Clinical trial NCT02494817: HIV Prevention Toolkit for HIV-negative Male Couples
Official title: Development of a HIV Prevention Toolkit for At-risk HIV-negative Male Couples
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Keywords: HIV prevention
Toolkit
Male couples
Sexual agreements
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2015-07-10
Enrollment: 298
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Formation of a Sexual Agreement at 6 Months
timeFrame: 6 month
measure: Adherence to a Sexual Agreement at 6 Months
timeFrame: 6 month
Secondary outcomes:
measure: Formation of a Sexual Agreement at 3 Months
timeFrame: 3 month
measure: Adherence to a Sexual Agreement
timeFrame: 3 month
measure: Had Condomless Anal Sex With Casual Male Sex Partner During Months 0-3
timeFrame: 3 month
measure: Had Condomless Anal Sex With Casual Male Sex Partner Reported at Month 6
timeFrame: month 6
measure: Test for HIV During Past 3 Months (Months 0-3)
timeFrame: 3 month
measure: Test for HIV During the Last 3 Months (Months 3-6)
timeFrame: month 6
Other outcomes:
Locations:
city: Miami
country: United States
facility: Clinical Research Building
state: Florida
Study officials:
affiliation: University of Miami
name: Jason W Mitchell, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mitchell JW, Lee JY, Wu Y, Sullivan PS, Stephenson R. Feasibility and Acceptability of an Electronic Health HIV Prevention Toolkit Intervention With Concordant HIV-Negative, Same-Sex Male Couples on Sexual Agreement Outcomes: Pilot Randomized Controlled Trial. JMIR Form Res. 2020 Feb 13;4(2):e16807. doi: 10.2196/16807.