N/A
Completed N=140
Addressing Substance Use Through CVCT
Sex, Unsafe · Drug Use
Source: ClinicalTrials.gov NCT03125915 ↗
Enrolled (actual)
140
Serious AEs
0.0%
Results posted
Feb 2020
Primary outcomePrimary: Proportion of Respondents Reporting Any Drug Use — 25; 26; 18; 17 Participants — p=.03
Summary
The proposed study developed and tested two adjunct components for use in Couples HIV Testing and Counseling (CHTC) with gay-male couples: a communication skills training video and a substance use agreement module. Phase I of the study involved the creation of intervention materials and Phase II was comprised of a small randomized controlled trial comparing the additive effects of the novel components to CHTC as usual.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Respondents Reporting Any Drug Use |
25; 26; 18; 17; 20; 17 | .03 sig |
| PRIMARY Condomless Anal Sex With Casual Partners |
3; 3; 3; 1; 0; 5 | 0.90 |
| PRIMARY Drug Abuse Screening Test-10 Total Scores |
2.52; 1.70; 1.16; 1.06; 1.98; 1.53 | 0.02 sig |
Eligibility Criteria
Inclusion Criteria
Both members of the couple:
- are born male and current male gender identity;
- identify as gay, bisexual or same-sex attracted;
- read English at 8th grade level or better;
- have access to the Internet;
- agree to audio and video recording of intervention sessions;
At least one member of the couple:
- reports the use of any drug listed on the DAST-10 in the previous 30 days.
- s identified as HIV negative during screening and baseline assessments.
The couple
- has been together for at least 3 months;
- has engaged in oral or anal sex with one another in the past 3 months;
Exclusion Criteria
- At baseline either member of the couple reports intimate partner violence (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 about safety.
- At the first in-person meeting, staff will be empowered to deem the couple ineligible for the intervention if they identify inconsistencies between information provided in the eligibility screener and the in-person meeting (e.g., discrepancies in age or duration of relationship) or any issues that might hinder participation (e.g., attending meeting high or drunk). The couple may also be deemed ineligible if participant responses are sufficiently inconsistent to call into question the validity of their individual responses.
Data sourced from ClinicalTrials.gov (NCT03125915). 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. Informational only — not medical advice.