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Completed

NCT Number: NCT02494817

HIV Prevention Toolkit for HIV-negative Male Couples

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.

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Key information

Conditions

HIV

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Clinical Research Building

Miami, Florida, 33136, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Male Couples Agreement Project

Behavioral

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.

Primary outcomes

  1. Formation of a Sexual Agreement at 6 Months

    Time frame: 6 month

    Self-reports of yes/no to forming a sexual agreement via electronic survey

  2. Adherence to a Sexual Agreement at 6 Months

    Time frame: 6 month

    Self-report of yes/no of adhering to a sexual agreement

Secondary outcomes

  1. Formation of a Sexual Agreement at 3 Months

    Time frame: 3 month

    Self-reports of yes/no to forming a sexual agreement via electronic survey

  2. Adherence to a Sexual Agreement

    Time frame: 3 month

    Self-reports of yes/no to adhering to a sexual agreement via electronic survey

  3. Had Condomless Anal Sex With Casual Male Sex Partner During Months 0-3

    Time frame: 3 month

    Self-reports of yes/no of any anal sex with casual male sex partner between months and month 3 via electronic survey

  4. Had Condomless Anal Sex With Casual Male Sex Partner Reported at Month 6

    Time frame: 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).

  5. Test for HIV During Past 3 Months (Months 0-3)

    Time frame: 3 month

    Self-reports of yes/no via electronic survey taken at 3 month.

  6. Test for HIV During the Last 3 Months (Months 3-6)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

Development of a HIV Prevention Toolkit for At-risk HIV-negative Male Couples

Acronym: MCAP

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jul 10, 2015
Registry last updated
Apr 16, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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