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

HIV Infections Clinical Trial

— PILLAR  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05374525
• Other study ID #: 217710
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: May 18, 2022
• Est. completion date: September 6, 2024

Study information

• Verified date: February 2024
• Source: ViiV Healthcare
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 116
• Est. completion date: September 6, 2024
• Est. primary completion date: September 6, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• HIV Infections

Intervention

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

Locations

Country	Name	City	State
United States	GSK Investigational Site	Boston	Massachusetts
United States	GSK Investigational Site	Bridgeport	Connecticut
United States	GSK Investigational Site	Bronx	New York
United States	GSK Investigational Site	Charleston	South Carolina
United States	GSK Investigational Site	Columbia	Missouri
United States	GSK Investigational Site	Harlingen	Texas
United States	GSK Investigational Site	Los Angeles	California
United States	GSK Investigational Site	Miami	Florida
United States	GSK Investigational Site	Orlando	Florida
United States	GSK Investigational Site	Pensacola	Florida
United States	GSK Investigational Site	Philadelphia	Pennsylvania
United States	GSK Investigational Site	Rochester	New York
United States	GSK Investigational Site	Saint Louis	Missouri
United States	GSK Investigational Site	San Francisco	California
United States	GSK Investigational Site	Sarasota	Florida
United States	GSK Investigational Site	Seattle	Washington
United States	GSK Investigational Site	Washington	District of Columbia

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 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	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
Secondary	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
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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
Secondary	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
Secondary	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
Secondary	ISQ Responses for Telehealth Delivery Assessed from SSPs	ISQ measures a range, including acceptability, feasibility, and utility.	Baseline (Month 1), Month 5, and 13
Secondary	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
Secondary	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
Secondary	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
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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
Secondary	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
Secondary	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
Secondary	ISQ Responses Assessed from SSPs	ISQ measures a range, including acceptability, feasibility, and utility.	Baseline (Month 1), Month 5 and 13
Secondary	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
Secondary	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
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Percentage of Site Staff who Administer Sexual Health Assessment		Up to Month 13
Secondary	Percentage of Eligible PSPs for Which Sexual Health Assessment are Administered		Up to Month 13
Secondary	Percentage of MSM and TGM who Take the Sexual Health Assessment		Up to Month 13
Secondary	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
Secondary	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
Secondary	Percentage of PSPs who Initiate APRETUDE After Taking the Sexual Health Assessment		Up to Month 13
Secondary	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
Secondary	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
Secondary	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
Secondary	Perceptions of Adaptations to Implementation Strategies Assessed from SSPs		Up to Month 13
Secondary	Perceptions of Adaptations to Implementation Strategies Assessed from PSPs		Up to Month 13
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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