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NCT06656676 · ClinicalTrials.gov registry record · NA
WePrEP: Developing a PrEP Shared Decision-making Tool for Transgender Women
A NA study of HIV Prevention, sponsored by University of Colorado, Denver.
- Recruiting
- Registry status
- NA
- Development phase
- 75
- Enrollment target
- 1
- Study location
NCT06656676: Recruiting NA study of HIV Prevention, sponsored by University of Colorado, Denver.
NCT06656676 is a NA study of HIV Prevention that is actively recruiting participants, run by University of Colorado, Denver. The registered enrollment target is 75 participants, below the 380-participant average among 32 other HIV Prevention trials with a reported enrollment target (80% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06656676, a NA study of HIV Prevention, is actively recruiting participants, sponsored by University of Colorado, Denver.
- RECRUITING
- Registry status
- NA
- Development phase
- 75 participants
- Enrollment target
- 1
- Study location
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
Primary Outcome
Feasibility of Intervention Measure (FIM) \[Range: 1-5; Higher scores mean greater feasibility\]
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 |
What NCT06656676 shows while recruiting
NCT06656676 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 75 participants, a relatively small participant target, below the 380-participant average among 32 other HIV Prevention trials with a reported enrollment target (80% lower).
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.
NCT06656676 reports a single indexed study location in Colorado.
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.
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).
Who is sponsoring clinical trial NCT06656676?
This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06656676's enrollment target sits among peer trials
75 21st of 32 higher than 12 of 32 other HIV Prevention trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other HIV Prevention trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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