4Us: Expanding the Potential of Couples HIV Testing: Adjunct Modules to Reduce Drug Use Among Vulnerable Male Couples
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| No Intervention: CHTC as usual Participants complete the standard Couples HIV Testing and Counseling session (CHTC). |
|
| Active Comparator: CHTC and communications skills training video Participants complete the standard Couples HIV Testing and Counseling session and also watch a communication skills training video together. |
Behavioral: Communication skills training video
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.
|
| Active Comparator: CHTC and substance use module Participants complete the standard Couples HIV Testing and Counseling session and also complete a substance use module together. |
Behavioral: Drug use module
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.
|
| Active Comparator: CHTC, communications skills training and substance use module 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
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.
Behavioral: Drug use module
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.
|
Outcome Measures
Primary Outcome Measures
- Drug use frequency [12 months]
Number of reported days of illicit drug use (amphetamines, cocaine/crack, GHB, ketamine or ecstasy) reported on quarterly timeline follow-back assessments
- Urine assay for drug use [12 months]
Positive urine screen for drug use assessed bi-annually
- CAS with casual partners [12 months]
Number of total anal sex acts (insertive and receptive) with casual partners reported on quarterly timeline follow-back assessments
- Bacterial STI's [12 months]
Any chlamydia or gonorrhea diagnosis assessed bi-annually
Secondary Outcome Measures
- Binge drinking [12 months]
Number of days on which 5 or more drinks containing alcohol were reported on the quarterly timeline follow-back interview
- Syphilis infection [12 months]
Reactive RPR test assessed bi-annually
- PrEP Uptake [12 months]
self-reported receipt of a PrEP-prescription
- PrEP adherence [12 months]
taking 4 or more doses weekly as prescribed reported on quarterly timeline follow-back assessments
Eligibility Criteria
Criteria
Inclusion Criteria:
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· Have a main partner who is another male and have been in a relationship for 3 month or longer
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One participant must be between 17 and 29; Main partner can be any age above 17.
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One participant must be HIV negative (as confirmed by rapid test)
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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)
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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
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Live in the NYC or Detroit metropolitan area
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Speak English
Exclusion Criteria:
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· Any signs of serious mental illness or cognitive deficit
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History of IPV with their main partner and safety concerns in the current relationship.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Michigan | Ann Arbor | Michigan | United States | 48109 |
| 2 | Hunter College | New York | New York | United States | 10018 |
Sponsors and Collaborators
- Hunter College of City University of New York
- National Institute on Drug Abuse (NIDA)
- University of Michigan
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- R01DA050508