PREP IMPLEMENTATION STUDY FOR CABOTEGRAVIR LONG ACTING FOR MEN IN THE REAL WORLD (PILLAR) STUDY
Background
Men who have sex with men (MSM) accounted for a majority of new HIV diagnoses in the United States —79% in 2019. Unfortunately, the lifetime risk for HIV infection among Black and Latino MSM and transgender men is even higher than that of the general male population. PrEP, an effective medication that prevents the acquisition of HIV, is available in the U.S. However, access to and use of PrEP remains very low, especially among Black and Latino MSM and transgender men. Barriers to use include but is not limited to, confidentiality concerns, stigma, or lack of geographic access to clinics providing PrEP. Cabotegravir long acting injectable for pre-exposure prophylaxis (CAB LA for PrEP), the first injectable HIV prevention option, may alleviate these barriers but implementation challenges of this new option must be rapidly addressed. CAB LA for PrEP has been developed to reduce the risk of sexually acquired HIV-1 infection in at-risk individuals. PILLAR is structured on assessing innovative strategies that address challenges associated with feasibility of CAB LA for PrEP delivery.
Goals
PILLAR will evaluate the process of integrating CAB LA for PrEP into standard of care at existing low and high PrEP sites from the perspective of staff and patients. The study will assess the feasibility of a set of enhanced toolkits and implementation strategies (dynamic implementation) relative to standard toolkits (routine implementation). The acceptability for CAB LA for PrEP by MSM and transgender men will also be assessed.
Design
PILLAR is designed to evaluate the impact of two implementation strategy conditions – dynamic and routine implementation- in high and low volume PrEP sites over 12 months. Clinical sites will be randomized 2:1 in the dynamic or routine implementation arms. Site will be randomized 2:1 in the Dynamic (DI) or Routine (RI) implementation arms. Approximately 220 HIV negative individuals will be enrolled once CAB LA for PrEP is prescribed to them; 50% will be Black or Latino. Participants will start CAB LA for PrEP as prescribed by their provider. Approximately 90 clinical staff will enroll as participants and complete questionnaires and interviews.
ViiV Study Lead and Contact
Nanlesta Pilgrim, Director Global Implementation Science
Collaborators
Participating Clinical Sites
Evidera
Syneos
Setting
Clinical sites offering PrEP
Location
United States
Duration
Aug 2022 – Aug 2024
Study ID
Collaboration Study – IMP 217710
Category
Health Related Quality of Life/Adherence and Retention in Care
Study focus areas
Our implementation research projects have a global reach and focus on improving the HIV prevention and care continuum.
NP-GBL-HVX-WCNT-220049 October 2023
Adverse events should be reported. Reporting forms and information can be found at yellowcard.mhra.gov.uk or search for MHRA Yellowcard in the Google Play or Apple App store. Adverse events should also be reported to GlaxoSmithKline on 0800 221441.
If you are from outside the UK, you can report adverse events to GSK/ViiV by selecting your region and market, here.
