HIV Prevention Toolkit for HIV-negative Male Couples (MCAP)

Development of a HIV Prevention Toolkit for At-risk 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.

Study Overview

• Status: Completed
• Conditions: HIV
• Intervention / Treatment: Behavioral: Male Couples Agreement Project

• Study Type: Interventional
• Enrollment (Actual): 298
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33136
      • Clinical Research Building

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control group; 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.	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.
Active Comparator: Intervention group; 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.	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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Formation of a Sexual Agreement at 3 Months	Self-reports of yes/no to forming a sexual agreement via electronic survey	3 month
Adherence to a Sexual Agreement	Self-reports of yes/no to adhering to a sexual agreement via electronic survey	3 month
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
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
Test for HIV During Past 3 Months (Months 0-3)	Self-reports of yes/no via electronic survey taken at 3 month.	3 month
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

Collaborators and Investigators

• Sponsor: University of Miami
• Collaborators: National Institute of Mental Health (NIMH)
• Investigators: Principal Investigator: Jason W Mitchell, PhD, University of Miami

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: October 1, 2015
• Primary Completion (Actual): September 1, 2016
• Study Completion (Actual): September 1, 2016

Study Registration Dates

• First Submitted: July 7, 2015
• First Submitted That Met QC Criteria: July 7, 2015
• First Posted (Estimate): July 10, 2015

Study Record Updates

• Last Update Posted (Actual): April 16, 2019
• Last Update Submitted That Met QC Criteria: March 28, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: HIV prevention; Toolkit; Male couples; Sexual agreements
• Other Study ID Numbers: 20140561; R34MH102098 (U.S. NIH Grant/Contract)