A Study Evaluating Implementation Strategies for the Delivery of APRETUDE for Black cis-and Transgender Women in United States EHE Territories

Last updated: February 17, 2025
Sponsor: ViiV Healthcare
Overall Status: Active - Not Recruiting

Phase

4

Condition

Hiv Infections

Aids And Aids Related Infections

Hiv/aids

Treatment

Cabotegravir tablet

APRETUDE

Clinical Study ID

NCT05514509
217711
  • Ages > 18
  • Female
  • Accepts Healthy Volunteers

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.

Eligibility Criteria

Inclusion

Inclusion criteria:

  • 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 PrEPprescribing 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

Exclusion

Exclusion criteria:

  • HIV indeterminate or positive test result during screening.

  • A participant of concurrent interventional clinical or implementation science studyat any time during the study.

  • Cis-gender or Transgender male

Study Design

Total Participants: 66
Treatment Group(s): 2
Primary Treatment: Cabotegravir tablet
Phase: 4
Study Start date:
October 28, 2022
Estimated Completion Date:
September 30, 2025

Connect with a study center

  • GSK Investigational Site

    Washington, District of Columbia 20017
    United States

    Site Not Available

  • GSK Investigational Site

    Miami, Florida 33137
    United States

    Site Not Available

  • GSK Investigational Site

    Miami Gardens, Florida 33055
    United States

    Site Not Available

  • GSK Investigational Site

    Orlando, Florida 32808
    United States

    Site Not Available

  • GSK Investigational Site

    Tampa, Florida 33611
    United States

    Site Not Available

  • GSK Investigational Site

    West Palm Beach, Florida 33401
    United States

    Site Not Available

  • GSK Investigational Site

    Atlanta, Georgia 30309
    United States

    Site Not Available

  • GSK Investigational Site

    Detroit, Michigan 48201
    United States

    Site Not Available

  • GSK Investigational Site

    Las Vegas, Nevada 89104
    United States

    Site Not Available

  • GSK Investigational Site

    Brooklyn, New York 10001
    United States

    Site Not Available

  • GSK Investigational Site

    New York, New York 10029
    United States

    Site Not Available

  • GSK Investigational Site

    Philadelphia, Pennsylvania 19114
    United States

    Site Not Available

  • GSK Investigational Site

    Columbia, South Carolina 29203
    United States

    Site Not Available

  • GSK Investigational Site

    Memphis, Tennessee 38104
    United States

    Site Not Available

  • GSK Investigational Site

    Dallas, Texas 75201
    United States

    Site Not Available

  • GSK Investigational Site

    Houston, Texas 77021
    United States

    Site Not Available

  • GSK Investigational Site

    Norfolk, Virginia 23510
    United States

    Site Not Available

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