Clinical trial NCT06656676: WePrEP: Developing a PrEP Shared Decision-making Tool for Transgender Women
Official title: WePrEP: A Bilingual Shared Decision-making Tool to Facilitate Conversations Between Transgender Women and Their Providers as They Select an Ideal PrEP Method
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: HIV Prevention
Keywords: PrEP
Biomedical HIV prevention
CAB-LA
Cabenuva
Truvada
Tenofovir
oral PrEP
injectable PrEP
shared decision-making
transgender women
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: Mile High Behavioral Healthcare Transgender Center of the Rockies
name: The Gay Lesbian Bisexual & Transgender Community Center of Colorado
First posted: 2024-10-24
Enrollment: 75
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: HIV prevalence among transgender women (TW) in the United States is high (\~14%). The best way to reduce HIV incidence in this population is to link TW to HIV pre-exposure prophylaxis (PrEP), which can reduce HIV transmission by up to 86%, with optimal adherence. The FDA approved the first long-acting form of PrEP, injectable cabotegravir (CAB-LA), in late 2021, which has the potential to decrease HIV transmission and increase PrEP adherence among TW. The addition of CAB-LA to available PrEP options necessitates TW and PrEP service providers select the best method (oral vs injectable) for each TW. However, TW have unique concerns about PrEP (e.g., interactions with gender-affirming hormones) and report that patient/provider discussions on this medication are suboptimal. Thus, to inform this shared decision process, the proposed study builds on formative work by developing and pilot-testing "WePrEP," a PrEP-focused bilingual digital shared decision-making tool (SDMT), tailored to diverse English- and Spanish-speaking TW and PrEP service providers. WePrEP will support communication between TW and PrEP service providers as they identify the ideal PrEP product for each TW and discuss associated adherence strategies by cuing conversations on TW's unique PrEP needs/concerns and presenting pertinent information that is culturally relevant and tailored to this population. To develop and test WePrEP, the investigators will partner with the Mile High Behavioral Healthcare Transgender Center of the Rockies, a Denver-based transgender-serving organization. They will use McNulty et al.'s adapted Shared Decision-Making Model for TW to guide the iterative participatory design process we will use with a group of racially/ethnically diverse TW and PrEP service providers, to develop WePrEP; we will begin this process using prototypes created from preliminary data (Aim 1a). The investigators will rigorously assess the usability of WePrEP via simulated patient/provider discussions (Aim 1b). Next, they will pilot test WePrEP in a randomized controlled trial (RCT; N=69 TW) with 2:1 randomization. In the RCT, PrEP service providers (N=4, of which n=1 is bilingual) will use WePrEP with intervention TW to select CAB-LA or oral PrEP and discuss adherence. Other providers (N=2, of which n=1 is bilingual) will give control TW a standard of care explanation of PrEP (CDC recommendations) to help them make their PrEP choice. TW will be referred to Sheridan Health Services to start PrEP. We will assess primary (feasibility; acceptability) and secondary (potential mechanisms of action of WePrEP; preliminary impact) outcome measures using validated scales and rigorous qualitative methods (Aims 2, 3). By creating a bilingual digital SDMT to enhance communication between TW and PrEP service providers as TW choose their ideal PrEP modality, this project is likely to make a widespread and lasting impact on TW's uptake and adherence to PrEP.


Eligibility criteria: Inclusion Criteria:

Eligible participants in the transgender women group (N=69) must:

* Self-identify as a transgender woman (e.g., was assigned male at birth, but currently reports a feminine gender identity)
* Be between the ages of 18 and 65
* Currently live in the Denver area
* Speak English or Spanish
* Be HIV-negative (via Alere Determine)
* Not have participated in the development of WePrEP
* Not currently take PrEP, but report they are "interested in doing more to protect themselves from HIV" \*\*We note that 1/3 of our RCT participants in the transgender women's group will be Black and/or Hispanic/Latina

Eligible participants in the PrEP service providers group (N=6) must:

* Not have participated in the development of WePrEP
* Live in the Denver area and (as a part of their employment responsibilities) discuss PrEP use with potential end-users.
* Have helped at least 1 TW make a decision about PrEP (e.g., whether or not to use it, which specific PrEP modality, etc...) in the last month.

Exclusion Criteria:

Participants in the transgender women group are excluded if they:

* Currently live with HIV
* Do not meet one or more of the inclusion criteria above

Participants in the PrEP service providers group are excluded if they:

* Do not live in the Denver area
* Do not meet one or more of the inclusion criteria above

Primary outcomes:
measure: Feasibility
timeFrame: At enrollment
measure: Acceptability
timeFrame: At enrollment
Secondary outcomes:
measure: Preliminary impact (1st of 3 measures)
timeFrame: The proportion of transgender women who receive either form of PrEP is measured at enrollment.
measure: Preliminary impact (2nd of 3 measures)
timeFrame: For oral PrEP: PrEP serum concentrations are measured at 3 months. For injectable PrEP: PrEP serum concentrations are measured at 2 months.
measure: Preliminary impact (3rd of 3 measures)
timeFrame: For oral PrEP: PrEP refills are measured at 3 months. For injectable PrEP: Injections are measured at 2 months.
measure: Mechanisms of action: Patient/provider communication (1st of 7 measures)
timeFrame: Measured at enrollment
measure: Mechanisms of action: Satisfaction with communication (2nd of 7 measures)
timeFrame: Measured at enrollment
measure: Mechanisms of action: Patient/provider engagement (3rd of 7 measures)
timeFrame: Measured at enrollment
measure: Mechanisms of action: Evidence of shared decision-making (4th of 7 measures)
timeFrame: Measured at enrollment
measure: Mechanisms of action: Satisfaction with control over PrEP decision (5th of 7 measures)
timeFrame: Measured at enrollment
measure: Mechanisms of action: Knowledge, motivation and self-efficacy to use PrEP (6th of 7 measures)
timeFrame: Measured at enrollment
measure: Mechanisms of action: Satisfaction with PrEP choice (7th of 7 measures)
timeFrame: Measured at follow-up (for oral PrEP users, this is at 3 months; for injectable PrEP users, this is at 2 months)
Other outcomes:
Locations:
city: Sheridan
country: United States
facility: Transgender Center of the Rockies
state: Colorado
Study officials:
References: