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

NCT06205368 | Active Not Recruiting

• 2 other identifiers: STUDY00006280R01MH134267-01
• Study Type: interventional
• Target: 473
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

HIV Infections; STI; HIV Pre-exposure Prophylaxis

Keywords

GBMSM; PrEP; HIV; Gay; HIV prevention; STI testing; HIV testing

Outcome Measures

Primary Outcomes (3)

• Uptake of HIV testing

  The investigator will look at the change in number of participants getting tested for HIV by using online surveys. Uptake of testing will be defined as ordering, using, and returning a kit for laboratory analysis or obtaining a test at an in-person provider and reporting the result.

  Screening, Month 6, Month 12, Month 18, Month 24

• Uptake of STI testing

  The investigator will look at the change in number of participants getting tested for STIs by using online surveys. Uptake of testing will be defined as ordering, using, and returning a kit for laboratory analysis or obtaining a test at an in-person provider and reporting the result.

  Screening, Month 6, Month 12, Month 18, Month 24

• PrEP initiation

  The investigator will look at the change in number of participants taking PrEP over the course of the study. PrEP initiation will be defined as obtaining a new PrEP prescription for the first time or after a period of non-use of at least three months

  Screening, Month 6, Month 12, Month 18, Month 24

Study Arms (4)

Combine app with all features except the ability to order self-test kits

OTHER

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.

Behavioral: Combine mobile app

Combine app + motivational interview

OTHER

In addition to the other Combine app features, participants will receive a motivational interview within 4 weeks of downloading the app.

Behavioral: Combine mobile app; Behavioral: Motivational interview

Combine app + ability to order up 2 free HIV/STI self-test kits

OTHER

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.

Behavioral: Combine mobile app; Behavioral: HIV/STI testing

Combine app + motivational interview + ability to order HIV/STI test kits via the app

OTHER

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.

Behavioral: Combine mobile app; Behavioral: Motivational interview; Behavioral: HIV/STI testing

Interventions

Combine mobile app BEHAVIORAL

* HIV/STI testing: learn more about testing options; create a plan to test 1-4 times in the coming year; locate places for those tests and/or order at-home test kits; and schedule reminders for periodic testing * Pre-exposure prophylaxis: PrEP self-assessment at first app use; monthly rescreening for PrEP eligibility; recommendation for PrEP based on Centers for Disease Control and Prevention (CDC) criteria; PrEP provider locator. * Behavioral risk assessment: e.g. HIV risk behaviors; sex while drunk or high, condomless anal intercourse with a positive or unknown HIV status partner, multiple sex partners, recent STI diagnosis, use of drugs) and protective behaviors * Non-occupational post-exposure prophylaxis (nPEP): information about nPEP; self-assessment; locator; referral to PrEP for men who evaluate multiple exposures for nPEP indication * Product ordering: participants can order condoms, condom-compatible lubricants, and at-home STI specimen collection kits.

Also known as: Mobile app

Combine app + ability to order up 2 free HIV/STI self-test kits; Combine app + motivational interview; Combine app + motivational interview + ability to order HIV/STI test kits via the app; Combine app with all features except the ability to order self-test kits

Motivational interview BEHAVIORAL

The interview will be grounded in the Social Cognitive Theory of self-regulation (SCT) to reflect the underlying theory of the Combine app. It will be designed to enhance the effectiveness of the app by highlighting app features (e.g., frequently asked questions, product ordering, testing locators) and discussing strategies for following through on goals related to sexual health (e.g., creating and adhering to a testing plan)

Combine app + motivational interview; Combine app + motivational interview + ability to order HIV/STI test kits via the app

HIV/STI testing BEHAVIORAL

Participants will be able to order free HIV/STI self-test kits; they will be able to order up to two sets of kits during each of years 1 and 2 of follow-up. HIV and STI test kit orders are independent: ordering an HIV test kit does not trigger shipment of an STI kit and vice versa. When an order is placed, kits containing biospecimen self-collection tools are shipped directly to the participant along with written instructions and a link to video instructions on how to collect each of the samples (e.g., urine, rectal, blood). Return packaging is enclosed with instructions for participants to locate a drop-off location to return their samples to the lab.

Combine app + ability to order up 2 free HIV/STI self-test kits; Combine app + motivational interview + ability to order HIV/STI test kits via the app

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Assigned male at birth and currently identifies as male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• \- Unable to provide consent

Sponsors & Collaborators

• Emory University: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Emory University

Atlanta, Georgia, 30322, United States

Location

Related Publications (1)

• Jones J, Manley G, Glynn TR, Wall KM, Baral SD, Harris ED, Benkeser D, Sullivan PS. Evaluating the Effectiveness of a Mobile HIV Prevention App to Increase HIV and Sexually Transmitted Infection Testing and Pre-Exposure Prophylaxis Initiation Among Rural Men Who Have Sex With Men in the Southern United States: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2025 Jul 23;14:e69540. doi: 10.2196/69540.

  PMID: 40699887 DERIVED

MeSH Terms

Conditions

HIV Infections; Sexually Transmitted Diseases; Homosexuality

Interventions

Motivational Interviewing

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Sexuality; Sexual Behavior; Behavior

Intervention Hierarchy (Ancestors)

Directive Counseling; Counseling; Mental Health Services; Behavioral Disciplines and Activities; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Jeb Jones, PhD

  Rollins School of Public Health

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: January 4, 2024
• First Posted: January 16, 2024
• Study Start: March 27, 2024
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: October 23, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: After the publication of primary outcome data
• Access Criteria: Analyses that don't overlap with specific aims, per PI approval will be shared with those who request them from the PI via email.

Locations

US (1)