HIV Prevention Toolkit for HIV-negative Male Couples (MCAP)

University of Miami

Status: Completed

Conditions: HIV

Treatments: Behavioral: Male Couples Agreement Project

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02494817

20140561

R34MH102098 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 298 patients

Sex: Male

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

Eligible male couples:

1. are identified as two men (i.e., main partners) who had been in a sexual relationship together for > 6 months;
2. are at least 18 years of age;
3. are self-reported as being HIV-negative;
4. had been practicing CAS in their relationship for > 6 months;
5. report no recent history (< 1 year) of intimate partner violence (IPV) or coercion;
6. have had no current sexual agreement; and
7. own a smartphone and have an alternate method to access the Internet (e.g., computer).

Exclusion criteria

1. 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.
2. Individuals who participated in Phase 1 or 2 will be were excluded from participating in Phase 3 of this study.
3. Adults who are unable to consent;
4. Individuals who are not yet adults;
5. Pregnant and non-pregnant women, and prisoners.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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298 participants in 2 patient groups, including a placebo group

Control group

Placebo Comparator group

Description:

Couples assigned to the control group will be directed to the website that only has the following: 1) module about learning about effective HIV prevention strategies, 2) sexual health resource center, and 3) a link to download a corresponding smartphone app that will include the sexual health resource center.

Treatment:

Behavioral: Male Couples Agreement Project

Intervention group

Active Comparator group

Description:

Couples assigned to the intervention group will first as individuals view general video about purpose of study and how to use website functions; timeline activity about their relationship; select top values about their relationship; learn about effective HIV prevention strategies; learn about sexual agreements; select what items they want to have in their agreement; explore a learning module about testing and view the sexual health resource center. As a couple, they will log back into the website to view and compare timelines and relationship values; watch a video about communicating more effectively; negotiate and decide together what items they want to include in their agreement; explore the sexual health resource center and/or any other modules from when they were logged into the website as individuals; download a corresponding smartphone app that will include a copy of their newly created agreement and sexual health resource center.

Treatment:

Behavioral: Male Couples Agreement Project