JMIR Publications

ABSTRACT

Background:

Transgender men and transmasculine people who have sex with men (TMSM) are at elevated risk for HIV acquisition, have unmet HIV prevention needs, and have low uptake of antiretroviral pre-exposure prophylaxis (PrEP). To our knowledge, there are no published efficacious behavioral interventions to decrease HIV risk specifically for TMSM; this includes peer-delivered strategies that demonstrate high acceptability in this population.

Objective:

This paper describes the development, refinement, and optimization of theory-informed, peer-delivered digital interventions—which were feasible to implement and highly acceptable among the participant population—designed to increase PrEP uptake and adherence among adult transmasculine people who have sex with individuals assigned male at birth within the context of a full-scale, randomized factorial trial.

Methods:

Between March 2023-March 2025, we used an iterative community-engaged approach that included: (1) community and key stakeholder input, (2) theory- and evidence-informed manualized content with iterative refinement, (3) interventionist training and preparation, and (4) process evaluation and fidelity monitoring. Two theoretical frameworks and one theory of behavior change guided content development, structure, format and evaluation: The Healthcare Accessibility Framework, the Gender Affirmation Framework, and the Information, Motivation, and Behavioral Skills Model of behavior change.

Results:

A 4-member Community Advisory Board of transmasculine individuals partnered with the research team to co-design interventions and study procedures. Additional input was obtained through one-on-one key stakeholder consultations with nine topic experts, clinicians, and community experts at partner organizations. Iterative refinement incorporated evidence synthesis, manual drafting, mock sessions, and structured feedback loops resulting in two refined virtually delivered interventions: (1) PrEP4T, a 6-session one-on-one peer navigation intervention (60-90 minutes/session) emphasizing goal setting, harm reduction, and supportive referrals; and (2) LS4TM, a 6-session peer-facilitated group-based behavioral intervention (2 hours/session), focusing on sexual health knowledge, gender affirmation, communication, and social support. A digital standard of care (SOC) resource guide of curated, gender-affirming sexual health, HIV prevention, and community resources was also developed. Interventionist training included approximately 15 hours of knowledge/skill building (asynchronous and live didactic sessions) and at least 12 hours of applied practice (mock sessions with structured feedback). Process evaluation and fidelity relied on participant- and interventionist-completed case reporting forms, reflecting community prioritization of interventionist and participant comfort during sessions. Key lessons learned included the importance of flexible, manualized intervention content structures that support fidelity while allowing personalized adaptation; using gender-affirming language through mirroring and dual phrasing; centering “voice” and “choice” in HIV prevention decision-making; incorporating behavior change scaffolding (e.g., goal setting, elicit-provide-elicit techniques); offering hands-on peer navigation and curated SOC resources to address structural access barriers; and leveraging digital tools to enhance engagement, shared learning, and community connection.

Conclusions:

Co-designing with transmasculine communities through an iterative, community-engaged development and refinement processes was essential for producing culturally responsive, theoretically-grounded, and gender-affirming HIV prevention interventions. Our findings can inform future peer-delivered and digital HIV prevention strategies tailored to the needs of specific populations, grounded in community partnerships and lived experience. Clinical Trial: ClinicalTrials.gov NCT06182280; https://clinicaltrials.gov/ct2/show/NCT06182280