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

NCT04836091 | Completed

• 1 other identifier: R21MH116684
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV/AIDS

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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 Outcomes (3)

• Change in HIV transmission and prevention knowledge

  Baseline, month 2

• Change in goal congruence on sexual health

  Baseline, month 2

• Change in mutual constructive communication

  Baseline, month 2

Study Arms (2)

Immediate intervention

EXPERIMENTAL

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

Behavioral: Intervention

Waitlist-delayed intervention

EXPERIMENTAL

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.

Behavioral: Waitlist

Interventions

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.

Waitlist-delayed intervention

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.

Immediate intervention

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Trans men and cisgender men
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Florida International University: lead
• University of Michigan: collaborator

Study Sites (1)

Florida International University

Miami, Florida, 33199, United States

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Interventions

Waiting Lists; Methods

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Appointments and Schedules; Organization and Administration; Health Services Administration; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Two-month pilot randomized controlled trial with a a waitlist control condition of one month

Study Record Dates

• First Submitted: April 5, 2021
• First Posted: April 8, 2021
• Study Start: March 16, 2021
• Primary Completion: July 31, 2021
• Study Completion: July 31, 2021
• Last Updated: September 16, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: Starting 6 months after publication
• Access Criteria: Interested researchers must email the PI with a request to access de-identified, anonymous IPD. The PI will review such requests for secondary analyses using de-identified data that have already been published.

Locations

US (1)