Human Immunodeficiency Virus TransmissionPC4PrEPNCT03617874
PC4PrEP: Integrating PrEP Into Primary Care
A study testing PC4PrEP- Intervention Clinics in people with Human Immunodeficiency Virus Transmission, run by Albert Einstein College of Medicine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Human Immunodeficiency Virus Transmission
- What is being tested?
- PC4PrEP- Intervention Clinics
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Feb 2020to 22 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Albert Einstein College of Medicine
The Bronx, New York, 10461
About this study
Official title: 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.
Read the 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:
- 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].
- Being tested
- PC4PrEP- Intervention Clinics, Standard of Care Clinics
- Keywords
- Pre-exposure prophylaxis, Human Immunodeficiency Virus, PrEP, Risk for HIV acquisition, PrEP candidacy
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PC4PrEP- Intervention ClinicsOther
PC4PrEP is a comprehensive, multi-level, structural and sustainable intervention designed to address barriers at system, provider, and user levels to increase PrEP uptake.
Standard of Care ClinicsOther
The standard of care model is the model approved by the health system for their health care clinics.
| Study group | Role | What they receive |
|---|---|---|
| PC4PrEP- Intervention Clinics | Active comparator | 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. Receives: Other: PC4PrEP- Intervention Clinics |
| Standard of Care Clinics | Placebo comparator | These clinics will not receive the PC4PrEP intervention but will continue with their standard of care model. Receives: Other: Standard of Care Clinics |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to12 months
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2018
- Study start28 Feb 2020
- Primary completion22 Apr 2022
- Study completion22 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (85)Papers the sponsor has linked to this study.
- Other trials for Human Immunodeficiency Virus TransmissionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Albert Einstein College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Columbia University, National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Laurie J. Bauman, PhD, Principal investigator, Albert Einstein College of MedicineJoanne Mantell, PhD, Principal investigator, NYSPI HIV Center for Clinical & Behavioral Studies at Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03617874
- Sponsor's protocol ID
- 2015-5847
- Other IDs
- R01MH107297
- Acronym
- PC4PrEP
- Status last verified
- Sep 2022
- First submitted
- 19 Apr 2018
- Last updated
- 16 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Centers for Disease Control and Prevention (CDC). Interim guidance for clinicians considering the use of preexposure prophylaxis for the prevention of HIV infection in heterosexually active adults. MMWR Morb Mortal Wkly Rep. 2012 Aug 10;61(31):586-9.
PubMed 22874836Centers for Disease Control and Prevention (CDC). Update to Interim Guidance for Preexposure Prophylaxis (PrEP) for the Prevention of HIV Infection: PrEP for injecting drug users. MMWR Morb Mortal Wkly Rep. 2013 Jun 14;62(23):463-5.
PubMed 23760186Caceres CF, O'Reilly KR, Mayer KH, Baggaley R. PrEP implementation: moving from trials to policy and practice. J Int AIDS Soc. 2015 Jul 20;18(4 Suppl 3):20222. doi: 10.7448/IAS.18.4.20222. eCollection 2015.
PubMed 26198349Mantell JE, Sandfort TG, Hoffman S, Guidry JA, Masvawure TB, Cahill S. Knowledge and Attitudes about Pre-Exposure Prophylaxis (PrEP) among Sexually Active Men Who Have Sex with Men (MSM) Participating in New York City Gay Pride Events. LGBT Health. 2014 Mar 13;1(2):93-97. doi: 10.1089/lgbt.2013.0047.
PubMed 25346930Mimiaga MJ, Case P, Johnson CV, Safren SA, Mayer KH. Preexposure antiretroviral prophylaxis attitudes in high-risk Boston area men who report having sex with men: limited knowledge and experience but potential for increased utilization after education. J Acquir Immune Defic Syndr. 2009 Jan 1;50(1):77-83. doi: 10.1097/QAI.0b013e31818d5a27.
PubMed 19295337Arnold EA, Hazelton P, Lane T, Christopoulos KA, Galindo GR, Steward WT, Morin SF. A qualitative study of provider thoughts on implementing pre-exposure prophylaxis (PrEP) in clinical settings to prevent HIV infection. PLoS One. 2012;7(7):e40603. doi: 10.1371/journal.pone.0040603. Epub 2012 Jul 11.
PubMed 22792384Wheelock A, Eisingerich AB, Gomez GB, Gray E, Dybul MR, Piot P. Views of policymakers, healthcare workers and NGOs on HIV pre-exposure prophylaxis (PrEP): a multinational qualitative study. BMJ Open. 2012 Jul 2;2(4):e001234. doi: 10.1136/bmjopen-2012-001234. Print 2012.
PubMed 22761288Puro V, Palummieri A, De Carli G, Piselli P, Ippolito G. Attitude towards antiretroviral Pre-Exposure Prophylaxis (PrEP) prescription among HIV specialists. BMC Infect Dis. 2013 May 14;13:217. doi: 10.1186/1471-2334-13-217.
PubMed 23672424Krakower D, Mayer KH. Engaging healthcare providers to implement HIV pre-exposure prophylaxis. Curr Opin HIV AIDS. 2012 Nov;7(6):593-9. doi: 10.1097/COH.0b013e3283590446.
PubMed 23032736Krakower D, Ware N, Mitty JA, Maloney K, Mayer KH. HIV providers' perceived barriers and facilitators to implementing pre-exposure prophylaxis in care settings: a qualitative study. AIDS Behav. 2014 Sep;18(9):1712-21. doi: 10.1007/s10461-014-0839-3.
PubMed 24965676Hoffman S, Guidry JA, Collier KL, Mantell JE, Boccher-Lattimore D, Kaighobadi F, Sandfort TG. A Clinical Home for Preexposure Prophylaxis: Diverse Health Care Providers' Perspectives on the "Purview Paradox". J Int Assoc Provid AIDS Care. 2016 Jan-Feb;15(1):59-65. doi: 10.1177/2325957415600798. Epub 2015 Aug 20.
PubMed 26293904White JM, Mimiaga MJ, Krakower DS, Mayer KH. Evolution of Massachusetts physician attitudes, knowledge, and experience regarding the use of antiretrovirals for HIV prevention. AIDS Patient Care STDS. 2012 Jul;26(7):395-405. doi: 10.1089/apc.2012.0030. Epub 2012 Jun 13.
PubMed 22694239Tripathi A, Ogbuanu C, Monger M, Gibson JJ, Duffus WA. Preexposure prophylaxis for HIV infection: healthcare providers' knowledge, perception, and willingness to adopt future implementation in the southern US. South Med J. 2012 Apr;105(4):199-206. doi: 10.1097/SMJ.0b013e31824f1a1b.
PubMed 22475669Guidance on Pre-Exposure Oral Prophylaxis (PrEP) for Serodiscordant Couples, Men and Transgender Women Who Have Sex with Men at High Risk of HIV: Recommendations for Use in the Context of Demonstration Projects. Geneva: World Health Organization; 2012 Jul. Available from http://www.ncbi.nlm.nih.gov/books/NBK132003/
PubMed 23586123Beyrer C, Bekker LG, Pozniak A, Barre-Sinoussi F. Pre-exposure prophylaxis works--it's time to deliver. Lancet. 2015 Apr 18;385(9977):1482-4. doi: 10.1016/S0140-6736(15)60724-3. No abstract available.
PubMed 25933264
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PC4PrEP: Integrating Pre-Exposure Prophylaxis (PrEP) Into Primary Care
- ClinicalTrials.gov ID
- NCT03617874
- Acronym / sponsor ID
- PC4PrEP / 2015-5847
- Keywords
- Pre-exposure prophylaxis, Human Immunodeficiency Virus, PrEP, Risk for HIV acquisition, PrEP candidacy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Albert Einstein College of MedicineUniversity, hospital or other
- Collaborators
- Columbia University, National Institute of Mental Health (NIMH)
- Study start
- 28 Feb 2020 (actual)
- Primary completion
- 22 Apr 2022 (actual)
- Study completion
- 22 Apr 2022 (actual)
- First posted
- 7 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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].
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PC4PrEP- Intervention Clinics | Active comparator | Other: PC4PrEP- Intervention ClinicsIntervention 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. |
| Standard of Care Clinics | Placebo comparator | Other: Standard of Care ClinicsThese clinics will not receive the PC4PrEP intervention but will continue with their standard of care model. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PC4PrEP- Intervention ClinicsPC4PrEP is a comprehensive, multi-level, structural and sustainable intervention designed to address barriers at system, provider, and user levels to increase PrEP uptake. | Other | PC4PrEP- Intervention Clinics |
| Standard of Care ClinicsThe standard of care model is the model approved by the health system for their health care clinics. | Other | Standard of Care Clinics |
Primary outcome
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.
5 secondary outcomes
Rate of Individuals at Risk for HIV Infection
Time frame: Up to12 months
Rate of Individuals Linked to Clinical Prevention
Time frame: Up to 12 months
Rate of Individuals Evaluated for PrEP
Time frame: Up to 12 months
Rate of PrEP Acceptance
Time frame: Up to 12 months
Rate of PrEP Adherence
Time frame: Up to 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2022.
- Background: PubMed 22874836Centers for Disease Control and Prevention (CDC). Interim guidance for clinicians considering the use of preexposure prophylaxis for the prevention of HIV infection in heterosexually active adults. MMWR Morb Mortal Wkly Rep. 2012 Aug 10;61(31):586-9.
- Background: PubMed 23760186Centers for Disease Control and Prevention (CDC). Update to Interim Guidance for Preexposure Prophylaxis (PrEP) for the Prevention of HIV Infection: PrEP for injecting drug users. MMWR Morb Mortal Wkly Rep. 2013 Jun 14;62(23):463-5.
- Background: PubMed 26198349Caceres CF, O'Reilly KR, Mayer KH, Baggaley R. PrEP implementation: moving from trials to policy and practice. J Int AIDS Soc. 2015 Jul 20;18(4 Suppl 3):20222. doi: 10.7448/IAS.18.4.20222. eCollection 2015.
- Background: PubMed 25346930Mantell JE, Sandfort TG, Hoffman S, Guidry JA, Masvawure TB, Cahill S. Knowledge and Attitudes about Pre-Exposure Prophylaxis (PrEP) among Sexually Active Men Who Have Sex with Men (MSM) Participating in New York City Gay Pride Events. LGBT Health. 2014 Mar 13;1(2):93-97. doi: 10.1089/lgbt.2013.0047.
- Background: PubMed 19295337Mimiaga MJ, Case P, Johnson CV, Safren SA, Mayer KH. Preexposure antiretroviral prophylaxis attitudes in high-risk Boston area men who report having sex with men: limited knowledge and experience but potential for increased utilization after education. J Acquir Immune Defic Syndr. 2009 Jan 1;50(1):77-83. doi: 10.1097/QAI.0b013e31818d5a27.
- Background: PubMed 22792384Arnold EA, Hazelton P, Lane T, Christopoulos KA, Galindo GR, Steward WT, Morin SF. A qualitative study of provider thoughts on implementing pre-exposure prophylaxis (PrEP) in clinical settings to prevent HIV infection. PLoS One. 2012;7(7):e40603. doi: 10.1371/journal.pone.0040603. Epub 2012 Jul 11.
- Background: PubMed 22761288Wheelock A, Eisingerich AB, Gomez GB, Gray E, Dybul MR, Piot P. Views of policymakers, healthcare workers and NGOs on HIV pre-exposure prophylaxis (PrEP): a multinational qualitative study. BMJ Open. 2012 Jul 2;2(4):e001234. doi: 10.1136/bmjopen-2012-001234. Print 2012.
- Background: PubMed 23672424Puro V, Palummieri A, De Carli G, Piselli P, Ippolito G. Attitude towards antiretroviral Pre-Exposure Prophylaxis (PrEP) prescription among HIV specialists. BMC Infect Dis. 2013 May 14;13:217. doi: 10.1186/1471-2334-13-217.
- Background: PubMed 23032736Krakower D, Mayer KH. Engaging healthcare providers to implement HIV pre-exposure prophylaxis. Curr Opin HIV AIDS. 2012 Nov;7(6):593-9. doi: 10.1097/COH.0b013e3283590446.
- Background: PubMed 24965676Krakower D, Ware N, Mitty JA, Maloney K, Mayer KH. HIV providers' perceived barriers and facilitators to implementing pre-exposure prophylaxis in care settings: a qualitative study. AIDS Behav. 2014 Sep;18(9):1712-21. doi: 10.1007/s10461-014-0839-3.
- Background: PubMed 26293904Hoffman S, Guidry JA, Collier KL, Mantell JE, Boccher-Lattimore D, Kaighobadi F, Sandfort TG. A Clinical Home for Preexposure Prophylaxis: Diverse Health Care Providers' Perspectives on the "Purview Paradox". J Int Assoc Provid AIDS Care. 2016 Jan-Feb;15(1):59-65. doi: 10.1177/2325957415600798. Epub 2015 Aug 20.
- Background: PubMed 22694239White JM, Mimiaga MJ, Krakower DS, Mayer KH. Evolution of Massachusetts physician attitudes, knowledge, and experience regarding the use of antiretrovirals for HIV prevention. AIDS Patient Care STDS. 2012 Jul;26(7):395-405. doi: 10.1089/apc.2012.0030. Epub 2012 Jun 13.
- Office of National AIDS Policy. The White House. National HIV/AIDS Strategy for the United StatesLink provided by the sponsor.
- Office of National AIDS Policy. The White House. National HIV/AIDS Strategy: Implementation UpdateLink provided by the sponsor.
- NIH HIV/AIDS Research Priorities and Guidelines for Determining AIDS FundingLink provided by the sponsor.
- Mera R, Rawlings M, Pechonkina A, et al. Status of Truvada (TVD) for HIV Pre-Exposure Prophylaxis (PrEP) in the United States: An Early Drug Utilization AnalysisLink provided by the sponsor.
- Glidden D, Buchbinder S, Anderson P, et al. PrEP Engagement for HIV Prevention: Results From the iPrEx Open Label Extension (OLE)Link provided by the sponsor.
- McCormack S, Dunn D. Pragmatic Open-Label Randomised Trial of Preexposure Prophylaxis: The PROUD StudyLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laurie J. Bauman, PhD principal investigator
Albert Einstein College of Medicine
Joanne Mantell, PhD principal investigator
NYSPI HIV Center for Clinical & Behavioral Studies at Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PC4PrEP- Intervention Clinics in people with Human Immunodeficiency Virus Transmission, run by Albert Einstein College of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of New PrEP Prescriptions (time frame: Up to12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03617874, which also lists 85 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2022.