Comparative- and Cost-effectiveness Research Determining the Optimal Intervention for Advancing Transgender Women with HIV to Full Viral Suppression (Text Me, Alexis!) (Preprint)

Abstract

Many trans women with HIV achieve suboptimal advancement through the HIV Care Continuum, including poor HIV healthcare utilization, retention in HIV medical care, and rates of viral suppression. These issues are exacerbated by comorbid conditions, such as substance use disorder (SUD), which is also associated with reduced quality-of-life, and increased overdose deaths, utilization of high-cost healthcare 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 trans women in HIV care through full viral suppression.

This study builds on the promising findings from our two Health Resources and Services Administration (HRSA)-funded demonstration projects, The Alexis Project and Text Me, Girl!, which utilized Peer Health Navigation (PHN) and SMS (i.e., text messaging), respectively, for advancing trans women with HIV to full viral suppression. Though the effectiveness of both interventions has been established, their comparative-effectiveness, required resources/costs, cost-effectiveness, and heterogeneous effects on subgroups, including those with SUD, have not been evaluated. Given the many negative personal and public-health consequences of untreated/undertreated HIV, and that HIV services for trans 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 policymakers.

Text Me, Alexis! is a three-arm randomized controlled trial (RCT). Participants (N = 195) will be randomized (1:1:1) into: PHN alone (n = 65), SMS alone (n = 65), or PHN+SMS (n = 65). Using the same time points as the HRSA 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 arm will receive 270 theory-based text messages (three messages daily) that are targeted, tailored, and personalized specifically for trans women with HIV; and participants in the PHN+SMS arm will receive a combined PHN and SMS intervention. The desired outcome of Text Me, Alexis! is viral suppression and cost effectiveness.

Recruitment 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.

Trans 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 trans women and guiding service provision and public policy.