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

HIV/AIDS Clinical Trial

— OurPlan  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04836091
• Other study ID #: R21MH116684
• Status: Completed
• Phase: N/A
• Start date: March 16, 2021
• Est. completion date: July 31, 2021

Study information

• Verified date: September 2021
• Source: Florida International University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: July 31, 2021
• Est. primary completion date: July 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• HIV/AIDS

Intervention

Behavioral:
• Waitlist
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
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.

Locations

Country	Name	City	State
United States	Florida International University	Miami	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Florida International University	University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in presence of a detailed risk-reduction plan	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	Baseline, month 2
Primary	Change in number of evidence-based prevention strategies being used over time	Men will be asked how many evidence-based HIV/STI prevention strategies they are currently using	Baseline, month 2
Primary	Change in willingness to use evidence-based prevention strategies over time	Men will be asked about their willingness to use evidence-based prevention strategies	Baseline, month 2
Primary	Change in intention to use evidence-based prevention strategies over time	Men will be asked about their intention to use evidence-based prevention strategies	Baseline, month 2
Secondary	Change in HIV transmission and prevention knowledge	Men will be asked about their knowledge on HIV transmission and prevention over time	Baseline, month 2
Secondary	Change in goal congruence on sexual health	Men will be asked about their goal congruence regarding sexual health and their relationship partner	Baseline, month 2
Secondary	Change in mutual constructive communication	Men will be asked about their mutual constructive communication patterns over time	Baseline, month 2