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

NCT05374525 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 217710
• Study Type: interventional
• Target: 287
• Locations: 1 country
• Sites: 17

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

Keywords

Cabotegravir; Long-acting injectables; Implementation science; HIV; Pre-exposure prophylaxis

Outcome Measures

Primary Outcomes (1)

• Mean Feasibility of Intervention Measure (FIM) Score Assessed for SSPs

  The FIM-Intervention (INT) was a four-item measure for APRETUDE intervention (1. APRETUDE seems implementable in our clinic/practice 2. APRETUDE seems possible in our clinic/practice 3. APRETUDE seems doable in our clinic/practice 4. APRETUDE seems easy to use in our clinic/practice) and was measured on a five-point rating scale (1 = completely disagree, 2 = disagree, 3 = neither agree nor disagree, 4 = agree, and 5 = completely agree). The mean score ranges from 1 to 5 with 1 indicating the least feasibility and 5 the most feasibility. Timeframe for evaluation of this outcome measure is Month (M)12 (equivalent to M13 for SSPs who assessed PSPs receiving OLI)

  At Month 12

Secondary Outcomes (73)

• Change From Baseline in FIM Score Assessed for SSPs

  At Month 4 and Month 12 compared to baseline (Month 1)

• Number of SSPs Assessed for Perceptions of Facilitators to RI, DI and Overall Implementation of PrEP Into Routine Care Through Month 12

  Up to Month 12

• Number of SSPs Assessed for Perceptions of Barriers to RI, DI and Overall Implementation of PrEP Into Routine Care Through Month 12

  Up to Month 12

• Mean FIM Score Assessed for PSPs

  At Baseline (Month 1), Month 6 and Month 12

• Mean Acceptability of Intervention Measure (AIM) Score Assessed for PSPs

  At Baseline (Month 1), Month 6 and Month 12

Study Arms (2)

Dynamic Implementation (DI) - PSP

EXPERIMENTAL

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.

Drug: APRETUDE; Drug: Cabotegravir OLI

Routine Implementation (RI) - PSP

EXPERIMENTAL

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.

Drug: APRETUDE; Drug: Cabotegravir OLI

Interventions

APRETUDE DRUG

Available as intramuscular injection.

Dynamic Implementation (DI) - PSP; Routine Implementation (RI) - PSP

Cabotegravir OLI DRUG

Available as marketed orally administered tablets.

Dynamic Implementation (DI) - PSP; Routine Implementation (RI) - PSP

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Men who have sex with Men or Transgender Men
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• ViiV Healthcare: lead

Study Sites (17)

GSK Investigational Site

Los Angeles, California, 90036, United States

Location

GSK Investigational Site

San Francisco, California, 94102, United States

Location

GSK Investigational Site

Washington D.C., District of Columbia, 20005, United States

Location

GSK Investigational Site

Miami, Florida, 33140, United States

Location

GSK Investigational Site

Orlando, Florida, 32806, United States

Location

GSK Investigational Site

Pensacola, Florida, 32503, United States

Location

GSK Investigational Site

Sarasota, Florida, 34237, United States

Location

GSK Investigational Site

Bridgeport, Kansas, 06605, United States

Location

GSK Investigational Site

Boston, Massachusetts, 02215, United States

Location

GSK Investigational Site

Columbia, Missouri, 65212, United States

Location

GSK Investigational Site

St Louis, Missouri, 63117, United States

Location

GSK Investigational Site

Rochester, New York, 14607, United States

Location

GSK Investigational Site

The Bronx, New York, 10467, United States

Location

GSK Investigational Site

Philadelphia, Pennsylvania, 19123, United States

Location

GSK Investigational Site

Charleston, South Carolina, 29407, United States

Location

GSK Investigational Site

Harlingen, Texas, 78550, United States

Location

GSK Investigational Site

Seattle, Washington, 98104, United States

Location

MeSH Terms

Conditions

HIV Infections

Interventions

cabotegravir

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

GSKClinicalSupportHD@gsk.com

866-435-7343

Study Officials

• GSK Clinical Trials

  ViiV Healthcare

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR
• Expanded Access: Yes

Study Record Dates

• First Submitted: May 10, 2022
• First Posted: May 16, 2022
• Study Start: May 18, 2022
• Primary Completion: August 8, 2024
• Study Completion: August 8, 2024
• Last Updated: December 15, 2025
• Results First Posted: December 15, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• 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.
• 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.

Locations

US (17)