A Study Evaluating Implementation Strategies for the Delivery of APRETUDE for Black cis-and Transgender Women in United States EHE Territories
Public ClinicalTrials.gov record NCT05514509. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 4, Randomized, Open-label, Three-arm Study to Evaluate Implementation Strategies for the Delivery of CAB for HIV Pre-exposure Prophylaxis (PrEP) Across Clinical Settings for Adult (≥18 Years) Black cis-and Transgender Women Without HIV Infection Living in the United States Ending the Epidemic (EHE) Territories
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of the study is to evaluate the appropriateness, adoption, feasibility, fidelity, and acceptability of implementation strategies and Cabotegravir (CAB) pre-exposure prophylaxis (PrEP). The study objectives are also to identify barriers and facilitators to implementation. The first of two participant types in the study are the Patient Study Participants (PSPs) will refer to individuals who are enrolled in the study and who will receive commercially available CAB PrEP via prescription from the PrEP provider. The second are Staff Study Participants (SSPs) who are site staff involved in the administrative and clinical aspects of offering and administering PrEP to PSPs at the clinical site.
Study identification
- NCT ID
- NCT05514509
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 4
- Enrollment
- 295 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- Female
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 28, 2022 (Actual)
- Primary completion
- Sep 2, 2025 (Actual)
- Completion
- Sep 2, 2025 (Actual)
- Last update posted
- Oct 1, 2026
2022 – 2025
United States locations
- U.S. sites
- 22
- U.S. states
- 11
- U.S. cities
- 16
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| GSK Investigational Site | Washington D.C. | District of Columbia | 20005 | — |
| GSK Investigational Site | Washington D.C. | District of Columbia | 20010 | — |
| GSK Investigational Site | Washington D.C. | District of Columbia | 20017-2149 | — |
| GSK Investigational Site | Miami | Florida | 33137 | — |
| GSK Investigational Site | Orlando | Florida | 32808 | — |
| GSK Investigational Site | Tampa | Florida | 33611 | — |
| GSK Investigational Site | West Palm Beach | Florida | 33401 | — |
| GSK Investigational Site | Atlanta | Georgia | 30303 | — |
| GSK Investigational Site | Atlanta | Georgia | 30309 | — |
| GSK Investigational Site | Atlanta | Georgia | 30312 | — |
| GSK Investigational Site | Bridgeport | Kansas | 06605 | — |
| GSK Investigational Site | Detroit | Michigan | 48201 | — |
| GSK Investigational Site | Las Vegas | Nevada | 89104 | — |
| GSK Investigational Site | Brooklyn | New York | 10001 | — |
| GSK Investigational Site | New York | New York | 10029 | — |
| GSK Investigational Site | Philadelphia | Pennsylvania | 19114 | — |
| GSK Investigational Site | Philadelphia | Pennsylvania | 19147 | — |
| GSK Investigational Site | Memphis | Tennessee | 38104 | — |
| GSK Investigational Site | Dallas | Texas | 75201 | — |
| GSK Investigational Site | Houston | Texas | 77006 | — |
| GSK Investigational Site | Houston | Texas | 77021 | — |
| GSK Investigational Site | Norfolk | Virginia | 23510 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05514509, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 1, 2026 · Synced Oct 22, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05514509 live on ClinicalTrials.gov.