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OpenTrials
Completed

NCT Number: NCT04836091

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Waitlist

Behavioral

From day 31 to day 60 (ie., during month 2) of the trial, participants in the waitlist arm will be granted access and instructed to use the OurPlan program as directed. The OurPlan program includes 4 modules covering topics of communication, HIV/STI prevention, HIV/STI statistics, and stigma / discrimination. Each module contains content, questions, and an activity for the participant and couple to complete. OurPlan also includes a resource locator using GPS-capabilities to allow participants to find sexual health resources, as well as a calendar and reminder system. One goal of OurPlan is to help both partners of the couple create and use a risk-reduction plan of evidence-based prevention strategies over time. Answers provided during the assessments will help determine whether participants/couples created a risk-reduction plan and used evidence-based strategies over time, including changes in their own and partner-related attitudes toward these strategies.

Intervention

Behavioral

From day 1 to day 60 (ie., entire 2 month duration) of the trial, participants in the intervention arm will be granted access and instructed to use the OurPlan program as directed. The OurPlan program includes 4 modules covering topics of communication, HIV/STI prevention, HIV/STI statistics, and stigma / discrimination. Each module contains content, questions, and an activity for the participant and couple to complete. OurPlan also includes a resource locator using GPS-capabilities to allow participants to find sexual health resources, as well as a calendar and reminder system. One goal of OurPlan is to help both partners of the couple create and use a risk-reduction plan of evidence-based prevention strategies over time. Answers provided during the assessments will help determine whether participants/couples created a risk-reduction plan and used evidence-based strategies over time, including changes in their own and partner-related attitudes toward these strategies.

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  1. Change in HIV transmission and prevention knowledge

    Time frame: Baseline, month 2

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

  2. Change in goal congruence on sexual health

    Time frame: Baseline, month 2

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

  3. Change in mutual constructive communication

    Time frame: Baseline, month 2

    Men will be asked about their mutual constructive communication patterns over time

Sponsors and collaborators

Lead sponsor

Florida International University

Other

Collaborators

  • University of Michigan

Registry information

Official study title

A Patient-centered Decision Aid to Inform HIV Prevention Choices for At-risk Male Couples in New Relationships

Acronym: OurPlan

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Apr 8, 2021
Registry last updated
Sep 16, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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