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

ViiV Healthcare370 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

370

Conditions

HIV Infections

Interventions

Eligibility

Sex: FEMALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (22)

GSK Investigational Site

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

GSK Investigational Site

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

GSK Investigational Site

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

GSK Investigational Site

Miami, Florida, United States

GSK Investigational Site

Orlando, Florida, United States

GSK Investigational Site

Tampa, Florida, United States

GSK Investigational Site

West Palm Beach, Florida, United States

GSK Investigational Site

Atlanta, Georgia, United States

GSK Investigational Site

Atlanta, Georgia, United States

GSK Investigational Site

Atlanta, Georgia, United States

...and 12 more locations

Outcomes

Primary Outcomes

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.

Time frame: Up to Month 13

Secondary Outcomes

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.

Time frame: Month 1, 4, 5, 12 and 13

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

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: Month 4, 5 12 and 13

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

Time frame: Month 1, 4, 5, 12 and 13

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

Time frame: 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.

Time frame: 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.

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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.

Time frame: Month 1 and 4, 5, 12 and 13

Change from Baseline in FIM Score in SSPs for Implementation Strategies

Time frame: 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.

Time frame: Month 1, 4, 5, 12 and 13

Feasibility and Utility of Strategy Assessed in SSPs by SSI at Month 4, 5, 12 and 13

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: Up to Month 13

Proportion of Injections Occurring Within Target Window from Target Date (+-7 days of target date)

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: Month 4, 5, 12 and 13

Proportion of PSPs completing target number of injections

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: Month 1, 12 and 13

Proportion of PSPs that have one Oral lead-in before CAB Injection

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: Month 1

Perception on Reason for Decision to Use Oral lead-in PSPs Assessed by Survey Responses

Time frame: Month 1

Proportion of PSPs that Complete a Sexual Health Assessment and Start or Switch from Oral PrEP to APRETUDE

Time frame: 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.

Time frame: Up to Month 13