Comparative- and cost-effectiveness research determining the optimal intervention for advancing transgender women living with HIV to full viral suppression

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Abstract Trans women (TW) achieve suboptimal advancement through the HIV Care Continuum,1-7 including poor HIV healthcare utilization,8,9 retention in HIV medical care,10-12 and rates of viral suppression.3,4,6,7,13,14 These issues are exacerbated by comorbid conditions, such as substance use disorder (SUD),15-22 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.23,24 Drug use among TW has been demonstrated to be a barrier to HIV care and advancement along the HIV Care Continuum.16 Thus, it is critical that efforts to End the HIV Epidemic (EHE) include effective interventions to link and retain TW in HIV care through full viral suppression.25-27 This study builds on the promising findings from our two HRSA-funded demonstration projects, The Alexis Project28 and Text Me, Girl!,29 which utilized Peer Health Navigation (PHN) and SMS (i.e., text messaging), respectively, for advancing TW living 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 TW are frequently delivered in resource-limited, community-based settings,30-33 a comprehensive economic evaluation is critical to inform decisions of stakeholders, such as providers, insurers, and policymakers. The “intent-to-treat” RCT will randomize participants (N=225) into: PHN alone (n=75), SMS alone (n=75), or PHN+SMS (n=75). Using the same time points as the HRSA projects, the repeated-measures design will assess participants at baseline, 3-, 6-, 12-, and 18-months post-randomization. The specific aims are: 1) Conduct a comparative effectiveness research trial to determine the relative effectiveness of PHN vs. SMS vs. PHN+SMS in terms of: Primary (a) virologic suppression; and Secondary outcomes (b) HIV Treatment Adherence Self-Efficacy Scale scores; (c) the AIDS Health Belief Scale scores; (d) the Inventory of Socially Supportive Behaviors scores; and (e) urine drug screen results; 2) Identify the resources required to prepare for, implement, and sustain each intervention, and estimate the associated costs; 3) Conduct a comprehensive cost-effectiveness analysis to determine the relative value of each intervention from the healthcare-sector, state-policymaker, and societal perspectives; and, a Secondary Aim to determine heterogeneous intervention effects across interventions due to social and structural determinants of health and individual-level characteristics. TW are a high-priority population for reaching EHE25-27 goals and Los Angeles County (the study location) is an EHE priority County.34,35 Findings have the potential to improve individual and population health outcomes by generating significant improvements in viral suppression among TW and guiding service provision and public policy.