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.
