HIV Prevention Toolkit for HIV-negative Male Couples

HIV Clinical Trial

— MCAP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02494817
• Other study ID #: 20140561
• Secondary ID: R34MH102098
• Status: Completed
• Phase: N/A
• Start date: October 2015
• Est. completion date: September 2016

Study information

• Verified date: March 2019
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 298
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• HIV

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	Clinical Research Building	Miami	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Miami	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Formation of a Sexual Agreement at 6 Months	Self-reports of yes/no to forming a sexual agreement via electronic survey	6 month
Primary	Adherence to a Sexual Agreement at 6 Months	Self-report of yes/no of adhering to a sexual agreement	6 month
Secondary	Formation of a Sexual Agreement at 3 Months	Self-reports of yes/no to forming a sexual agreement via electronic survey	3 month
Secondary	Adherence to a Sexual Agreement	Self-reports of yes/no to adhering to a sexual agreement via electronic survey	3 month
Secondary	Had Condomless Anal Sex With Casual Male Sex Partner During Months 0-3	Self-reports of yes/no of any anal sex with casual male sex partner between months and month 3 via electronic survey	3 month
Secondary	Had Condomless Anal Sex With Casual Male Sex Partner Reported at 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).	month 6
Secondary	Test for HIV During Past 3 Months (Months 0-3)	Self-reports of yes/no via electronic survey taken at 3 month.	3 month
Secondary	Test for HIV During the Last 3 Months (Months 3-6)	Self-reports of yes/no any test for HIV at month 6 assessment, collected via electronic survey for timeframe between months 3 and 6.	month 6