Clinical trial NCT05514509: A Study Evaluating Implementation Strategies for the Delivery of APRETUDE for Black cis-and Transgender Women in United States EHE Territories
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
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)
Lead sponsor: ViiV Healthcare
Sponsor class: INDUSTRY
First posted: 2022-08-24
Enrollment: 156
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Mean Intervention Appropriateness Measure (IAM) Score in SSPs
timeFrame: Up to Month 13
Secondary outcomes:
measure: Mean IAM Score in SSPs at Month 1, 4, 5, 12 and 13
timeFrame: Month 1, 4, 5, 12 and 13
measure: Change from Baseline in Mean IAM Score in SSPs at Month 4, 5, 12 and 13
timeFrame: Baseline (Month 1) and Month 4, 5, 12 and 13
measure: Appropriateness of APRETUDE Assessed by SSP Questionnaire responses at Month 1, 4, 5, 12 and 13
timeFrame: Month 1, 4, 5, 12 and 13
measure: Appropriateness of APRETUDE Assessed by Semi-structured interview (SSI) at Month 4, 5, 12 and 13
timeFrame: Month 1, 4, 5, 12 and 13
measure: Appropriateness of APRETUDE Assessed by Semi-structured interview (SSI) at Month 4, 5, 12 and 13
timeFrame: Month 4, 5 12 and 13
measure: Mean IAM Score in PSPs at Month 1, 4, 5, 12 and 13
timeFrame: Month 1, 4, 5, 12 and 13
measure: Change from Baseline in Mean IAM Score in PSPs at Month 4, 5, 12 and 13
timeFrame: Baseline (Month 1) and Month 4, 5, 12 and 13
measure: Perception of Appropriateness of APRETUDE Assessed by PSP Questionnaire responses at Month 1, 4, 5, 12 and 13
timeFrame: Month 1, 4, 5, 12 and 13
measure: Perception of Appropriateness of APRETUDE Assessed by SSI in PSPs at Month 4, 5, 12 and 13
timeFrame: Month 4, 5, 12 and 13
measure: 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
timeFrame: Up to Month 13
measure: Number of PSPs who Complete a Sexual Health Assessment through Month 13 in ECI Arm based on Site-level PrEP Information Questionnaire
timeFrame: Up to Month 13
measure: Number of cis-and trans Black Women who Initiate APRETUDE through Month 13 by Study Arm Based on Site level PrEP Information Questionnaire
timeFrame: Up to Month 13
measure: Number of cis-and trans Black Women who Initiate APRETUDE through Month 13 by Clinic Characteristics Based on Site level PrEP Information Questionnaire
timeFrame: Up to Month 13
measure: Proportion of cis-and trans Black Women who Initiate APRETUDE through Month 13 by Study Arm Based on Site level PrEP Information Questionnaire
timeFrame: Up to Month 13
measure: Proportion of cis-and trans Black Women who Initiate APRETUDE through Month 13 by Clinic Characteristics Based on Site level PrEP Information Questionnaire
timeFrame: Up to Month 13
measure: 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
timeFrame: Up to Month 13
measure: 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
timeFrame: Up to Month 13
measure: Mean Feasibility of Intervention Measure (FIM) score in SSPs for Implementation Strategies
timeFrame: Month 1 and 4, 5, 12 and 13
measure: Change from Baseline in FIM Score in SSPs for Implementation Strategies
timeFrame: Baseline (Month 1) and Month 4, 5, 12 and 13
measure: Feasibility of Strategy Assessed by SSPs Questionnaire responses at Month 1, 4, 5, 12 and 13
timeFrame: Month 1, 4, 5, 12 and 13
measure: Feasibility and Utility of Strategy Assessed in SSPs by SSI at Month 4, 5, 12 and 13
timeFrame: Month 4, 5, 12 and 13
measure: 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
timeFrame: Up to Month 13
measure: 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
timeFrame: Up to Month 13
measure: 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
timeFrame: Up to Month 13
measure: 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
timeFrame: Up to Month 13
measure: 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
timeFrame: Up to Month 13
measure: 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
timeFrame: Up to Month 13
measure: Perceptions of Utility of Implementation tools and strategies Assessed by SSIs in PSPs through Month 13 based on Patient Subgroups
timeFrame: Up to Month 13
measure: Proportion of Injections Occurring Within Target Window from Target Date (+-7 days of target date)
timeFrame: Up to Month 13
measure: Perception of Barriers and Facilitators to Fidelity to Injections Window Assessed by SSIs in PSPs
timeFrame: Month 1, 12 and 13
measure: Perception of Barriers and Facilitators to Fidelity to Injections Window Assessed by Surveys in PSPs
timeFrame: Month 1, 4, 5, 12 and 13
measure: Perception of Barriers and Facilitators to Fidelity to Injections Window Assessed by Implementation Monitoring Calls (IMC) in SSPs
timeFrame: Month 4, 5, 12 and 13
measure: Proportion of PSPs completing target number of injections
timeFrame: Up to Month 13
measure: Barriers, Facilitators, Concerns and Perception to Implementation in SSPs and PSPs Assessed by Questionnaire responses
timeFrame: Month 1, 4, 5, 12 and 13
measure: Perception to Facilitators and Barriers to Implementation in SSPs Assessed by SSI
timeFrame: Month 4, 5, 12 and 13
measure: Perception to Facilitators and Barriers to Implementation in SSPs Assessed by IMC
timeFrame: Month 4, 5, 12 and 13
measure: Perception to Facilitators and Barriers to Implementation in PSPs Assessed by SSI
timeFrame: Month 1, 12 and 13
measure: Acceptability of Intervention Measure (AIM) Score for APRETUDE in SSPs and PSPs
timeFrame: Month 1, 4, 5, 12 and 13
measure: FIM Score for APRETUDE in SSPs and PSPs
timeFrame: Month 1, 4, 5, 12 and 13
measure: Feasibility and Acceptability of APRETUDE in SSPs and PSPs Assessed by Questionnaire Responses
timeFrame: Month 1, 4, 5, 12 and 13
measure: Feasibility and Acceptability of APRETUDE in SSPs Assessed by SSIs
timeFrame: Month 4, 12 and 13
measure: Feasibility and Acceptability of APRETUDE in PSPs Assessed by SSIs
timeFrame: Month 1, 12 and 13
measure: Proportion of PSPs that have one Oral lead-in before CAB Injection
timeFrame: Up to Month 13
measure: Perception on Reason for Decision to Use Oral lead-in in SSPs Assessed by SSI
timeFrame: Month 1, 4, 5, 12 and 13
measure: Perception on Reason for Decision to Use Oral lead-in SSPs Assessed by Survey responses
timeFrame: Month 1, 4, 5, 12 and 13
measure: Perception on Reason for Decision to Use Oral lead-in PSPs Assessed by SSIs
timeFrame: Month 1
measure: Perception on Reason for Decision to Use Oral lead-in PSPs Assessed by Survey Responses
timeFrame: Month 1
measure: Proportion of PSPs that Complete a Sexual Health Assessment and Start or Switch from Oral PrEP to APRETUDE
timeFrame: Up to Month 13
measure: Reasons for Choosing or Switching from Oral PrEP to APRETUDE in PSPs Assessed by SSIs
timeFrame: Up to Month 13
Other outcomes:
Locations:
city: Washington
country: United States
facility: GSK Investigational Site
state: District of Columbia
city: Washington
country: United States
facility: GSK Investigational Site
state: District of Columbia
city: Washington
country: United States
facility: GSK Investigational Site
state: District of Columbia
city: Miami
country: United States
facility: GSK Investigational Site
state: Florida
city: Orlando
country: United States
facility: GSK Investigational Site
state: Florida
city: Tampa
country: United States
facility: GSK Investigational Site
state: Florida
city: West Palm Beach
country: United States
facility: GSK Investigational Site
state: Florida
city: Atlanta
country: United States
facility: GSK Investigational Site
state: Georgia
city: Atlanta
country: United States
facility: GSK Investigational Site
state: Georgia
city: Detroit
country: United States
facility: GSK Investigational Site
state: Michigan
city: Las Vegas
country: United States
facility: GSK Investigational Site
state: Nevada
city: Brooklyn
country: United States
facility: GSK Investigational Site
state: New York
city: New York
country: United States
facility: GSK Investigational Site
state: New York
city: Philadelphia
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Memphis
country: United States
facility: GSK Investigational Site
state: Tennessee
city: Dallas
country: United States
facility: GSK Investigational Site
state: Texas
city: Houston
country: United States
facility: GSK Investigational Site
state: Texas
city: Houston
country: United States
facility: GSK Investigational Site
state: Texas
city: Norfolk
country: United States
facility: GSK Investigational Site
state: Virginia
Study officials:
affiliation: ViiV Healthcare
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: