Creating a decision-making tool for transgender women to choose HIV prevention methods
WePrEP: A Bilingual Shared Decision-making Tool to Facilitate Conversations Between Transgender Women and Their Providers as They Select an Ideal PrEP Method
This study is testing a new digital tool called WePrEP to help transgender women choose the best HIV prevention options, including a new injectable treatment, while improving conversations with their healthcare providers.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 75 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | Male |
| Sponsor | University of Colorado, Denver Academic / other |
| Locations | 1 site (Sheridan, Colorado) |
| Trial ID | NCT06656676 on ClinicalTrials.gov |
What this trial studies
This study aims to develop and pilot-test 'WePrEP,' a bilingual digital shared decision-making tool tailored for transgender women to help them choose between different HIV pre-exposure prophylaxis (PrEP) options, including the newly approved injectable cabotegravir. The tool addresses unique concerns of transgender women regarding PrEP, such as interactions with gender-affirming hormones, and aims to improve discussions between patients and providers. Participants will include transgender women interested in HIV prevention and PrEP service providers in the Denver area. The study will compare the effectiveness of the WePrEP tool against standard CDC recommendations for discussing PrEP.
Who should consider this trial
Good fit: Ideal candidates for this study are transgender women aged 18 to 65 who are HIV-negative, live in the Denver area, and are interested in HIV prevention.
Not a fit: Patients who are not transgender women or those who are already taking PrEP may not benefit from this study.
Why it matters
Potential benefit: If successful, this tool could significantly improve PrEP uptake and adherence among transgender women, thereby reducing HIV transmission rates in this high-risk population.
How similar studies have performed: While there have been studies focusing on PrEP for various populations, the specific approach of developing a tailored decision-making tool for transgender women is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Sheridan, Colorado
- Transgender Center of the Rockies — Sheridan, Colorado, United States (Recruiting)
Study contacts
- Study coordinator: Christine T Rael, PhD
- Email: christine.rael@cuanschutz.edu
- Phone: 303-734-8541
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.