Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
NA
Total Enrollment
22 participants
Study Classification
INTERVENTIONAL
Study Start Date
2020-02-28
Study Completion Date
2022-04-22
Brief Summary
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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.
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.
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Detailed Description
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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 \[e.g., electronic medical record (EMR) "best practice" alerts, screening tools, HIV counselors, continuing medical education\].
Conditions
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Human Immunodeficiency Virus Transmission
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
OTHER
Blinding Strategy
NONE
Study Groups
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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.
Group Type
ACTIVE_COMPARATOR
PC4PrEP- Intervention Clinics
Intervention Type
OTHER
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 Clinics
These clinics will not receive the PC4PrEP intervention but will continue with their standard of care model.
Group Type
PLACEBO_COMPARATOR
Standard of Care Clinics
Intervention Type
OTHER
The standard of care model is the model approved by the health system for their health care clinics.
Interventions
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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.
Intervention Type
OTHER
Standard of Care Clinics
The standard of care model is the model approved by the health system for their health care clinics.
Intervention Type
OTHER
Eligibility Criteria
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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
* 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
* 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
Minimum Eligible Age
18 Years
Maximum Eligible Age
65 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
Yes
Sponsors
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HIV Center for Clinical & Behavioral Studies at Columbia University
UNKNOWN
Sponsor Role
collaborator
National Institute of Mental Health (NIMH)
NIH
Sponsor Role
collaborator
Albert Einstein College of Medicine
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Laurie J. Bauman, PhD
Role: PRINCIPAL_INVESTIGATOR
Albert Einstein College of Medicine
Joanne Mantell, PhD
Role: PRINCIPAL_INVESTIGATOR
NYSPI HIV Center for Clinical & Behavioral Studies at Columbia University
Locations
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Albert Einstein College of Medicine
The Bronx, New York, United States
Site Status
Countries
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United States
References
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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.
Reference Type
BACKGROUND
Centers 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.
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BACKGROUND
Caceres 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.
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BACKGROUND
Mantell 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.
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BACKGROUND
Mimiaga 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.
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BACKGROUND
Arnold 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.
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BACKGROUND
Wheelock 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.
Reference Type
BACKGROUND
Puro 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.
Reference Type
BACKGROUND
Krakower 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.
Reference Type
BACKGROUND
Krakower 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.
Reference Type
BACKGROUND
Hoffman 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.
Reference Type
BACKGROUND
White 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.
Reference Type
BACKGROUND
Tripathi 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.
Reference Type
BACKGROUND
Guidance 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/
Reference Type
BACKGROUND
Beyrer 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.
Reference Type
BACKGROUND
Kirby T, Thornber-Dunwell M. Uptake of PrEP for HIV slow among MSM. Lancet. 2014 Feb 1;383(9915):399-400. doi: 10.1016/s0140-6736(14)60137-9. No abstract available.
Reference Type
BACKGROUND
Flash C, Landovitz R, Giler RM, Ng L, Magnuson D, Wooley SB, Rawlings K. Two years of Truvada for pre-exposure prophylaxis utilization in the US. J Int AIDS Soc. 2014 Nov 2;17(4 Suppl 3):19730. doi: 10.7448/IAS.17.4.19730. eCollection 2014.
Reference Type
BACKGROUND
Liu A, Cohen S, Follansbee S, Cohan D, Weber S, Sachdev D, Buchbinder S. Early experiences implementing pre-exposure prophylaxis (PrEP) for HIV prevention in San Francisco. PLoS Med. 2014 Mar 4;11(3):e1001613. doi: 10.1371/journal.pmed.1001613. eCollection 2014 Mar.
Reference Type
BACKGROUND
King HL, Keller SB, Giancola MA, Rodriguez DA, Chau JJ, Young JA, Little SJ, Smith DM. Pre-exposure prophylaxis accessibility research and evaluation (PrEPARE Study). AIDS Behav. 2014 Sep;18(9):1722-5. doi: 10.1007/s10461-014-0845-5.
Reference Type
BACKGROUND
Cohen SE, Vittinghoff E, Bacon O, Doblecki-Lewis S, Postle BS, Feaster DJ, Matheson T, Trainor N, Blue RW, Estrada Y, Coleman ME, Elion R, Castro JG, Chege W, Philip SS, Buchbinder S, Kolber MA, Liu AY. High interest in preexposure prophylaxis among men who have sex with men at risk for HIV infection: baseline data from the US PrEP demonstration project. J Acquir Immune Defic Syndr. 2015 Apr 1;68(4):439-48. doi: 10.1097/QAI.0000000000000479.
Reference Type
BACKGROUND
McDougal SJ, Alexander J, Dhanireddy S, Harrington RD, Stekler JD. Non-occupational post-exposure prophylaxis for HIV: 10-year retrospective analysis in Seattle, Washington. PLoS One. 2014 Aug 20;9(8):e105030. doi: 10.1371/journal.pone.0105030. eCollection 2014.
Reference Type
BACKGROUND
Centers for Disease Control and Prevention (CDC). Interim guidance: preexposure prophylaxis for the prevention of HIV infection in men who have sex with men. MMWR Morb Mortal Wkly Rep. 2011 Jan 28;60(3):65-8.
Reference Type
BACKGROUND
Norton WE, Larson RS, Dearing JW. Primary care and public health partnerships for implementing pre-exposure prophylaxis. Am J Prev Med. 2013 Jan;44(1 Suppl 2):S77-9. doi: 10.1016/j.amepre.2012.09.037. No abstract available.
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BACKGROUND
Castel AD, Feaster DJ, Tang W, Willis S, Jordan H, Villamizar K, Kharfen M, Kolber MA, Rodriguez A, Metsch LR. Understanding HIV Care Provider Attitudes Regarding Intentions to Prescribe PrEP. J Acquir Immune Defic Syndr. 2015 Dec 15;70(5):520-8. doi: 10.1097/QAI.0000000000000780.
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BACKGROUND
Morin SF, Yamey G, Rutherford GW. HIV pre-exposure prophylaxis. BMJ. 2012 Aug 13;345:e5412. doi: 10.1136/bmj.e5412. No abstract available.
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Campbell JD, Herbst JH, Koppenhaver RT, Smith DK. Antiretroviral prophylaxis for sexual and injection drug use acquisition of HIV. Am J Prev Med. 2013 Jan;44(1 Suppl 2):S63-9. doi: 10.1016/j.amepre.2012.09.045.
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BACKGROUND
Grant RM, Anderson PL, McMahan V, Liu A, Amico KR, Mehrotra M, Hosek S, Mosquera C, Casapia M, Montoya O, Buchbinder S, Veloso VG, Mayer K, Chariyalertsak S, Bekker LG, Kallas EG, Schechter M, Guanira J, Bushman L, Burns DN, Rooney JF, Glidden DV; iPrEx study team. Uptake of pre-exposure prophylaxis, sexual practices, and HIV incidence in men and transgender women who have sex with men: a cohort study. Lancet Infect Dis. 2014 Sep;14(9):820-9. doi: 10.1016/S1473-3099(14)70847-3. Epub 2014 Jul 22.
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BACKGROUND
Baeten JM, Donnell D, Ndase P, Mugo NR, Campbell JD, Wangisi J, Tappero JW, Bukusi EA, Cohen CR, Katabira E, Ronald A, Tumwesigye E, Were E, Fife KH, Kiarie J, Farquhar C, John-Stewart G, Kakia A, Odoyo J, Mucunguzi A, Nakku-Joloba E, Twesigye R, Ngure K, Apaka C, Tamooh H, Gabona F, Mujugira A, Panteleeff D, Thomas KK, Kidoguchi L, Krows M, Revall J, Morrison S, Haugen H, Emmanuel-Ogier M, Ondrejcek L, Coombs RW, Frenkel L, Hendrix C, Bumpus NN, Bangsberg D, Haberer JE, Stevens WS, Lingappa JR, Celum C; Partners PrEP Study Team. Antiretroviral prophylaxis for HIV prevention in heterosexual men and women. N Engl J Med. 2012 Aug 2;367(5):399-410. doi: 10.1056/NEJMoa1108524. Epub 2012 Jul 11.
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BACKGROUND
Molina JM, Pintado C, Gatey C, Ponscarme D, Charbonneau P, Loze B, Rozenbaum W, Delaugerre C. Challenges and opportunities for oral pre-exposure prophylaxis in the prevention of HIV infection: where are we in Europe? BMC Med. 2013 Aug 23;11:186. doi: 10.1186/1741-7015-11-186.
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BACKGROUND
Hosek SG, Siberry G, Bell M, Lally M, Kapogiannis B, Green K, Fernandez MI, Rutledge B, Martinez J, Garofalo R, Wilson CM; Adolescent Trials Network for HIVAIDS Interventions (ATN). The acceptability and feasibility of an HIV preexposure prophylaxis (PrEP) trial with young men who have sex with men. J Acquir Immune Defic Syndr. 2013 Apr 1;62(4):447-56. doi: 10.1097/QAI.0b013e3182801081.
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BACKGROUND
Mayer KH, Krakower DS. Editorial Commentary: Scaling Up Antiretroviral Preexposure Prophylaxis: Moving From Trials to Implementation. Clin Infect Dis. 2015 Nov 15;61(10):1598-600. doi: 10.1093/cid/civ665. Epub 2015 Aug 13. No abstract available.
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BACKGROUND
Kelley CF, Kahle E, Siegler A, Sanchez T, Del Rio C, Sullivan PS, Rosenberg ES. Applying a PrEP Continuum of Care for Men Who Have Sex With Men in Atlanta, Georgia. Clin Infect Dis. 2015 Nov 15;61(10):1590-7. doi: 10.1093/cid/civ664. Epub 2015 Aug 13.
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Brooks RA, Landovitz RJ, Regan R, Lee SJ, Allen VC Jr. Perceptions of and intentions to adopt HIV pre-exposure prophylaxis among black men who have sex with men in Los Angeles. Int J STD AIDS. 2015 Dec;26(14):1040-8. doi: 10.1177/0956462415570159. Epub 2015 Jan 30.
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BACKGROUND
Eaton LA, Driffin DD, Bauermeister J, Smith H, Conway-Washington C. Minimal Awareness and Stalled Uptake of Pre-Exposure Prophylaxis (PrEP) Among at Risk, HIV-Negative, Black Men Who Have Sex with Men. AIDS Patient Care STDS. 2015 Aug;29(8):423-9. doi: 10.1089/apc.2014.0303. Epub 2015 Jun 17.
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BACKGROUND
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Related Links
Access external resources that provide additional context or updates about the study.
https://obamawhitehouse.archives.gov/sites/default/files/uploads/NHAS.pdf
Office of National AIDS Policy. The White House. National HIV/AIDS Strategy for the United States
https://obamawhitehouse.archives.gov/sites/default/files/uploads/hiv_aids_july_2011.pdf
Office of National AIDS Policy. The White House. National HIV/AIDS Strategy: Implementation Update
https://grants.nih.gov/grants/guide/notice-files/NOT-OD-15-137.html
NIH HIV/AIDS Research Priorities and Guidelines for Determining AIDS Funding
http://www.natap.org/2013/ICAAC/ICAAC_18.htm
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 Analysis
http://www.croiconference.org/sessions/prep-engagement-hiv-prevention-results-iprex-open-label-extension-ole
Glidden D, Buchbinder S, Anderson P, et al. PrEP Engagement for HIV Prevention: Results From the iPrEx Open Label Extension (OLE)
http://www.croiconference.org/sessions/pragmatic-open-label-randomised-trial-preexposure-prophylaxis-proud-study
McCormack S, Dunn D. Pragmatic Open-Label Randomised Trial of Preexposure Prophylaxis: The PROUD Study
http://www.croiconference.org/sessions/demand-prep-oral-tdf-ftc-msm-results-anrs-ipergay-trial
Molina J-M, Capitant C, Spire B, et al. On Demand PrEP With Oral TDF-FTC in MSM: Results of the ANRS Ipergay Trial
https://archive.ahrq.gov/research/findings/factsheets/translating/tripfac/trip2fac.html
Agency for Quality Healthcare Research and Quality. Translating Research Into Practice (TRIP)-II
http://www.theaidsinstitute.org/sites/default/files/attachments/PrEP%20implementation%20strategies%20document.pdf
Strategies for Using Pre-Exposure Prophylaxis (PrEP) to Lower HIV Incidence in Select Populations
https://www.mercurynews.com/2012/06/08/fda-delays-decision-on-gilead-drug-that-could-prevent-hiv/
Murcury News, June 2012. FDA delays decision on Gilead drug that could prevent HIV.
http://www.iapac.org/AdherenceConference/assets/Adherence2014_Program.pdf
Patel V, Smith K, Estabrook S, Golub S. High acceptability but low uptake of oral PrEP among high risk MSM using mobile dating 'apps' in New York City. IAPAC; 2014
http://www.iapac.org/AdherenceConference/presentations/ADH7_80040.pdf
Liu G, Colfax S, Cohen O, et al. The spectrum of engagement in HIV. Prevention: Proposal for a PrEP cascade. IAPAC June 5, 2012
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Solutions PH. HIV prevention programs: RFA issued by Public Health Solutions on behalf lf the New York City Department of Health and Mental Hygiene. Bureau of HIV/AIDS Prevention and Control. March 15, 2015
https://www1.nyc.gov/assets/doh/downloads/pdf/ah/surveillance2011-table-all.pdf
New York City Department of Health and Mental Hygiene. New York City HIV/AIDS Annual Surveillance Statistics 2011
https://a816-healthpsi.nyc.gov/epiquery/CHS/CHSXIndex.html
New York City Department of Health and Mental Hygiene. Epiquery: New York City Interactive Health Data System - New York City Community Health Survey 2011 \[HIV testing, condom use frequency (anal sex)\].
https://www1.nyc.gov/site/doh/data/data-sets/hiv-aids-annual-surveillance-statistics.page
New York City Department of Health and Human Hygiene. NYC HIV/AIDS Surveillance Statistics
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Health Resource and Service Administration. Primary Care: The Health Center Program 2012
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Crunch T. HealthKeep launches an anonymous social network to let you share and track health information. April 16, 2013.
https://sensehealth.com
Sense Health
https://www.prnewswire.com/news-releases/randomized-control-trial-finds-sense-healths-mobile-care-management-platform-can-boost-patient-adherence-266414041.html
Randomized Control Trial Finds Sense Health's Mobile Care Management Platform Can Boost Patient Adherence. July 9, 2014
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Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2015-5847
Identifier Type: -
Identifier Source: org_study_id
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