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

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

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 Overview

• Status: Completed
• Conditions: HIV Infections
• Intervention / Treatment: Drug: APRETUDE; Drug: Cabotegravir tablet

• Study Type: Interventional
• Enrollment (Actual): 370
• Phase: Phase 4

Expanded Access

Available outside the clinical trial. See expanded access record.

Contacts and Locations

Study Locations

• United States
  • District of Columbia
    • Washington D.C., District of Columbia, United States, 20005
      • GSK Investigational Site
    • Washington D.C., District of Columbia, United States, 20010
      • GSK Investigational Site
    • Washington D.C., District of Columbia, United States, 20017
      • GSK Investigational Site
  • Florida
    • Miami, Florida, United States, 33137
      • GSK Investigational Site
    • Orlando, Florida, United States, 32808
      • GSK Investigational Site
    • Tampa, Florida, United States, 33611
      • GSK Investigational Site
    • West Palm Beach, Florida, United States, 33401
      • GSK Investigational Site
  • Georgia
    • Atlanta, Georgia, United States, 30309
      • GSK Investigational Site
    • Atlanta, Georgia, United States, 30312
      • GSK Investigational Site
    • Atlanta, Georgia, United States, 30303
      • GSK Investigational Site
  • Kansas
    • Bridgeport, Kansas, United States, 06605
      • GSK Investigational Site
  • Michigan
    • Detroit, Michigan, United States, 48201
      • GSK Investigational Site
  • Nevada
    • Las Vegas, Nevada, United States, 89104
      • GSK Investigational Site
  • New York
    • Brooklyn, New York, United States, 10001
      • GSK Investigational Site
    • New York, New York, United States, 10029
      • GSK Investigational Site
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19114
      • GSK Investigational Site
    • Philadelphia, Pennsylvania, United States, 19147
      • GSK Investigational Site
  • Tennessee
    • Memphis, Tennessee, United States, 38104
      • GSK Investigational Site
  • Texas
    • Dallas, Texas, United States, 75201
      • GSK Investigational Site
    • Houston, Texas, United States, 77006
      • GSK Investigational Site
    • Houston, Texas, United States, 77021
      • GSK Investigational Site
  • Virginia
    • Norfolk, Virginia, United States, 23510
      • GSK Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 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

Exclusion criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard Implementation (SI); 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; Available as intramuscular injection.; Drug: Cabotegravir tablet; Available as marketed orally administered tablets.
Experimental: Enhanced Implementation (EI); 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; Available as intramuscular injection.; Drug: Cabotegravir tablet; Available as marketed orally administered tablets.
Experimental: Enhanced Collaborative Implementation (ECI); 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; Available as intramuscular injection.; Drug: Cabotegravir tablet; Available as marketed orally administered tablets.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean IAM Score in SSPs at Month 1, 4, 5, 12 and 13	The responses for appropriateness will be measured on a Likert scale ranging from 0 to 5 with higher values representing better outcomes. Data will be collected at Month 1, 4, and 12 for participants who start with injections and at Month 1, 5, 13 for participants who start with the oral lead in.	Month 1, 4, 5, 12 and 13
Change from Baseline in Mean IAM Score in SSPs at Month 4, 5, 12 and 13	The responses for appropriateness will be measured on a Likert scale ranging from 0 to 5 with higher values representing better outcomes. Data will be collected at Month 1, 4, and 12 for participants who start with injections and at Month 1, 5, 13 for participants who start with the oral lead in.	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	Data will be collected at Month 1, 4, and 12 for participants who start with injections and at Month 1, 5, 13 for participants who start with the oral lead in.	Month 1, 4, 5, 12 and 13
Appropriateness of APRETUDE Assessed by Semi-structured interview (SSI) at Month 4, 5, 12 and 13	Appropriateness of APRETUDE will be measured from themes emerging from Proctor and Consolidated Framework for Implementation Research (CFIR) guided semi-structured qualitative interview. Data will be collected at Month 1, 4, and 12 for participants who start with injections and at Month 1, 5, 13 for participants who start with the oral lead in.	Month 1, 4, 5, 12 and 13
Appropriateness of APRETUDE Assessed by Semi-structured interview (SSI) at Month 4, 5, 12 and 13	Appropriateness of APRETUDE will be measured from themes emerging from Proctor and CFIR framework guided semi-structured qualitative interview. Data will be collected at Month 4, and 12 for participants who start with injections and at Month 5, 13 for participants who start with the oral lead in.	Month 4, 5 12 and 13
Mean IAM Score in PSPs at Month 1, 4, 5, 12 and 13	The responses for appropriateness will be measured on a Likert scale ranging from 0 to 5 with higher values representing better outcomes. Data will be collected at Month 1, 4, and 12 for participants who start with injections and at Month 1, 5, 13 for participants who start with the oral lead in.	Month 1, 4, 5, 12 and 13
Change from Baseline in Mean IAM Score in PSPs at Month 4, 5, 12 and 13	The responses for appropriateness will be measured on a Likert scale ranging from 0 to 5 with higher values representing better outcomes. Data will be collected at Month 1, 4, and 12 for participants who start with injections and at Month 1, 5, 13 for participants who start with the oral lead in.	Baseline (Month 1) and Month 4, 5, 12 and 13
Perception of Appropriateness of APRETUDE Assessed by PSP Questionnaire responses at Month 1, 4, 5, 12 and 13	Data will be collected at Month 1, 4, and 12 for participants who start with injections and at Month 1, 5, 13 for participants who start with the oral lead in.	Month 1, 4, 5, 12 and 13
Perception of Appropriateness of APRETUDE Assessed by SSI in PSPs at Month 4, 5, 12 and 13	Perception of Appropriateness of APRETUDE will be measured from themes emerging from Proctor and CFIR framework guided semi-structured qualitative interview. Data will be collected at Month 4, and 12 for participants who start with injections and at Month 5, 13 for participants who start with the oral lead in.	Month 4, 5, 12 and 13
Number of cis-and trans Black women who Complete a Sexual Health Assessment through Month 13 in ECI Arm based on site-level PrEP Information Questionnaire		Up to Month 13
Number of PSPs who Complete a Sexual Health Assessment through Month 13 in ECI Arm based on Site-level PrEP Information Questionnaire		Up to Month 13
Number of cis-and trans Black Women who Initiate APRETUDE through Month 13 by Study Arm Based on Site level PrEP Information Questionnaire		Up to Month 13
Number of cis-and trans Black Women who Initiate APRETUDE through Month 13 by Clinic Characteristics Based on Site level PrEP Information Questionnaire		Up to Month 13
Proportion of cis-and trans Black Women who Initiate APRETUDE through Month 13 by Study Arm Based on Site level PrEP Information Questionnaire		Up to Month 13
Proportion of cis-and trans Black Women who Initiate APRETUDE through Month 13 by Clinic Characteristics Based on Site level PrEP Information Questionnaire		Up to Month 13
Number of cis-and trans Black Women who Continue APRETUDE beyond a First Dose through Month 13 by study arm based on Site-level PrEP Information Questionnaire		Up to Month 13
Number of cis-and trans Black Women who Continue APRETUDE beyond a First Dose through Month 13 by Clinic Characteristics based on Site-level PrEP Information Questionnaire		Up to Month 13
Mean Feasibility of Intervention Measure (FIM) score in SSPs for Implementation Strategies	The responses for feasibility will be measured on a 5-point Likert scale ranging from 0 to 5 with higher values representing better outcomes. Data will be collected at Month 1, 4, and 12 for participants who start with injections and at Month 1, 5, 13 for participants who start with the oral lead in.	Month 1 and 4, 5, 12 and 13
Change from Baseline in FIM Score in SSPs for Implementation Strategies	The responses for feasibility will be measured on a 5-point Likert scale ranging from 0 to 5 with higher values representing better outcomes. Data will be collected at Month 1, 4, and 12 for participants who start with injections and at Month 1, 5, 13 for participants who start with the oral lead in.	Baseline (Month 1) and Month 4, 5, 12 and 13
Feasibility of Strategy Assessed by SSPs Questionnaire responses at Month 1, 4, 5, 12 and 13	Data will be collected at Month 1, 4, and 12 for participants who start with injections and at Month 1, 5, 13 for participants who start with the oral lead in.	Month 1, 4, 5, 12 and 13
Feasibility and Utility of Strategy Assessed in SSPs by SSI at Month 4, 5, 12 and 13	Perception of Appropriateness of APRETUDE will be measured from themes emerging from Proctor and CFIR framework guided semi-structured qualitative interview. Data will be collected at Month 4, and 12 for participants who start with injections and at Month 5, 13 for participants who start with the oral lead in.	Month 4, 5, 12 and 13
Proportion of SSPs that Respond in Agreement on Relevant Items on the Implementation science questionnaire (ISQ) that each implementation tool and strategy is fit for use through Month 13 Based on Study Arm	ISQ measures a range, including acceptability, feasibility, and utility.	Up to Month 13
Proportion of SSPs that Respond in Agreement on Relevant Items on the ISQ that each implementation tool and strategy is fit for use through Month 13 Based on Clinic Characteristics	ISQ measures a range, including acceptability, feasibility, and utility.	Up to Month 13
Proportion of SSPs that Respond in Agreement on Relevant Items on the ISQ that each implementation tool and strategy is fit for use through Month 13 Based on Patient Subgroups	ISQ measures a range, including acceptability, feasibility, and utility.	Up to Month 13
Proportion of PSPs that Respond in Agreement on Relevant Items on the Implementation science questionnaire (ISQ) that each implementation tool and strategy is fit for use through Month 13 Based on Study Arm	ISQ measures a range, including acceptability, feasibility, and utility.	Up to Month 13
Proportion of PSPs that Respond in Agreement on Relevant Items on the ISQ that each implementation tool and strategy is fit for use through Month 13 Based on Clinic Characteristics	ISQ measures a range, including acceptability, feasibility, and utility.	Up to Month 13
Proportion of PSPs that Respond in Agreement on Relevant Items on the ISQ that each implementation tool and strategy is fit for use through Month 13 Based on Patient Subgroups	ISQ measures a range, including acceptability, feasibility, and utility.	Up to Month 13
Perceptions of Utility of Implementation tools and strategies Assessed by SSIs in PSPs through Month 13 based on Patient Subgroups	Perceptions of Utility of Implementation tools and strategies will be measured from themes emerging from Proctor and CFIR framework guided semi-structured qualitative interview.	Up to Month 13
Proportion of Injections Occurring Within Target Window from Target Date (+-7 days of target date)		Up to Month 13
Perception of Barriers and Facilitators to Fidelity to Injections Window Assessed by SSIs in PSPs	Perception of Barriers and Facilitators to Fidelity to Injections Window will be measured from themes emerging from Proctor and CFIR framework guided semi-structured qualitative interview. Data will be collected at Month 1 and 12 for participants who start with injections and at Month 1 and 13 who start with oral lead in.	Month 1, 12 and 13
Perception of Barriers and Facilitators to Fidelity to Injections Window Assessed by Surveys in PSPs	Data will be collected at Month 1, 4, and 12 for participants who start with injections and at Month 1, 5, 13 for participants who start with the oral lead in.	Month 1, 4, 5, 12 and 13
Perception of Barriers and Facilitators to Fidelity to Injections Window Assessed by Implementation Monitoring Calls (IMC) in SSPs	Data will be collected at Month 4, and 12 for participants who start with injections and at Month 5 and 13 for participants who start with the oral lead in.	Month 4, 5, 12 and 13
Proportion of PSPs completing target number of injections		Up to Month 13
Barriers, Facilitators, Concerns and Perception to Implementation in SSPs and PSPs Assessed by Questionnaire responses	Data will be collected at Month 1, 4, and 12 for participants who start with injections and at Month 1, 5, 13 for participants who start with the oral lead in.	Month 1, 4, 5, 12 and 13
Perception to Facilitators and Barriers to Implementation in SSPs Assessed by SSI	Perception to Facilitators and Barriers to Implementation will be measured from themes emerging from Proctor and CFIR framework guided semi-structured qualitative interview. Data will be collected at Month 4, and 12 for participants who start with injections and at Month 5 and 13 for participants who start with the oral lead in.	Month 4, 5, 12 and 13
Perception to Facilitators and Barriers to Implementation in SSPs Assessed by IMC	Data will be collected at Month 4, and 12 for participants who start with injections and at Month 5 and 13 for participants who start with the oral lead in.	Month 4, 5, 12 and 13
Perception to Facilitators and Barriers to Implementation in PSPs Assessed by SSI	Perception to Facilitators and Barriers to Implementation will be measured from themes emerging from Proctor and CFIR framework guided semi-structured qualitative interview. Data will be collected at Month 1 and 12 for participants who start with injections and at Month 1 and 13 for participants who start with the oral lead in.	Month 1, 12 and 13
Acceptability of Intervention Measure (AIM) Score for APRETUDE in SSPs and PSPs	The responses for acceptability will be measured on a Likert scale ranging from 0 to 5 with higher values representing better outcomes. Data will be collected at Month 1, 4, and 12 for participants who start with injections and at Month 1, 5, 13 for participants who start with the oral lead in.	Month 1, 4, 5, 12 and 13
FIM Score for APRETUDE in SSPs and PSPs	The responses for feasibility will be measured on a Likert scale ranging from 0 to 5 with higher values representing better outcomes. Data will be collected at Month 1, 4, and 12 for participants who start with injections and at Month 1, 5, 13 for participants who start with the oral lead in.	Month 1, 4, 5, 12 and 13
Feasibility and Acceptability of APRETUDE in SSPs and PSPs Assessed by Questionnaire Responses	Data will be collected at Month 1, 4, and 12 for participants who start with injections and at Month 1, 5, 13 for participants who start with the oral lead in.	Month 1, 4, 5, 12 and 13
Feasibility and Acceptability of APRETUDE in SSPs Assessed by SSIs	Feasibility and Acceptability of APRETUDE will be measured from themes emerging from Proctor and CFIR framework guided semi-structured qualitative interview. Data will be collected at Month 4, and 12 for participants who start with injections and at Month 13 for participants who start with the oral lead in.	Month 4, 12 and 13
Feasibility and Acceptability of APRETUDE in PSPs Assessed by SSIs	Feasibility and Acceptability of APRETUDE will be measured from themes emerging from Proctor and CFIR framework guided semi-structured qualitative interview. Data will be collected at Month 1 and 12 for participants who start with injections and at Month 1 and 13 for participants who start with the oral lead in.	Month 1, 12 and 13
Proportion of PSPs that have one Oral lead-in before CAB Injection		Up to Month 13
Perception on Reason for Decision to Use Oral lead-in in SSPs Assessed by SSI	Perception on Reason for Decision to Use Oral lead-in will be measured from themes emerging from Proctor and CFIR framework guided semi-structured qualitative interview. Data will be collected at Month 1, 4, and 12 for participants who start with injections and at Month 1, 5, 13 for participants who start with the oral lead in.	Month 1, 4, 5, 12 and 13
Perception on Reason for Decision to Use Oral lead-in SSPs Assessed by Survey responses	Data will be collected at Month 1, 4, and 12 for participants who start with injections and at Month 1, 5, 13 for participants who start with the oral lead in.	Month 1, 4, 5, 12 and 13
Perception on Reason for Decision to Use Oral lead-in PSPs Assessed by SSIs	Perception on Reason for Decision to Use Oral lead-in will be measured from themes emerging from Proctor and CFIR framework guided semi-structured qualitative interview.	Month 1
Perception on Reason for Decision to Use Oral lead-in PSPs Assessed by Survey Responses		Month 1
Proportion of PSPs that Complete a Sexual Health Assessment and Start or Switch from Oral PrEP to APRETUDE		Up to Month 13
Reasons for Choosing or Switching from Oral PrEP to APRETUDE in PSPs Assessed by SSIs	Reasons for Choosing or Switching from Oral PrEP to APRETUDE will be measured from themes emerging from Proctor and CFIR framework guided semi-structured qualitative interview.	Up to Month 13

Collaborators and Investigators

• Sponsor: ViiV Healthcare
• Investigators: Study Director: GSK Clinical Trials, ViiV Healthcare

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 28, 2022
• Primary Completion (Actual): September 2, 2025
• Study Completion (Actual): September 2, 2025

Study Registration Dates

• First Submitted: August 22, 2022
• First Submitted That Met QC Criteria: August 22, 2022
• First Posted (Actual): August 24, 2022

Study Record Updates

• Last Update Posted (Actual): February 9, 2026
• Last Update Submitted That Met QC Criteria: February 4, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: HIV; PrEP; Implementation science; Cabotegravir; Long acting injectables; HIV Disparities; Ending the Epidemic; Engaging Black Women on APRETUDE by Optimizing Novel Implementation Strategies (EBONI)
• Additional Relevant MeSH Terms: Blood-Borne Infections; Urogenital Diseases; Genital Diseases; Immune System Diseases; Infections; RNA Virus Infections; Virus Diseases; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; HIV Infections; Anti-Infective Agents; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antiviral Agents; Anti-HIV Agents; Anti-Retroviral Agents; HIV Integrase Inhibitors; Integrase Inhibitors; cabotegravir
• Other Study ID Numbers: 217711

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: IPD for this study will be made available via the Clinical Study Data Request site.
• IPD Sharing 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.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No