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

NCT ID: NCT05374525

Last Updated: 2025-12-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 287 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-18
• Study Completion Date: 2024-08-08

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).

Conditions

HIV Infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Dynamic Implementation (DI) - PSP

Men who have sex with men (MSM) and transgender men (TGM) who were HIV negative as PSPs received APRETUDE injection (Direct to Injection - DTI) and had the choice to receive an optional cabotegravir tablets as oral lead in (OLI). PSPs had access to enhanced toolkits and digital health implementation supports.

Group Type: EXPERIMENTAL

APRETUDE

Intervention Type: DRUG

Available as intramuscular injection.

Cabotegravir OLI

Intervention Type: DRUG

Available as marketed orally administered tablets.

Routine Implementation (RI) - PSP

MSM and transgender men who were HIV negative as PSPs received APRETUDE injection (DTI) and had the choice to use an optional cabotegravir tablets as OLI. PSPs had access to standard toolkits for APRETUDE to use as needed.

Group Type: EXPERIMENTAL

APRETUDE

Intervention Type: DRUG

Available as intramuscular injection.

Cabotegravir OLI

Intervention Type: DRUG

Available as marketed orally administered tablets.

Interventions

APRETUDE

Available as intramuscular injection.

Intervention Type: DRUG

Cabotegravir OLI

Available as marketed orally administered tablets.

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

ViiV Healthcare

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

ViiV Healthcare

Locations

GSK Investigational Site

Los Angeles, California, United States

GSK Investigational Site

San Francisco, California, 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

Pensacola, Florida, United States

GSK Investigational Site

Sarasota, Florida, United States

GSK Investigational Site

Bridgeport, Kansas, United States

GSK Investigational Site

Boston, Massachusetts, United States

GSK Investigational Site

Columbia, Missouri, United States

GSK Investigational Site

St Louis, Missouri, United States

GSK Investigational Site

Rochester, New York, United States

GSK Investigational Site

The Bronx, New York, United States

GSK Investigational Site

Philadelphia, Pennsylvania, United States

GSK Investigational Site

Charleston, South Carolina, United States

GSK Investigational Site

Harlingen, Texas, United States

GSK Investigational Site

Seattle, Washington, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

217710

Identifier Type: -

Identifier Source: org_study_id