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WePrEP: Developing a PrEP Shared Decision-making Tool for Transgender Women
NCT06656676 · View on ClinicalTrials.gov ↗
Study 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
Conditions Studied
Interventions
- BEHAVIORAL WePrEP: A shared decision-making tool
- BEHAVIORAL Active comparator: CDC recommendations for discussing PrEP
Study Locations (1)
Colorado
- Transgender Center of the Rockies — Sheridan
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 75 participants |
| Start Date | 2025-01-29 |
| Est. Completion | 2027-02 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06656676
The ClinicalTrials.gov registry entry for NCT06656676 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 75 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Colorado, Denver, which has 1,447 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with HIV Prevention appearing as the primary indexed condition, and to 2 interventions — of which WePrEP: A shared decision-making tool is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06656676 reports 1 study location spanning 1 distinct geographic area — top geographies include Colorado. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06656676 about?
NCT06656676 is a clinical study titled "WePrEP: Developing a PrEP Shared Decision-making Tool for Transgender Women". 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-acti...
What is the current status of trial NCT06656676?
This trial is currently recruiting. It is a NA study. The enrollment target is 75 participants. The study started on 2025-01-29. Estimated completion is 2027-02.
What conditions does trial NCT06656676 study?
This clinical trial studies the following conditions: HIV Prevention. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06656676?
The interventions under investigation include: WePrEP: A shared decision-making tool (BEHAVIORAL), Active comparator: CDC recommendations for discussing PrEP (BEHAVIORAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06656676?
This trial is sponsored by University of Colorado, Denver, which has 1,447 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06656676 being conducted?
This trial has 1 study location across Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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