Behavioral Efficacy of a Sexual Health Mobile App for Men Who Have Sex With Men: Randomized Controlled Trial of Mobile Messaging for Men

Patrick Sean Sullivan, Rob Stephenson, Sabina Hirshfield, Cyra Christina Mehta, Ryan Zahn, Jose A Bauermeister, Keith Horvath, Mary Ann Chiasson, Deborah Gelaude, Shelby Mullin, Martin J Downing Jr, Evelyn Jolene Olansky, Sarah Wiatrek, Erin Q Rogers, Eli Rosenberg, Aaron J Siegler, Gordon Mansergh, Patrick Sean Sullivan, Rob Stephenson, Sabina Hirshfield, Cyra Christina Mehta, Ryan Zahn, Jose A Bauermeister, Keith Horvath, Mary Ann Chiasson, Deborah Gelaude, Shelby Mullin, Martin J Downing Jr, Evelyn Jolene Olansky, Sarah Wiatrek, Erin Q Rogers, Eli Rosenberg, Aaron J Siegler, Gordon Mansergh

Abstract

Background: Gay, bisexual, and other men who have sex with men (GBMSM) face the highest burden of HIV in the United States, and there is a paucity of efficacious mobile health (mHealth) HIV prevention and care interventions tailored specifically for GBMSM. We tested a mobile app combining prevention messages and access to core prevention services for GBMSM.

Objective: This study aims to measure the efficacy of the Mobile Messaging for Men (M-cubed) app and related services to increase HIV prevention and care behaviors in diverse US GBMSM.

Methods: We conducted a randomized open-label study with a waitlist control group among GBMSM in 3 groups (low-risk HIV-negative group, high-risk HIV-negative group, and living-with-HIV [LWH] group) recruited online and in venues in Atlanta, Detroit, and New York City. Participants were randomly assigned to receive access to the app immediately or at 9 months after randomization. The app provided prevention messages in 6 domains of sexual health and offered ordering of at-home HIV and sexually transmitted infection test kits, receiving preexposure prophylaxis (PrEP) evaluations and navigation, and service locators. Serostatus- and risk-specific prevention outcomes were evaluated at baseline, at the end of the intervention period, and at 3, 6, and 9 months after the intervention period.

Results: In total, 1226 GBMSM were enrolled and randomized; of these 611 (49.84%) were assigned to the intervention group and 608 (99.51%) were analyzed, while 615 (50.16%) were assigned to the control group and 612 (99.51%) were analyzed. For high-risk GBMSM, allocation to the intervention arm was associated with higher odds of HIV testing during the intervention period (adjusted odds ratio [aOR] 2.02, 95% CI 1.11-3.66) and with higher odds of using PrEP in the 3 months after the intervention period (aOR 2.41, 95% CI 1.00-5.76, P<.05). No changes in HIV prevention or care were associated with allocation to the intervention arm for the low-risk HIV-negative and LWH groups.

Conclusions: Access to the M-cubed app was associated with increased HIV testing and PrEP use among high-risk HIV-negative GBMSM in 3 US cities. The app could be made available through funded HIV prevention providers; additional efforts are needed to understand optimal strategies to implement the app outside of the research setting.

Trial registration: ClinicalTrials.gov NCT03666247; https://ichgcp.net/clinical-trials-registry/NCT03666247.

International registered report identifier (irrid): RR2-10.2196/16439.

Keywords: HIV; HIV prevention; MSM; PrEP; STI; United States; app; behavior; bisexual; efficacy; gay; mHealth; men who have sex with men; prevention; randomized clinical trial; sexuality; testing; tool; video.

Conflict of interest statement

Conflicts of Interest: None declared.

©Patrick Sean Sullivan, Rob Stephenson, Sabina Hirshfield, Cyra Christina Mehta, Ryan Zahn, Jose A Bauermeister, Keith Horvath, Mary Ann Chiasson, Deborah Gelaude, Shelby Mullin, Martin J Downing Jr, Evelyn Jolene Olansky, Sarah Wiatrek, Erin Q Rogers, Eli Rosenberg, Aaron J Siegler, Gordon Mansergh. Originally published in the Journal of Medical Internet Research (https://www.jmir.org), 02.02.2022.

Figures

Figure 1
Figure 1
CONSORT diagram for the M-cubed randomized controlled trial among GBMSM (screening through randomization). CONSORT: Consolidated Standards of Reporting Trials; GBMSM: gay, bisexual, and other men who have sex with men; M-cubed: Mobile Messaging for Men.
Figure 2
Figure 2
CONSORT diagram for a randomized controlled trial of the M-cubed intervention for GBMSM (randomization through analysis). CONSORT: Consolidated Standards of Reporting Trials; GBMSM: gay, bisexual, and other men who have sex with men; M-cubed: Mobile Messaging for Men.
Figure 3
Figure 3
HIV testing of high-risk GBMSM, reported by study time point and randomized allocation, in Atlanta, Detroit, and New York City (2018-2019). GBMSM: gay, bisexual, and other men who have sex with men.
Figure 4
Figure 4
PrEP use among GBMSM who reported anal intercourse not protected by condoms or PrEP at baseline, reported by study time point and randomized allocation, in Atlanta, Detroit, and New York City (2018-2019). GBMSM: gay, bisexual, and other men who have sex with men; PrEP: preexposure prophylaxis.

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