NCT05514509CompletedPhase 4
A Study Evaluating Implementation Strategies for the Delivery of APRETUDE for Black cis-and Transgender Women in United States EHE Territories
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
Source: ClinicalTrials.gov · Last updated 1 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 295 (actual)
- First submitted
- 22 Aug 2022
- Start date
- 28 Oct 2022
- Primary completion date
- 2 Sept 2025
- Lead sponsor
- ViiV Healthcare
- Diseases
- HIV
- NCT number
- NCT05514509
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 295
- From 28 Oct 2022 to the primary completion date, 2 Sept 2025
- 16 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- A participant of concurrent interventional clinical or implementation science study at any time during the study.
Other illness
- HIV indeterminate or positive test result during screening.
Other
- Cis-gender or Transgender male
Who the study is looking for
- Participant must be ≥18 years of age, at the time of signing the informed consent.
- HIV negative at screening. Type of HIV-1 test is per standard of care.
- No prior history of receiving oral CAB or CAB LA injections.
- PrEP provider deems CAB PrEP use to be appropriate per the applicable CAB PrEP prescribing information prior to enrollment in the study.
- Female at birth or self-identified Transgender Female.
- Self-identified as African American/Black
- Capable of giving signed informed consent
Age in the registry: 18 years to - · Sex: Female · Accepts healthy volunteers
Sites (16)
Sites in registry order. Pick your city on the disease page to sort them by distance.
This page is information, not medical advice. Discuss any trial with your doctor.