NCT06205368Active, not recruiting
Evaluating the Effectiveness of a Mobile HIV Prevention App to Increase HIV and Sexually Transmitted Infections (STI) Testing and PrEP Initiation Among Rural Men Who Have Sex With Men
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
Source: ClinicalTrials.gov · Last updated 30 Oct 2026
Brief summary (registry, in English)
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
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 473 (actual)
- First submitted
- 4 Jan 2024
- Start date
- 27 Mar 2024
- Primary completion date
- 30 Sept 2027
- Lead sponsor
- Emory University
- Diseases
- HIV
- NCT number
- NCT06205368
What you commit to
- Study type: Interventional
- Participants enrolled: 473
- From 27 Mar 2024 to the primary completion date, 30 Sept 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- \- Unable to provide consent
Who the study is looking for
- 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
Age in the registry: 18 years to 45 years · Sex: Male · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Emory University Coordinator of this site? Confirm its status | Atlanta | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.