Creating a decision-making tool for transgender women to choose HIV prevention methods

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.