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NCT05514509 · ClinicalTrials.gov registry record · Phase 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 study, sponsored by ViiV Healthcare.

Completed
Registry status
Phase 4
Development phase
370
Enrollment target

NCT05514509: Completed Phase 4 study, sponsored by ViiV Healthcare.

NCT05514509 is a Phase 4 study that has completed, run by ViiV Healthcare. The registered enrollment target is 370 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (29% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05514509, a Phase 4 study, has completed, sponsored by ViiV Healthcare.

COMPLETED
Registry status
Phase 4
Development phase
370 participants
Enrollment target

Study Summary

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.

Primary Outcome

The responses for appropriateness will be measured on a Likert scale ranging from 0 to 5 with higher values representing better outcomes.

Interventions

  • DRUG APRETUDE
  • DRUG Cabotegravir tablet

Trial Details

FieldValue
Enrollment Target 370 participants
Start Date 2022-10-28
Est. Completion 2025-09-02
Phase Phase 4
ViiV Healthcare

182 total trials

What the finished NCT05514509 record still lists

NCT05514509 is an interventional study that assigns participants to a tested intervention. The registered 370 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (29% lower).

The record links to 0 conditions, and to 2 interventions - of which APRETUDE is the first listed.

NCT05514509 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT05514509 about?

NCT05514509 is a clinical study titled "A Study Evaluating Implementation Strategies for the Delivery of APRETUDE for Black cis-and Transgender Women in United States EHE Territories". 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...

What is the current status of trial NCT05514509?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 370 participants. The study started on 2022-10-28. Estimated completion is 2025-09-02.

What interventions are being tested in trial NCT05514509?

The interventions under investigation include: APRETUDE (DRUG), Cabotegravir tablet (DRUG).

Who is sponsoring clinical trial NCT05514509?

This trial is sponsored by ViiV Healthcare, which has 182 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT05514509's enrollment target sits among peer trials

370 223rd of 2000 higher than 1,777 of 2,000 other Phase 4 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 4 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.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT05514509, the US trial registry maintained by the National Library of Medicine. NCT05514509 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.