Cabotegravir Delivery Strategies for HIV Prevention

(PILLAR Trial)

Recruiting at16 trial locations

Age: 18+

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: ViiV Healthcare

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

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).

Research Team

GSK Clinical Trials

Principal Investigator

ViiV Healthcare

Eligibility Criteria

This trial is for men who have sex with men and transgender men over 18 in the US, who are HIV negative and haven't used Cabotegravir PrEP before. They must be able to consent to the study. People with an indeterminate or positive HIV test, or those participating in another clinical study during this time cannot join.

Inclusion Criteria

I am able to understand and sign the consent form.

I am 18 years old or older.

Exclusion Criteria

I have tested positive or indeterminate for HIV before starting CAB PrEP.

A participant of concurrent interventional clinical or implementation science study at any time during the study

Treatment Details

Interventions

• APRETUDE (Drug)
• Cabotegravir OLI (Integrase Inhibitor)

Trial Overview The study compares two ways of giving Cabotegravir PrEP: one group starts with pills then moves to injections (OLI), while the other goes straight to injections (DTI). It looks at how well each method works in different clinic settings.

Participant Groups

Group I: Routine Implementation (RI) Experimental Treatment 2 Interventions

PSPs will receive APRETUDE injection and optional Cabotegravir tablets as oral lead in (OLI) . PSPs and SSPs will have access to standard toolkits for APRETUDE to use as needed.

Group II: Dynamic Implementation (DI) Experimental Treatment 2 Interventions

PSPs will receive APRETUDE injection and optional Cabotegravir tablets as oral lead in (OLI). PSPs and SSPs will have access to enhanced toolkits, a digital health implementation strategy and implementation facilitation for APRETUDE to use.

Who Is Running the Clinical Trial?

ViiV Healthcare

Lead Sponsor

Trials

379

Recruited

479,000+

Founded

2009

Headquarters

London, England, UK

Known For

HIV Research

Top Products

- Tivicay (dolutegravir), - Triumeq (abacavir/dolutegravir/lamivudine), - Juluca (dolutegravir/rilpivirine), - Apretude (cabotegravir)

Dr. Harmony Garges

ViiV Healthcare

Chief Medical Officer

MD

Deborah Waterhouse

ViiV Healthcare

Chief Executive Officer since 2017

Bachelor's degree in Business Administration