PC4PrEP: Integrating PrEP Into Primary Care (PC4PrEP)

September 14, 2022 updated by: Albert Einstein College of Medicine

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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].

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Bronx, New York, United States, 10461
        • Albert Einstein College of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: PC4PrEP- Intervention Clinics
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
PC4PrEP is a comprehensive, multi-level, structural and sustainable intervention designed to address barriers at system, provider, and user levels to increase PrEP uptake.
Placebo Comparator: Standard of Care Clinics
These clinics will not receive the PC4PrEP intervention but will continue with their standard of care model.
Other: Standard of Care Clinics
The standard of care model is the model approved by the health system for their health care clinics.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of New PrEP Prescriptions
Time Frame: Up to12 months
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
Time Frame: Up to12 months
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
Time Frame: Up to 12 months
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
Time Frame: Up to 12 months
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
Time Frame: Up to 12 months
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
Time Frame: Up to 12 months
The quantitative outcome is the percentage of individuals adhering to PrEP and returning for medical follow-up.
Up to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Albert Einstein College of Medicine

Collaborators

National Institute of Mental Health (NIMH)
HIV Center for Clinical & Behavioral Studies at Columbia University

Investigators

  • Principal Investigator: Laurie J. Bauman, PhD, Albert Einstein College of Medicine
  • Principal Investigator: Joanne Mantell, PhD, NYSPI HIV Center for Clinical & Behavioral Studies at Columbia University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 28, 2020

Primary Completion (Actual)

April 22, 2022

Study Completion (Actual)

April 22, 2022

Study Registration Dates

First Submitted

April 19, 2018

First Submitted That Met QC Criteria

August 1, 2018

First Posted (Actual)

August 7, 2018

Study Record Updates

Last Update Posted (Actual)

September 16, 2022

Last Update Submitted That Met QC Criteria

September 14, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015-5847
  • R01MH107297 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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