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PC4PrEP: Integrating PrEP Into Primary Care (PC4PrEP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03617874
Recruitment Status : Suspended (Temporarily paused due to COVID-19 and expected to resume. This is not a suspension of IRB approval.)
First Posted : August 7, 2018
Last Update Posted : May 20, 2020
HIV Center for Clinical & Behavioral Studies at Columbia University
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Laurie Bauman, Albert Einstein College of Medicine

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.

Condition or disease Intervention/treatment Phase
Human Immunodeficiency Virus Transmission Other: PC4PrEP- Intervention Clinics Other: Standard of Care Clinics Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 219 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: PC4PrEP: Integrating Pre-Exposure Prophylaxis (PrEP) Into Primary Care
Actual Study Start Date : February 6, 2020
Estimated Primary Completion Date : July 1, 2020
Estimated Study Completion Date : February 28, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

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.

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03617874

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United States, New York
Albert Einstein College of Medicine
Bronx, New York, United States, 10461
Sponsors and Collaborators
Albert Einstein College of Medicine
HIV Center for Clinical & Behavioral Studies at Columbia University
National Institute of Mental Health (NIMH)
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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
Additional Information:

Pequegnat W, Szacpocznik J, Bauman LJ, et al. Measurement relevant to the role of families in prevention and adaptation to HIV/AIDS. AIDS and Behavior. 2001;5(1):1-19.
Ajzen I, The theory of planned behavior. Organizational Behavior and Human Decision Process. 1991;50(2):179-211
Ajzen I, Madden TJ. Prediction of goal-directed behavior: attitudes, intentions, and perceived behavioral control. Journal of Experimental Social Psychology. 1986;22(5):453-474
Nair H, Manchanda P, Bhatia T. Asymmetric social interactions in physician prescription behavior: The role of opinion Leaders. Journal of Marketing Research 47(5): 883-895, 2010.
Hollway W, Jefferson T. Eliciting narrative through the in-depth interview. Qualitative Inquiry. 3(1): 53-70, 1997.

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Responsible Party: Laurie Bauman, Director, Preventive Intervention Research Center, Albert Einstein College of Medicine Identifier: NCT03617874    
Other Study ID Numbers: 2015-5847
R01MH107297 ( U.S. NIH Grant/Contract )
First Posted: August 7, 2018    Key Record Dates
Last Update Posted: May 20, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Laurie Bauman, Albert Einstein College of Medicine:
Pre-exposure prophylaxis
Human Immunodeficiency Virus
Risk for HIV acquisition
PrEP candidacy
Additional relevant MeSH terms:
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Acquired Immunodeficiency Syndrome
HIV Infections
Immunologic Deficiency Syndromes
Immune System Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases