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

NAActive, not recruitingINTERVENTIONAL
Enrollment

473

Participants

Timeline

Start Date

March 27, 2024

Primary Completion Date

August 31, 2027

Study Completion Date

August 31, 2027

Conditions
HIV InfectionsSTIHIV Pre-exposure Prophylaxis
Interventions
BEHAVIORAL

Combine mobile app

"* 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."

BEHAVIORAL

Motivational interview

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)

BEHAVIORAL

HIV/STI testing

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.

Trial Locations (1)

30322

Emory University, Atlanta

All Listed Sponsors
collaborator

National Institute of Mental Health (NIMH)

NIH

lead

Emory University

OTHER

NCT06205368 - 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 | Biotech Hunter | Biotech Hunter