HIV Prevention Toolkit for HIV-negative Male Couples

Not Applicable

Completed

• Conditions: HIV
• Interventions: Behavioral: Male Couples Agreement Project

• Registration Number: NCT02494817
• Lead Sponsor: University of Miami

Brief 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2015-07-07
• Study First Submitted QC: 2015-07-07
• Study First Posted: 2015-07-10
• Study Start: 2015-10
• Primary Completion: 2016-09
• Study Completion: 2016-09
• Results First Submitted: 2019-02-04
• Status Verified: 2019-03
• Results First Submitted QC: 2019-03-28
• Last Update Submitted: 2019-03-28
• Results First Posted: 2019-04-16
• Last Update Posted: 2019-04-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 298

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).

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	Male Couples Agreement Project	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.
Control group	Male Couples Agreement Project	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.

Primary Outcome Measures

Name	Time	Method
Formation of a Sexual Agreement at 6 Months	6 month	Self-reports of yes/no to forming a sexual agreement via electronic survey
Adherence to a Sexual Agreement at 6 Months	6 month	Self-report of yes/no of adhering to a sexual agreement

Secondary Outcome Measures

Name	Time	Method
Adherence to a Sexual Agreement	3 month	Self-reports of yes/no to adhering to a sexual agreement via electronic survey
Had Condomless Anal Sex With Casual Male Sex Partner During Months 0-3	3 month	Self-reports of yes/no of any anal sex with casual male sex partner between months and month 3 via electronic survey
Had Condomless Anal Sex With Casual Male Sex Partner Reported at Month 6	month 6	Self-reports of yes/no any anal sex with casual male sex partner, measured at month 6 via electronic survey (about the previous 3 months, i.e., timeframe between months 3-6).
Formation of a Sexual Agreement at 3 Months	3 month	Self-reports of yes/no to forming a sexual agreement via electronic survey
Test for HIV During Past 3 Months (Months 0-3)	3 month	Self-reports of yes/no via electronic survey taken at 3 month.
Test for HIV During the Last 3 Months (Months 3-6)	month 6	Self-reports of yes/no any test for HIV at month 6 assessment, collected via electronic survey for timeframe between months 3 and 6.

Trial Locations

Locations (1)

Clinical Research Building; 🇺🇸 Miami, Florida, United States