N/A
N=298
HIV Prevention Toolkit for HIV-negative Male Couples
HIV
Bottom Line
View on ClinicalTrials.gov: NCT02494817 ↗Enrolled (actual)
298
Serious AEs
0.0%
Results posted
Apr 2019
Primary outcome: Primary: Formation of a Sexual Agreement at 6 Months — 56; 66; 48; 24 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Male Couples Agreement Project (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- University of Miami
- Primary completion
- Sep 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Formation of a Sexual Agreement at 6 Months |
56; 66; 48; 24 | — |
| PRIMARY Adherence to a Sexual Agreement at 6 Months |
48; 60; 8; 6 | — |
| SECONDARY Formation of a Sexual Agreement at 3 Months |
70; 58; 48; 30 | — |
| SECONDARY Adherence to a Sexual Agreement |
62; 54; 8; 4 | — |
| SECONDARY Had Condomless Anal Sex With Casual Male Sex Partner During Months 0-3 |
7; 5; 109; 78 | — |
| SECONDARY Had Condomless Anal Sex With Casual Male Sex Partner Reported at Month 6 |
5; 4; 99; 86 | — |
| SECONDARY Test for HIV During Past 3 Months (Months 0-3) |
27; 15; 98; 77 | — |
| SECONDARY Test for HIV During the Last 3 Months (Months 3-6) |
27; 11; 88; 87 | — |
Summary
Though technology is integrated into the lives of our target population, use of any particular technology will depend on the content delivered, aesthetic appeal, and overall design. Based on the completion and analysis of data from Phase 1, the investigators were able to obtain feedback on HIV-negative male couples' attitudes toward the original content in the prevention toolkit modules. The research team, along with the web-developers, used this feedback to specifically tailor the content of the modules to fit the unique needs of the intervention's target population: at risk HIV-negative male couples. For Phase 2, the investigators conducted focus groups at each site to help identify strengths and potential areas for improvement of the prevention toolkit, which will be incorporated before piloting it in the intervention for Phase 3 of this project. After assessing the acceptability of the prevention toolkit, including the content of modules, aesthetic appeal, and overall design with HIV-negative male couples target population, the research team will pilot test whether the RCT with the prevention toolkit will help reduce HIV risk through formation and adherence to a sexual agreement, reduction in occurrences of condomless anal sex with casual sex partners, and increase testing behaviors among at-risk HIV-negative male couples. The interactive website, herein referred to as the "HIV prevention toolkit" will contain unique modules about sexual agreements and effective HIV prevention strategies.
Eligibility Criteria
Inclusion Criteria
Eligible male couples:
- are identified as two men (i.e., main partners) who had been in a sexual relationship together for > 6 months;
- are at least 18 years of age;
- are self-reported as being HIV-negative;
- had been practicing CAS in their relationship for > 6 months;
- report no recent history (< 1 year) of intimate partner violence (IPV) or coercion;
- have had no current sexual agreement; and
- own a smartphone and have an alternate method to access the Internet (e.g., computer).
Exclusion Criteria
- Interested participants, including both men of a male couple, who did not meet the inclusion criteria above will be excluded from participating in Phase 3 of this study.
- Individuals who participated in Phase 1 or 2 will be were excluded from participating in Phase 3 of this study.
- Adults who are unable to consent;
- Individuals who are not yet adults;
- Pregnant and non-pregnant women, and prisoners.
Data sourced from ClinicalTrials.gov (NCT02494817). 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.