Evaluation of a Multi-Component Intervention to Support HIV Testing and Linkage to Services Among MSM in Peru

This study will evaluate the feasibility, acceptability, and preliminary effectiveness of a multi-component HIV testing and linkage-to-services intervention ("Mercury") among MSM in Lima, Peru. The Mercury intervention includes two core components: 1) HIV testing offered at sex-on-premises venues (SOPVs, e.g., saunas, hourly hotels, bars/discos with dark rooms); and 2) a mobile health (mHealth) application consisting of bidirectional SMS text messaging and tailored multimedia content related to HIV treatment/prevention and other sexual health topics.

The Mercury application is adapted from a previously validated mHealth technology platform (WelTel). In addition to its use as a system for secure two-way messaging with healthcare providers, the application is programmed to send two types of standardized weekly text messages:

• "Checkins" containing a generic greeting, phrased in the form of a question (e.g., "Hi [username], how are you?"), with user responses automatically classified ("OK", "NOT OK", or "Unrecognized") and presented in a web-based dashboard to facilitate follow-up, as needed, by the provider team
• "Topical Messages" containing links to tailored multimedia content (infographics, videos, service locator maps) based on the user's HIV testing scenario and result (HIV+, HIV-, pending HIV result).

In this randomized trial, the researchers will compare four HIV testing strategies in the context of the Mercury intervention, corresponding to the following intervention arms:

• Arm 1: Rapid HIV Test, participants will receive a rapid HIV test performed on-site at the venue.
• Arm 2: HIV Self-Test, participants will be given an HIV self-test kit to take home.
• Arm 3: Coupon, participants will receive a digital coupon redeemable for a free HIV test at one of the referral clinics affiliated with the study.
• Arm 4: "Choice", participants can choose whichever one of the three above-mentioned forms of HIV testing they most prefer.

Every Thursday, Friday, and Saturday during recruitment, the intervention will be offered at a single SOPV in downtown Lima. There will be three recruitment venues overall, which will alternate based on day of the week: SOPV#1 [Thursdays], SOPV#2 [Fridays], SOPV#3 [Saturdays]). On each given recruitment date, only one of the four HIV testing strategies (i.e., intervention arms) will be offered - assigned at random using a block randomization scheme designed to generate an even (1:1:1:1) distribution of recruitment dates by intervention arm, balanced by day of week (Thu vs Fri vs Sat) and recruitment venue (SOPV#1 vs SOPV#2 vs SOPV#3). All participants will receive the mHealth application, including tailored content related to the HIV testing format they received. The study team will approach potential participants as they enter or leave the venue, introducing the study with a brief (< 30 second) standardized script describing the HIV testing format on offer. For those who accept the intervention and enroll in the study, eligibility screening, informed consent, and receipt of the corresponding HIV testing format will be done in a private space (either inside the venue or in a secure van parked outside). All participants will receive standard HIV pre-test counseling according to Peruvian national guidelines and complete a baseline questionnaire collecting data on socio-demographics, use of mobile technology, and experience with HIV testing/prevention. There are no in-person follow-up visits as part of this study. Participants will be enrolled in the mHealth application for a total of 3 months, at which time they will be contacted by the study team and asked to complete a follow-up questionnaire. The researchers may continue to observe participants for up to 6 months, if necessary, to ascertain outcomes.

The study will evaluate two co-primary outcomes: uptake of the intervention (number who accept the intervention divided by the number offered), and continued engagement with the mHealth application (assessed at 3 months). Additionally, the following secondary outcomes will be assessed: HIV test completion, and user satisfaction with the mHealth application. Exploratory outcomes will include: linkage to care and HIV treatment initiation (if HIV+); linkage to prevention and HIV pre-exposure prophylaxis (PrEP) initiation (if HIV-).