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

ViiV Healthcare

Status and phase: Completed; Phase 4

Conditions: HIV Infections

Treatments: Drug: Cabotegravir OLI; Drug: APRETUDE

Study type: Interventional

Funder types: Industry

Identifiers

NCT05374525

217710

Details and patient eligibility

About

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).

Enrollment: 287 patients

Sex: Male

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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287 participants in 2 patient groups

Dynamic Implementation (DI) - PSP

Experimental group

Description:

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.

Treatment:

Drug: APRETUDE

Drug: Cabotegravir OLI

Routine Implementation (RI) - PSP

Experimental group

Description:

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.

Treatment:

Drug: APRETUDE

Drug: Cabotegravir OLI