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

NCT05514509 | Completed Phase 4 FDA Drug

• 1 other identifier: 217711
• Study Type: interventional
• Target: 370
• Locations: 1 country
• Sites: 22

Brief 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.

Conditions

HIV Infections

Keywords

Cabotegravir; Long acting injectables; Implementation science; HIV; PrEP; HIV Disparities; Ending the Epidemic; Engaging Black Women on APRETUDE by Optimizing Novel Implementation Strategies (EBONI)

Outcome Measures

Primary Outcomes (1)

• Mean Intervention Appropriateness Measure (IAM) Score in SSPs

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

  Up to Month 13

Secondary Outcomes (49)

• Mean IAM Score in SSPs at Month 1, 4, 5, 12 and 13

  Month 1, 4, 5, 12 and 13

• Change from Baseline in Mean IAM Score in SSPs at Month 4, 5, 12 and 13

  Baseline (Month 1) and Month 4, 5, 12 and 13

• Appropriateness of APRETUDE Assessed by SSP Questionnaire responses at Month 1, 4, 5, 12 and 13

  Month 1, 4, 5, 12 and 13

• Appropriateness of APRETUDE Assessed by Semi-structured interview (SSI) at Month 4, 5, 12 and 13

  Month 1, 4, 5, 12 and 13

• Appropriateness of APRETUDE Assessed by Semi-structured interview (SSI) at Month 4, 5, 12 and 13

  Month 4, 5 12 and 13

Study Arms (3)

Standard Implementation (SI)

ACTIVE COMPARATOR

PSPs will receive APRETUDE injection and could receive optional Cabotegravir tablets as oral lead in (OLI). The SI arm receives the standard toolkits that are anticipated to be available for APRETUDE that includes information resource for PSPs and SSPs.

Drug: APRETUDE; Drug: Cabotegravir tablet

Enhanced Implementation (EI)

EXPERIMENTAL

PSPs will receive APRETUDE injection and could receive optional Cabotegravir tablets as OLI. The EI arm will receive all components of SI arm and additional provider-focused implementation strategies. Provider-focused strategies will include a patient-provider communication tool, Provider Education, and enhanced tool kit materials.

Drug: APRETUDE; Drug: Cabotegravir tablet

Enhanced Collaborative Implementation (ECI)

EXPERIMENTAL

PSPs will receive APRETUDE injection and could receive optional Cabotegravir tablets as OLI. The ECI arm will involve implementation strategies to support patient activation and provider awareness. Clinics randomized to ECI will receive all components of SI and additional implementation strategies to support patient activation and ensure provider awareness. ECI strategies will include a patient information and product resources and peer support.

Drug: APRETUDE; Drug: Cabotegravir tablet

Interventions

APRETUDE DRUG

Available as intramuscular injection.

Enhanced Collaborative Implementation (ECI); Enhanced Implementation (EI); Standard Implementation (SI)

Cabotegravir tablet DRUG

Available as marketed orally administered tablets.

Enhanced Collaborative Implementation (ECI); Enhanced Implementation (EI); Standard Implementation (SI)

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Female at birth or self-identified Transgender Female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• HIV indeterminate or positive test result during screening.
• A participant of concurrent interventional clinical or implementation science study at any time during the study.
• Cis-gender or Transgender male

Sponsors & Collaborators

• ViiV Healthcare: lead

Study Sites (22)

GSK Investigational Site

Washington D.C., District of Columbia, 20005, United States

Location

GSK Investigational Site

Washington D.C., District of Columbia, 20010, United States

Location

GSK Investigational Site

Washington D.C., District of Columbia, 20017, United States

Location

GSK Investigational Site

Miami, Florida, 33137, United States

Location

GSK Investigational Site

Orlando, Florida, 32808, United States

Location

GSK Investigational Site

Tampa, Florida, 33611, United States

Location

GSK Investigational Site

West Palm Beach, Florida, 33401, United States

Location

GSK Investigational Site

Atlanta, Georgia, 30303, United States

Location

GSK Investigational Site

Atlanta, Georgia, 30309, United States

Location

GSK Investigational Site

Atlanta, Georgia, 30312, United States

Location

GSK Investigational Site

Bridgeport, Kansas, 06605, United States

Location

GSK Investigational Site

Detroit, Michigan, 48201, United States

Location

GSK Investigational Site

Las Vegas, Nevada, 89104, United States

Location

GSK Investigational Site

Brooklyn, New York, 10001, United States

Location

GSK Investigational Site

New York, New York, 10029, United States

Location

GSK Investigational Site

Philadelphia, Pennsylvania, 19114, United States

Location

GSK Investigational Site

Philadelphia, Pennsylvania, 19147, United States

Location

GSK Investigational Site

Memphis, Tennessee, 38104, United States

Location

GSK Investigational Site

Dallas, Texas, 75201, United States

Location

GSK Investigational Site

Houston, Texas, 77006, United States

Location

GSK Investigational Site

Houston, Texas, 77021, United States

Location

GSK Investigational Site

Norfolk, Virginia, 23510, United States

Location

Related Publications (1)

• Nelson KL, Evans Cooper T, Lawson Y, Baker D, Mocherla S, Dieterich M, Hodge T, Dyson A, Sutherland-Philips D, Swygard H, Petty L, Jeffery P, Sutton K, Bonner CP, Andrews SM, Chang S, Budnik P, Smith K, de Ruiter A, Czarnogorski M, Pilgrim N. Strategies for implementing long-acting cabotegravir for PrEP in US clinics serving Black women: interim healthcare provider findings from the EBONI study. J Int AIDS Soc. 2025 Jul;28 Suppl 2(Suppl 2):e26497. doi: 10.1002/jia2.26497.

  PMID: 40600480 DERIVED

MeSH Terms

Conditions

HIV Infections

Interventions

cabotegravir

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• GSK Clinical Trials

  ViiV Healthcare

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR
• Expanded Access: Yes

Study Record Dates

• First Submitted: August 22, 2022
• First Posted: August 24, 2022
• Study Start: October 28, 2022
• Primary Completion: September 2, 2025
• Study Completion: September 2, 2025
• Last Updated: February 9, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: IPD will be made available within 6 months of publishing the results of the primary endpoints, a key secondary endpoints and safety data of the study.
• Access Criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.

Locations

US (22)