Comparative- and Cost-Effectiveness Research Determining the Optimal Intervention for Advancing Transgender Women With HIV to Full Viral Suppression (Text Me, Alexis!): Protocol for a Randomized Controlled Trial.

backgroundMany transgender women with HIV achieve suboptimal advancement through the HIV Care Continuum, including poor HIV health care usage, retention in HIV medical care, and rates of viral suppression. These issues are exacerbated by comorbid conditions, such as substance use disorder, which is also associated with reduced quality of life, increased overdose deaths, usage of high-cost health care services, engagement in a street economy, and cycles of incarceration. Thus, it is critical that efforts to End the HIV Epidemic include effective interventions to link and retain transgender women in HIV care through full viral suppression.

objectiveThis study builds on the promising findings from our two Health Resources and Services Administration-funded demonstration projects, The Alexis Project and Text Me, Girl!, which used peer health navigation (PHN) and SMS text messaging, respectively, for advancing transgender women with HIV to full viral suppression. Though the effectiveness of both interventions has been established, their comparative effectiveness, required resources or costs, cost-effectiveness, and heterogeneous effects on subgroups, including those with substance use disorder, have not been evaluated. Given the many negative personal and public health consequences of untreated or undertreated HIV, and that HIV services for transgender women are frequently delivered in resource-limited, community-based settings, a comprehensive economic evaluation is critical to inform decisions of stakeholders, such as providers, insurers, and policy makers.

methodsText Me, Alexis! is a 3-arm randomized controlled trial. Participants (N=195) will be randomized (1:1:1) into: PHN alone (n=65), SMS text messaging alone (n=65), or PHN+SMS text messaging (n=65). Using the same time points as the Health Resources and Services Administration demonstration projects, the repeated-measures design will assess participants at baseline, 3, 6, 12, and 18 months post randomization. Over the course of the 90 days, participants in the PHN arm will receive unlimited navigation sessions; participants in the SMS text messaging arm will receive 270 theory-based SMS text messages (3 messages daily) that are targeted, tailored, and personalized specifically for transgender women with HIV; and participants in the PHN+SMS text messaging arm will receive a combined PHN and SMS text message intervention. The desired outcome of Text Me, Alexis! is viral suppression and cost-effectiveness.

resultsRecruitment began on April 10, 2024, and the first participant was enrolled on April 11, 2024. Data collection is expected to be completed in July 2027. Primary outcome analyses will begin immediately following the conclusion of the follow-up evaluations.

conclusionsTransgender women are a high-priority population for reaching End the HIV Epidemic goals. Findings have the potential to improve individual and population health outcomes by generating significant improvements in viral suppression among transgender women and guiding service provision and public policy. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/65313.