Adaptation of a Protocol to Evaluate Online Recruitment Strategies for Mailing HIV Self-Tests and Pilot an Intervention to Improve Linkage to HIV Prevention and Care Among Transgender Women: Protocol for a Randomized Controlled Trial.

Background: Transgender women are disproportionately affected by HIV in the United States. Evidence shows that HIV self-testing increases awareness of HIV status, preventing transmission. Culturally appropriate strategies are needed to provide HIV self-tests (HIVSTs) to transgender women. Objective: This paper aims to describe an adaptation for transgender women of a comparative effectiveness trial of an intervention (Know@Home website) on the use of HIVSTs, counseling, and linkage of participants to appropriate services initially designed to reach Black or African American and Hispanic or Latino men who have sex with men (Implementation of Rapid HIV Self-Testing Among MSM Project). Methods: The ADAPT-ITT (Assessment, Decision, Adaptation, Production, Topical Experts, Integration, Training, and Testing) framework guided the adaptation. Project staff worked with consultants and a community advisory board to revise all study materials (ie, intervention web content, marketing text and images, and language used in the surveys) to be tailored to, and inclusive of, health topics relevant to transgender women. We conducted a pilot study with transgender women recruited through online venues. Participants were randomly assigned 2:1 to the intervention arm or control arm. All participants were mailed 2 HIVSTs, the OraQuick In-Home HIV Test, and had access to a standard resource list including information on how to find a nearby testing location, HIV prevention, and sexual health. Only intervention arm participants had access to the study website, "Know@Home.org." The Know@Home website allowed participants in the intervention arm to order sexually transmitted infection test kits, condoms, and lubricant and provided HIV prevention information, service locators, and risk assessment tools. Adaptations to the intervention included modifying language, images, and links to outside resources to be transgender specific or gender neutral. Online surveys were adapted by removing inappropriate gender terms and replacing them with culturally appropriate terms for gender identity, genitalia, and condom use. Four months after completing the baseline (enrollment) survey, all participants were asked to complete a final follow-up survey. Upon completing the 4-month survey, participants were mailed a dried blood spot collection kit to be returned by mail for the laboratory testing of the sample. The results of all HIVSTs could be reported in real time in an online survey. Video health counseling was available, upon request, for all participants during study participation. Results: Enrollment into the pilot study began on April 22, 2021, and concluded on July 7, 2021, yielding a total of 102 transgender women participants, with data collection completed in January 2022. Conclusions: By using the ADAPT-ITT model, we produced materials to be culturally and linguistically appropriate for transgender women. The findings of this study have the potential to inform future research studies among transgender women and underscore the importance of involving subject matter experts and community members in the development of tailored materials.