# Developing and Pilot Testing an Adaptive Intervention to Facilitate PrEP Uptake and Maximize PrEP Adherence among At-Risk Transgender Women

> **NIH NIH R34** · UNIVERSITY OF CALIFORNIA LOS ANGELES · 2021 · $216,860

## Abstract

PROJECT SUMMARY
BACKGROUND. PrEP has dramatically changed the promise of HIV prevention, particularly for transgender
women (TGW) who are among the highest risk group for HIV in the U.S. While PrEP reduces HIV acquisition
by >90% with adequate adherence, TGW face multiple transgender-specific barriers with PrEP access, uptake,
adherence, and retention. The PIs have longstanding partnerships with community-based organizations that
provide gender-affirming services to this group in Providence, RI and operate one of the first clinical PrEP
programs in the U.S., led by our team at Miriam Hospital/Brown University. CONCEPTUAL MODEL. The
intervention package (“PrEP N’ Shine”) is based on over a decade of formative and programmatic work
grounded in the social-cognitive and contextual realities of high-risk TGW, and as such, the conceptual model
underlying the intervention draws on Empowerment Theory and Social Cognitive Theory. The “PrEP N’ Shine”
package includes two separate but complementary interventions: 1) peer-led, strengths-based case
management (SBCM) for PrEP linkage and uptake; and 2) a resource-efficient, adaptive “stepped-care”
technology and counseling intervention to optimize PrEP adherence. “Stepped-care” is a healthcare delivery
model in which the least resource intensive part of an intervention is delivered first, and only those who
continue to have problems adhering to PrEP receive the more resource-intensive components. APPROACH.
Initially, we will continue to work with community members and a community advisory board to further inform
the “PrEP N’ Shine” intervention (Aim 1a). Next, we will iteratively refine the intervention, in an open pilot trial
with exit interviews, with up to 10 TGW to enhance participant acceptability, feasibility of study procedures, and
finalize study protocols (Aim 1b). For Aim 2, we will conduct a pilot randomized controlled trial (RCT) of the
“PrEP N’ Shine” intervention using a 2-stage randomization design: For Stage 1, we aim randomize 106 TGW
who are candidates for PrEP to receive either the peer-led SBCM for PrEP linkage and uptake or standard of
care (SOC; i.e., PrEP referrals only). For Stage 2, those from Stage 1 who initiate PrEP (n~44), regardless of
their randomization condition, will then be equally re-randomized to either the resource-efficient, adaptive
“stepped-care” intervention to optimize PrEP adherence (initially TGW in this arm will receive daily 2-way
gender-affirming text message reminders, and then those continuing to have poor adherence will receive the 4
more intensive counseling sessions) or the SOC condition. Primary outcomes include PrEP linkage and
uptake; PrEP adherence (both biomedical and self-report assessments); and retention in PrEP care.
INNOVATION. The “PrEP N’ Shine” intervention is highly scalable and sustainable in the real world, as it takes
into account the “future of PrEP access,” while simultaneously 1) addressing the barriers surrounding access,
2) aiding in na...

## Key facts

- **NIH application ID:** 10239233
- **Project number:** 5R34MH122499-02
- **Recipient organization:** UNIVERSITY OF CALIFORNIA LOS ANGELES
- **Principal Investigator:** Katie Brooks Biello
- **Activity code:** R34 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $216,860
- **Award type:** 5
- **Project period:** 2020-08-15 → 2023-05-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10239233

## Citation

> US National Institutes of Health, RePORTER application 10239233, Developing and Pilot Testing an Adaptive Intervention to Facilitate PrEP Uptake and Maximize PrEP Adherence among At-Risk Transgender Women (5R34MH122499-02). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10239233. Licensed CC0.

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