A Patient-centered Decision Aid to Inform HIV Prevention Choices for At-risk Male Couples in New Relationships
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 84
- Locations
- 2
- Primary Endpoint
- Change in presence of a detailed risk-reduction plan
Study Overview
Brief Summary
The study will evaluate the use and preliminary impact of an mHealth app for improving sexual health outcome measures among male couples by assessing whether exposure and use of the app results in improvements in participants and couples' self-reported sexual health and prevention behaviors, beliefs, and attitudes. The study will enroll both men of the couple into a randomized controlled trial. Participants/couples randomized to the intervention will have access to the app for two months while those assigned to the waitlist group will receive and have access to the app for one month. Participants will complete surveys at baseline and at month 2.
Detailed Description
The study will evaluate the use and preliminary impact of an mHealth app for improving sexual health outcome measures among male couples by assessing whether exposure and use of the app results in improvements in participants and couples' self-reported sexual health and prevention behaviors, beliefs, and attitudes. The study will enroll both partners of the 42 male couples into a 2-month randomized controlled trial with a waitlist control condition of one month. Couples will be assigned to either the immediate intervention group ("intervention arm") or the waitlist-control group ("waitlist-control arm"). All participants will take an assessment survey at baseline, and the intervention group will be oriented on the installation and use of the app upon randomization to that group. The waitlist-control group will follow the same procedures one month later. Participants/couples randomized to the intervention arm will have access to the intervention app for two months (ie, day 1-60) while those assigned to the waitlist-control group will have access to the app for one month (ie, day 31-60). All participants in the randomized controlled trial will complete a short follow-up survey at month 2 and a brief exit interview.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- Not provided
Exclusion Criteria
- •Does not meet one or more the inclusion criteria
Outcomes
Primary Outcomes
Change in presence of a detailed risk-reduction plan
Time Frame: Baseline, month 2
Men will be asked if they created a detailed risk-reduction plan containing evidence-based strategies of routine HIV/STI testing, consistent condom use, PrEP, and ART
Change in number of evidence-based prevention strategies being used over time
Time Frame: Baseline, month 2
Men will be asked how many evidence-based HIV/STI prevention strategies they are currently using
Change in willingness to use evidence-based prevention strategies over time
Time Frame: Baseline, month 2
Men will be asked about their willingness to use evidence-based prevention strategies
Change in intention to use evidence-based prevention strategies over time
Time Frame: Baseline, month 2
Men will be asked about their intention to use evidence-based prevention strategies
Secondary Outcomes
- Change in HIV transmission and prevention knowledge(Baseline, month 2)
- Change in goal congruence on sexual health(Baseline, month 2)
- Change in mutual constructive communication(Baseline, month 2)
Investigators
Dr. Jason Mitchell
Associate Professor
Florida International University