Clinical trial NCT05374525: A Study Evaluating Implementation Strategies for the Delivery of Cabotegravir in Low and High-Volume PrEP Site in the United States
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: HIV Infections
Keywords: Cabotegravir
Long-acting injectables
Implementation science
HIV
Pre-exposure prophylaxis
Lead sponsor: ViiV Healthcare
Sponsor class: INDUSTRY
First posted: 2022-05-16
Enrollment: 201
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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).


Eligibility criteria: 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

Primary outcomes:
measure: Mean Feasibility of Intervention Measure (FIM) Score Assessed from SSPs
timeFrame: Month 13
Secondary outcomes:
measure: Change from Baseline in FIM Score Assessed from SSPs
timeFrame: Baseline (Month 1), Month 5 and 13
measure: Perceptions of Facilitators and Barriers to RI, DI, and Overall Implementation of PrEP into Routine Care Assessed from SSPs Through Month 13
timeFrame: Up to Month 13
measure: Mean FIM Score Assessed from PSPs
timeFrame: Baseline (Month 1), Month 6 (DTI) / Month 7 (OLI) and Month 12 (DTI) / Month 13 (OLI)
measure: Mean Acceptability of Implementation Measure (AIM) Score Assessed from PSPs
timeFrame: Baseline (Month 1), Month 6 (DTI) / Month 7 (OLI) and Month 12 (DTI) / Month 13 (OLI)
measure: ISQ Responses Assessed from PSPs
timeFrame: Baseline (Month 1), Month 6 (DTI) / Month 7 (OLI) and Month 12 (DTI) / Month 13 (OLI)
measure: Change from Baseline in AIM Score Assessed from PSPs
timeFrame: Baseline (Month 1), Month 6 (DTI) / Month 7 (OLI) and Month 12 (DTI) / Month 13 (OLI)
measure: Change from Baseline in FIM Score Assessed from PSPs
timeFrame: Baseline (Month 1), Month 6 (DTI) / Month 7 (OLI) and Month 12 (DTI) / Month 13 (OLI)
measure: Change from Baseline in ISQ Responses Assessed from PSPs
timeFrame: Baseline (Month 1), Month 6 (DTI) / Month 7 (OLI) and Month 12 (DTI) / Month 13 (OLI)
measure: Perception of Facilitators and Barriers to Feasibility and Acceptability of APRETUDE Assessed from PSPs
timeFrame: Up to Month 13
measure: Mean FIM Score for Telehealth Delivery Assessed from SSPs
timeFrame: Baseline (Month 1), Month 5, and 13
measure: Mean AIM Score for Telehealth Delivery Assessed from SSPs
timeFrame: Baseline (Month 1), Month 5, and 13
measure: ISQ Responses for Telehealth Delivery Assessed from SSPs
timeFrame: Baseline (Month 1), Month 5, and 13
measure: Change from Baseline in FIM Score for Telehealth Delivery Assessed from SSPs
timeFrame: Baseline (Month 1) and Month 5, and 13
measure: Change from Baseline in AIM Score for Telehealth Delivery Assessed from SSPs
timeFrame: Baseline (Month 1) and Month 5, and 13
measure: Change from Baseline in ISQ Responses for Telehealth Delivery Assessed from SSPs
timeFrame: Baseline (Month 1) and Month 5, and 13
measure: Mean FIM Score for Telehealth Delivery Assessed from PSPs
timeFrame: Baseline (Month 1), Month 6 (DTI) / Month 7 (OLI) and Month 12 (DTI) / Month 13 (OLI)
measure: Mean AIM Score for Telehealth Delivery Assessed from PSPs
timeFrame: Baseline (Month 1), Month 6 (DTI) / Month 7 (OLI) and Month 12 (DTI) / Month 13 (OLI)
measure: ISQ Responses for Telehealth Delivery Assessed from PSPs
timeFrame: Baseline (Month 1), Month 6 (DTI) / Month 7 (OLI) and Month 12 (DTI) / Month 13 (OLI)
measure: Change from Baseline in FIM Score for Telehealth Delivery Assessed from PSPs
timeFrame: Baseline (Month 1), Month 6 (DTI) / Month 7 (OLI) and Month 12 (DTI) / Month 13 (OLI)
measure: Change from Baseline in AIM Score for Telehealth Delivery Assessed from PSPs
timeFrame: Baseline (Month 1), Month 6 (DTI) / Month 7 (OLI) and Month 12 (DTI) / Month 13 (OLI)
measure: Change from Baseline in ISQ Responses for Telehealth Delivery Assessed from PSPs
timeFrame: Baseline (Month 1), Month 6 (DTI) / Month 7 (OLI) and Month 12 (DTI) / Month 13 (OLI)
measure: Perception of Facilitators and Barriers to Feasibility and Acceptability for Telehealth Delivery Assessed for SSPs
timeFrame: Up to Month 13
measure: Perception of Facilitators and Barriers to Feasibility and Acceptability for Telehealth Delivery Assessed for PSPs
timeFrame: Up to Month 13
measure: Mean AIM Score Assessed from SSPs
timeFrame: Baseline (Month 1), Month 5 and 13
measure: ISQ Responses Assessed from SSPs
timeFrame: Baseline (Month 1), Month 5 and 13
measure: Change From Baseline in AIM Score Assessed from SSPs
timeFrame: Baseline (Month 1) and Month 5 and 13
measure: Change From Baseline in ISQ Responses Assessed from SSPs
timeFrame: Baseline (Month 1) and Month 5 and 13
measure: Mean AIM Score Based on Implementation Strategy in PSPs
timeFrame: Baseline (Month 1), Month 6 (DTI) / Month 7 (OLI) and Month 12 (DTI) / Month 13 (OLI)
measure: ISQ Responses Based on Implementation Strategy in PSPs
timeFrame: Baseline (Month 1), Month 6 (DTI) / Month 7 (OLI) and Month 12 (DTI) / Month 13 (OLI)
measure: Change from Baseline in Mean AIM Score Under Implementation Strategy in PSPs
timeFrame: Baseline (Month 1), Month 6 (DTI) / Month 7 (OLI) and Month 12 (DTI) / Month 13 (OLI)
measure: Change from Baseline in ISQ Responses Under Implementation Strategy in PSPs
timeFrame: Baseline (Month 1), Month 6 (DTI) / Month 7 (OLI) and Month 12 (DTI) / Month 13 (OLI)
measure: Percentage of SSPs that Respond in Agreement on Relevant Items on the ISQ that each Implementation Strategy is Fit for Use
timeFrame: Up to Month 13
measure: Percentage of PSPs that Respond in Agreement on Relevant Items on the ISQ that each Implementation Strategy is Fit for Use
timeFrame: Up to Month 13
measure: Perceptions of Utility of Implementation Strategies and Facilitators and Barriers to Acceptability of RI and DI Assessed from SSPs
timeFrame: Up to Month 13
measure: Perceptions of Utility of Implementation Strategies Through SSIs Assessed from PSPs
timeFrame: Up to Month 13
measure: Proportion of Injections Occurring within Target Window from Target Date
timeFrame: Up to Month 13
measure: Percentage of PSPs Completing Target Number of Injections
timeFrame: Up to Month 13
measure: Perception of Barriers and Facilitators to Fidelity to Injections Assessed from PSPs
timeFrame: Up to Month 13
measure: Perception of Barriers and Facilitators to Fidelity to Injections Assessed from SSPs
timeFrame: Up to Month 13
measure: Percentage of Site Staff who Administer Sexual Health Assessment
timeFrame: Up to Month 13
measure: Percentage of Eligible PSPs for Which Sexual Health Assessment are Administered
timeFrame: Up to Month 13
measure: Percentage of MSM and TGM who Take the Sexual Health Assessment
timeFrame: Up to Month 13
measure: Percentage of MSM and TGM who Report Having had Sex in the Last 6 Months Through Month 13 on the Sexual Health Assessment
timeFrame: Up to Month 13
measure: 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
timeFrame: Up to Month 13
measure: Percentage of PSPs who Initiate APRETUDE After Taking the Sexual Health Assessment
timeFrame: Up to Month 13
measure: Perceptions of Sexual Health Assessment Assessed from SSPs
timeFrame: Up to Month 13
measure: Perceptions of Sexual Health Assessment Assessed from PSPs
timeFrame: Up to Month 13
measure: Number of Participants who Discussed Components of Adaptations and Changes to Implementation Strategies Using FRAME-IS
timeFrame: Pre-implementation and up to Month 13
measure: Perceptions of Adaptations to Implementation Strategies Assessed from SSPs
timeFrame: Up to Month 13
measure: Perceptions of Adaptations to Implementation Strategies Assessed from PSPs
timeFrame: Up to Month 13
measure: Percentage of PSPs with History of PrEP Use that Complete the Sexual Health Assessment and ISQ and Start APRETUDE
timeFrame: Up to Month 13
measure: Reasons for Choosing and Switching to APRETUDE Assessed by SSI From PSPs
timeFrame: Up to Month 13
measure: Reasons for Choosing and Switching to APRETUDE Assessed by ISQ From PSPs
timeFrame: Up to Month 13
measure: Perception of Barriers and Facilitators Assessed from PSPs
timeFrame: Up to Month 13
measure: Perception of Barriers and Facilitators Assessed from SSPs
timeFrame: Up to Month 13
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: GSK Investigational Site
state: California
city: San Francisco
country: United States
facility: GSK Investigational Site
state: California
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: Pensacola
country: United States
facility: GSK Investigational Site
state: Florida
city: Sarasota
country: United States
facility: GSK Investigational Site
state: Florida
city: Bridgeport
country: United States
facility: GSK Investigational Site
state: Kansas
city: Boston
country: United States
facility: GSK Investigational Site
state: Massachusetts
city: Columbia
country: United States
facility: GSK Investigational Site
state: Missouri
city: Saint Louis
country: United States
facility: GSK Investigational Site
state: Missouri
city: Bronx
country: United States
facility: GSK Investigational Site
state: New York
city: Rochester
country: United States
facility: GSK Investigational Site
state: New York
city: Philadelphia
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Charleston
country: United States
facility: GSK Investigational Site
state: South Carolina
city: Harlingen
country: United States
facility: GSK Investigational Site
state: Texas
city: Seattle
country: United States
facility: GSK Investigational Site
state: Washington
Study officials:
affiliation: ViiV Healthcare
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: