PC4PrEP: Integrating PrEP Into Primary Care
| Status: | Not yet recruiting |
|---|---|
| Conditions: | HIV / AIDS, HIV / AIDS, HIV / AIDS |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 8/9/2018 |
| Start Date: | September 1, 2018 |
| End Date: | July 1, 2020 |
| Contact: | Angelic Rivera-Edwards, MPH,MBA |
| Email: | angelic.rivera@einstein.yu.edu |
| Phone: | 718-862-1738 |
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.
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.
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].
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].
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
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