Clinical trial NCT03617874: PC4PrEP: Integrating PrEP Into Primary Care
Official title: PC4PrEP: Integrating Pre-Exposure Prophylaxis (PrEP) Into Primary Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Human Immunodeficiency Virus Transmission
Keywords: Pre-exposure prophylaxis
Human Immunodeficiency Virus
PrEP
Risk for HIV acquisition
PrEP candidacy
Lead sponsor: Albert Einstein College of Medicine
Sponsor class: OTHER
Collaborators: name: HIV Center for Clinical & Behavioral Studies at Columbia University
name: National Institute of Mental Health (NIMH)
First posted: 2018-08-07
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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 \[e.g., electronic medical record (EMR) "best practice" alerts, screening tools, HIV counselors, continuing medical education\].

Eligibility criteria: 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

Primary outcomes:
measure: Rate of New PrEP Prescriptions
timeFrame: Up to12 months
Secondary outcomes:
measure: Rate of Individuals at Risk for HIV Infection
timeFrame: Up to12 months
measure: Rate of Individuals Linked to Clinical Prevention
timeFrame: Up to 12 months
measure: Rate of Individuals Evaluated for PrEP
timeFrame: Up to 12 months
measure: Rate of PrEP Acceptance
timeFrame: Up to 12 months
measure: Rate of PrEP Adherence
timeFrame: Up to 12 months
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Albert Einstein College of Medicine
state: New York
Study officials:
affiliation: Albert Einstein College of Medicine
name: Laurie J. Bauman, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: NYSPI HIV Center for Clinical & Behavioral Studies at Columbia University
name: Joanne Mantell, PhD
role: PRINCIPAL_INVESTIGATOR
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