JMIR Publications

ABSTRACT

Background:

Gay and bisexual men who have sex with men (GBMSM) in the rural United States are less likely to test for HIV and sexually transmitted infections (STIs) and to use pre-exposure prophylaxis (PrEP) compared to urban GBMSM. Given challenges in building brick and mortar facilities serving the sexual health needs for GBMSM in rural communities, there is a need to evaluate digital engagement strategies. Combine is a smartphone application designed to provide HIV prevention information and resources GBMSM that may be particularly well suited to support rural GBMSM. HealthMindr, an app from which Combine is adapted, has previously bene shown to increase HIV testing and PrEP uptake among urban GBMSM. Because rural GBMSM face additional barriers to accessing HIV prevention services, a motivational interview focused on HIV prevention strategies might enhance the effectiveness of Combine to increase uptake of HIV testing, STI testing, and PrEP.

Objective:

The aim of this study is to determine the effectiveness of the Combine app to increase HIV testing, STI testing, and PrEP initiation among rural cisgender GBMSM. We will also assess the effectiveness of two adjunctive interventions: availability of free HIV and STI self-test kits and offering of a motivational interview.

Methods:

In this type 2 hybrid implementation-effectiveness randomized controlled trial (RCT), we will assess the effectiveness of Combine to increase HIV testing, STI testing, and PrEP initiation among rural GBMSM across the southern US. A total of 464 men will be recruited and randomized to one of 4 arms. Participants in all 4 arms will have access to most app features (health resources, quizzes, provider locators, ordering free condoms and lubricant, etc.). Using a 2x2 factorial design, half of participants will be randomized to receive access to free at-home HIV and STI self-test kits and half will be randomized to receive a motivational interview. Participants will complete surveys every six months to allow for assessment of self-reported outcomes: app use, HIV testing, STI testing, and PrEP initiation over the 24-month follow-up period. Self-reported PrEP uptake will be verified by dried blood spot testing or uploading a photograph of a PrEP prescription.

Results:

Participant recruitment began in March 2024.

Conclusions:

This trial will determine whether the Combine app increases HIV testing, STI testing, and PrEP uptake among rural GBMSM in the southern United States. Clinical Trial: ClinicalTrials.gov NCT06205368; https://clinicaltrials.gov/study/NCT06205368