PC4PrEP: Integrating PrEP Into Primary Care

Study Overview
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Brief Summary
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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
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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: Assess effects of PC4PrEP measured as the rate of new PrEP prescriptions per clinic per year; Through a phased implementation of the four components of PC4PrEP, determine the incremental contribution of each component; Evaluate the effects of PC4PrEP on measures of the PrEP Cascade; 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].

Official Title
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PC4PrEP: Integrating Pre-Exposure Prophylaxis (PrEP) Into Primary Care

Conditions
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Human Immunodeficiency Virus Transmission

Intervention / Treatment
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* Other: PC4PrEP- Intervention Clinics
* Other: Standard of Care Clinics


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient at Montefiore Medical Center or Bronx Community Based Organization (CBO) Assessed to be eligible for PrEP by PCP Willing to provide dried blood spot (DBS) samples for antiretroviral anabolite testing Willing to provide access to medical records Willing to have interview audio-recorded No grossly evident cognitive impairment precluding consent and participation Speaks Spanish or English Exclusion Criteria: Less than 18 years of age Not a patient at Montefiore Medical Center or Bronx Community Based Organization (CBO) Assessed to be ineligible for PrEP by PCP Unwilling to provide dried blood spot samples for ARV anabolite testing Unwilling to provide access to medical records Unwilling to have interview audio-recorded Unable to provide informed consent due to grossly evident cognitive impairment Does not speak Spanish or English

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: PC4PrEP- Intervention Clinics<br>Intervention clinics will receive the PC4PrEP intervention. The intervention includes Montefiore PrEP policy awareness, provider and patient education, pre-screening to identify PrEP eligible patients, and identifying high risk individuals in the community and providing referral and linkage to primary care. | Other: PC4PrEP- Intervention Clinics<br>* PC4PrEP is a comprehensive, multi-level, structural and sustainable intervention designed to address barriers at system, provider, and user levels to increase PrEP uptake.<br>|
| Placebo Comparator: Standard of Care Clinics<br>These clinics will not receive the PC4PrEP intervention but will continue with their standard of care model. | Other: Standard of Care Clinics<br>* The standard of care model is the model approved by the health system for their health care clinics.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of New PrEP Prescriptions | The primary outcome parameter of the trial is rate of new PrEP prescriptions/FQHC/year of observation. The primary quantitative outcome is the number of new PrEP prescriptions written in the past 12 months, determined when all PC4PrEP components have been implemented and in place for 12 months. The analysis will compare the rate of new PrEP prescriptions per clinic per year of observation in intervention and control clinics. We are not recruiting patients for this trial; outcomes are based on de-identified clinic data. | Up to12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Individuals at Risk for HIV Infection | The quantitative outcome is the number of HIV- individuals screened, and identified as potential PrEP candidates as assessed by the PrEP Eligibility Tool administered in the Intervention clinic. Outcomes are based on de-identified PrEP Eligibility Tool data. | Up to12 months | 
| Rate of Individuals Linked to Clinical Prevention | The quantitative outcome is percentage of documented referrals or refusals by individuals being linked for clinical prevention. | Up to 12 months | 
| Rate of Individuals Evaluated for PrEP | PC4PrEP will educate, train, and mentor Primary Care Physicians to evaluate individuals for PrEP. The quantitative outcome is the percentage of individuals evaluated for PrEP, and PrEP eligibility as determined by providers. | Up to 12 months | 
| Rate of PrEP Acceptance | The quantitative outcome is the percentage of individuals who were interested in, accepted, initiated, or refused PrEP. | Up to 12 months | 
| Rate of PrEP Adherence | The quantitative outcome is the percentage of individuals adhering to PrEP and returning for medical follow-up. | Up to 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pre-exposure prophylaxis, Human Immunodeficiency Virus, PrEP, Risk for HIV acquisition, PrEP candidacy