Acceptability, Feasibility and Preliminary Impact of OurPlan, an mHealth HIV Prevention Intervention for Male Couples
- Conditions
- HIV/AIDS
- Interventions
- Behavioral: WaitlistBehavioral: Intervention
- Registration Number
- NCT04836091
- Lead Sponsor
- Florida International University
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 84
Not provided
- Does not meet one or more the inclusion criteria
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Waitlist-delayed intervention Waitlist Participants in this study arm will not have access to the OurPlan program in the app from baseline to day 30 (month 1) of the trial. From day 31 to day 60, participants in this study arm will be given access to the OurPlan program in the app. Immediate intervention Intervention From baseline to 2-month post-test, participants in the intervention arm will have access to the OurPlan program app.
- Primary Outcome Measures
Name Time Method Change in presence of a detailed risk-reduction plan 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 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 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 Baseline, month 2 Men will be asked about their intention to use evidence-based prevention strategies
- Secondary Outcome Measures
Name Time Method Change in HIV transmission and prevention knowledge Baseline, month 2 Men will be asked about their knowledge on HIV transmission and prevention over time
Change in goal congruence on sexual health Baseline, month 2 Men will be asked about their goal congruence regarding sexual health and their relationship partner
Change in mutual constructive communication Baseline, month 2 Men will be asked about their mutual constructive communication patterns over time
Trial Locations
- Locations (1)
Florida International University
🇺🇸Miami, Florida, United States