Expanding the Potential of Couples HIV Testing: Adjunct Modules to Reduce Drug Use Among Vulnerable Male Couples

Study Overview
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Brief Summary
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This study utilizes a randomized controlled trial design to evaluate the efficacy of two intervention components for couples HIV testing and counseling (CHTC): a communication skills training video and a substance use module. Participants are randomized in a full-factorial design to one of 4 conditions: CHTC as usual; CHTC + communication skills training videos; CHTC + substance use module; or CHTC plus both adjunct components.

Official Title
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Expanding the Potential of Couples HIV Testing: Adjunct Modules to Reduce Drug Use Among Vulnerable Male Couples

Conditions
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Substance Use, HIV Infections

Intervention / Treatment
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* Behavioral: Communication skills training video
* Behavioral: Drug use module


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: · Have a main partner who is another male and have been in a relationship for 3 month or longer One participant must be between 17 and 29; Main partner can be any age above 17. One participant must be HIV negative (as confirmed by rapid test) One participant must have used at least 1 drug in the past 90 days (cocaine/crack, opiates, misuse of prescription medication, stimulants, psychedelics, ecstasy, ketamine, GHB) One participant must have engaged in Transmission Risk Behavior (TRB) in the past 90 days o Defined as Condom-less Anal Sex (CAS) with a casual partner and/or CAS with a non-monogamous or serodiscordant main partner Live in the NYC or Detroit metropolitan area Speak English Exclusion Criteria: · Any signs of serious mental illness or cognitive deficit History of IPV with their main partner and safety concerns in the current relationship.

Ages Eligible for Study
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Minimum Age: 17 Years
Maximum Age: 29 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Factorial Assignment
Interventional Model Description: This study utilizes a randomized controlled trial design to evaluate the efficacy of two intervention components for couples HIV testing and counseling (CHTC): a communication skills training video and a substance use module. Participants are randomized in a full-factorial design to one of 4 conditions: CHTC as usual; CHTC + communication skills training videos; CHTC + substance use module; or CHTC plus both adjunct components.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: CHTC as usual<br>Participants complete the standard Couples HIV Testing and Counseling session (CHTC). | |
| Active Comparator: CHTC and communications skills training video<br>Participants complete the standard Couples HIV Testing and Counseling session and also watch a communication skills training video together. | Behavioral: Communication skills training video<br>* The communication skills training video component is designed to be self-delivered. Four couples are depicted in separate scenes discussing HIV testing, drug use, sexual agreements, and drug use during sex. Each scene is viewed twice. In the initial viewing, the couple in the video makes one or more communication errors. The scene is subsequently viewed a second time and the couple utilizes more effective communication skills, resulting in a more adaptive resolution. Each scene is introduced by a narrator who points out communication errors and orients viewers to skills utilized in adaptive versions of each scene.<br>|
| Active Comparator: CHTC and substance use module<br>Participants complete the standard Couples HIV Testing and Counseling session and also complete a substance use module together. | Behavioral: Drug use module<br>* The substance use module is administered after step 5 of CHTC and prior to the delivery of rapid HIV-test results. The couple was first asked to fill in a calendar for the past 30 days, indicating each day on which either member used drugs or consumed alcohol. Completion of the calendar is done through an ACCESS database to facilitate remote intervention delivery. After completion of the calendar, the HIV tester asked a series of debriefing questions designed to elicit the couples' perspective on their use, establish the couple's goals and limits for drug use, and make plans to achieve these goals.<br>|
| Active Comparator: CHTC, communications skills training and substance use module<br>Participants complete the standard Couples HIV Testing and Counseling session and watch a communication skills training video and complete a substance use module together. | Behavioral: Communication skills training video<br>* The communication skills training video component is designed to be self-delivered. Four couples are depicted in separate scenes discussing HIV testing, drug use, sexual agreements, and drug use during sex. Each scene is viewed twice. In the initial viewing, the couple in the video makes one or more communication errors. The scene is subsequently viewed a second time and the couple utilizes more effective communication skills, resulting in a more adaptive resolution. Each scene is introduced by a narrator who points out communication errors and orients viewers to skills utilized in adaptive versions of each scene.<br>Behavioral: Drug use module<br>* The substance use module is administered after step 5 of CHTC and prior to the delivery of rapid HIV-test results. The couple was first asked to fill in a calendar for the past 30 days, indicating each day on which either member used drugs or consumed alcohol. Completion of the calendar is done through an ACCESS database to facilitate remote intervention delivery. After completion of the calendar, the HIV tester asked a series of debriefing questions designed to elicit the couples' perspective on their use, establish the couple's goals and limits for drug use, and make plans to achieve these goals.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Drug use frequency | Number of reported days of illicit drug use (amphetamines, cocaine/crack, GHB, ketamine or ecstasy) reported on quarterly timeline follow-back assessments | 12 months | 
| Urine assay for drug use | Positive urine screen for drug use assessed bi-annually | 12 months | 
| CAS with casual partners | Number of total anal sex acts (insertive and receptive) with casual partners reported on quarterly timeline follow-back assessments | 12 months | 
| Bacterial STI's | Any chlamydia or gonorrhea diagnosis assessed bi-annually | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Binge drinking | Number of days on which 5 or more drinks containing alcohol were reported on the quarterly timeline follow-back interview | 12 months | 
| Syphilis infection | Reactive RPR test assessed bi-annually | 12 months | 
| PrEP Uptake | self-reported receipt of a PrEP-prescription | 12 months | 
| PrEP adherence | taking 4 or more doses weekly as prescribed reported on quarterly timeline follow-back assessments | 12 months |