Couples Health Project: Couples-based Intervention to Reduce Drug Use and HIV Transmission Risk
Phase: NA
Conditions: Risk Behavior, Drug Use, Sex, Anal
Sponsor: Hunter College of City University of New York

                                                     Study Procedure Guide (SPG) 
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Couples Health Project 
 
 
Development of a couples-based intervention to reduce drug use and enhance sexual health 
among partnered emerging adults. 
NCT# 03386110 
LAST UPDATED: May 15, 2019 

                                                     Study Procedure Guide (SPG) 
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May 2019 
 
FOR INTERNAL USE ONLY. THIS IS NOT AN IRB PROTOCOL. 
 
Table of Contents 
STUDY ABSTRACT ........................................................................................................................2 
OBJECTIVES .................................................................................................................................3 
Study Timeline: ...........................................................................................................................2 
STUDY POPULATION....................................................................................................................2 
3.1 
Inclusion and Exclusion Criteria .............................................................................2 
3.2 
Recruitment and Screening ...................................................................................2 
3.3 
Contact Information ..............................................................................................3 
4.0 STUDY PROCEDURES .............................................................................................................3 
4.1 
Enrollment Procedures ..........................................................................................3 
4.1.1 Informed Consent Process .....................................................................................3 
4.2 
Randomization Process/Systems ...........................................................................4 
4.3 
Schedule of Assessments .......................................................................................4 
4.3.1    Timeline Follow Back Interview .............................. Error! Bookmark not defined. 
4.4 
Managing and Tracking Study Visits .......................................................................5 
4.5 
Retention and Follow Up .......................................................................................6 
4.6 
Specimen Collection ..............................................................................................6 
4.6.1    Key Biological Testing ...............................................................................................7 
4.7 
Incentives and Compensation ................................................................................8 
4.8 
Criteria for Premature Discontinuation .................... Error! Bookmark not defined. 
4.9 
Measures...............................................................................................................8 
5.0 
CHP INTERVENTION/EDUCATION PROCEDURES ...............................................................9 
5.1 
Intervention Design and Procedures ......................................................................9 
5.1.1 
Three Sessions of CHP (Intervention) .....................................................................9 
5.1.2    Three Sessions of Education....................................................................................10 
5.2 
Intervention Training and Supervision .................................................................11 
6.0 
SAFETY MONITORING PLAN ...........................................................................................12 
6.1 
Data and Safety Monitoring Board.......................................................................12 
 

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FOR INTERNAL USE ONLY. THIS IS NOT AN IRB PROTOCOL. 
Abbreviations: 
TRB – Transmission Risk Behavior  
MSM – Men who have Sex with Men 
YMSM – Young Men who have Sex with Men 
TLFB – Time Line Follow Back 
STI – Sexual Transmitted Infection 
BL – Baseline appointment 
FU – Follow Up appointment   
STUDY ABSTRACT 
 
DESIGN:  
This study utilizes qualitative methods during a formative phase 
to inform intervention development.  Subsequently a small 
randomized controlled trial is utilized in Phase 2 to evaluate the 
feasibility, acceptability, and preliminary efficacy of the new 
intervention relative to an attention-matched education control 
condition. 
 
 
SAMPLE SIZE: 
In Phase 2  we will recruit a sample of 50 couples (n = 100 
individuals). At least one member of the couple must be a YMSM 
between the ages of 18 and 29; report recent (past 30 days) 
drug use; and recent (past 30 day) Transmission Risk Behavior 
(TRB).  
 
POPULATION:  
Partnered MSM aged 18-29 who are in a primary relationship 
with another man for at least 3 months, who also uses some 
kind of illicit drug, and also had some TRB in the last 30 days 
with a casual partner or with a non-monogamous serodiscordant 
partner. In addition all participants will have to be able to 
communicate in English. 
  
STRATIFICATION:  
Participants will be randomized at baseline to receive their first 
CHP or Education session directly following their baseline 
appointment. The study will employ a stratified randomization 
procedure using Qualtrics.  
 
DATA 
COLLECTION: 
Participants have the options to first complete a brief CASI at 
home before or during their BL appointment. Regardless, they 
will then complete another survey at their BL appointment along 
with a TLFB, STI testing (Gonorrhea & Chlamydia Urethral and 
Rectal), and Drug testing. During session 3, participants will 
complete a CHTC session that involves Rapid HIV testing for 
couples. For 1m FU participants will complete an at home 
Qualtrics survey. At 3M FU participants will complete a Qualtrics 
survey, a TLFB and a Fingernail specimen collection for drug use. 

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Finally, at 6M FU participants will complete a Qualtrics survey, a 
TLFB and Specimen collection to test drug use on fingernail 
sample and Gonorrhea & Chlamydia for STI testing (Urethral and 
Rectal).  
 
OBJECTIVES 
1) Develop content to address PrEP uptake/adherence and 
integrate biological testing 
 
2) Evaluate the efficacy, feasibility, and acceptability of CHP at 3- 
and 6-month follow-up. 
 

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STUDY DESIGN:  
 
 
 
Recruitment of Candidates 
Screening 
Candidates offered phone 
Eligible 
Ineligible 
Baseline ($50 each) 
•
CASI/CVS 
•
TLFB 
•
Fingernail assay 
•
STI Testing G&C 
(urethral & rectal) 
Randomized to CHP (n=25) 
Randomized to Education (n=25) 
3 Condition Sessions + 4th Booster 
session 
($20 dollars a session per participant, 
except Session 3 $25 per participant) 
1-Month Follow-Up At Home ($20 each)  
•
CASI Survey 
•
Assessment of intervention feedback 
3-Month Follow-Up In House ($50 each) 
•
CASI Survey 
•
TLFB 
•
Fingernail Collection for Drug use 
6-Month Follow-Up In House ($60 each) 
•
CASI Survey 
•
TLFB 
•
Specimen collection:  
o
STI testing (G&C) 
o
Fingernails for Drug use 
Ineligible on 
CASI/CVSA 
Dropped  
Ineligible through at home CASI: $10 
 
Eligible are Enrolled (n=50 Couples) 
Recruit partner 
for Baseline 
appointment 
together 

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Original Study Timeline: 
 
STUDY POPULATION 
3.1 
Inclusion and Exclusion Criteria 
a. Inclusion 
i. One partner must be 18 to 29 years of age 
ii. Both partners born male and currently identify as male  
iii. One partner must be HIV-negative (one partner can be HIV positive) 
iv. In a relationship with another man for at least 3 months 
v. Either partner reporting the use of at least one of the following substances in 
the past 30 days Marijuana, cocaine and crack, amphetamines, ecstasy, GHB, 
ketamine, nitrates 
vi. Either partner reporting CAS with a casual partner and/or CAS with a non-
monogamous or serodiscordant main partner in past 30 days.  
vii. Must be able to communicate English 
viii. Must reside in the NYC metro area 
 
b. Exclusion 
i. Either member of the couple reports IPV, which is defined as serious physical or 
sexual violence that occurs outside the context of consensual bondage or sado-
masochistic sexual play, which results in concerns of safety (IPV-GBM scale) 
ii. Unstable, serious psychiatric symptoms 
iii. Currently suicidal/homicidal 
iv. Evidence of gross cognitive impairment 
3.2 
Recruitment and Screening 
This study will utilize an index case approach for the recruitment of couples in which one 
partner will be screened. Those providing data that indicate they are eligible will then be 
asked to schedule a baseline appointment during a timeslot on a day that they can attend with 
their partner. This strategy has proven effective in our previous studies of gay couples, 
substantially more effective than procedures that require advanced screening of both 
partners. The study will utilize active and passive approaches to recruit index participants. 
Month
1-2
3-4
5-8
9 10-12
13-18
19-24
25-30
31-36
Planned activity
Phase I: intervention development
Startup
Interviews with partnered YMSM (n = 20)
Qualitative data analysis
Intervention development and staff training
Phase II: enrollment
Enrollment (n = 50 couples; 100 individuals)
Follow up data collection
Data analysis
Dissemination of qualitative findings
Intervention outcome analyses
Year 1
Year 3
Year 2

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3.3 
Contact Information  
 
Once they are screened eligible through our online screener participants contact 
information will be collected and they will be asked if messages can be left at the 
numbers provided or if text can be sent. Study staff will not leave messages or send 
text messages unless expressly permitted to do so by the participant, which also will 
be documented on the participant Locator Form and Access DB.  
4.0 STUDY PROCEDURES 
 
4.1 
At-home CASI 
Once participants schedule their baseline appointment, they will be sent an appointment 
reminder email with instructions to find PRIDE’s office and the time of the appointment. This 
email will contain a link to a Qualtrics survey for them to complete prior to the baseline 
appointment. The index partner (participant 1) will be sent two emails: one will contain their 
unique Qualtrics survey link and a second email to be forwarded to their partner (participant 2) 
so they can access their Qualtrics survey link. When participant 2 completes the at-home CASI 
they will be asked to leave contact information.  
 
In the unlikely event that either participant in the couple answers “yes” to the question about 
IPV or coercion, both members of the couple will be ineligible for the study. In this scenario, 
each participant will be compensated $10 for completing the at-home CASI via Amazon gift 
card.  
 
If participants do not complete this CASI prior to their baseline appointment, they will have to 
complete it in the office the day of their baseline.  
4.2 
Enrollment Procedures 
 
Participants are considered enrolled in the study databases when they have 
completed informed consent in person.  
4.2.1 Informed Consent Process 
 
Details of the study will be reviewed with the prospective study participant by a 
designated site study staff member 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 Principal Investigator (PI) or 
his/her designee will be available to answer questions about the study including 
participant responsibilities, benefits, risks, and alternatives. A shortened version of the 
consent form will be delivered electronically to the participant prior to beginning 
participation in the study, and then the full consent form will be reviewed at the 

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beginning of the in-person baseline appointment. The participant will review the 
consent form and it will be 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. 
 
4.3 
Randomization Process/Systems 
 
Participants will be randomized at the end of their baseline assessment into one of 
two control conditions: 1) delivery of the 3 session CHP intervention or 2) delivery of a 
3 education sessions. Each participant’s condition will be tracked in the access tracking 
database maintained by the Research Coordinator.  
 
The study will employ a stratified randomization procedure for each interventionist using 
Qualtrics. Randomization will be stratified on:  
1. Age discrepancy Question: is the couples age difference (3 years or less/ longer than 3 
years) 
2. Relationship Length Question: is the couple’s relationship length (2 years or less/longer 
than 2 years) 
3. Racial makeup question: is the couples racial makeup (both partners identify as white 
and non-Hispanic/one or both partners identify as nonwhite or Hispanic) 
 
4.4 
Schedule of Assessments 
 
Intervention or education sessions will occur approximately once per week for two 
weeks beginning one week after completion of the baseline assessment and session 1. 
There is a 6 week window (45 days) for intervention or education completion, i.e. 
opportunities to complete all three sessions must be provided before the 1 month 
online follow up survey is sent out.  
 
Participants will complete the first follow-up assessment online 1 month after baseline 
(1M FU). For those who have completed all sessions by day 30 post BL, they will be 
sent their 1 month follow up survey. For those who have yet to complete all 3 sessions 
they will be given until day 45 post baseline until their session window closes and they 
must be sent their 1 month follow up survey. The 1 month follow up survey will close 
60 days post baseline. Follow up assessment windows for 3 month and 6 month follow 
ups will be programmed to open on day 90 and day 180 respectively and will remain 
open for 30 days.  
 

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Component 
Screening 
Baseline 
Session 1 
Session 2 
Session 3 
Booster 
1-Month 
Follow-Up
3-Month 
Follow-Up
6-Month 
Follow-Up 
Informed Consent 
 
x 
 
 
 
 
 
 
 
CASI 
 
x 
 
 
 
 
x 
x 
x 
HIV Testing 
 
 
 
 
x 
 
 
 
 
STI Testing (G&C) 
 
x 
 
 
 
 
 
 
x 
Fingernail Drug Test 
 
x 
 
 
 
 
 
x 
x 
Randomization 
 
x 
 
 
 
 
 
 
 
Randomized Condition Session 
 
 
x 
x 
x 
x 
 
 
 
TLFB 
 
x 
 
 
 
 
 
x 
x 
Assessment of Intervention feedback  
 
 
 
 
x 
 
 
 
 
Assessment of Intervention feedback 
(If not completed or captured in session 3) 
 
 
 
 
 
 
X 
 
 
 
Refer to “Study Design” for a visual representation of the schedule of assessments. 
 
4.5 
Managing and Tracking Study Visits 
 
There are two different types of visits during the study timeline: 
 
Intervention/Education Sessions: All CHP sessions will be managed by trained staff 
members. Therapists and Educators will notify the project coordinator whether visits 
were completed for tracking purposes, provide receipt for session compensation and 
audio files will be uploaded to the designated secure location on PRIDE servers. 
Session 1 for CHP or Education session will ideally begin directly after the completion 
of the baseline appointment when feasible. Otherwise it will be scheduled for a later 
date. Randomization to CHP or education will occur during the baseline appointment.   
 
Research Appointments: Research visits include the baseline visit, 3 sessions, and all 
other follow-up assessments.  

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Research visits will be tracked using Access Database, encrypted and secure on a 
private server at PRIDE offices, as well as Qualtrics which is a secure web application 
for managing online surveys. This system allows study staff to monitor the completion 
of study visits and surveys, and generate reports on enrollment and retention as 
needed. Study staff is expected to track all completed study components in Access 
immediately after completing an assessment and no later than end of business day. 
 
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 is expected to keep 
in touch with participants and remind them of the upcoming visit or reschedule if 
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). 
 
4.6 
Retention and Follow Up 
Intervention visits: For participants who are actively taking part in the CHP 
intervention or Education condition their assigned clinician or educator will be 
charged with scheduling sessions and rescheduling missed sessions. Participants will 
be reminded 1 day prior to their scheduled sessions by a study staff.  
 
Research visits: Study staff will maintain strong and consistent relationships with 
study participants, and should contact study participants by text, phone, and/or email 
at minimum once per every follow up assessment to assure follow up scheduling and 
attendance. During this phone outreach, site study staff can verify existing contact 
information. Study staff should take note of participants who are less stable in terms 
of contact information i.e. Phone number/e-mail address, and devote outreach efforts 
toward these participants strategically. 
 
***NOTE: Due to COVID-19, all follow-up assessments completed after 3/15/2020 were 
conducted remotely via Zoom and online survey administration via Qualtrics. 
4.7 
Specimen Collection 
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 and then send it 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. In addition to the STI 
detection 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. HIV testing is performed at session 3 

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with both members of the couple present and will be performed utilizing HIV 4th 
Generation Rapid Test Determine Ab/Ag. Reporting to any required Departments of 
Health will occur using standard protocols. 
4.7.1    Key Biological Testing 
• 5-panel fingernail drug assay. Though studies have consistently supported the 
validity of self-reported drug use data94-97, when individuals are informed that 
their self-reported behavior will be validated through biological measurement, 
they are more likely to report their behaviors accurately98. Drug testing will be 
completed using the Nail Testing Panel from the United States Drug Testing Lab® 
(USDTL). Participants will clip 100 mg of nail (approximately 10 clippings of 2mm 
each). Clippings will be weighed on a jeweler’s scale to ensure the collection of 
an adequate sample. Clippings are transferred to a foil packet, stored at room 
temperature, and shipped to USDTL via secure envelope. Results are available in 
4 to 5 business days52. 
• Urethral STIs. Urethral STIs (chlamydia and gonorrhea) are being tested with 
laboratory assay from Sunrise Medical Laboratory, which detects both chlamydia 
and gonorrhea precisely. Participants will collect a urine sample and then place 
the specimen tube into a clear plastic biohazard bag. Specimens will be sent to 
Sunrise Medical Laboratory for processing. Sunrise Medical Laboratory will 
provide us with test results and will report positive results to the NYC DOH 
complying with New York City Health Department Reporting Requirements 101.  
• Rectal STIs. Participants will also perform testing for rectal chlamydia and 
gonorrhea using a test kit from Sunrise Medical Laboratory. The swab is 
approximately the size of a Q-tip and is grasped between the thumb and 
forefinger about an inch from the base. The swab is inserted until the fingers 
touch the anus, and then it is rotated as it is removed. Swabs are stored in a 
specimen tube and a clear plastic biohazard bag. Specimens will be sent to 
Sunrise Medical Laboratory for processing. Sunrise Medical Laboratory will 
provide us with test results and will report positive results to the NYC DOH 
complying with New York City Health Department Reporting Requirements 101.  
• Disclosure of Urethral and Rectal STI Results:  Test results will be conveyed to 
participants through a secure Qualtrics-based interface along with a list of local 
resources. Per New York City's Health Code Article 11, the lab Sunrise Medical 
Laboratories will report positive results directly to the DOHMH 
• HIV testing. HIV testing will be conducted in the context of couples’ HIV testing 
conducted in session 3 of both conditions. Testing will be performed using the 
Alere Determine Ab/Ag Testing Kit®. An RA trained in CHTC will utilize a lancet to 
gather a sample of blood from the participant’s finger. This blood is then 
collected with a capillary tube and placed on the designated area of the test 
strip, and then a drop of chase buffer is added to the testing area to culture. Test 
results are available in 20 minutes and delivered to participants immediately 

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during the couples HIV testing and counselling session. For additional 
information on HIV confirmatory testing and reporting see Attachments.  
 
***NOTE: Due to COVID-19, collection of biological specimen data was suspended on 
3/15/2020.  All follow-up assessments completed after that date were conducted remotely via 
Zoom and online survey administration via Qualtrics. 
4.8 
Incentives and Compensation 
Participants can be compensated individually up to $245 for participation in the study.  
$50 for completing a Baseline assessment 
$20 for session 1 
$20 for session 2 
$25 for session 3   
$20 for completing a 1-Month Follow-Up Assessment 
$50 for completing a 3-Month Follow-Up Assessment 
$60 for completing a 6-Month Follow-Up Assessment 
4.9 
Measures 
-Table 1- 
Construct 
Measure 
Screening 
Demographics 
NHBS demographics inventory73 
information 
Sexual HIV transmission risk 
Self-Reported Sexual Behavior 
 
Problematic drug use 
Drug Abuse Screening Test – 1074  
 
Alcohol and Drug Use Behavior 
NHBS Substance Use History Inventory73 
 
Intimate Partner Violence (IPV) 
IPV among gay and bisexual men 75 
 
Verification of couple status 
Couples Verification Screener63 
Individual   
Interpersonal Communication Skills 
Interpersonal Communication Competence Scale76 
functioning 
HIV knowledge 
Brief HIV knowledge questionnaire77 * 
 
Pros and Cons of substance use 
Decisional Balance - Club Drugs78 
 
Pros and Cons of Condomless sex 
Decisional Balance - Unsafe Sex78 
 
Condom use skills/efficacy 
Condom use self-efficacy scale79 
 
Condom attitudes/beliefs 
Adapted condom attitudes scale30 * 
 
Anxiety and Depression 
Brief Symptom Inventory80 (subscales) 
 
Experiences of stigma 
Everyday discrimination81 
 
Problematic alcohol use 
Alcohol Use Disorders Identification Test (AUDIT)82 
 
Self-reported STI and HIV testing 
history; PrEP; and ART  
 
Dyadic 
functioning 
Relationship satisfaction, cohesion, 
consensus & affectional expression  
Dyadic adjustment scale83 
 
 
Partner communication strategies  
Communication patterns questionnaire84 
 
Couples HIV Coping 
Perceived severity of HIV infection85 
Preferences for sexual health outcomes85 
Couple efficacy to reduce HIV threat85 
 
Stigma directed at the relationship 
Relationship marginalization86 
 
Relationship Control & Dominance 
Sexual Relationship Power Scale (SRPS)87  
 
Attitudes about Sexual Agreements 
Sexual Agreement Investment Scale (SAIS)88 
 

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5.0 
CHP INTERVENTION/EDUCATION PROCEDURES 
 
5.1 
Intervention Design and Procedures 
 
CHP is an intervention that utilizes motivational interviewing (MI) and personalized 
feedback to reduce CAS and substance use among partnered emerging adults. The 
CHP intervention will be delivered by MI-trained Clinical staff members. Participants 
will be randomized to receive the intervention during baseline appointment. The CHP 
intervention is comprised of 3 sessions. The intervention focuses on enhancing 
communication skills, and addressing drug use, risky sexual practices, couples HIV 
testing and counseling, PrEP and PEP, as well as navigation services to for PrEP for 
interested participants. 
 
5.1.1 Three Sessions of CHP (Intervention) 
 
Session 
Objectives 
Purpose 
Method 
Session 1 
  
  
 
1. Establish rapport 
Facilitate intervention delivery 
MI 
 
2. Assess communication and 
problem solving skills 
Determine the extent of skills training necessary 
MI focused on: 
Communication challenges 
with others and then within 
the couple 
 
3. Develop communication 
skills 
Improve partner's ability to express and understand 
one another's attitudes, opinions and emotions 
CBST 
 
4. Develop explicit problem 
solving strategy  
Improve partner's ability to effectively identify 
problems, generate and select solutions 
CBST 
 
5. Plan a date 
Practice communication skills and increase positive 
dyadic interaction 
Positive event scheduling 
 
HOMEWORK 
Practice communication and problem solving skills. 
Go on a date. 
  
Session 2 
 
 
 
1.  Assess use of skills and 
date completion 
Assess successes and barriers to skill generalization 
MI 
 
2. Discuss mutual and 
individual goals 
Assess the degree of dyadic dependence and broader 
goals and values 
MI: Value's card sort 
completed jointly 
 
3. Discuss the impact of 
substance use on goals 
Identify potential areas in which substance use may 
interfere with broader individual and couple-level 
goals and values 
MI 
 
4. Establish substance use 
goals 
Assess each partner’s perception of ideal use for 
themselves and each other.  In addition, identify 
ways in which partners can support goal 
achievement. 
Mutual reinforcement 
training 

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5. Ongoing skill practice 
Strengthen the use of effective communication and 
problem solving skills as applied in session. 
MI and CBST  
 
HOMEWORK 
Practice communication and problem solving skills.  
Go on a date.  Implement plan to achieve substance 
use goals. 
  
Session 3 
  
  
 
1. Assess use of skills and 
substance use goals 
Assess successes and barriers to skill generalization 
MI 
 
2. Complete individual or 
couples HIV testing† 
Establish sero-status and discuss joining sexual goals 
and risk reduction 
CVCT or individual HIV testing 
and counseling 
 
3. HIV medication adherence 
counseling†† 
Increase partner support for health-related behavior, 
particularly medication adherence 
Life Steps 
 
4. Establish a sexual 
agreement †† 
Establish joint sexual goals and risk reduction 
MI 
 
5. Discuss links between 
substance use and sexual risk 
goals 
Increase awareness of substance use and sex links 
MI 
 
5. Ongoing skill practice 
 
MI and CBST  
 
† Completed by HIV negative 
participants.  Note: men in 
HIV negative seroconcordant 
couples will complete sexual 
agreement negotiation as 
part of CVCT. 
 
 
  †† Completed by HIV positive 
participants and HIV negative 
participants in serodiscordant 
relationships.   
  
  
 
6. Relapse 
Prevention/Planning 
Develop long-term goals for substance use, 
sexual behavior, and HIV risk reduction 
MI Change planning 
 
7. Termination 
Summarize intervention work and 
conclude the intervention 
 
 
5.2    Three Sessions of Education 
 
Session 
Objectives 
Purpose 
Method 
Session 1 
  
Lecture + Question & 
Answers 
 
Introductions 
What do we “want” in a partner? 
 
 
 
What do we “need” in order to get close? 
 
 
 
What do couples “do” in relationships generally?  
 

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Strategies to reduce HIV risk 
 
Session 2 
 
Lecture + Question & 
Answers 
 
Drug Use Education 
 
Review the effects of several drugs on the brain and 
body 
 
 
 
Short term effects of drug use 
 
 
 
Long term effects of drug use 
 
 
 
Review the literature on drug use and sex 
 
 
 
Discuss drug and alcohol use in the gay community  
 
 
 
Review the effects of several drugs on the brain and 
body 
 
Session 3 
  
Lecture + Question & 
Answers + CHTC 
 
Communication 
Do’s and Don’ts of Couples Communication   
 
 
Couples HIV Testing and 
Counseling (CHTC) 
Introduces testing 
 
 
 
Finger stick 
 
 
 
Sexual agreement 
 
 
 
Deliver test results 
 
 
 
Debrief 
 
5.3 Sessions Training and Supervision 
CHP Sessions training will occur prior to the initiation of Phase 2, with ongoing 
coaching, supervision and training of new therapists as well as educators, as required. 
The training manuals are located on appendix B for Intervention & CHTC and Appendix 
C for Educators.  
 
Training for CHTC entails going through a series of trainings as well as mock sessions in 
order to get “Cleared” by clinical staff to conduct CHTC with participants. 
The same procedure will be followed for Educators, but they will be evaluated in their 
ability to present the education information and how to engage with the participant 
while avoiding the use of MI techniques.  
 
5.4 Intervention Fidelity and Process Measures 
We will assess the fidelity of CHP in two ways. First, CHP is an MI-based intervention. 
We will utilize the Motivational Treatment Integrity coding system, with additional 
codes relevant to MI with couples developed in our formative work, to evaluate 
fidelity to MI during the intervention. Dr. Starks is a member of the Motivational 
Interviewing Network of Trainers, and PRIDE maintains a staff of coders trained to use 
the system. We will MITI code 25% of CHP sessions. In addition, Dr. Starks will develop 

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a checklist based on the existing protocol which will be used to ensure that essential 
skills training components are completed. 
 5.5 Intervention & Education Monitoring and Supervision 
All sessions (in-person based) will be audio-recorded, and one recording per facilitator 
will be randomly selected for MITI coding by the research team on a regular basis. 
Supervisors will complete fidelity checklists for the supervision session so the team 
can monitor implementation. 
Education providers were trained by the project director or a trained clinical staff 
member. This involved a two-day workshop and subsequent mock deliveries of the 
education sessions. Educators were required to achieve fidelity to the protocol before 
delivering the condition to participants. The project director developed a session 
check-list that was approved by Dr. Tyrel Starks, which was used to determine fidelity. 
A trained clinical staff member reviewed each mock session and provided feedback. 
After being cleared to deliver the education condition to participants, a trained clinical 
staff member reviewed a minimum of 30% of completed sessions and provided 
feedback to education providers to ensure fidelity overtime. 
CHP CHTC Supervisors: Tyrel Starks. 
CHP Education Supervisors: Gabriel Alberto 
6.0 
SAFETY MONITORING PLAN 
7.1 
Data and Safety Monitoring Board 
The study will be conducted under the supervision of an independent DSMB compried 
of Drs. Karen Ingersoll (chair); David Huebner and Eli Rosenberg.  All DSMB members 
have extensive experience in either clinical trials and/or management of HIV or HIV 
prevention experience. The DSMB is responsible for the ongoing review of CHP 
research and for making recommendations concerning the continuation, modification, 
and termination of the study. 

                                                     Study Procedure Guide (SPG) 
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FOR INTERNAL USE ONLY. THIS IS NOT AN IRB PROTOCOL. 
 
Appendix A (CHTC Training Manual and Protocol) 
 
 
 
 
 
 
 
 
 
 
 
• For Full Manual (142 pages) for CHTC please follow the Link:  
https://www.cdc.gov/globalaids/resources/prevention/docs/2014docs/chtc-participant-
manual.pdf 
 
 
 

                                                     Study Procedure Guide (SPG) 
Version 2.0 
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FOR INTERNAL USE ONLY. THIS IS NOT AN IRB PROTOCOL. 
 
 
Step 1 
Introduce yourself 
Hello, my name is ____, and I will be your HIV testing counselor for your session today. 
Explain CHTC 
Today, you'll be completing an HIV test together, you will receive your results together, which means you'll hear 
each others' test results. And you will have the opportunity to discuss how you guys handle HIV risk in your 
relationship together. 
 
(OPTIONAL) We think of CHTC as being "forward looking."  In other words, I'm not going to ask you to 
discuss your sexual history, instead we'll focus on how you guys want to handle HIV risk going forward.  
Benefits of CHTC 
The benefit of completing CHTC is that you'll both know each other's status and can make plans to keep each 
other healthy. 
Conditions of CHTC 
1. Agree to discuss any concerns you have about HIV and the ways you'll handle HIV risk going forward. 
 
2. Agree to receive your results together as a couple. 
 
3. Agree to handle disclosure decisions together. 
Roles/Responsibilities 
Because CHTC is a bit different from individual testing, I would like to take just a minute to talk about what is 
expected of you as individuls and as a couple during the session.  The couples who get the best out of this 
experience are the ones who agree to... 
 
Some couples think of these as ground rules. 
 
1. Participate equally 
 
2. Listen and respond to one another 
 
3. be respectful, open and honest 
 
4. be understanding and supportive 
Overview of procedures 
I'd like to tell you about how the session typically proceeds 
 
1. We'll complete the HIV test itself 
 
2. While the test developes, we'll talk about your relationship and what brought you in for testing together. 
 
3. We'll discuss HIV risk concerns and any agreements you have about sex. 
 
4. We'll review your HIV test results. 
 
5. I'll provide any information you'd like about results and risk management and we'll discuss your 
agreement in light of your results today. 
 
Any questions? 
Obtain concurrence 
How does that sound?  Are you both comfortable continuing with the session? 
 
 

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Step 2 
Explain the test 
We use a finger prick test here.  I'll prick your finger with a small needle and draw a small amount of blood.  
We'll then wait 20 minutes for the test to develop. 
Explain individual results 
The test looks for HIV antigens and antibodies to the HIV virus  
 
A positive test result means antibodies or antigens were detected in your blood.  
Antigens stimulates the immune system to produce antibodies, so this test is better at picking up recent infections.  
 
1. The test we use is highly accurate, which means it is highly likely that you have HIV if the test comes back 
positive.  
 
2. When a positive test result occurs, a confirmatory test is done.  We do not offer confirmatory testing services 
however, we have agreements with community partners who provide confirmatory testing and linkage to care for 
anyone who receives a preliminary positive HIV test result here at PRIDE. 
 
 
An HIV-negative test result means that the test did not detect HIV antibodies or antigen. 
. 
1. While our tests are very accurate for detecting antibodies, there is a "window period."  It takes a while for your 
body to produce antibodies to HIV, so we cannot reliably detect an infection that occurred in the past 3 months, 
but if your test comes back antigen positive you might have been infected recently but the virus is not settled yet 
in your system, that's why we offer a confirmatory test option for that type of results and the turnover it's 24 
hours approx and requires 1 blood vial to send the laboratory. 
 
2. We recommend to all couples that you be retested in 3 months. 
 
3. For couples who are considering stopping condom use, we generally recommend they continue using condoms 
until they are retested. 
Explain couple results 
So there are three possible results that you could have as a couple. 
 
1. You could both be HIV negative 
 
2. You could both be HIV positive 
 
3. Or your results could be different.  One of you could be HIV negative and the other HIV positive. 
Obtain consent to test 
 
Collect specimen 
 
 
 
 

                                                     Study Procedure Guide (SPG) 
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FOR INTERNAL USE ONLY. THIS IS NOT AN IRB PROTOCOL. 
Step 3 
Explore couple's 
relationship 
While the test develops, we have some time to talk about the two of you. 
 
1. Tell me a bit about your relationship. 
 
(OPTIONAL) When and how did you meet? 
 
(OPTIONAL) Do you live together now? 
 
2. What is most important to you about this relationship? 
 
3. When you look ahead in this relationship, what do you envision? 
Summarize and reflect strengths 
 
 
 
 
 
 
Step 4 
Why CHTC? 
What brought you in to receive HIV testing as a couple? 
Feelings on CHTC? 
How do you both feel about getting tested (and receiving your results) together? 
Current risk management 
Assess current risk management practices in the couple 
 
2. How do you guys handle or manage HIV risk? 
HIV risk concerns 
Again, my goal here is not to "look back" or review sexual history, but I am curious, right now, as of today: 
 
1. What effect has HIV risk or thinking about HIV had on you guys as a couple? 
 
2. What concerns do you have about HIV and the risk for HIV in your relationship. 
 
3. How concerned are you both about the results you might receive today? 
Summarize 
 
Step 5 
Explain agreements 
Many couples have agreements or understandings about how they have sex together and with partners outisde 
their relationships.  Some couples may be monogamous or exclusive.  Some couples may be open, which means 
one or both partners may have sex with other people. Other couples go for something in the middle. 
Explore agreement 
What agreements or understandings do the two of you have around sex? 
 
If yes, explore the agreement 
 
1. What does it look like? 
 
2. Where do condoms fit in? 
 
If no, normalize and clarify 

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It's ok to not have an agreement.  Many couples don't.  Most couples find it useful to develop an agreement. It can 
help guys get on the same page, build trust, and reduce risk.  
 
1. What kind of an agreement do you think would work for you guys? 
 
2. What kinds of "rules" or "terms" would you like to establish if you were to put an agreement in place? 
 
3. Where would condoms fit into this agreement? 
Summarize agreement  
 
Obtain concurrence 
 
Agreement and risk 
Whatever agreement you guys choose is ultimately up to you.  With any couple, I ask them to think about a 
couple of things related to HIV risk. 
 
1. In what ways does this agreement reduce your risk for HIV? 
 
2. Where might HIV risk occur in this agreement? 
 
3.  If someone were to step outside of the agreement (and even in the best relationships, that's not 
impossible), what would you want to know and how would you want to be told? 
 
 
Step 6 
Confirm ready 
I have your test results.  Are you ready to receive them together? 
Provide results 
Say one of the following: 
 
1. Your results are the same, you are both HIV negative 
 
2. Your results are the same, you are both HIV positive. 
 
3. Your results are different, (look at positive partner) and your result is HIV positive. 
Step 7 
Explore reaction to result 
What thoughts, if any, do you have about these results? 
[FOR CONCORDANT NEGATIVE COUPLES] 
Risk Prevention Planning 
Revisit (Summarize) Sexual agreement and existing HIV risk reduction strategies 
 
Given your result today, what if anything do you guys plan to do to manage HIV risk going forward? 
 
1. Revisit condom use if relevant and not addressed previously 
 
2. Revisit PrEP if relevant and not addressed previously 
 
a. What have you heard about PrEP? 
 
b. Provide information as needed, confirm that couples know where they could access PrEP if they wanted to 
 
c. How useful do you guys think PrEP would be for you personally? 
 

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FOR INTERNAL USE ONLY. THIS IS NOT AN IRB PROTOCOL. 
What have you heard about U=U? 
Retesting 
[IF NO EXPOSURE CONCERNS WERE DISCLOSED] "We recommend that all couples get retested in 6 
months, just as part of routine sexual-health care." 
 
[IF SPECIFIC EXPOSURE CONCERNS WERE DISCUSSED] "For any couple, we recommend they get 
retested routinely every 6 months, just as a part of routine sexual-health care. For you guys, we recommend that 
you get retested in 3 months, just as a routine follow up given the exposure you discussed earlier." 
 
[FOR COUPLES WHERE ONE OR BOTH PARTNERS ARE HIV POSITIVE] 
Connection to care 
1. Allow the participant to express his feelings about this result. 
[for positive member(s)] 
2. Remind the participant of confirmatory testing options and ask, "What would you like to do from here?" 
 
3. Plan for connection to care: 
 
If the participant does not wish to be taken for confirmatory testing: Discuss a plan for confirmatory testing 
access. 
 
If the participant wishes to be taken for confirmatory testing: Complete step 8 and proceed with post-test protocol 
 
4. Discuss self-care, including sexual risk reduction and emotional/physical health care referrals 
 
Risk Prevention Planning 
Revisit (Summarize) Sexual agreement and existing HIV risk reduction strategies 
 
Given your result today, what if anything do you guys plan to do to manage HIV risk going forward? 
 
1. Revisit condom use if relevant and not addressed previously 
[For discordant couples] 
2. Revisit PrEP if relevant and not addressed previously 
 
a. What have you heard about PrEP? 
 
b. Provide information as needed, confirm that couples know where they could access PrEP if they wanted to 
 
c. How useful do you guys think PrEP would be for you personally? 
 
Retesting [for negatives] 
If you have not already, make sure to check in with the negative partner in a discordant relationship. 
 
1. How are you feeling? 
 
2. What do you need right now? 
 
3. What are your thoughts, hopes, or concerns about PARTNER NAME's next steps. 
 
Discuss the need for retesting  
 
 "For any couple, we recommend they get retested routinely every 6 months, just as a part of routine sexual-
health care. For you guys, we recommend that you get retested in 3 months, just as a routine follow up given the 
exposure you discussed earlier." 

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FOR INTERNAL USE ONLY. THIS IS NOT AN IRB PROTOCOL. 
Step 8 
Provide referrals 
All couples should get the We Test referral sheet 
 
Specifically point out: 
 
1. Locations for HIV testing (though it likely will not be CHTC) 
 
2. PrEP providers (for any couple with at least one negative result) 
 
3. The presence of general health, mental health, as well as sexual health providers on the list