HIV Prevention Toolkit for HIV-negative Male Couples

NCT02494817 | Completed Results

• 2 other identifiers: 20140561R34MH102098
• Study Type: interventional
• Target: 298
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV

Keywords

HIV prevention; Toolkit; Male couples; Sexual agreements

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• Formation of a Sexual Agreement at 3 Months

  3 month

• 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

• Test for HIV During Past 3 Months (Months 0-3)

  3 month

Study Arms (2)

Control group

PLACEBO COMPARATOR

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

Intervention group

ACTIVE COMPARATOR

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

Interventions

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.

Control group; Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Miami: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Clinical Research Building

Miami, Florida, 33136, United States

Location

Related Publications (1)

• 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.

  PMID: 32044754 DERIVED

Results Point of Contact

• Title: Jason W. Mitchell, PhD, MPH
• Organization: University of Hawaii

jasonmit@hawaii.edu

8082196729

Study Officials

• Jason W Mitchell, PhD

  University of Miami

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 7, 2015
• First Posted: July 10, 2015
• Study Start: October 1, 2015
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: April 16, 2019
• Results First Posted: April 16, 2019

Record last verified: 2019-03

Locations

US (1)