PC4PrEP: Integrating PrEP Into Primary Care
Condition: Human Immunodeficiency Virus Transmission
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections; Immunologic Deficiency Syndromes
Study type: Interventional

Summary: 
      Oral pre-exposure prophylaxis (PrEP) has been proven effective in reducing HIV infection in
      high-risk men who have sex with men, heterosexually active women and men, and injecting drug
      users. Despite its 2012 approval by the FDA and the development of Centers for Disease
      Control and Prevention (CDC) clinical guidelines, PrEP uptake has been limited. Significant
      impediments to PrEP implementation include: system barriers (lack of a medical "home" and of
      models for implementing PrEP); provider barriers (difficulty identifying those likely to
      benefit from PrEP, inexperience with PrEP, and concerns about adherence and risk
      compensation); and user barriers (lack of awareness of PrEP, inability to access providers
      comfortable with prescribing PrEP, and concerns about stigma and side effects). Cost is not a
      barrier in New York State, where PrEP is covered by many insurance plans, including Medicaid.

      Primary Care for PrEP (PC4PrEP) is a structural, multilevel intervention that will integrate
      PrEP into primary care practices that care for underserved communities in the Bronx, NY, an
      epicenter of continuing HIV infection in the US. PC4PrEP will develop an organizational
      protocol for prescribing PrEP in primary care; identify high-risk individuals in primary care
      clinics and community HIV testing sites using a new PrEP Eligibility Tool; link them to
      primary care providers (PCPs) who can provide PrEP; and counsel potential users about PrEP
      both before they receive a prescription (to enhance receptivity), and after they initiate
      PrEP (to enhance adherence). In the course of this study, investigator(s) will (1) develop
      and pilot PC4PrEP; (2) implement and evaluate it in "real-world" settings (Federally
      Qualified Health Centers; FQHCs) on objective outcomes as well as provider and patient
      reports; and (3) present a new model, the PrEP Cascade that - as with the HIV Care Cascade
      for HIV+ populations - may be used to evaluate the impact of PrEP programs in the US and
      other countries. PC4PrEP is consistent with CDC and New York State Department of Health
      (NYSDOH) Guidelines and the Affordable Care Act in integrating PrEP into primary care
      practices and is responsive to recent 2014 NYSDOH recommendations which now position PrEP as
      a first-line intervention for MSM and transgender women who engage in ongoing anal sex
      without condoms, HIV- partners in sero-discordant relationships, and high-risk heterosexual
      women in high seroprevalence areas.There are two Specific Aims: (1) Finalize the PC4PrEP
      intervention and, in a clinic-randomized Phase 2 futility trial, assess whether it shows
      promise for increasing PrEP prescription rates in the Bronx, NY; and (2) Identify strengths
      and limitations of PC4PrEP in two ways: (a) through a mixed-methods process evaluation
      PrEP-eligible patients and PCPs, counselors and navigators; and (b) by identifying "fall-off"
      at each step of the PrEP Cascade.
    

Detailed description: 
      Primary Care for PrEP (PC4PrEP)

      Although oral pre-exposure prophylaxis (PrEP) was approved by the FDA in 2012, and the CDC
      has developed interim clinical practice guidelines, uptake has been limited. The literature
      has identified system, provider, and user barriers to PrEP implementation. System barriers
      include lack of a medical home ("the purview paradox") and of organizational models for
      implementing PrEP. Provider barriers include difficulty identifying those likely to benefit
      from PrEP, inexperience with PrEP, and concerns about adherence and risk compensation. User
      barriers include lack of awareness of PrEP, inability to access providers who are comfortable
      prescribing it, and concerns about stigma and side effects. Cost is not a barrier in New York
      State (NYS), where PrEP is covered by many insurance plans, including Medicaid, and is
      provided to the uninsured. To date, real-world interventions to promote PrEP uptake for those
      at high risk of HIV acquisition have not been developed and formally evaluated.
      Implementation science research demonstration projects are urgently needed to determine the
      most effective strategies for integrating PrEP into primary care. The long term goal of
      PC4PrEP is to reduce the number of new HIV infections through developing a transferable model
      of PrEP delivery in primary care settings that are situated in high HIV incidence
      communities. The objective of this study is to develop, implement and evaluate Primary Care
      for PrEP (PC4PrEP), a new multilevel structural intervention that will address system,
      provider, and user barriers to PrEP uptake.

      PC4PrEP has four components. It will: (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 developed by our team; and (4)
      identify high-risk out-of-care individuals (in collaboration with a community-based
      organization that conducts outreach and HIV testing in HIV-risk groups) and link them to PCPs
      who can provide PrEP. Investigator(s) will counsel potential users about PrEP both before
      they receive a prescription (to enhance receptivity), and after they initiate PrEP (to
      enhance adherence).

      Investigator(s) will conduct a Phase 2 clinic-randomized futility trial of PC4PrEP in six
      Montefiore Medical Center Federally Qualified Health Centers (FQHCs) and a non-randomized
      Bronx Community Based Organization (CBO) 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 Specific Aims are:

        1. Assess effects of PC4PrEP measured as the rate of new PrEP prescriptions per clinic per
           year;

        2. Through a phased implementation of the four components of PC4PrEP, determine the
           incremental contribution of each component;

        3. Evaluate the effects of PC4PrEP on measures of the "PrEP Cascade";

        4. Assess challenges to PC4PrEP adoption through (1) in-depth interviews with PCPs and
           support staff about PC4PrEP; (2) in-depth interviews with selected patient-provider
           dyads to understand their communication about PrEP; (3) a nested longitudinal
           qualitative study of patients who initiate PrEP that will include exploration of risk
           compensation and self-reported adherence augmented by an objective measure of adherence,
           dried blood spot assays for tenofovir disphosphate.

      Investigator(s) will develop, pilot, implement PC4PrEP; evaluate it in "real-world" settings
      (FQHCs) via objective outcomes as well as provider and patient reports. PC4PrEP will be
      developed by our multidisciplinary academic-community team from the Montefiore Medical
      Center, the Albert Einstein College of Medicine, the HIV Center for Clinical and Behavioral
      Studies at NYS Psychiatric Institute and Columbia University, and Bronx CBO. PC4PrEP is
      driven by Montefiore Medical Center policy (that PCPs promote PrEP); designed by those who
      will actually use it for seamless implementation, efficiency and sustainability; and uses
      existing staff in their current job titles and prevailing health care practices [e.g.,
      electronic medical record (EMR) "best practice" alerts, screening tools, HIV counselors,
      continuing medical education].
    

Intervention name(s): PC4PrEP- Intervention Clinics; Standard of Care Clinics
Intervention type(s): Other; Other
Intervention description(s): PC4PrEP is a comprehensive, multi-level, structural and sustainable intervention designed to address barriers at system, provider, and user levels to increase PrEP uptake.; The standard of care model is the model approved by the health system for their health care clinics.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Pre-exposure prophylaxis; Human Immunodeficiency Virus; PrEP; Risk for HIV acquisition; PrEP candidacy