N/A
N=100
Couples Health Project: Couples-based Intervention to Reduce Drug Use and HIV Transmission Risk
Risk Behavior · Drug Use · Sex, Anal
Bottom Line
View on ClinicalTrials.gov: NCT03386110 ↗Enrolled (actual)
100
Serious AEs
0.0%
Results posted
Aug 2021
Primary outcome: Primary: Illicit Drug Use — 3.36; 0.84; 3.13; 0.73 Days (in the past 30 days) — p=0.08
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Couples Health Project (CHP) (Behavioral); Education (Behavioral)
- Age
- Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Hunter College of City University of New York
- Primary completion
- Sep 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Illicit Drug Use |
3.36; 0.84; 3.13; 0.73; 1.17; 0.58 | 0.08 |
| PRIMARY Number of HIV Transmission Risk Events |
1.68; 1.68; 2.13; 1.49; 0.88; 1.05 | 0.36 |
| SECONDARY Marijuana Use |
9.61; 7.02; 9.62; 5.95; 10.00; 7.89 | 0.15 |
Summary
This project tests the feasibility, acceptability, and preliminary efficacy of the Couples Health Project (CHP). CHP is a brief (3-session) couples-based Motivational Interviewing intervention which addresses drug use and sexual HIV transmission risk among partnered HIV negative YMSM (ages 18-29). The proposed project includes a randomized controlled trial (RCT) involving 50 couples who are randomized to complete either the CHP intervention or an attention-matched education control condition.
Eligibility Criteria
Inclusion Criteria
- At least one member of the couple must be 18 to 29 years of age
- Both members assigned male gender at birth and currently identify as male
- At least one member of the couple reports an HIV-negative serostatus
- Couple has been together for at least 3 months
- The use of at least one of the following substances in the past 30 days (only one partner): marijuana, cocaine/crack, amphetamines, ecstasy, GHB, ketamine, nitrates, prescriptionn drug misuse
- At least one member of the couple, in the past 30 days, had condomless anal sex (CAS) with a casual partner and/or CAS with a non-monogamous or serodiscordant main partner.
- Both members must be able to communicate in English
- Both members must reside in the NYC metro area
Exclusion Criteria
- 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.
- Inconsistencies between information provided in the eligibility screener and the in-person meeting or any issues that might hinder participation. The couple may also be deemed ineligible if participant responses are sufficiently inconsistent to call into question the validity of their individual responses
- The couple reports a sero-concordant HIV-positive serostatus
- Unstable, serious psychiatric symptoms (assessed at Baseline)
- Currently suicidal/homicidal
- Evidence of gross cognitive impairment
Data sourced from ClinicalTrials.gov (NCT03386110). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.