Clinical trial NCT04836091: Acceptability, Feasibility and Preliminary Impact of OurPlan, an mHealth HIV Prevention Intervention for Male Couples
Official title: A Patient-centered Decision Aid to Inform HIV Prevention Choices for At-risk Male Couples in New Relationships
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV/AIDS
Lead sponsor: Florida International University
Sponsor class: OTHER
Collaborators: name: University of Michigan
First posted: 2021-04-08
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two-month pilot randomized controlled trial with a a waitlist control condition of one month
Primary purpose: PREVENTION

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.

Eligibility 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

Primary outcomes:
measure: Change in presence of a detailed risk-reduction plan
timeFrame: Baseline, month 2
measure: Change in number of evidence-based prevention strategies being used over time
timeFrame: Baseline, month 2
measure: Change in willingness to use evidence-based prevention strategies over time
timeFrame: Baseline, month 2
measure: Change in intention to use evidence-based prevention strategies over time
timeFrame: Baseline, month 2
Secondary outcomes:
measure: Change in HIV transmission and prevention knowledge
timeFrame: Baseline, month 2
measure: Change in goal congruence on sexual health
timeFrame: Baseline, month 2
measure: Change in mutual constructive communication
timeFrame: Baseline, month 2
Other outcomes:
Locations:
city: Miami
country: United States
facility: Florida International University
state: Florida
Study officials:
References: