# Formative work to develop differentiated communication tools to facilitate transgender women's recruitment, enrollment, and retention in HIV vaccine trials

> **NIH NIH R21** · UNIVERSITY OF COLORADO DENVER · 2023 · $261,134

## Abstract

ABSTRACT
In the United States (US), HIV prevalence among transgender women (TW) is high (~14%). Yet, uptake of HIV
pre-exposure prophylaxis (PrEP) among TW is low (5-20% of US TW report ever using PrEP) and adherence is
often poor. This is in large part because TW were poorly represented in PrEP trials, leading to data quality issues,
and gaps in knowledge about TW's experiences with PrEP. Our previous studies and other literature found that
TW are unwilling to use biomedical HIV prevention strategies unless they have been tested for safety, tolerability,
and efficacy with TW. HIV vaccines are a promising alternative or companion to PrEP, since vaccines would not
require long-term, near-perfect adherence to a daily or bi-monthly product. However, it is currently impossible to
evaluate HIV vaccine candidates for safety, tolerability, and efficacy among TW, since TW represent <2% of HIV
vaccine trials participants. This dearth of data on TW is likely to limit, or preclude, the uptake of a future approved
HIV vaccine in the population that may benefit the most from it. Further, given TW's sensitivity to data
quantity/quality, it is likely that the lack of early trials data about them impedes their willingness to enroll in other
HIV vaccine trials phases. Thus, to increase TW's participation across all phases of HIV vaccine trials, we must
first focus on increasing their recruitment and enrollment in Phase 1 trials. Recruiting and enrolling more TW in
Phase 1 will generate more meaningful safety data on this population, which can be used to promote TW's
participation in subsequent phases. Unfortunately, TW face multiple social and structural barriers to HIV vaccine
trials participation, including stigma, discrimination, and transphobia (among others), all of which require large
sociocultural changes to address. However, our formative work found a lack of tailored communication is also a
critical, and more proximal, barrier to HIV vaccine trials engagement. For example, current efforts do not provide
sufficient information on topics of concern to TW, nor do they offer information in a way that resonates with them.
To intervene on this, we propose “VaxCom” a digital health communication tool to facilitate recruitment and
enrollment of TW in Phase 1 HIV vaccine trials. We hypothesize VaxCom will improve recruitment and enrollment
of TW into Phase 1 HIV vaccine trials by supporting discussions between recruitment and enrollment (R&E)
specialists and TW regarding HIV vaccine questions/concerns, Phase 1 trials participation, and by providing
relevant associated information to TW in a meaningful and tailored way. To develop VaxCom, we will first elicit
TW's and R&E specialists' information needs and preferences for VaxCom. We will then incorporate them into
an initial prototype of VaxCom that we further develop/refine alongside TW and R&E specialists through an
iterative participatory design process. The resulting prototype will be evaluated for feasibility...

## Key facts

- **NIH application ID:** 10620450
- **Project number:** 1R21MH132421-01
- **Recipient organization:** UNIVERSITY OF COLORADO DENVER
- **Principal Investigator:** Christine Tagliaferri Rael
- **Activity code:** R21 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2023
- **Award amount:** $261,134
- **Award type:** 1
- **Project period:** 2023-05-10 → 2025-04-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10620450

## Citation

> US National Institutes of Health, RePORTER application 10620450, Formative work to develop differentiated communication tools to facilitate transgender women's recruitment, enrollment, and retention in HIV vaccine trials (1R21MH132421-01). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10620450. Licensed CC0.

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