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Clinical Trials/NCT02494817
NCT02494817
Completed
Not Applicable

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

University of Miami1 site in 1 country298 target enrollmentOctober 2015
ConditionsHIV

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
HIV
Sponsor
University of Miami
Enrollment
298
Locations
1
Primary Endpoint
Formation of a Sexual Agreement at 6 Months
Status
Completed
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 2015
End Date
September 2016
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Male

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Daniel J Feaster

Professor

University of Miami

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.

Outcomes

Primary Outcomes

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

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

  • Adherence to a Sexual Agreement(3 month)
  • Had Condomless Anal Sex With Casual Male Sex Partner During Months 0-3(3 month)
  • Had Condomless Anal Sex With Casual Male Sex Partner Reported at Month 6(month 6)
  • Formation of a Sexual Agreement at 3 Months(3 month)
  • Test for HIV During Past 3 Months (Months 0-3)(3 month)
  • Test for HIV During the Last 3 Months (Months 3-6)(month 6)

Study Sites (1)

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