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

HIV Infections Clinical Trial

— EBONI  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05514509
• Other study ID #: 217711
• Status: Recruiting
• Phase: Phase 4
• Start date: October 28, 2022
• Est. completion date: September 30, 2025

Study information

• Verified date: May 2024
• Source: ViiV Healthcare
• Contact: US GSK Clinical Trials Call Center
• Phone: 877-379-3718
• Email: GSKClinicalSupportHD[@]gsk.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: September 30, 2025
• Est. primary completion date: September 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• Infections

Intervention

Drug:
• APRETUDE
Available as intramuscular injection.
• Cabotegravir tablet
Available as marketed orally administered tablets.

Locations

Country	Name	City	State
United States	GSK Investigational Site	Atlanta	Georgia
United States	GSK Investigational Site	Columbia	South Carolina
United States	GSK Investigational Site	Dallas	Texas
United States	GSK Investigational Site	Detroit	Michigan
United States	GSK Investigational Site	Houston	Texas
United States	GSK Investigational Site	Houston	Texas
United States	GSK Investigational Site	Las Vegas	Nevada
United States	GSK Investigational Site	Memphis	Tennessee
United States	GSK Investigational Site	Miami	Florida
United States	GSK Investigational Site	Miami	Florida
United States	GSK Investigational Site	Miami Gardens	Florida
United States	GSK Investigational Site	New York	New York
United States	GSK Investigational Site	New York	New York
United States	GSK Investigational Site	Norfolk	Virginia
United States	GSK Investigational Site	Orlando	Florida
United States	GSK Investigational Site	Philadelphia	Pennsylvania
United States	GSK Investigational Site	Philadelphia	Pennsylvania
United States	GSK Investigational Site	Tampa	Florida
United States	GSK Investigational Site	Washington	District of Columbia
United States	GSK Investigational Site	Washington	District of Columbia
United States	GSK Investigational Site	Washington	District of Columbia
United States	GSK Investigational Site	West Palm Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
ViiV Healthcare

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Proportion of Injections Occurring Within Target Window from Target Date (+-7 days of target date)		Up to Month 13
Secondary	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
Secondary	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
Secondary	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
Secondary	Proportion of PSPs completing target number of injections		Up to Month 13
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Proportion of PSPs that have one Oral lead-in before CAB Injection		Up to Month 13
Secondary	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
Secondary	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
Secondary	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
Secondary	Perception on Reason for Decision to Use Oral lead-in PSPs Assessed by Survey Responses		Month 1
Secondary	Proportion of PSPs that Complete a Sexual Health Assessment and Start or Switch from Oral PrEP to APRETUDE		Up to Month 13
Secondary	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