PC4PrEP: Integrating PrEP into Primary Care

Funding Agency:

National Institute of Mental Health (NIMH)

Study Location:

Bronx, NY, USA

Description:

Primary Care for PrEP (PC4PrEP) is a new multilevel structural intervention that will address provider, system, and user barriers to PrEP uptake in adults who reside in underserved communities in the Bronx, NY, a U.S HIV epicenter. 

PC4PrEP has 4 components: (1) designate a “home” for PrEP in primary care clinics; (2) train and support primary care providers (PCPs) to prescribe and manage PrEP, and create provider norms that promote the value of PrEP; (3) identify high-risk individuals in primary care clinics using a new PrEP Eligibility Tool; and (4) identify high risk out-of-care individuals (in collaboration with a community-based organization that serves high risk HIV-groups) and link them to PCPs who can provide PrEP. 

Phase 2 of the study will include a clinic-randomized futility trial of PC4PrEP in six Federally Qualified Health Centers and six nonrandomized community HIV testing sites to determine whether PC4PrEP shows promise for increasing the rate of new PrEP prescriptions, assess its effect on outcomes at each stage of our conceptualization of the “PrEP Cascade,” and assess challenges to PrEP adoption. 

The study aims are to (1) assess whether PC4PrEP shows promise, measured as the rate of new PrEP prescriptions per clinic per year; (2) through a phased implementation of PC4PrEP components, determine the incremental contribution of each component; (3) evaluate the effects of PC4PrEP on measures of the “PrEP Cascade”; and (4) assess challenges to PC4PrEP adoption through (a) in-depth interviews with PCPs and support staff about PC4PrEP; (b) in-depth interviews with selected patient-provider dyads to understand their communication about PrEP; and (c) a nested longitudinal qualitative study of patients who initiate PrEP that will include exploration of risk compensation and self-reported adherence augmented by dried blood spot assays for tenofovir disphosphate.