Evaluating the Effectiveness of a Mobile HIV Prevention Application to Increase HIV and STI Testing and PrEP Initiation Among Rural Men Who Have Sex With Men

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The goal of this clinical trial is to test the efficacy of a mobile app, Combine, to increase the uptake of HIV and STI testing and pre-exposure prophylaxis (PrEP) over 24 months and to assess the effects of different implementation strategies on intervention maintenance among GBMSM in rural southern United States. The main aims of the study are: * To assess the relative effects of three treatment conditions on gains in engagement in HIV prevention compared to a modified standard of care control condition * Measure and assess secondary factors affecting app implementation * Refine implementation strategies and coordinate with potential funders Participants will download an HIV prevention smartphone app and be randomly assigned to one of four groups: * Control: App access only * Self-testing: App access + ability to order HIV and STI self-test kits * Motivational interview: App access + motivational interview to develop plans to use app effectively. * Self-testing + motivational interview: App access + ability to order HIV and STI self-test kits + motivational interview to develop plans to use app effectively. Researchers will compare each of the latter three groups to the control condition to see if HIV and STI testing increase in these groups

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Maximum Age: 45
Healthy Volunteers: t
View:

• Assigned male at birth and currently identifies as male

• Age 18-45 years, inclusive

• Reside in the U.S. South as defined by the Census Bureau or in Missouri

• Reside in a county classified as rural using the Index of Relative Rurality

• Have an Android or iPhone operating system (iOS) phone with active service

• Willing to download a study app to their phone

• English speaker

• Report anal sex with a man in the past 12 months

• HIV-negative or unknown serostatus

• Not currently using PrEP

Locations
United States
Georgia
Emory University
RECRUITING
Atlanta
Contact Information
Primary
Jeb Jones, PhD
jeb.jones@emory.edu
404-712-2275
Backup
Georgia Marks
georgia.ann.marks@emory.edu
678-769-6133
Time Frame
Start Date: 2024-03-27
Estimated Completion Date: 2027-08
Participants
Target number of participants: 464
Treatments
Other: Combine app with all features except the ability to order self-test kits
Participants will receive a modified standard of care which consists of the Combine app with all features except the ability to order self-test kits. The HIV/STI testing locator in the app will be available.
Other: Combine app + motivational interview
In addition to the other Combine app features, participants will receive a motivational interview within 4 weeks of downloading the app.
Other: Combine app + ability to order up 2 free HIV/STI self-test kits
In addition to the other Combine app features, participants in this arm will be able to order up to two HIV/STI self-test kits at no charge during each year of follow-up.
Other: Combine app + motivational interview + ability to order HIV/STI test kits via the app
In addition to the other Combine app features, participants in this arm will receive both the motivational interview and the ability to order HIV/STI test kits via the app.
Related Therapeutic Areas
Sponsors
Collaborators: National Institute of Mental Health (NIMH)
Leads: Emory University

This content was sourced from clinicaltrials.gov