Intervention to Reduce Drug Use and HIV Incidence Among High PrEP Priority Partnered YMSM
Phase: NA
Conditions: Adherence, Medication, Risk Reduction, Drug Use, Sex, Anal, HIV/AIDS
Sponsor: Hunter College of City University of New York

Project PARTNER Study Procedural Guide 
FOR INTERNAL USE ONLY. THIS IS NOT AN IRB PROTOCOL 
 
 
 
STUDY PROTOCOL 
with 
STATISTICAL ANALYSIS PLAN 
 
 
Prevention and Risk: Treatment with a new emphasis on Relationships 
(Project Partner) 
 
NCT03396367 
 
Sponsor: 
National Institute of Drug Abuse (NIDA) 
 
 
Principal Investigator: 
 
 
Tyrel J. Starks, PhD 
 
 
 
 
 
 
Professor 
Hunter College 
City University of New York 
New York, NY 
 
 
 
 
 
 
 
 
 
 
 
Version Date: January 1, 2024 
 
 
 

Project PARTNER Study Procedural Guide 
FOR INTERNAL USE ONLY. THIS IS NOT AN IRB PROTOCOL 
 
Table of Contents 
STUDY DESIGN .............................................................................................................................................. 6 
 ...................................................................................................................................................................... 6 
STUDY TIMELINE ........................................................................................................................................... 6 
STUDY POPLUATION ..................................................................................................................................... 7 
Inclusion and Exclusion Criteria: ............................................................................................................... 7 
Contact Information ................................................................................................................................. 8 
STUDY PROCEDURES ..................................................................................................................................... 8 
Enrollment Procedures ............................................................................................................................. 8 
Informed Consent Process ........................................................................................................................ 8 
Post-COVID: Participants review written consent information prior to their baseline appointment. The 
baseline survey link directs participants to a landing page containing detailed consent information. At 
the beginning of the baseline assessment, study staff provides an oral review of consent information 
and confirms age eligibility via Zoom. After reviewing this information, participants are asked to affirm 
their consent/assent to participate. A copy of the electronic consent form is emailed to the 
participant upon request. ......................................................................................................................... 8 
Randomization Process/Systems .............................................................................................................. 8 
Schedule of Assessments .......................................................................................................................... 9 
Managing and Tracking Study Visits ....................................................................................................... 10 
Retention and Follow Up ........................................................................................................................ 11 
Specimen Collection Pre-COVID .............................................................................................................. 11 
Incentives and Compensation ................................................................................................................. 12 
MEASURES .................................................................................................................................................. 17 
CASI Measures ........................................................................................................................................ 17 
INTERVENTION PROCEDURES ..................................................................................................................... 13 
Intervention Monitoring ......................................................................................................................... 16 
DATA MANAGEMENT AND ANALYSIS PLAN............................................................................................ 17 
Data Management and Data Quality ...................................................................................................... 17 
Quantitative Analysis Plan ...................................................................................................................... 19 
Moderation/mediation analyses ............................................................... Error! Bookmark not defined. 
Qualitative analysis of intervention feedback ........................................... Error! Bookmark not defined. 
Power analyses ....................................................................................................................................... 21 
Equivalency Checks ................................................................................................................................. 22 

Project PARTNER Study Procedural Guide 
FOR INTERNAL USE ONLY. THIS IS NOT AN IRB PROTOCOL 
 
IMPLICATIONS AND LIMITATIONS .......................................................................................................... 22 
Policy/Methodological Implications ....................................................................................................... 22 
Primary limitations .................................................................................................................................. 22 
SAFETY MONITORING PLAN ........................................................................................................................ 23 
Adverse Events Reporting ....................................................................................................................... 23 
ETHICAL CONSIDERATIONS ......................................................................................................................... 23 
Informed Consent Process ...................................................................................................................... 23 
REFERENCES ................................................................................................................................................ 25 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Project PARTNER Study Procedural Guide 
FOR INTERNAL USE ONLY. THIS IS NOT AN IRB PROTOCOL 
 
 
 
 
STUDY ABSTRACT 
DESIGN: 
The study utilizes a randomized control trial design, with two 
conditions (the experimental PARTNER intervention and an 
attention-matched Education control) receiving equal 
allocation.   
 
SAMPLE SIZE: 
240 Sexual minority men (SMM) (18-29) who are in a same 
gender relationship. Or 30-34 if they are in a relationship with a 
partner who is 18-29 
 
POPULATION: 
HIV negative SMM who have used drugs in the past 30 days, 
and who have engaged in CAS in the past 30 days with a casual 
partner, a serodiscordant main partner, or a non-monogamous 
main partner. 
 
STRATIFICATION: 
 
The study will employ a stratified block randomization 
procedure with will equate study conditions based upon 1) age 
discrepancy between partners, 2) relationship length, and 3) 
race and ethnicity using Qualtrics.   
 
DATA COLLECTION: 
 
Participants have the options to first complete a CASI at home 
before their BL appointment (or during BL if they have not done 
so beforehand). All other aspects of data collection occur at 
Hunter College. A second CASI survey will also be administered 
at the BL appointment. Time line follow back interviews to 
assess drug use, sexual behavior and PrEP adherence (where 
applicable) will at all assessments. Drug screening and PrEP 
adherence will be accomplished by obtaining fingernail samples 
from participants at all assessments. Blood will be collected for 
testing PrEP medication adherence. STI testing will be 
accomplished by collecting urine and rectal samples at BL, 6m, 
and 12m. HIV testing will be conducted at BL, 6m, and 12m.  
 
 
Post-COVID: Participants receive a CASI link via email and an at-
home STI and HIV testing kit, a dried blood spot (DBS) collection 
kit for PrEP adherence, and a fingernail collection kit for drug 
screening (via regular mail) prior to assessment appointments. 

Project PARTNER Study Procedural Guide 
FOR INTERNAL USE ONLY. THIS IS NOT AN IRB PROTOCOL 
 
All other aspects of data collection occur remotely via HIPAA-
compliant Zoom. 
 
 
 
OBJECTIVES: 
 
1) Evaluate the efficacy of PARTNER in regards to three primary 
outcomes: 1) PrEP uptake and adherence 2) sexual transmission 
risk behavior and 3) drug use. 
2) Identify individual and relationship factors which 
moderate/mediate intervention efforts. 
3) Gather ideographic data to inform a future effectiveness-
implementation study. 
4) Validate the use of fingernail assays as a biological marker for 
PrEP adherence. 
 
 
 

Project PARTNER Study Procedural Guide 
FOR INTERNAL USE ONLY. THIS IS NOT AN IRB PROTOCOL 
 
Baseline (n = 
240) 
Qualtrics 
survey 
TLFB 
STI testing 
Fingernail 
assaya 
DBSb 
 HIV Testing 
Figure 3. Participation timeline 
a To detect drug use for all participants and PrEP adherence for those 
on PrEP. 
b Gathered only for those on PrEP 
3-month (n = 
240) 
Qualtrics 
survey 
TLFB 
Fingernail 
assaya 
DBSb 
 
6-month (n = 
240) 
Qualtrics 
survey 
TLFB 
STI testing 
Fingernail 
assaya 
DBSb 
  HIV Testing 
9-month (n = 
240) 
Qualtrics 
survey 
TLFB 
Fingernail 
assaya 
DBSb 
 
  
12-month(n = 
240) 
Qualtrics 
survey 
TLFB 
STI testing 
Fingernail 
assaya 
DBSb 
  HIV Testing 
PARTNER 
(n = 120) 
Sessions 1-4 
Education 
(n = 120) 
Sessions 1-4 
 
Appointment 1 
STUDY DESIGN 
 
 
 
 
 
 
STUDY TIMELINE 
 
 
 
 
 
 

Project PARTNER Study Procedural Guide 
FOR INTERNAL USE ONLY. THIS IS NOT AN IRB PROTOCOL 
 
STUDY POPLUATION 
Inclusion and Exclusion Criteria: 
Participants who express interest in PARTNER must demonstrate the following 
inclusion criteria to be enrolled in the study: 
• 18 – 29 years old; or 30-34 with a partner who is 18-29 (inclusive) 
• Have a main partner who is another male for 1 month or longer 
o Main partner must be 18 years old or older 
• Be HIV negative (as confirmed by rapid test) 
• Have used drugs in the past 30 days 
• Have engaged in TRB in the past 30 days 
o Defined as CAS with a casual partner and/or CAS with a non-monogamous or 
serodiscordant main partner 
• Live in the NYC metropolitan area (Enrollment expanded nationwide in the US in 
September 2022.) 
• Speak English 
 
Participants are excluded from the study if they any indicate the following: 
• Any signs of serious mental illness or cognitive deficit 
• History of intimate partner violence with their main partner or feel unsafe in their 
current relationship. 
 
Recruitment and Screening 
We utilize a multi-faceted recruitment effort including both active and passive approaches. Our 
previous research focused on MSM in relationships has indicated that online recruitment is 
particularly effective at reaching this target population. We anticipate enrolling 6 new 
participants each month. Contacts obtained through our online screener will be contacted for 
scheduling. Contacts that come from the online master screener will be sent 2 emails with links 
to take our study specific screener. Once scheduled, participants are sent their at-home survey 
link. They do not have to complete this survey beforehand, but we do remind them two times 
before their baseline appointment to complete it as it cuts down on the time they need to be in 
the office.   
Post COVID: Contacts obtained through our cross project online screener are contacted to 
schedule a baseline appointment on Zoom. Before the baseline appointment, the study staff 
contacts the participants via text or phone call to obtain preferred mailing address for testing 
kit shipments, confirm contact information, and obtain participant PrEP status in order to ship 
the correct laboratory testing kit. The baseline assessment is scheduled and study staff sends 
participants their at-home survey link and orders their STI/HIV testing kits. Participants must 

Project PARTNER Study Procedural Guide 
FOR INTERNAL USE ONLY. THIS IS NOT AN IRB PROTOCOL 
 
complete this survey and have received their testing kits before their remote baseline 
appointment can occur. 
Contact Information  
Once they are screened eligible through our online screener, participants’ contact 
information is collected and they are asked if messages can be left at the numbers 
provided or if text can be sent. Study staff do not leave messages or send text 
messages unless expressly permitted to do so by the participant, which is documented 
on the participant Locator Form and Access DB.  
STUDY PROCEDURES 
 
Enrollment Procedures 
Participants are considered enrolled in the study when they have completed informed 
consent. Randomization occurs immediately after the baseline appointment. 
 
Informed Consent Process 
Details of the study are reviewed with the prospective study participant by a research 
assistant who is trained and cleared to conduct assessments and is knowledgeable 
about the research study. This discussion is a critical component of the consent 
process and the prospective study participant will be given adequate time for this 
discussion and to read the written consent form. The research assistant is available to 
answer questions about the study including participant responsibilities, benefits, risks, 
and alternatives. The participant reviews the consent form and it is signed and dated 
by both the participant and study staff member conducting the assessment. A copy of 
the signed consent form will be given to the participant and the original will be kept 
securely by the project coordinator separate from other assessment materials. 
Post-COVID: Participants review written consent information prior to their baseline 
appointment. The baseline survey link directs participants to a landing page containing detailed 
consent information. At the beginning of the baseline assessment, study staff provides an oral 
review of consent information and confirms age eligibility via Zoom. After reviewing this 
information, participants are asked to affirm their consent/assent to participate. A copy of the 
electronic consent form is emailed to the participant upon request.  
Randomization Process/Systems 
Participants are randomized at the end of their baseline assessment into one of two 
intervention conditions: 1) delivery of the 4 session PARTNER intervention or 2) 

Project PARTNER Study Procedural Guide 
FOR INTERNAL USE ONLY. THIS IS NOT AN IRB PROTOCOL 
 
delivery of 4 education sessions. Each participant’s condition is tracked in the access 
tracking database maintained by the project manager.  
 
The study employs a stratified block randomization procedure with equate study conditions based upon 
1) age discrepancy between partners, 2) relationship length, and 3) race and ethnicity using Qualtrics.   
 
Schedule of Assessments 
Sessions occurs approximately once per week for three weeks beginning one week 
after completion of the baseline assessment and session 1. There is a 12 week window 
for intervention completion, i.e. all four sessions must be completed within 12 weeks 
of the baseline assessment.  
 
Participants complete the first follow-up assessment 3 months after the baseline, and 
subsequent follow ups at 6, and 9 months after baseline with a final appointment 
scheduled for 12 months following the baseline appointment. Study staff should aim 
to schedule and complete these follow-ups as close as possible to each target date. To 
keep track of longitudinal data collection dates, assessment visit windows will be 
defined as 15 days prior and after the target as “in window.” The assessment visit 
window for the 12 month follow-up ends 30 days after the target date. Site study staff 
should prioritize the completion of sessions before the first follow-up assessment, and 
should not schedule this follow-up less than 12 weeks after baseline if a participant is 
available to complete any additional sessions first.  
Post-COVID: The 12-month assessment window ends 60 days after the target date. 
 
 
 
Component 
Baseline 
Session 1 
Session 2 
Session 3 
Session 4 
3-Month 
Follow-Up 
6-Month 
Follow-Up 
9-Month 
Follow-Up 
12-Month 
Follow-Up 
Informed Consent 
X 
 
 
 
 
 
 
 
X 
Randomization 
X 
 
 
 
 
 
 
 
 
CASI 
X 
 
 
 
 
X 
X 
X 
X 
TLFB 
X 
 
 
 
 
X 
X 
X 
X 
HIV Testing 
 (Rapid for those not on PrEP – 
X 
 
 
 
 
 
X 
 
X 

Project PARTNER Study Procedural Guide 
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Architect for those on PrEP) 
STI Testing 
X 
 
 
 
 
 
X 
 
X 
Fingernail Assay for Drugs 
X 
 
 
 
 
X 
X 
X 
X 
Dried Blood Spot 
(For those on PrEP) 
X 
 
 
 
 
X 
X 
X 
X 
PrEP Video 
 
 
 
X 
 
 
 
 
 
Video Recall Survey for 
those who seen the Video 
 
 
 
 
X 
x 
 
 
x 
Session feedback  
 
 
 
 
X 
 
 
 
 
Qualitative Interview 
 
 
 
 
 
 
 
 
x 
 
Managing and Tracking Study Visits 
There are two different types of visits during the study timeline: 
 
Session Visits: Session visits refer to both the four education and four intervention 
sessions. Intervention sessions are conducted by trained and cleared MI-trained 
clinicians. Intervention sessions will be managed by the clinicians with their individual 
study participants. Clinicians will notify site study staff of whether visits were 
completed for tracking purposes, provide receipts for session compensation to site 
study staff, and upload audio files to Project Partners respective folder on the M drive 
as per study procedures. Education sessions are conducted by trained and cleared 
health educators. Education sessions will be managed by the educators with their 
individual study participants. Educators will notify site study staff of whether visits 
were completed for tracking purposes, provide receipts for session compensation to 
site study staff, and upload audio files to Project Partners respective folder on the M 
drive as per study procedures. 
 
Research Visits: Research visits include all assessments including the baseline visit, the 
post-test assessment, and all other follow-up assessments. All participants, in either 
condition, are expected to complete five assessment visits as part of full participation 
in the study. 
 
Study staff will schedule participants during times that they will be available or will 
contact other staff to ensure coverage for appointments. Study staff will also ensure 
that there is available space to conduct these assessments.  
 
Future visits should be scheduled during the study visit. Study staff are expected to 
keep in touch with participants and remind them of the upcoming visit or reschedule if 

Project PARTNER Study Procedural Guide 
FOR INTERNAL USE ONLY. THIS IS NOT AN IRB PROTOCOL 
 
needed. A reminder call should be made the day before a participant is due to come in 
for their visit (or the Friday before a Monday visit). 
Retention and Follow Up 
 
Session visits: For participants who are actively taking part in the PARTNER 
intervention or the Education control condition, site study staff will not add an 
additional level of outreach to the procedures.  
 
Specimen Collection Pre-COVID 
HIV testing will be performed at the baseline using the HIV 4th Generation assays and 
those will be administered following the below criteria: 
1- Participants on PrEP, upon PrEP self-report confirmation will provide 1 tube of 
blood to send to the LAB for HIV Confirmatory testing with Architect 
equipment to avoid any inaccurate test results as a result of PrEP drugs in 
blood. Results are downloaded from the LAB’s web portal.  
2- Participants NOT on PrEP, will be administered a rapid HIV Test named 
“Determine Ab/Ag” which detects HIV antibodies and antigen P24 (the last one 
is a very sensitive part of this specific test and can detect early acute HIV 
infections).  
 
At baseline we test for Urethral and Rectal Gonorrhea & Chlamydia presence. The 
testing method for Urethral G&C will involve the participant urinating in a sterile urine 
collection cup then to pipette just a portion of that urine sample into a sample tube in 
order to be sent for testing to Sunrise medical Laboratory. For Rectal detection we will 
provide the participant with an anal swab collection kit, and send the specimen for STI 
detection to Sunrise Medical Laboratory. 
 
We will collect participant’s fingernails and potentially toenails in case the sample is 
not enough, to test illicit drug use in the last 6 months, this 5-Panel drug assay will be 
conducted by USDTL Laboratory.  
 
A second vial of blood will also be collected at the same time as the HIV test vial with 
participants reporting being on PrEP, to perform dried blood spot (DBS) cards to test 
for PrEP adherence, which will be sent to Colorado Antiviral Pharmacology Laboratory. 
 
Post-COVID Specimen Collection 
 
HIV and STI tests are completed using tests shipped and processed by Molecular 
Testing Labs (MTL). Prior to the RA administered portion of the baseline assessment 
and 6- and 12-month follow-ups, participants are mailed a package containing an at-
home OraQuick testing kit for HIV, self-administered rectal and urethral gonorrhea 
and chlamydia testing kits, one dried blood spot (DBS) card (if on PrEP), collection 

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materials (alcohol prep pads, lancets, gauze pad, and adhesive bandages), an 
instruction card, and a postage-paid shipping envelope. During the RA administered 
portion of the baseline, 6M, and 12M, the RA will review instructions and 
demonstrate the collection procedure. The RA will then remain on the Zoom call to 
provide any additional guidance as needed during the collection procedure. 
Participants will then place the collected specimens in the addressed envelope for 
shipping to the lab for processing. Participants will also be mailed a fingernail 
collection kit to examine drug use rates during all assessments. 
 
 
Incentives and Compensation 
Participants will be compensated up to $380 for full participation in the study. They 
will receive: 
$50 for completing a Baseline assessment. 
$20 for each completed session (up to $80 total). 
$60 for completing a 3-Month Follow-Up Assessment. 
$60 for completing a 6-Month Follow-Up Assessment. 
$60 for completing a 9-Month Follow-Up Assessment. 
$70 for completing a 12-Month Follow-Up Assessment. (Post-COVID: $100 for 
completing a 12-Month Follow-Up Assessment) 
 
 
 

Project PARTNER Study Procedural Guide 
FOR INTERNAL USE ONLY. THIS IS NOT AN IRB PROTOCOL 
 
 
INTERVENTION PROCEDURES 
 
The PARTNER intervention comprises 4 sessions of Motivational interviewing (MI)  to address 3 target 
behaviors that correspond to the study’s primary outcomes: drug use, PrEP uptake/adherence, and HIV 
transmission risk. Miller and Rollnick suggested that 4 processes are ongoing during an MI session: 
engagement (establishment of a therapeutic alliance), focusing (clarification of session goals), evoking 
(eliciting speech in favor or change while softening arguments for the status quo), and planning (the 
identification of action steps that can be taken toward the accomplishment of an identified goal). The 
salience of these various processes is dependent upon the duration of the relationship between the 
interventionist and the participant as well as the client’s stage of change.  
 
The first session emphasizes the engaging process. It begins with an introduction to the participant 
followed by an exploration of participant’s primary relationship, understanding how he and his partner 
handle sex outside their relationship, and enhancing motivation to reduce both drug use and HIV 
infection risk. This conversation then focuses on what strategies, if any, the participant and his partner 
use to manage their HIV risk. The interventionist then seeks to evoke motivation to reduce HIV related 
risk, potentially through PrEP uptake or adherence. The values card sort activity is utilized midway 
through the session to integrate a conversation about how the participant’s values are expressed in his 
relationship and the decisions made around HIV prevention. The second session engages the participant 
in a review of the previous week and then transitions to focus on drug use. The interventionist seeks to 
evoke motivation to reduce drug use, with particular attention given to how the participant’s 
relationship partner feels about use. The third session integrates a focus on the links between drugs and 
CAS with main and casual partners, PrEP, and presents video-based modeling to enhance 
communication skills. This facilitates a longer discussion about planning toward any identified goals. The 
interventionist gives particular attention to the role of relationship partners during the planning phase. 
The final session engages the participant in a review of the previous week. The session then proceeds to 
review the participant’s perception of the overall intervention process with emphasis on successes and 
challenges. The session emphasizes the planning process by inviting the participant to identify long-term 
goals related to the target behavior and develop plans to accomplish these goals. A discussion of 
relevant resources and referrals occurs during this time.  

Project PARTNER Study Procedural Guide 
FOR INTERNAL USE ONLY. THIS IS NOT AN IRB PROTOCOL 
 
 
PARTNER incorporates a video-based approach to relationship skill building with a structured series of 
debriefing questions asked by the MI provider after the video is viewed. The video utilized was 
comprised of 3 scenes, each depicting a different couple. It is integrated into Session 3 of the 
intervention and serves a dual purpose. First, it provides information specific to PrEP. Each scene depicts 
either a nonmonogamous or serodiscordant couple discussing PrEP and HIV prevention. In this way, 
participants viewing the video see men in relationships with men talking about reasons why PrEP might 
be relevant, while also receiving basic information about PrEP and its efficacy. Second, the videos 
directly teach communication skills through modeling. Each scene is divided into 2 parts. In the initial 
portion of the scene, the couple makes a specific communication error. Midway through the scene, a 
narrator interrupts the couple, explains their error, and suggests an alternative strategy. The scene then 
continues, and the couple communicates more effectively.  
 
 
 
SESSION 1: Focus on CAS with main and casual partners 
• Opening statement – provide information as appropriate; set the stage for 
collaboration; introduce target behaviors 
• Values Card Sort – Use Open Questions and Reflections, close with a major Summary  
• Use strategies for eliciting change talk & managing discord 
• At the end of the session, offer a closing summary highlighting any change talk or steps 
towards change; evoke commitment to attend future session 
 
 
SESSION 2: Focus on drug use 
• Opening statement – highlight any change talk or plan from previous session; introduce 
second target behavior and collaborate on setting session agenda with client 
• Briefly revisit last session’s topic and check for any changes or recent events since you 
last met  
• Ask permission to discuss second target behavior 
• Use strategies for eliciting change talk and managing discord 
• Offer to help in creating a strategy to change target behavior 
• Offer a closing summary at the end of the session, highlighting change talk and any 
steps taken towards change  
 

Project PARTNER Study Procedural Guide 
FOR INTERNAL USE ONLY. THIS IS NOT AN IRB PROTOCOL 
 
SESSION 3: Focus on drugs, CAS with main and casual partners, and PrEP 
• Opening statement: Highlight and integrate change talk on both target behaviors and 
any ideas or goals the client has articulated around these behaviors; work 
collaboratively to set the agenda for the session 
• Ask the client where they would like to go from here; or, ask permission to discuss 
collaborating on a change plan together 
• Evoke client’s ideas about change; build on past success; evoke and reinforce self-
efficacy for taking steps towards change 
• If appropriate, use the Ask-ask-tell-ask-reflect approach for offering information or 
suggestions; if offering suggestions be sure to reinforce client autonomy and offer a 
menu of options 
• Collaborate with the client to build a change plan that reflects their goals, priorities and 
readiness to change; elicit the client’s ideas about how the plan could be carried out, 
when the steps will occur – and why these changes are important  
• Offer a closing summary highlighting change talk and briefly reiterating the basic plan; 
reinforce client autonomy; remind the client that the next session will be focused on 
moving ahead independently. 
 
SESSION 4: Focus on drugs, and CAS with main and casual partners 
• Opening Statement: Summarize the plan developed previously and collaborate on 
setting the session agenda; introduce termination / last YMHP session;  
• Check in on how the plan has been going since you last met; use strategies for evoking 
change talk / managing discord as appropriate; affirm client for any steps towards 
change; 
• Evoke client’s ideas about how to improve or adapt the plan; evoke and reinforce 
commitment for maintaining the plan moving forward 
• Evoke client’s ideas about what to do should problems arise in the future; develop a 
‘backup plan’ as appropriate 
• Summarize progress over the 4 sessions and termination  
 
Post-COVID: The PARTNER intervention is administered via Zoom following the procedures 
outline above. Interventionists share their screen with participants when needed to present 
video components of the intervention. The values card sort activity is completed using a version 
of the task programmed into Qualtrics. Interventionists share their screen, and participants 
direct them how to sort values.  
 

Project PARTNER Study Procedural Guide 
FOR INTERNAL USE ONLY. THIS IS NOT AN IRB PROTOCOL 
 
Education Intervention (Control Condition) 
The education intervention is administered one-on-one by a health educator. The sessions are guided by 
a PowerPoint presentation that helps to insure fidelity of delivery while also increasing the participant’s 
engagement through the integration of pictures, animation, and video. The presentation is viewed on a 
personal computer located in the intervention room. Dual monitors are used to ensure that both the 
educator and participant can readily view material.  
 
The condition comprises of 4 sessions of health education addressing sexual risk and drug use. The 
sessions utilize a mixture of modalities including lecture, question and answer, and video. Session 1 
focuses on HIV risk and prevention. Lecture content is supplemented by videos focusing on HIV 
transmission generally and HIV prevention strategies among gay and bisexual men specifically. Session 2 
is focused on drug use. Information about the biological effects of drug use is largely provided through 
videos. Lecture content and discussion questions focus on the impact of drug use within the local gay 
community. Session 3 examines the intersection of drugs and sex in the local gay community. Education 
content also focuses on mitigating the risks associated with having sex while intoxicated. Session 4 again 
focuses on drug use with video and lecture-delivered content describing the signs and warnings of 
potential substance use disorders.  
Post-COVID: The education intervention is administered via Zoom following the procedures outlined 
above. Health educators share their screen with participants to present PowerPoint slides and review 
session content. 
 
Intervention Monitoring  
All sessions will be audio recorded. MI fidelity in the PARTNER intervention will be evaluated 
using the Motivational Treatment Integrity coding system141. We will randomly select 25% of 
session to be coded. A team of trained coders is maintained and utilized in all NIH-funded 
studies involving MI-based interventions. The educators for the control condition will undergo 
similar fidelity procedures in which 25% of their education sessions will be evaluated for fidelity. These 
recordings will be reviewed and matched to a fidelity checklist that outlines the content of the 
Education session. Successful Education sessions will have accurately discussed at least 90% of the 
content. 
 

Project PARTNER Study Procedural Guide 
FOR INTERNAL USE ONLY. THIS IS NOT AN IRB PROTOCOL 
 
DATA MANAGEMENT AND ANALYSIS PLAN 
Data Management and Data Quality 
Qualtrics, a secure online survey platform which can be accessed from computers on site, is 
used to administer survey measures during in-person appointments. Qualtrics is sufficiently 
flexible to permit the use of a wide range of question and response types. 
 
Qualitative interviews will be recorded, transcribed, and de-identified.  
MEASURES 
CASI Measures 
 
 
Construct 
Measure 
Screening 
Demographics 
NHBS demographics inventory107 
information 
Sexual HIV transmission risk 
Self-Reported Sexual Behavior 
 
PrEP uptake and related 
attitudes 
PrEP uptake questionnaire15,68 
 
Problematic drug use 
Drug Abuse Screening Test – 10108  
 
Alcohol and Drug Use 
Behavior 
NHBS Substance Use History 
Inventory107 
 
Partner health behavior 
Partner health behavior survey 
IMB factors  
Knowledge: Drug use 
Drug use knowledge questionnaire 
 
Knowledge: HIV infection 
(including condom and PrEP 
supplement) 
Brief HIV knowledge questionnaire109  
 
Motivation: Drug use 
Decisional Balance - Club Drugs110 
 
Motivation: Condom use 
Decisional Balance - Unsafe Sex110 
 
Motivation: PrEP 
Decisional Balance - PrEP 
 
Behavioral Skill: Drug use 
Drug Taking Confidence 
Questionnaire111 
 
Behavioral Skill: Condom 
use 
Condom use self-efficacy scale112 
 
Behavioral Skill: PrEP 
Adapted Adherence Self-Efficacy Scale113 
Individual 
Condom attitudes/beliefs 
Adapted condom attitudes scale32  
functioning 
Anxiety and Depression 
Brief Symptom Inventory114 (subscales) 
 
Experiences of stigma 
Everyday discrimination115 
 
Intimate Partner Violence 
(IPV) 
IPV among gay and bisexual men 116 
 
Problematic alcohol use 
Alcohol Use Disorders Identification Test 
(AUDIT)117 
 
Self-reported STI and HIV 
 

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testing history; PrEP; and 
ART  
Relationship 
functioning 
Relationship satisfaction, 
cohesion, consensus & 
affectional expression  
Dyadic adjustment scale118 
 
 
Interpersonal 
Communication Skills 
Interpersonal Communication 
Competence Scale119 
 
Partner communication 
strategies  
Communication patterns 
questionnaire120 
Sexual communication121 
 
Couples HIV Coping 
Perceived severity of HIV infection122 
Preferences for sexual health 
outcomes122 
Couple efficacy to reduce HIV threat122 
 
Stigma directed at the 
relationship 
Relationship marginalization123 
 
Relationship Control & 
Dominance 
Sexual Relationship Power Scale 
(SRPS)124  
 
Attitudes about Sexual 
Agreements 
Sexual Agreement Investment Scale 
(SAIS)100 
 
 
Primary outcomes 
Drug use. During TLFB interviews, participants indicated whether they used any of 10 different 
drug types. Responses produced two count variables indicating the number of days participants 
used cannabis and the number of days they reported the use of any illicit drugs, including: 
cocaine, crack, methamphetamine, ecstasy, ketamine, GHB, and psychedelics. Self-reported 
drug use was corroborated by fingernail assay. See supplemental material for details.  
Current PrEP uptake was assessed using a single survey item, “Have you ever been prescribed 
PrEP (HIV pre-exposure prophylaxis)?” Participants taking PrEP reported days they missed their 
PrEP on the TLFB interview. Responses were used to create a dichotomous variable indicating 
whether or not participants took PrEP on at least 57% of days (corresponding to at least 4 days 
out of 7 on average). Self-reported PrEP adherence was corroborated with DBS results. See 
supplemental material for details. 
Sexual HIV TRB. During TLFB interviews, participants indicated days they had (insertive or 
receptive) anal sex with any casual partners and whether a condom was used. Responses were 
aggregated to create a variable indicating the number of times the participant had CAS with a 
casual partner. If participants were prescribed PrEP and reported missing 13 doses or fewer, 
they were assigned a value of 0, reflecting that the use of PrEP on at least 4 of 7 days is 
sufficient to achieve reductions in HIV TRB (28). Self-reported CAS with casual partners was 
corroborated by bacterial STI diagnosis. See supplemental material for details. 

Project PARTNER Study Procedural Guide 
FOR INTERNAL USE ONLY. THIS IS NOT AN IRB PROTOCOL 
 
 
Putative moderators 
Relationship satisfaction was assessed using the approximation to ideal subscale of Kurdek’s 
(29, 30) Multiple Determinants of Relationship Commitment Inventory (MDRCI). The subscale 
consists of 4 items (e.g., "My current relationship comes close to matching what I would 
consider to be my ideal relationship"). Response options ranged from 1 (strongly disagree) to 5 
(strongly agree). Total score reliability was good (Cronbach’s α = .848). 
Communication skills. Self-disclosure, social anxiety, assertiveness, and empathy subscales of 
the Interpersonal Communication Competence Scale (31) assessed aspects of communication 
skills. Each subscale was assessed by 3 statements (e.g., “I can put myself in others' shoes” and 
“It's difficult to find the right words to express myself”). Participants evaluated each statement 
using a 5-point scale Likert-type scale ranging from 0 (“Almost never”) to 4 (“Almost always”). 
Total score reliability was good (Cronbach’s α = .787). 
Quantitative Analysis Plan 
The primary hypotheses are that SMM receiving the PARTNER intervention will be more likely 
to initiate and/or be adherent to PrEP throughout the follow up period. As a result, it is 
hypothesized they will have a lower probability of TRB. In addition, it is hypothesized that the 
PARTNER intervention will be associated with lower levels of drug use (number of use 
instances) compared to the education condition.  
 
Corroboration of self-reported behavior with biomarkers 
Self-reported drug use was corroborated by fingernail assays. At baseline and all follow-ups, at 
least 80% of participants who tested positive for cannabis indicated at least one instance of 
cannabis use. In addition, at least 60% of those who did not test positive for cannabis on 
fingernail assays indicated they used cannabis at least once. At baseline, and all follow-ups, at 
least 55% of those who tested nail positive for cocaine, crack, or amphetamine use reported at 
least one instance of illicit drug use. In addition, 12% of those who did not test positive for illicit 
drug use on nail samples self-reported the use of at least one drug. 
Self-reported PrEP adherence was corroborated with DBS results. At baseline and all follow-up 
time points, no fewer than 69% of participants who reported taking their PrEP on 57% of days 
or more had a DBS test result of 700 units of TFV-DP per DBS punch or greater at all follow-up 
time points. One participant at baseline and another at the 3month follow-up reported missing 
more than 57% of their PrEP but produced a DBS result of 700 units of TFV-DP per DBS punch or 
more. 
Self-reported CAS with casual partners was corroborated by bacterial STI diagnosis. Participants 
were indicated as having a bacterial STI if they received a positive result for rectal or urethral 
gonorrhea or chlamydia at baseline, 6, or 12-month follow-up or if they self-reported receiving 
a diagnosis in the past 3 months at any assessment point. At baseline, 30.5% of those who 

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reported CAS with a casual partner had a bacterial STI compared to 7.7% of those who did not. 
Similarly, 44.2% of participants who reported having CAS with a casual partner at either the 3 or 
6-month follow-up had a bacterial STI, compared to 23.9% of those who did not. Finally, 39% of 
those who reported having CAS with a casual partner at the 9 or 12-month follow-up had a 
bacterial STI compared to 9.5% of those who did not. 
 
Detailed analytic plan 
A series of bivariate analyses (χ2 tests of independence and independent samples t-tests) 
conducted in SPSS (version 29) evaluated the success of randomization and the presence of 
differential attrition. The generalized linear model function in SPSS was used to evaluate 
between-condition differences in baseline frequency of primary outcomes with count 
distributions (cannabis use days, other illicit drug use days, sexual HIV TRB) and baseline odds 
of PrEP uptake (a dichotomous variable).  
Outcome analyses were conducted using piece-wise latent growth curve (LGC) models 
following procedures outlined by Chou et al. Growth trajectories over time following the 
delivery of an intervention may be characterized by a large initial response followed by a more 
sustained trajectory with a less dramatic slope. Piece-wise LGC models quantify this kind of 
trajectory using two slopes. Slope 1 quantifies the change from baseline to the immediate post-
test (3-month follow-up). Meanwhile, Slope 2 quantifies the trajectory over the post-
intervention follow-up period.  
Two models were calculated for each outcome. Model 1 included the main effect of treatment 
on growth factors. Model 2 added the main effects of moderators (communication skills and 
relationship quality) as well as the interaction terms between these moderators and the main 
effect of treatment.  
Several considerations led to the inclusion of model covariates. Consistent with guidance for 
the analysis of data from randomized controlled trials that utilize stratified randomization (16), 
stratification variables were included as covariates in regressions predicting latent growth 
factors. The COVID-19 pandemic and recovery corresponded with changes in substance use and 
sexual behavior among SMM. To account for this, models incorporated a dichotomous, time-
varying predictor indicating whether an assessment occurred before or after March 2020. 
All models were calculated using full-information maximum likelihood estimation in Mplus 
Version 8.0. This permitted the retention of all randomized cases consistent with the intent-to-
treat paradigm. Model significance was evaluated using a robust log-likelihood χ2 test 
comparing the log-likelihood of the specified model to a null-model – in which all structural 
coefficients associated with the regression of latent growth factors on condition and site were 
constrained to be zero. Where model results were significant, the effect of the PARTNER 
intervention was evaluated by examination of regression parameters for Slopes 1 and 2. Given 
the directional nature of hypotheses, single-sided p-values were used to determine the 

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significance of the intervention effect. When evaluating the significance of putative moderators 
and associated interaction terms, two-sided p-values were used. 
Power analyses 
We utilized the Test for the Ratio of Two Negative Binomial Rates module in PASS 19 to evaluate power 
to detect between-condition differences in drug use frequency at any one follow-up time point. Power 
(1-beta) was set to .80 and the probability of type II error (alpha) was set to .05. The number of 
exposures was set to 30 (the number of days of use assessed in the TLFB). The rate of use in the 
education condition was set to 3, 6, and 9. Meanwhile dispersion values of 1, 2, and 4 were tested. 
Power was highest at low levels of dispersion and high based rates of use in the education condition. 
Under these circumstances, the study has power=.80 to detect a rate ratio of 0.70 or a 30% reduction in 
drug use instances. At high levels of dispersion and low base rates, the study would be expected to 
detect a rate ratio of 0.48. 
 
Power to detect differences in HIV transmission risk behavior was calculated in 2 ways. First, using 
procedures similar to those described for drug use, the study has power to detect a rate ratio between 
0.48 and 0.69 in the number of CAS events in the absence of PrEP. This calculation tested average rates 
of CAS in the absence of PrEP in the education condition of 1, 3, and 5 instances and dispersion was 
tested at values of 1, 2, and 4. Power to detect significant differences in the odds of a positive STI test 
was calculated using the inequality tests for 2 proportions in a repeated measures design module [60]. 
Analyses specified 4 waves of data, power (1-beta) was set to .80, and the probability of type II error 
(alpha) was set to .05. Autocorrelation (rho) was permitted to vary between .25 and .75. The proportion 
of positive STI diagnosis in the education condition was tested at values of .13, .10, and .07. Power 
declined as rho increased. Power increased with the proportion of positive diagnoses in the education 
condition. Analyses suggested that the study is adequately powered to detect large effects, associated 
with an odds ratio between 0.20 (under the least favorable conditions) and 0.32 (under the most 
favorable). 
 
Power to detect differences in PrEP uptake was similarly calculated using the inequality tests for 2 
proportions in a repeated measures design module [60]. Analyses specified 4 waves of data, power (1-
beta) was set to .80, and the probability of type II error (alpha) was set to .05. Autocorrelation (rho) was 
permitted to vary between .25 and .75. We estimated that on average 35% of the education condition 
would be on PrEP during the follow-up period. The proposed sample is sufficient to detect an odds ratio 

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FOR INTERNAL USE ONLY. THIS IS NOT AN IRB PROTOCOL 
 
of 1.90 even at the highest values of rho, which corresponds to approximately 51% of the PARTNER 
condition initiating PrEP. With regard to adherence, assuming approximately 100 participants (45% of 
the sample assuming 80% retention) are on PrEP at any follow-up point and 75% of the control 
condition is adherent to their PrEP medication (Cronbach alpha=.05; and ρ=.25 to .50), results suggested 
that the study has power=.80 to detect an odds ratio of approximately 3.0.  
Equivalency Checks 
We will strive to ensure that randomization will not produce any significant differences in 
participant characteristics that require control in subsequent longitudinal analyses. Baseline 
cross-site variance in participant characteristics will be assessed using standard tests of mean 
differences for both biological markers and self-reported measures of substance use, TRB, and 
PrEP uptake/adherence. Assignment differences in baseline demographics will be assessed 
using standard non-parametric measures of association. Any observed differences will be 
controlled for in subsequent models. 
IMPLICATIONS AND LIMITATIONS 
Policy/Methodological Implications  
This application has focused implications for the biomedical prevention of HIV in a highly 
vulnerable population as well as broad methodological implications for PrEP research. The 
proposed project tests an intervention which addresses PrEP uptake in a high-priority 
population for whom no existing interventions are tailored (partnered SMM meeting CDC 
criteria for PrEP candidacy). It therefore addresses PrEP uptake and adherence (critical steps in 
the cascade) for an under-served and highly vulnerable population. Furthermore, the secondary 
aims of this proposal include the validation of fingernail assays to assess PrEP adherence. This 
innovation has broad implications for the study of PrEP. 
 
Primary limitations 
1) The absence of data from relationship partners. The use of individual (rather than dyadic) 
intervention is intended to enhance scalability. Participants will report relationship functioning 
as well as their perception of their partners’ drug use, sexual behavior, PrEP uptake (see 
APPENDIX B; Partner health behavior survey). This will provide proxy data which can inform 
future studies. 2) Limited data on the efficacy of the PARTNER intervention. We have 
completed all aspects of intervention development and established the acceptability/feasibility 
of PARTNER. The need for pilot efficacy data is reduced by the fact that PARTNER incorporates 
all aspects of YMHP, which has demonstrated efficacy16, and the use of a control condition 
which has been employed in previous NIH funded trials16. 3) Recruiting partnered SMM. A 
strong infrastructure exists to support recruitment efforts. We have developed recruitment 

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protocols and tracking systems that have facilitated a detailed examination of the efficiency of 
recruitment efforts18,105,106,146. We have also specifically examined issues related to dyadic vs. 
individual participation in research on partnered MSM18. 
SAFETY MONITORING PLAN 
 
Adverse Events Reporting 
The Site PI is responsible for the detection and documentation of events meeting the 
criteria and definition of an AE or SAE. Study staff may ask PI questions concerning 
adverse events, but must formally report them via email. Information on unexpected 
events including serious adverse effects (SAEs) will be reported as per the policy of the 
IRB. 
 
Information to be collected includes the nature, date of onset, stop date, intensity, 
duration, treatment, causality, and outcome of the event. PIs should follow usual 
clinical practices for reporting serious, unexpected events related to standard of care. 
SAEs that occur after 30 days after completion of the study will be collected only if 
they are considered by the PI to be related to study participation. In addition, any AE 
resulting in potential participant withdrawal must been reported to the PI prior to 
participant withdrawal when possible. 
 
PIs must report any Adverse Event to the IRB within five business days of learning of it. 
 
ETHICAL CONSIDERATIONS 
 
 
Informed Consent Process 
Site PIs must ensure that participants are fully informed about the purpose, responsibilities of 
participating and potential risks or other critical issues related to participation in the study. 
Written informed consent is obtained from every participant or, in those situations where 
consent cannot be given by participants, their legally acceptable representative, prior to clinical 
study participation.  
 
The rights, safety, and well-being of study participants are the most important considerations 
and should prevail over interests of science and society. If there is any question that the 
prospective participant will not reliably comply with study procedures and/or follow-up, they 
should not be enrolled in the study. 

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