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

Florida International University (FIU)

Status: Completed

Conditions: HIV/AIDS

Treatments: Behavioral: Intervention; Behavioral: Waitlist

Study type: Interventional

Funder types: Other

Identifiers

NCT04836091

R21MH116684

Details and patient eligibility

About

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.

Full 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.

Enrollment: 84 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria for both partners of the male couple:

• self-reported that currently self-identifies as a male
• self-reported in a sexual relationship with another self-identified male
• self-reported relationship length between 1 and 12 months
• self-reported anal sex with relationship partner in past 2 months
• owns and uses an Internet-connected smartphone or tablet
• resides in the U.S.
• self-reported ability to read and understand English-language

Exclusion Criteria:

• Does not meet one or more the inclusion criteria

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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84 participants in 2 patient groups

Immediate intervention

Experimental group

Description:

From baseline to 2-month post-test, participants in the intervention arm will have access to the OurPlan program app.

Treatment:

Behavioral: Intervention

Waitlist-delayed intervention

Experimental group

Description:

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.

Treatment:

Behavioral: Waitlist