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Acceptability, Feasibility and Preliminary Impact of OurPlan, an mHealth HIV Prevention Intervention for Male Couples

Not Applicable
Completed
Conditions
HIV/AIDS
Interventions
Behavioral: Waitlist
Behavioral: 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
Inclusion Criteria

Not provided

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Exclusion Criteria
  • Does not meet one or more the inclusion criteria
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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Waitlist-delayed interventionWaitlistParticipants 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 interventionInterventionFrom baseline to 2-month post-test, participants in the intervention arm will have access to the OurPlan program app.
Primary Outcome Measures
NameTimeMethod
Change in presence of a detailed risk-reduction planBaseline, 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 timeBaseline, 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 timeBaseline, 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 timeBaseline, month 2

Men will be asked about their intention to use evidence-based prevention strategies

Secondary Outcome Measures
NameTimeMethod
Change in HIV transmission and prevention knowledgeBaseline, month 2

Men will be asked about their knowledge on HIV transmission and prevention over time

Change in goal congruence on sexual healthBaseline, month 2

Men will be asked about their goal congruence regarding sexual health and their relationship partner

Change in mutual constructive communicationBaseline, 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

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