A Multilevel Tailored Web App–Based Intervention for Linking Young Men Who Have Sex With Men to Quality Care (Get Connected): Protocol for a Randomized Controlled Trial

Abstract

BackgroundHIV epidemic among young men who have sex with men (YMSM) is characterized by strong racial disparities and concerns about the availability and access to culturally appropriate HIV prevention and care service delivery. Get Connected, a Web-based intervention that employs individual- and system-level tailoring technology to reduce barriers to HIV prevention care (eg, HIV or sexually transmitted infection [STI] testing, pre-exposure prophylaxis [PrEP]), was developed for YMSM (age 15-24 years). This protocol details the design and procedures of a 2-phase project that includes mystery shopping and a randomized controlled trial (RCT) to test the efficacy of Get Connected among YMSM in Philadelphia, Atlanta, and Houston.ObjectiveThe objective of mystery shopping is to examine the quality of HIV test counseling and PrEP-related referrals for YMSM within local HIV or STI testing sites. The objective of the RCT is to test the efficacy of Get Connected for increasing HIV-negative or HIV-unknown YMSM’s successful uptake of HIV prevention services (eg, routine HIV or STI testing), PrEP awareness, and likelihood to start PrEP (PrEP willingness), compared with those in the control condition, over a 12-month period.MethodsFor Phase 1, we will create a master list of HIV and STI testing sites in each city. We will enroll and train 10-15 mystery shoppers per city; each testing site will be separately visited and assessed by 2 mystery shoppers. After each site visit, the mystery shoppers will complete a site evaluation to record their perceptions of various measures including lesbian, gay, bisexual, transgender, queer visibility and inclusivity, privacy and confidentiality, provider-patient interactions, and clinic environment. For Phase 2, we will enroll 480 YMSM for 12 months across the 3 iTech cities into a 2-arm prospective RCT. Participants randomized to the control condition are directed to the AIDSVu.org testing site locator. Participants randomized to the intervention condition will be granted access to a Web app with content tailored to their specific demographic characteristics (eg, age, race or ethnicity, location, and relationship status), HIV and STI risk behaviors (eg, HIV and STI testing history, substance use, communication with partners regarding status) and sociocultural context (eg, homelessness, incarceration). Study assessments will occur at enrollment and at 1, 3, 6, 9, and 12 months postenrollment.ResultsGet Connected research activities began in September 2016 and are ongoing. To date, institutional review board (IRB) submission is complete and IRB authorization agreements are pending at several other universities.ConclusionsThe deployment of Get Connected through a mobile-optimized Web app seeks to optimize the intervention’s acceptability, accessibility, availability, and long-term affordability among YMSM.Trial RegistrationClinicalTrials.gov (NCT03132415); https://clinicaltrials.gov/ct2/show/NCT03132415 (Archived by WebCite at http://www.webcitation.org/70j4gSFbZ)Registered Report IdentifierRR...

Paradata Analysis of an eHealth HIV Testing Intervention for Young Men Who Have Sex With Men

“…In the context of a pilot study, paradata analyses—knowing what content areas participants engaged with and for how long—can prove useful for intervention refinement and future study scale-up. In preparation for our efficacy trial with 480 YMSM living in three cities in the United States (Bauermeister et al, 2018), we used paradata analyses to understand what content received little use in the pilot, and replaced it with new content emerging from HIV prevention advances (e.g., information about PrEP). Furthermore, paradata metrics discussed in this paper may assist in the evaluation of future theoretically-informed eHealth interventions, especially as interventions are developed for mobile platforms (mHealth).…”

“…For example, the Get Connected! team will be examining how paradata metrics are associated with the on-going efficacy trial’s outcomes (see Bauermeister et al, 2018). Paradata may provide opportunities to test the proposed mechanisms of change through mediation analyses, or to examine whether the intervention’s effects are subject to dose-response relationships.…”

Maximizing Digital Interventions for Youth in the Midst of Covid-19: Lessons from the Adolescent Trials Network for HIV Interventions

“…Table 1 provides information about current iTech studies, including current enrollment status. All studies have been described previously [8][9][10][11][12][13][14]; additional information about iTech can be found at itechnetwork.org.…”

A community-engaged mHealth intervention to increase uptake of HIV Pre-Exposure Prophylaxis (PrEP) among gay, bisexual and other men who have sex with men in China: Study protocol for a pilot randomized controlled trial

“…Our study team will work with local GBMSM CBOs to disseminate the study results to participants and the community via social media, journal publication, and offline workshops at local CBOs. This research addresses a critical need as GBMSM bear a disproportionate burden of China's HIV infections and remain underserved in to promote PrEP (35)(36)(37)(38), including using mHealth technologies to approach GBMSM "where they are". In an online survey of 1,035 Chinese GBMSM in 2017, about 75% of the participants mainly met their sex partners online (61), and Chinese GBMSM have been using the Internet frequently to search for HIV-related information, counseling or testing services (32).…”

“…Among the few published mHealth PrEP intervention efficacy studies, text messaging has been effective in improving PrEP adherence in GBMSM via reducing missed doses (33,34). More mHealth PrEP uptake intervention studies are underway, however all are in high-income countries (35)(36)(37)(38). To date, little is known about the optimal design and efficacy of using mHealth-enabled interventions for PrEP promotion in Chinese populations, especially among GBMSM.…”