A Study Evaluating Implementation Strategies for the Delivery of Cabotegravir in Low and High-Volume PrEP Site in the United States (PILLAR)

A Phase 4, Randomized, Open-label, Two-arm Study Evaluating Implementation Strategies for the Delivery of Cabotegravir in Low and High-volume Pre-exposure Prophylaxis (PrEP) Sites in the U.S. for HIV Uninfected MSM and Transgender Men ≥ 18

This is a two-arm study evaluating the impact of two implementation strategy conditions, dynamic implementation and routine implementation on the feasibility of delivering of Cabotegravir PrEP in low and high-volume PrEP sites in the United States for men who have sex with men (MSM) and Transgender men ≥ 18 years of age. There are two types of participants in the study. Patient Study Participants (PSPs) will refer to individuals who are enrolled in the study and who will receive commercially available Cabotegravir PrEP via prescription from the PrEP provider at the corresponding site. Staff Study Participants (SSPs) will refer to site staff who are involved in administrative and clinical aspects of offering and administering PrEP to PSPs and will participate in the staff study assessments. PSPs who choose to opt for 1-month oral lead-in (OLI) will receive cabotegravir tablets for PrEP at Month 1 followed by APPRETUDE intramuscular (IM) injections on Month 2, 3 and every two months thereafter up to Month 13. PSPs who opt for Direct to injections (DTI) will receive APPRETUDE IM injections on Month 1, 2 and every two months thereafter up to Month 12. Month 6/7 refers to Month 6 (DTI)/ Month 7 (OLI). Month 12/13 refers to Month 12 (DTI)/ Month 13 (OLI).

Study Overview

• Status: Active, not recruiting
• Conditions: HIV Infections
• Intervention / Treatment: Drug: APRETUDE; Drug: Cabotegravir OLI

• Study Type: Interventional
• Enrollment (Actual): 116
• Phase: Phase 4

Expanded Access

Available outside the clinical trial. See expanded access record.

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90036
      • GSK Investigational Site
    • San Francisco, California, United States, 94102
      • GSK Investigational Site
  • Connecticut
    • Bridgeport, Connecticut, United States, 06605
      • GSK Investigational Site
  • District of Columbia
    • Washington, District of Columbia, United States, 20005
      • GSK Investigational Site
  • Florida
    • Miami, Florida, United States, 33140
      • GSK Investigational Site
    • Orlando, Florida, United States, 32806
      • GSK Investigational Site
    • Pensacola, Florida, United States, 32503
      • GSK Investigational Site
    • Sarasota, Florida, United States, 34237
      • GSK Investigational Site
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • GSK Investigational Site
  • Missouri
    • Columbia, Missouri, United States, 65212
      • GSK Investigational Site
    • Saint Louis, Missouri, United States, 63117
      • GSK Investigational Site
  • New York
    • Bronx, New York, United States, 10467
      • GSK Investigational Site
    • Rochester, New York, United States, 14607
      • GSK Investigational Site
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19123
      • GSK Investigational Site
  • South Carolina
    • Charleston, South Carolina, United States, 29407
      • GSK Investigational Site
  • Texas
    • Harlingen, Texas, United States, 78550
      • GSK Investigational Site
  • Washington
    • Seattle, Washington, United States, 98104
      • 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 inclusive, at the time of signing the informed consent.
• No prior history of receiving CAB PrEP
• HIV negative test result at screening
• Capable of giving signed informed consent form

Exclusion Criteria:

• HIV indeterminate or positive test result during screening and prior to initiation of CAB PrEP
• A participant of concurrent interventional clinical or implementation science study at any time during the study

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Routine Implementation (RI); PSPs will receive APRETUDE injection and optional Cabotegravir tablets as oral lead in (OLI) . PSPs and SSPs will have access to standard toolkits for APRETUDE to use as needed.	Drug: APRETUDE; Available as intramuscular injection.; Drug: Cabotegravir OLI; Available as marketed orally administered tablets.
Experimental: Dynamic Implementation (DI); PSPs will receive APRETUDE injection and optional Cabotegravir tablets as oral lead in (OLI). PSPs and SSPs will have access to enhanced toolkits, a digital health implementation strategy and implementation facilitation for APRETUDE to use.	Drug: APRETUDE; Available as intramuscular injection.; Drug: Cabotegravir OLI; Available as marketed orally administered tablets.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Feasibility of Intervention Measure (FIM) Score Assessed from SSPs	The responses for feasibility will be measured on a 5-point Likert scale ranging from 1 to 5 with higher values representing better outcomes.	Month 13

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline in FIM Score Assessed from SSPs	The responses for feasibility will be measured on a 5-point Likert scale ranging from 1 to 5 with higher values representing better outcomes.	Baseline (Month 1), Month 5 and 13
Perceptions of Facilitators and Barriers to RI, DI, and Overall Implementation of PrEP into Routine Care Assessed from SSPs Through Month 13	Perception of facilitators and barriers to RI, DI and overall implementation of PrEP measured from themes emerging from Proctor and Consolidated Framework for Implementation Research (CFIR) framework guided semi-structured qualitative interview.	Up to Month 13
Mean FIM Score Assessed from PSPs	The responses for feasibility will be measured on a 5-point Likert scale ranging from 1 to 5 with higher values representing better outcomes.	Baseline (Month 1), Month 6 (DTI) / Month 7 (OLI) and Month 12 (DTI) / Month 13 (OLI)
Mean Acceptability of Implementation Measure (AIM) Score Assessed from PSPs	The responses for acceptability will be measured on a Likert scale ranging from 1 to 5 with higher values representing better outcomes.	Baseline (Month 1), Month 6 (DTI) / Month 7 (OLI) and Month 12 (DTI) / Month 13 (OLI)
ISQ Responses Assessed from PSPs	Implementation Science Questionnaire (ISQ) measures a range, including acceptability, feasibility, and utility.	Baseline (Month 1), Month 6 (DTI) / Month 7 (OLI) and Month 12 (DTI) / Month 13 (OLI)
Change from Baseline in AIM Score Assessed from PSPs	The responses for acceptability will be measured on a Likert scale ranging from 1 to 5 with higher values representing better outcomes.	Baseline (Month 1), Month 6 (DTI) / Month 7 (OLI) and Month 12 (DTI) / Month 13 (OLI)
Change from Baseline in FIM Score Assessed from PSPs	The responses for feasibility will be measured on a 5-point Likert scale ranging from 1 to 5 with higher values representing better outcomes.	Baseline (Month 1), Month 6 (DTI) / Month 7 (OLI) and Month 12 (DTI) / Month 13 (OLI)
Change from Baseline in ISQ Responses Assessed from PSPs	ISQ measures a range, including acceptability, feasibility, and utility.	Baseline (Month 1), Month 6 (DTI) / Month 7 (OLI) and Month 12 (DTI) / Month 13 (OLI)
Perception of Facilitators and Barriers to Feasibility and Acceptability of APRETUDE Assessed from PSPs	Facilitators and barriers to feasibility and acceptability of APRETUDE measured from themes emerging from Proctor and Consolidated Framework for Implementation Research (CFIR) framework guided semi-structured qualitative interviews.	Up to Month 13
Mean FIM Score for Telehealth Delivery Assessed from SSPs	The responses for feasibility will be measured on a 5-point Likert scale ranging from 1 to 5 with higher values representing better outcomes.	Baseline (Month 1), Month 5, and 13
Mean AIM Score for Telehealth Delivery Assessed from SSPs	The responses for acceptability will be measured on a Likert scale ranging from 1 to 5 with higher values representing better outcomes.	Baseline (Month 1), Month 5, and 13
ISQ Responses for Telehealth Delivery Assessed from SSPs	ISQ measures a range, including acceptability, feasibility, and utility.	Baseline (Month 1), Month 5, and 13
Change from Baseline in FIM Score for Telehealth Delivery Assessed from SSPs	The responses for feasibility will be measured on a 5-point Likert scale ranging from 1 to 5 with higher values representing better outcomes.	Baseline (Month 1) and Month 5, and 13
Change from Baseline in AIM Score for Telehealth Delivery Assessed from SSPs	The responses for acceptability will be measured on a Likert scale ranging from 1 to 5 with higher values representing better outcomes.	Baseline (Month 1) and Month 5, and 13
Change from Baseline in ISQ Responses for Telehealth Delivery Assessed from SSPs	ISQ measures a range, including acceptability, feasibility, and utility.	Baseline (Month 1) and Month 5, and 13
Mean FIM Score for Telehealth Delivery Assessed from PSPs	The responses for feasibility will be measured on a 5-point Likert scale ranging from 1 to 5 with higher values representing better outcomes.	Baseline (Month 1), Month 6 (DTI) / Month 7 (OLI) and Month 12 (DTI) / Month 13 (OLI)
Mean AIM Score for Telehealth Delivery Assessed from PSPs	The responses for acceptability will be measured on a Likert scale ranging from 1 to 5 with higher values representing better outcomes.	Baseline (Month 1), Month 6 (DTI) / Month 7 (OLI) and Month 12 (DTI) / Month 13 (OLI)
ISQ Responses for Telehealth Delivery Assessed from PSPs	ISQ measures a range, including acceptability, feasibility, and utility.	Baseline (Month 1), Month 6 (DTI) / Month 7 (OLI) and Month 12 (DTI) / Month 13 (OLI)
Change from Baseline in FIM Score for Telehealth Delivery Assessed from PSPs	The responses for feasibility will be measured on a 5-point Likert scale ranging from 1 to 5 with higher values representing better outcomes.	Baseline (Month 1), Month 6 (DTI) / Month 7 (OLI) and Month 12 (DTI) / Month 13 (OLI)
Change from Baseline in AIM Score for Telehealth Delivery Assessed from PSPs	The responses for acceptability will be measured on a Likert scale ranging from 1 to 5 with higher values representing better outcomes.	Baseline (Month 1), Month 6 (DTI) / Month 7 (OLI) and Month 12 (DTI) / Month 13 (OLI)
Change from Baseline in ISQ Responses for Telehealth Delivery Assessed from PSPs	ISQ measures a range, including acceptability, feasibility, and utility.	Baseline (Month 1), Month 6 (DTI) / Month 7 (OLI) and Month 12 (DTI) / Month 13 (OLI)
Perception of Facilitators and Barriers to Feasibility and Acceptability for Telehealth Delivery Assessed for SSPs	Perception of Facilitators and Barriers to Feasibility and Acceptability for Telehealth Delivery will be measured from themes emerging from Proctor and CFIR framework guided semi-structured qualitative interview.	Up to Month 13
Perception of Facilitators and Barriers to Feasibility and Acceptability for Telehealth Delivery Assessed for PSPs	Perception of Facilitators and Barriers to Feasibility and Acceptability for Telehealth Delivery will be measured from themes emerging from Proctor and CFIR framework guided semi-structured qualitative interview.	Up to Month 13
Mean AIM Score Assessed from SSPs	The responses for acceptability of the implementation interventions will be measured on a Likert scale ranging from 1 to 5 with higher values representing better outcomes.	Baseline (Month 1), Month 5 and 13
ISQ Responses Assessed from SSPs	ISQ measures a range, including acceptability, feasibility, and utility.	Baseline (Month 1), Month 5 and 13
Change From Baseline in AIM Score Assessed from SSPs	The responses for acceptability of the implementation interventions will be measured on a Likert scale ranging from 1 to 5 with higher values representing better outcomes	Baseline (Month 1) and Month 5 and 13
Change From Baseline in ISQ Responses Assessed from SSPs	ISQ measures a range, including acceptability, feasibility, and utility.	Baseline (Month 1) and Month 5 and 13
Mean AIM Score Based on Implementation Strategy in PSPs	The responses for acceptability will be measured on a Likert scale ranging from 1 to 5 with higher values representing better outcomes.	Baseline (Month 1), Month 6 (DTI) / Month 7 (OLI) and Month 12 (DTI) / Month 13 (OLI)
ISQ Responses Based on Implementation Strategy in PSPs	ISQ measures a range, including acceptability, feasibility, and utility.	Baseline (Month 1), Month 6 (DTI) / Month 7 (OLI) and Month 12 (DTI) / Month 13 (OLI)
Change from Baseline in Mean AIM Score Under Implementation Strategy in PSPs	The responses for acceptability will be measured on a Likert scale ranging from 1 to 5 with higher values representing better outcomes.	Baseline (Month 1), Month 6 (DTI) / Month 7 (OLI) and Month 12 (DTI) / Month 13 (OLI)
Change from Baseline in ISQ Responses Under Implementation Strategy in PSPs	ISQ measures a range, including acceptability, feasibility, and utility.	Baseline (Month 1), Month 6 (DTI) / Month 7 (OLI) and Month 12 (DTI) / Month 13 (OLI)
Percentage of SSPs that Respond in Agreement on Relevant Items on the ISQ that each Implementation Strategy is Fit for Use	ISQ measures a range, including acceptability, feasibility, and utility.	Up to Month 13
Percentage of PSPs that Respond in Agreement on Relevant Items on the ISQ that each Implementation Strategy is Fit for Use	ISQ measures a range, including acceptability, feasibility, and utility.	Up to Month 13
Perceptions of Utility of Implementation Strategies and Facilitators and Barriers to Acceptability of RI and DI Assessed from SSPs	Perceptions of Utility of Implementation Strategies and Facilitators and Barriers to Acceptability of RI and DI measured from themes emerging from Proctor and CFIR framework guided semi-structured qualitative interview.	Up to Month 13
Perceptions of Utility of Implementation Strategies Through SSIs Assessed from PSPs	Perceptions of Utility of Implementation Strategies and Facilitators and Barriers to Acceptability of RI and DI 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	The target window is ± 7 days for injection dose 2 and subsequent injections.	Up to Month 13
Percentage of PSPs Completing Target Number of Injections	The target window is ± 7 days for injection dose 2 and subsequent injections.	Up to Month 13
Perception of Barriers and Facilitators to Fidelity to Injections Assessed from PSPs	Perceptions of fidelity to injections measured from themes emerging from Proctor and CFIR framework guided semi-structured qualitative interview.	Up to Month 13
Perception of Barriers and Facilitators to Fidelity to Injections Assessed from SSPs	Perception to fidelity of injections measured from themes emerged from IMC with sites using an interview guide.	Up to Month 13
Percentage of Site Staff who Administer Sexual Health Assessment		Up to Month 13
Percentage of Eligible PSPs for Which Sexual Health Assessment are Administered		Up to Month 13
Percentage of MSM and TGM who Take the Sexual Health Assessment		Up to Month 13
Percentage of MSM and TGM who Report Having had Sex in the Last 6 Months Through Month 13 on the Sexual Health Assessment		Up to Month 13
Percentage of MSM and TGM who Expressed Interest in PrEP or Never Heard of PrEP out of Those who Report Having had Sex in the last 6 Months Through Month 13		Up to Month 13
Percentage of PSPs who Initiate APRETUDE After Taking the Sexual Health Assessment		Up to Month 13
Perceptions of Sexual Health Assessment Assessed from SSPs	Perceptions of sexual health assessment measured from themes emerging from Proctor and CFIR framework guided semi-structured qualitative interview	Up to Month 13
Perceptions of Sexual Health Assessment Assessed from PSPs	Perceptions of sexual health assessment measured from themes emerging from Proctor and CFIR framework guided semi-structured qualitative interview.	Up to Month 13
Number of Participants who Discussed Components of Adaptations and Changes to Implementation Strategies Using FRAME-IS	The Framework for Reporting Adaptations and Modifications to Evidence-based Implementation Strategies (FRAME-IS) is a measure that will provide a precise understanding of modifications, the process of modifying or adapting, and the relationship between different forms of modification and subsequent health and implementation outcomes.	Pre-implementation and up to Month 13
Perceptions of Adaptations to Implementation Strategies Assessed from SSPs		Up to Month 13
Perceptions of Adaptations to Implementation Strategies Assessed from PSPs		Up to Month 13
Percentage of PSPs with History of PrEP Use that Complete the Sexual Health Assessment and ISQ and Start APRETUDE	ISQ measures a range, including acceptability, feasibility, and utility.	Up to Month 13
Reasons for Choosing and Switching to APRETUDE Assessed by SSI From PSPs	Reasons for choosing and switching to APRETUDE assessed from themes emerging from Proctor and CFIR framework guided semi-structured qualitative interview.	Up to Month 13
Reasons for Choosing and Switching to APRETUDE Assessed by ISQ From PSPs	ISQ measures a range, including acceptability, feasibility, and utility.	Up to Month 13
Perception of Barriers and Facilitators Assessed from PSPs	Perception of facilitators and barriers to RI, DI and overall implementation of PrEP measured from themes emerging from Proctor and Consolidated Framework for Implementation Research (CFIR) framework guided semi-structured qualitative interview.	Up to Month 13
Perception of Barriers and Facilitators Assessed from SSPs	Perception of facilitators and barriers to RI, DI and overall implementation of PrEP measured from themes emerging from Proctor and Consolidated Framework for Implementation Research (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

Study record dates

Study Major Dates

• Study Start (Actual): May 18, 2022
• Primary Completion (Estimated): September 6, 2024
• Study Completion (Estimated): September 6, 2024

Study Registration Dates

• First Submitted: May 10, 2022
• First Submitted That Met QC Criteria: May 10, 2022
• First Posted (Actual): May 16, 2022

Study Record Updates

• Last Update Posted (Actual): February 14, 2024
• Last Update Submitted That Met QC Criteria: February 13, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: HIV; Pre-exposure prophylaxis; Implementation science; Cabotegravir; Long-acting injectables
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; Urogenital Diseases; Genital Diseases; HIV Infections; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Enzyme Inhibitors; Anti-HIV Agents; Anti-Retroviral Agents; HIV Integrase Inhibitors; Integrase Inhibitors; Cabotegravir
• Other Study ID Numbers: 217710

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
• product manufactured in and exported from the U.S.: Yes