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WePrEP: Developing a PrEP Shared Decision-making Tool for Transgender Women

RecruitingNAAges 18 Years - 65 YearsMaleUniversity of Colorado, Denver
NCT06656676 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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-testi

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📋 Eligibility rules (as published)
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
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What it tests

  • WePrEP: A shared decision-making tool
  • Active comparator: CDC recommendations for discussing PrEP
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Where

1 site
Transgender Center of the Rockies
Sheridan, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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