boston University School of Public Health (BUSPH) has been a resource 
since 1984, providing research services to BU investigators, government, foundations, 
and industry partners. The BEDAC will provide the following services for this study: 
• 
Project Management: Provides the structure through which study operations are 
planned, tracked, and managed, provides a vehicle to foster effective 
communication and information exchange, and ensures that project deliverables 
are completed on-time. 
• 
Data Management: Leads the development, implementation, and maintenance 
of the Data Management Plan (DMP) to ensure that data is traceable and of high 
quality throughout the entire data life cycle. The DMP provides documentation of 
data sources, describes the software development life cycle, data collection, and 
data cleaning procedures, and ensures validation of final datasets to meet 
Sponsor requirements. 
• 
Study Monitoring: Along with the MPIs, provides risk-based approaches to 
ensure adherence to the protocol, standard operating procedures (SOP), Good 
Clinical Practice (GCP), and other regulatory requirements. 
• 
Reporting: Provides tables, figures, and listing for data management, safety, 
and statistical findings, using both static and interactive platforms. 
Data collection and accurate documentation are the responsibility of the study staff 
under the supervision of the two PIs. All source documents and laboratory reports must 
be reviewed by the study team and data entry staff, who will ensure that they are 
accurate and complete. Unanticipated problems and adverse events must be reviewed 
by the investigator or designee.  
16.2 
Data Capture Methods 
Data will be collected using several methods. Signed and dated consent forms will be 
completed by the participants in the study on REDCap or, in the event of internet 
interruption, on paper forms and stored at the GSDM offices under secured conditions 
with a copy uploaded to the participant file on REDCap. Data will also be collected 
through a secure web-based REDCap database. Paper forms will be used for screeners 
and questionnaires if they are not entered directly into REDCap. Text message 
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message responses. Only the participant’s study identification number will appear on 
any data. Data collected from research participants will be stored in a secured, 
password-protected computer file that is separate from identifiers. Any paper data will 
be placed in a locked file cabinet. A file will be maintained that associates the subject's 
name with that subject’s study identification number. This file will be kept in a secure, 
password-protected file, separate from the actual study data (e.g., screener and 
questionnaire data).  
16.3 
Types of Data 
Data includes screening forms, informed consent documents, questionnaires, and TM 
data. Electronic forms of all data forms will be recorded through the secure web-based 
REDCap database. The Agile Health database will contain the text messaging system, 
including information on what text messages each participant has received, where they 
are in the study, and what feedback they have given.  
16.4 
Schedule and Content of Reports 
The schedule and content of reports is included in the Data Management Plan. 
16.5 
Study Records Retention 
All paper documents will be stored in locked secured cabinets at the offices of GSDM’s 
Department of Health Policy and Health Services Research at 560 Harrison Ave. in 
Boston, Massachusetts.  
The primary databases will reside on a secured server, accessible to appropriate GSDM 
staff, Agile Health staff, and at the central Coordinating Center at BU School of Public 
Health.  
All study records and computer files will be retained for at least 7 years after the final 
financial report for the award is filed, or the final study manuscript is published, 
whichever is later. At each 7-year interval, the necessity of keeping the study records 
and computer files longer will be reviewed and decided upon. 
Study documents should be retained for a minimum of 2 years after the last approval of 
a marketing application in an ICH region and until there are no pending or contemplated 
marketing applications in an ICH region or until at least 2 years have elapsed since the 
formal discontinuation of clinical development of the investigational product. These 
documents should be retained for a longer period, however, if required by local 
regulations. No records will be destroyed without the written consent of the sponsor, if 
applicable. It is the responsibility of the sponsor to inform the investigator when these 
documents no longer need to be retained. 
16.6 
Protocol Deviations 
A protocol deviation is any noncompliance with the clinical study protocol, Good Clinical 
Practice, or Manual of Procedures requirements. The noncompliance may be on the 

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part of the subject, the investigator, or the study staff. As a result of deviations, 
corrective actions are to be developed by the study staff and implemented promptly. 
These practices are consistent with investigator and sponsor obligations in ICH E6: 
• Compliance with Protocol, Sections 4.5.1, 4.5.2, 4.5.3, and 4.5.4. 
• Quality Assurance and Quality Control, Section 5.1.1 
• Noncompliance, Sections 5.20.1 and 5.20.2. 
All deviations from the protocol must be addressed in study subject source documents 
and promptly reported to NIDCR and the local IRB, according to their requirements.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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17 PUBLICATION/DATA SHARING POLICY 
This study will comply with the NIH Public Access Policy, which ensures that the public 
has access to the published results of NIH-funded research. It requires scientists to 
submit final peer-reviewed journal manuscripts that arise from NIH funds to the digital 
archive PubMed Central upon acceptance for publication. 
The International Committee of Medical Journal Editors (ICMJE) member journals have 
adopted a clinical trials registration policy as a condition for publication. The ICMJE 
defines a clinical trial as any research project that prospectively assigns human subjects 
to intervention or concurrent comparison or control groups to study the cause-and-effect 
relationship between a medical intervention and a health outcome. Medical 
interventions include drugs, surgical procedures, devices, behavioral treatments, 
process-of-care changes, and the like. Health outcomes include any biomedical or 
health-related measures obtained in patients or participants, including pharmacokinetic 
measures and adverse events. The ICMJE policy requires that all clinical trials be 
registered in a public trials registry such as ClinicalTrials.gov, which is sponsored by the 
National Library of Medicine. Other biomedical journals are considering adopting similar 
policies. For interventional clinical trials performed under NIDCR grants and cooperative 
agreements, it is the grantee’s responsibility to register the trial in an acceptable registry 
so that the research results may be considered for publication in ICMJE member 
journals. The ICMJE does not review specific studies to determine whether registration 
is necessary; instead, the committee recommends that researchers who have questions 
about the need to err on the side of registration or consult the editorial office of the 
journal in which they wish to publish.” 
 
 
 
 
 
 
 
 
 
 
 

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REFERENCES 
1. 
Centers for Disease Control and Prevention. Monitoring selected national HIV 
prevention and care objectives by using HIV surveillance data—United States 
and 6 dependent areas, 2017. June 2019 2019. 
2. 
Centers for Disease Control and Prevention. Ending the HIV Epidemic. 
https://www.cdc.gov/endhiv/index.html. Published 2020. Updated July 30, 2020. 
Accessed January 26, 2021. 
3. 
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APPENDIX A 
TABLE 1: Schedule of Event (SoE) 
 
SC 
BL 
D0 
M3 
M6 
WK24 
EoE 
Brief screening agreement 
☓ 
 
 
 
 
 
 
Screening 
☓ 
 
 
 
 
 
 
AH phone verification 
☓ 
 
 
 
 
 
 
Eligibility confirmation 
☓ 
 
 
 
 
 
 
Informed Consent Form 
☓ 
 
 
 
 
 
 
Contact Form 
 
☓ 
 
 
 
 
 
Demographics 
 
☓ 
 
 
 
 
☓ 
GAD-7 
 
☓ 
 
 
 
 
☓ 
CES-D 20 
 
☓ 
 
 
 
 
☓ 
HIV/HCV Testing 
 
☓ 
 
☓ 
☓ 
 
☓ 
KAP Survey 
 
☓ 
 
☓ 
☓ 
 
☓ 
PRHS 
 
☓ 
 
☓ 
☓ 
 
☓ 
HIV Testing Self-Efficacy 
 
☓ 
 
☓ 
☓ 
 
☓ 
PrEP Knowledge 
 
☓ 
 
☓ 
☓ 
 
☓ 
PrEP Stigma 
 
☓ 
 
☓ 
☓ 
 
☓ 
PrEP Subjective Norms 
 
☓ 
 
☓ 
☓ 
 
☓ 
PrEP Descriptive Norms 
 
☓ 
 
☓ 
☓ 
 
☓ 
PrEP Experience 
 
☓ 
 
☓ 
☓ 
 
☓ 
PrEP-ASES 
 
☓ 
 
☓ 
☓ 
 
☓ 
IBM Model for PrEP Use 
 
☓ 
 
☓ 
☓ 
 
☓ 
PrEP Intentions 
 
☓ 
 
☓ 
☓ 
 
☓ 
CUSES 
 
☓ 
 
☓ 
☓ 
 
☓ 
ARBA 
 
☓ 
 
☓ 
☓ 
 
☓ 
ASI-Lite 
 
☓ 
 
 
 
 
☓ 
TCU 
 
☓ 
 
☓ 
☓ 
 
☓ 
SCT Mediators 
 
☓ 
 
☓ 
☓ 
 
☓ 
InDI-A 
 
☓ 
 
☓ 
☓ 
 
☓ 
InDI-D 
 
☓ 
 
☓ 
☓ 
 
☓ 
mMOS-SS 
 
☓ 
 
☓ 
☓ 
 
☓ 
Randomization 
 
☓ 
 
 
 
 
 
Intervention Starting Point 
 
 
☓ 
 
 
 
 
Intervention Ending Point 
 
 
 
 
 
☓ 
 
TM Program Satisfaction 
 
 
 
☓ 
☓ 
 
 
End of study instructions 
 
 
 
 
 
 
☓ 
Screening (SC), Baseline (BL), Day 0 (D0), Month-3 (M3), Month-6 (M6), Week 24 (WK24), End of Study (EoE).