Publications by authors named "Viraj V Patel"

36 Publications

Breaking Inertia: Movement Along the PrEP Cascade in a Longitudinal US National Cohort of Sexual Minority Individuals at Risk for HIV.

J Acquir Immune Defic Syndr 2021 Apr;86(5):e118-e125

CUNY Institute for Implementation Science in Population Health, New York, NY; and.

Background: The pre-exposure prophylaxis (PrEP) cascade outlines sequential steps to maximize PrEP's impact and highlights potential intervention targets to improve PrEP implementation. We evaluate the PrEP cascade in the Together 5000 study (T5K).

Methods: T5K is an internet-based, US national cohort study of PrEP-eligible men and trans persons who have sex with men who were not taking PrEP at enrollment. Using longitudinal data from baseline (2017-2018) and year 1 follow-up (2018-2019, n = 4229), we evaluated 5 steps of the PrEP cascade-PrEP contemplation: believes they are a good candidate for PrEP; PrEParation: plans to initiate PrEP; PrEP action: speaks to a provider about PrEP; PrEP initiation: receives a prescription for PrEP; and PrEP maintenance: continues to take PrEP. We compared the cascade across geographic region and identified factors associated with gaps in the cascade.

Results: After 1 year, 1092 (26%) participants had initiated PrEP, 709 (17%) were still using PrEP, and 177 (4%) were no longer clinically indicated for PrEP. Participants in the South and Midwest were less likely to speak to a provider about PrEP or initiate PrEP. Baseline characteristics associated with lower odds of PrEP initiation at year 1 include: not having a college degree; earning <$20,000/year; not having health insurance; having very low food security; and not having a primary care doctor.

Conclusions: Lack of health care access is a major barrier to PrEP implementation and may exacerbate disparities in PrEP uptake across geographic regions.
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http://dx.doi.org/10.1097/QAI.0000000000002611DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7942983PMC
April 2021

Awareness and Willingness to Use HIV Pre-exposure Prophylaxis Among Men Who Have Sex With Men in Rwanda: A Cross-Sectional Descriptive Survey.

J Assoc Nurses AIDS Care 2021 Jan 13. Epub 2021 Jan 13.

Athanase Munyaneza, RN, MPH, is a Research Operations and Nurse Coordinator, Division of Clinical Education and Research, Rwanda Military Hospital (RMH), Kigali, Rwanda. Adebola Adedimeji, PhD, MPH, is an Associate Professor, Department of Epidemiology and Population Health, Albert Einstein College of Medicine, Bronx, New York, USA. Hae-Young Kim, DrPH, is an Associate Professor and Director of Biostatistics Division, Department of Public Health, New York Medical College, Valhalla, New York, USA. Qiuhu Shi, PhD, is a Biostatistician, Department of Public Health, New York Medical College, Valhalla, New York, USA. Donald R. Hoover, PhD, is a Biostatistician, Department of Statistics and Institute for Health, Health-Care Policy and Aging Research, Rutgers University, New Brunswick, New Jersey, USA. Jonathan Ross, MD, MSc, is an Assistant Professor, Division of General Internal Medicine, Albert Einstein College of Medicine/Montefiore Medical Center, Bronx, New York, USA. Lynn Murchison, MPH, is a Grant Manager, Division of General Internal Medicine, Albert Einstein College of Medicine/Montefiore Medical Center, Bronx, New York, USA. Gad Murenzi, MD, MPH, is a Program Director, Division of Clinical Education and Research, Rwanda Military Hospital (RMH), Kigali, Rwanda. Jules Kabahizi, MD, is a Chief Consultant Physician, Division of General Internal Medicine, Rwanda Military Hospital (RMH), Kigali, Rwanda. Josephine Gasana, BSc, is a Social Worker, Rwanda Military Hospital (RMH), Kigali, Rwanda. Boniface Nsengiyumva, MSc, is a Biostatistician, Division of Clinical Education and Research, Rwanda Military Hospital (RMH), Kigali, Rwanda. Gallican Kubwimana, MBA, is a Grant Manager, Division of Clinical Education and Research, Rwanda Military Hospital (RMH), Kigali, Rwanda. Faustin Kanyabwisha, MPH, is a Senior Laboratory Technician, Division of Clinical Education and Research, Rwanda Military Hospital (RMH), Kigali, Rwanda. Benjamin Muhoza, MSc, is a Database Manager, Division of Clinical Education and Research, Rwanda Military Hospital (RMH), Kigali, Rwanda. Charles Ingabire, MPH, is a Qualitative Research Coordinator, Division of Clinical Education and Research, Rwanda Military Hospital (RMH), Kigali, Rwanda. Leon Mutesa, MD, PhD, is a Professor, College of Medicine and Health Sciences, University of Rwanda, Kigali, Rwanda. Philip E. Castle, PhD, MPH, is a Professor, Department of Epidemiology and Population Health, Albert Einstein College of Medicine, Bronx, New York, USA. Joel M. Palefsky, MD, is a Professor of Medicine, Department of Infectious Diseases, University of California, San Francisco, San Francisco, California, USA. Kathryn Anastos, MD, is a Professor of Medicine and Population Health, Division of General Internal Medicine, Albert Einstein College of Medicine/Montefiore Medical Center, Bronx, New York, USA. Viraj V. Patel, MD, MPH, is an Assistant Professor, Division of General Internal Medicine, Albert Einstein College of Medicine/Montefiore Medical Center, Bronx, New York, USA.

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http://dx.doi.org/10.1097/JNC.0000000000000228DOI Listing
January 2021

Clinical Outcomes and Inflammatory Markers by HIV Serostatus and Viral Suppression in a Large Cohort of Patients Hospitalized With COVID-19.

J Acquir Immune Defic Syndr 2021 02;86(2):224-230

Department of Epidemiology and Population Health, Albert Einstein College of Medicine, Montefiore Health System, Bronx, NY.

Background: Limited data exist about clinical outcomes and levels of inflammatory and immune markers among people hospitalized with COVID-19 by HIV serostatus and by HIV viral suppression.

Setting: Large tertiary care health system in the Bronx, NY, USA.

Methods: We conducted a retrospective cohort study of 4613 SARS-CoV-2 PCR-positive patients admitted between March 10, 2020, and May 11, 2020. We examined in-hospital intubation, acute kidney injury (AKI), hospitalization length, and in-hospital mortality by HIV serostatus, and by HIV-viral suppression and CD4 counts among people living with HIV (PLWH) using adjusted competing risks regression. We also compared immune and inflammatory marker levels by HIV serostatus and viral suppression.

Results: Most patients were either non-Hispanic Black (36%) or Hispanic (37%); 100/4613 (2.2%) were PLWH, among whom 15 had detectable HIV viral load. PLWH compared to patients without HIV had increased intubation rates (adjusted hazard ratio 1.73 [95% CI: 1.12 to 2.67], P = 0.01). Both groups had similar rates of AKI, length of hospitalization, and death. No (0%) virally unsuppressed PLWH were intubated or died, versus 21/81 (26%, P = 0.04) and 22/81 (27%, P = 0.02) of virally suppressed PLWH, respectively. Among PLWH, higher CD4 T-cell counts were associated with increased intubation rates. C-reactive protein, IL-6, neutrophil counts, and ferritin levels were similar between virally suppressed PLWH and patients without HIV, but significantly lower for unsuppressed PLWH (all P < 0.05).

Conclusions: PLWH had increased risk of intubation but similarly frequent rates of AKI and in-hospital death as those without HIV. Findings of no intubations or deaths among PLWH with unsuppressed HIV viral load warrant further investigation.
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http://dx.doi.org/10.1097/QAI.0000000000002578DOI Listing
February 2021

HIV Prevention and Treatment in the Context of the COVID-19 in the Bronx, New York: Implications for Practice and Research.

AIDS Rev 2020 ;22(3):143-147

Division of General Internal Medicine, Department of Medicine, Montefiore Health System/Albert Einstein College of Medicine, Bronx, NY, United States.

New York City has been one of the major epicenters of the coronavirus disease (COVID-19) pandemic, experiencing among the highest case rates, hospitalizations, and deaths globally. The Bronx borough in New York City, which has been disproportionately impacted by HIV, has also experienced significant disparities in COVID-19. In this perspective, we discuss the disruptions faced by our community and primary-care based HIV programs at Montefiore Health System in the Bronx in the context of the COVID-19 pandemic. We discuss how the COVID-19 pandemic has impacted our HIV prevention and treatment programs, the resulting adaptations to clinical care, and the implications for practice and future research.
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http://dx.doi.org/10.24875/AIDSRev.20000075DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7883660PMC
November 2020

Algorithm to identify transgender and gender nonbinary individuals among people living with HIV performs differently by age and ethnicity.

Ann Epidemiol 2021 02 1;54:73-78. Epub 2020 Oct 1.

Department of Epidemiology and Population Health, Montefiore Medical Center-Albert Einstein College of Medicine, Bronx, NY.

Purpose: HIV research among transgender and gender nonbinary (TGNB) people is limited by lack of gender identity data collection. We designed an EHR-based algorithm to identify TGNB people among people living with HIV (PLWH) when gender identity was not systematically collected.

Methods: We applied EHR-based search criteria to all PLWH receiving care at a large urban health system between 1997 and 2017, then confirmed gender identity by chart review. We compared patient characteristics by gender identity and screening criteria, then calculated positive predictive values for each criterion.

Results: Among 18,086 PLWH, 213 (1.2%) met criteria as potential TGNB patients and 178/213 were confirmed. Positive predictive values were highest for free-text keywords (91.7%) and diagnosis codes (77.4%). Confirmed TGNB patients were younger (median 32.5 vs. 42.5 years, P < .001) and less likely to be Hispanic (37.1% vs. 62.9%, P = .03) than unconfirmed patients. Among confirmed patients, 15% met criteria only for prospective gender identity data collection and were significantly older.

Conclusion: EHR-based criteria can identify TGNB PLWH, but success may differ by ethnicity and age. Retrospective versus intentional, prospective gender identity data collection may capture different patients. To reduce misclassification in epidemiologic studies, gender identity data collection should address these potential differences and be systematic and prospective.
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http://dx.doi.org/10.1016/j.annepidem.2020.09.013DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7883669PMC
February 2021

Awareness and Acceptability of Undetectable = Untransmittable Among a U.S. National Sample of HIV-Negative Sexual and Gender Minorities.

AIDS Behav 2021 Feb;25(2):634-644

Department of Community Health and Health Policy, CUNY Graduate School of Public Health and Health Policy, 55 W. 125th St., 7th Floor Mailroom, New York, NY, 10027, USA.

While the "Undetectable = Untransmittable" (U=U) message is widely endorsed, little is known about its breadth and reach. Our study describes socio-demographic characteristics and sexual behaviors associated with having heard of and trusting in U =U in a U.S. national sample of HIV-negative participants. Data were derived from the Together 5,000 cohort study, an internet-based U.S. national cohort of cis men, trans men and trans women who have sex with men. Approximately 6 months after enrollment, participants completed an optional survey included in the present cross-sectional analysis (n = 3286). Measures included socio-demographic and healthcare-related characteristics; questions pertaining to knowledge of and trust in U=U (dependable variable). We used descriptive statistics and multivariable logistic models to identify characteristics associated with these variables and explored patterns in willingness to engage in condomless anal sex (CAS) with regard to trust in U=U. In total, 85.5% of participants reported having heard of U=U. Among those aware of U=U, 42.3% indicated they trusted it, 19.8% did not, and 38.0% were unsure about it. Latinx, Asian, lower income, and Southern participants were less likely to have heard of U=U. Having had a recent clinical discussion about PrEP or being a former-PrEP user were associated with trust in U=U. Willingness to engage in CAS was positively associated with trust in U=U, and varied based on the partner's serostatus, PrEP use and viral load. Although we found high rates of awareness and low levels of distrust, our study indicated that key communities remain unaware and/or skeptical of U=U.
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http://dx.doi.org/10.1007/s10461-020-02990-3DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7854953PMC
February 2021

Factors Associated with Being PrEP-Naïve Among a U.S. National Cohort of Former-PrEP and PrEP-Naïve Participants Meeting Objective Criteria for PrEP Care.

Arch Sex Behav 2020 Aug 13. Epub 2020 Aug 13.

Department of Community Health and Social Sciences, CUNY Graduate School of Public Health and Health Policy, 55 W 125th St., 7th Floor Mailroom, New York, NY, 10027, USA.

There is an urgent need to increase uptake and persistence in HIV pre-exposure prophylaxis (PrEP) in PrEP-eligible candidates. Little is known about the similarities and differences between groups of PrEP-naïve and former users, an important consideration for future interventions. We explored factors associated with being PrEP-naïve in a U.S. national cohort of naïve and former-PrEP users, all of whom met objective criteria for PrEP care at enrollment. Data were derived from the Together 5000 cohort study, an Internet-based U.S. national cohort of cisgender and trans men and trans women who have sex with men. Participants were recruited via ads on men-for-men geosocial networking apps. All participants were not on PrEP at the time of enrollment. We conducted bivariate analysis to explore differences between the two groups and used multivariable logistic regression to assess factors associated with being PrEP-naïve. Of the 6283 participants, 5383 (85.7%) were PrEP-naïve and 900 (14.3%) were former-PrEP users. There were significant differences between PrEP-naïve and former-PrEP users across multiple demographic variables, in addition to PrEP-related and psychosocial variables. Factors associated with being PrEP-naïve included younger age, sexual identity other than gay/queer, lower perception of candidacy for PrEP care, less willingness to take PrEP, lower access to PrEP care, and individual-level barriers such as health- and provider-related concerns. Programs and policies designed to address uptake and persistence of PrEP should be aware of these differences. Providing care in non-traditional LGBTQ-care settings, home-based PrEP interventions, and provision by healthcare providers other than physicians could improve uptake. Future research should investigate mechanisms that can improve uptake and persistence in communities in need of PrEP.
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http://dx.doi.org/10.1007/s10508-020-01791-yDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7881054PMC
August 2020

Reducing the Discussion Divide by Digital Questionnaires in Health Care Settings: Disruptive Innovation for HIV Testing and PrEP Screening.

J Acquir Immune Defic Syndr 2020 11;85(3):302-308

Department of Community Health and Social Sciences, CUNY Graduate School of Public Health and Health Policy; the CUNY Institute for Implementation Science in Population Health, New York, NY.

Background: Health care provider assessment of patient sexual behavior and substance use is essential for determining appropriate prevention interventions-including HIV pre-exposure prophylaxis (PrEP)-for sexual minority men (SMM). We sought to explore acceptability and utility of using electronic surveys to conduct health behavior assessments in clinical settings among SMM.

Methods: Among a US nationwide sample of SMM (n = 4187; mean age = 38.3 years; 60% white; 82% HIV-negative), we examined associations of demographics, recruitment venue, sexual behavior characteristics, and recent substance use with participants' comfort communicating verbally and through electronic survey with a health care provider about sexual and substance use behavior.

Results: On average, SMM had greater comfort communicating through electronic survey vs. verbally. In our fully adjusted analysis, preference favoring electronic surveys more strongly than verbal communication differed by age (β = -0.07, P ≤ 0.001). SMM with a bachelor's degree or more (β = 0.04, P < 0.05), those recruited from nonclinical settings (β = 0.06, P ≤ 0.001), and those without primary care providers (β = 0.04, P < 0.05) favored electronic surveys more strongly in the fully adjusted multivariable model. SMM who reported any recent casual sex partners (β = 0.05, P < 0.01), those never tested for HIV (β = 0.03, P < 0.05), and HIV-negative/unknown men not on PrEP (compared with PrEP users; β = 0.09, P ≤ 0.001) also favored electronic surveys in the fully adjusted model.

Conclusions: Reducing communication barriers by incorporating electronic surveys into patient assessments could help identify HIV testing and PrEP needs for SMM most susceptible to HIV acquisition. Nonetheless, no one screening strategy is likely to work for most SMM, and multiple approaches are needed.
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http://dx.doi.org/10.1097/QAI.0000000000002459DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7572720PMC
November 2020

Characteristics Associated with Trust in and Disclosure of Sexual Behavior to Primary Care Providers Among Gay, Bisexual, and Other Men Who Have Sex with Men in the United States.

LGBT Health 2020 May/Jun;7(4):208-213. Epub 2020 Apr 20.

Department of Medicine, Albert Einstein College of Medicine, Bronx, New York, USA.

Characteristics associated with having a primary care provider (PCP), patient-provider trust, and sexual behavior disclosure were examined among men who have sex with men (MSM). MSM ( = 4239) were surveyed regarding demographic, behavioral, and medical characteristics. Multivariable logistic regression analyses were used. Among 86.3% of MSM with a PCP, characteristics associated with lower patient-provider trust included younger age, Asian, bisexual, HIV-negative-not-on-pre-exposure prophylaxis, HIV-unknown, and lower medical literacy; with nondisclosure: Asian, bisexual, straight, HIV-negative, HIV-unknown, fewer partners, recruitment source, lower medical literacy, and lower patient-provider trust. Medical literacy and patient-provider trust are promising points of intervention to improve health outcomes among MSM.
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http://dx.doi.org/10.1089/lgbt.2019.0214DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7301311PMC
April 2020

An Internet-Based, Peer-Delivered Messaging Intervention for HIV Testing and Condom Use Among Men Who Have Sex With Men in India (CHALO!): Pilot Randomized Comparative Trial.

JMIR Public Health Surveill 2020 04 16;6(2):e16494. Epub 2020 Apr 16.

Department of Psychology, Hunter College, City University of New York, New York, NY, United States.

Background: Leveraging internet-based communication tools (eg, messaging apps, SMS text messaging, and email) may be an effective avenue for delivery of HIV prevention messages to men who have sex with men (MSM) in India, but there are limited models for such internet-based interventions.

Objective: The CHALO! pilot was an online educational and behavioral intervention aimed to determine the feasibility, acceptability, and preliminary impact of a peer-delivered, internet-based messaging intervention for HIV testing and consistent condom use for MSM in India. The messages addressed barriers to HIV testing and condom use and were theoretically based on the information-motivation-behavioral skills model.

Methods: Between February and March 2015, we recruited, enrolled, and randomized 244 participants via online advertisements on mobile dating apps and Facebook. Eligible men (18 years or older, sexually active with other men, and self-reported HIV-negative or unknown status) were randomized to receive educational and motivational messages framed as either approach (ie, a desirable outcome to be achieved) or avoidance (an undesirable outcome to be avoided) over 12 weeks via internet-based messaging platforms. Participants completed online surveys at baseline and immediately postintervention.

Results: Participants were similar across arms with respect to sociodemographic and behavioral characteristics. Over 82.0% (200/244) of participants were retained (ie, viewed final messages), and 52.3% (130/244) of them completed the follow-up survey. Of those completing the follow-up survey, 82.3% (107/130) liked or strongly liked participating in CHALO!. The results showed a significant increase in self-reported HIV testing in the past 6 months from baseline to follow-up (41/130, 31.5% to 57/130, 43.8%; P=.04). When including those who reported intentions to test, this percentage increased from 44.6% (58/130) at baseline to 65.4% (85/130) at follow-up (P<.01). When examining intentions to test among those without prior HIV testing, intentions increased from 32% (16/50) of the sample at baseline to 56% (28/50) of the sample at follow-up (P=.02). Condom use during anal sex did not significantly change from baseline to follow-up. HIV testing and condom use did not significantly differ between approach and avoidance conditions at follow-up.

Conclusions: As one of the first studies of an online HIV prevention intervention for Indian MSM, CHALO! was feasible to implement by a community-based organization, was acceptable to participants, and demonstrated potential to improve HIV testing rates.
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http://dx.doi.org/10.2196/16494DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7193444PMC
April 2020

Evaluation of Algorithms Used for PrEP Surveillance Using a Reference Population From New York City, July 2016-June 2018.

Public Health Rep 2020 Mar/Apr;135(2):202-210. Epub 2020 Feb 6.

Division of General Internal Medicine, Department of Medicine, Montefiore Health System/Albert Einstein College of Medicine, Bronx, NY, USA.

Objective: Daily tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) use as HIV preexposure prophylaxis (PrEP) is monitored by identifying TDF/FTC prescriptions from pharmacy databases and applying diagnosis codes and antiretroviral data to algorithms that exclude TDF/FTC prescribed for HIV postexposure prophylaxis (PEP), HIV treatment, and hepatitis B virus (HBV) treatment. We evaluated the accuracy of 3 algorithms used by the Centers for Disease Control and Prevention (CDC), Gilead Sciences, and the New York State Department of Health (NYSDOH) using a reference population in Bronx, New York.

Methods: We extracted diagnosis codes and data on all antiretroviral prescriptions other than TDF/FTC from an electronic health record database for persons aged ≥16 prescribed TDF/FTC during July 2016-June 2018 at Montefiore Medical Center. We reviewed medical records to classify the true indication of first TDF/FTC use as PrEP, PEP, HIV treatment, or HBV treatment. We applied each algorithm to the reference population and compared the results with the medical record review.

Results: Of 2862 patients included in the analysis, 694 used PrEP, 748 used PEP, 1407 received HIV treatment, and 13 received HBV treatment. The algorithms had high specificity (range: 98.4%-99.0%), but the sensitivity of the CDC algorithm using a PEP definition of TDF/FTC prescriptions ≤30 days was lower (80.3%) than the sensitivity of the algorithms developed by Gilead Sciences (94.7%) or NYSDOH (96.1%). Defining PEP as TDF/FTC prescriptions ≤28 days improved CDC algorithm performance (sensitivity, 95.8%; specificity, 98.8%).

Conclusions: Adopting the definition of PEP as ≤28 days of TDF/FTC in the CDC algorithm should improve the accuracy of national PrEP surveillance.
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http://dx.doi.org/10.1177/0033354920904085DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7036610PMC
May 2020

Preferences for implementation of HIV pre-exposure prophylaxis (PrEP): Results from a survey of primary care providers.

Prev Med Rep 2020 Mar 21;17:101012. Epub 2019 Oct 21.

Albert Einstein College of Medicine, Montefiore Health System, Bronx, NY, United States.

Primary care physicians (PCPs) are critical for promoting HIV prevention by prescribing pre-exposure prophylaxis (PrEP). Yet, there are limited data regarding PCP's preferred approaches for PrEP implementation. In 2015, we conducted an online survey of PCPs' PrEP prescribing and implementation. Participants were general internists recruited from a national professional organization. We examined provider and practice characteristics and perceived implementation barriers and facilitators associated with preferred models for PrEP implementation. Among 240 participants, the majority (85%) favored integrating PrEP into primary care, either by training all providers ("all trained") (42%) or having an onsite PrEP specialist ("on-site specialist") (43%). Only 15% preferred referring patients out of the practice to a specialist ("refer out"). Compared to those who preferred to "refer out," participants who preferred the "all trained" model were more likely to spend most of their time delivering direct patient care and to practice in the Northeast. Compared to participants who preferred the "refer out" or on-site specialist" models, PCPs preferring the all trained model were less likely to perceive lack of clinic PrEP guidelines/protocols as a barrier to PrEP. Most PCPs favored integrating PrEP into primary care by either training all providers or having an on-site specialist. Time devoted to clinical care and geography may influence preferences for PrEP implementation. Establishing clinic-specific PrEP protocols may promote on-site PrEP implementation. Future studies should focus on evaluating the effectiveness of different PrEP implementation models on PrEP delivery.
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http://dx.doi.org/10.1016/j.pmedr.2019.101012DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6926349PMC
March 2020

Demographic, Behavioral, and Geographic Differences Between Men, Transmen, and Transwomen Currently on PrEP, Former PrEP Users, and Those Having Never Used PrEP.

AIDS Behav 2020 May;24(5):1304-1311

Institute for Implementation Science in Population Health (ISPH), City University of New York, New York, USA.

Many recent studies have compared men currently taking pre-exposure prophylaxis (PrEP) to men not taking PrEP. However, less is known about demographic, behavioral, and geographic characteristics of men formerly, but not currently, taking PrEP. Using a 2017-2018 U.S. national, internet-based sample (n = 10,504) of men, transmen, and transwomen who have sex with men, we compared three groups based on their PrEP experiences. Results highlight individual-level financial and geo-contextual barriers to PrEP use that can inform prevention efforts to improve PrEP initiation and continuation for both PrEP-naïve and PrEP-experienced individuals, respectively.
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http://dx.doi.org/10.1007/s10461-019-02722-2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7162710PMC
May 2020

A Web-Based Study of HIV Prevention in the Era of Pre-Exposure Prophylaxis Among Vulnerable HIV-Negative Gay and Bisexual Men, Transmen, and Transwomen Who Have Sex With Men: Protocol for an Observational Cohort Study.

JMIR Res Protoc 2019 Sep 17;8(9):e13715. Epub 2019 Sep 17.

Institute for Implementation Science in Population Health, City University of New York, New York, NY, United States.

Background: Gay, bisexual, and other men who have sex with men continue to bear a large burden of the HIV epidemic in the United States and are among the only populations with increasing incidence in recent years.

Objective: The Together 5000 (T5K) Study aimed to enroll a US-based, racially diverse sample of HIV-negative men, transmen, and transwomen who are not on pre-exposure prophylaxis (PrEP) into an observational cohort to inform the design, implementation, scale-up, and evaluation of HIV prevention programs.

Methods: We used internet-based strategies to enroll a large, racially diverse national sample of HIV-negative men, transmen, and transwomen aged 16 to 49 years at high risk of HIV acquisition via sexual networking apps. Study participants are contacted every 6 months (in between annual surveys) for a brief survey on HIV testing, HIV diagnosis, and PrEP use (ie, attempts to access, PrEP initiation, and PrEP discontinuation). Participants complete annual self-administered at-home HIV testing and Web-based surveys. Using baseline serologic data and self-reported HIV testing history, we reconstructed a cohort of persons who were HIV negative at 12 months before baseline to estimate HIV incidence leading up to cohort enrollment.

Results: The study sample included 8777 participants from all 50 US states, Puerto Rico, and Guam; 50.91% (4468/8777) were persons of color and 25.30% (2221/8777) were young individuals aged 16 to 24 years. Per eligibility criteria, all T5K participants reported having sex with >2 male partners in the 90 days before enrollment, self-reported not having been diagnosed with HIV, and were not actively taking PrEP. In addition, 79.39% (6968/8777) reported >2 insertive condomless anal sex (CAS) acts, 61.02% (5356/8777) reported >1 receptive CAS acts in the past 90 days. Furthermore, most (7525/8777, 85.74%) reported never having taken PrEP. In total, 70.25% (6166/8777) were sent a self-administered at-home HIV test kit and 82.29% (5074/6166) of those sent a kit returned a sample for testing. The HIV incidence rate during the 12-month period leading up to enrollment was estimated to be 2.41 (95% CI 2.02-2.90) per 100 person-years.

Conclusions: A large, national, and racially diverse fully Web-based cohort of HIV-negative men, transmen, and transwomen at high risk for HIV seroconversion has successfully been recruited into longitudinal follow-up. This cohort is at high risk for HIV acquisition and can provide important insights related to the real-world uptake, impact, and equity of HIV prevention interventions in the United States. Participants can be invited to participate in trials aimed at testing strategies to improve the uptake of and engagement in these interventions.

International Registered Report Identifier (irrid): RR1-10.2196/13715.
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http://dx.doi.org/10.2196/13715DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6754683PMC
September 2019

Recruiting vulnerable populations to participate in HIV prevention research: findings from the Together 5000 cohort study.

Ann Epidemiol 2019 07 16;35:4-11. Epub 2019 May 16.

CUNY Institute for Implementation Science in Population Health, New York, NY; Department of Epidemiology and Biostatistics, CUNY Graduate School of Public Health and Health Policy, New York, NY.

Purpose: The aim of the article was to examine factors associated with completing enrollment milestones in the Together 5000 cohort of at-risk men (n = 8661), transmen (n = 53), and transwomen (n = 63) who have sex with men.

Methods: Between 2017 and 2018, participants completed an online enrollment survey and were offered opportunities to complete an incentivized secondary online survey as well as self-administered at-home HIV testing (OraSure). We explored factors associated with completing each study component.

Results: In total, 8777 individuals completed our enrollment survey, 6166 (70.3%) completed the secondary survey, and 5010 returned the at-home HIV test kit that was mailed to them (81.3% of those mailed a kit). In our multivariable models, those who were White, with more years of education, were more likely to complete study components, although the magnitude of these associations was small. For example, 50.9% of those enrolled, 47.9% of those completing the secondary survey, and 46.8% of those completing HIV testing were persons of color-a statistically significant, but meaningfully insignificant decline.

Conclusions: These findings highlight the need for researchers to identify barriers that may prevent persons of color and younger individuals from participating in research studies.
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http://dx.doi.org/10.1016/j.annepidem.2019.05.003DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7202362PMC
July 2019

Social contexts as mediator of risk behaviors in Rwandan men who have sex with men (MSM): Implications for HIV and STI transmission.

PLoS One 2019 18;14(1):e0211099. Epub 2019 Jan 18.

Department of Epidemiology and Population Health, Albert Einstein College of Medicine, Bronx, New York, United States of America.

Introduction: Men who have sex with men (MSM) are disproportionately impacted by HIV/AIDS resulting from risky sexual behaviors. Social and contextual factors are known to mediate risk behaviors, but there is limited information about the prevalence of risky sexual practices of Rwandan MSM and the concomitant socio-contextual determinants making it difficult to assess implications for preventing HIV/STI transmission in this key population.

Methods: Using exploratory qualitative design, we obtained socio-contextual information regarding prevalence of risky sexual behavior and assessed implications for HIV/ STIs transmission and preventive measures taken by MSM to improve sexual health and wellbeing. Thirty MSM were recruited to participate in in-depth interviews using respondent-driven sampling from LGBT associations in Kigali. Data were analyzed using standard qualitative data analysis procedures.

Results: Respondents' were between 18-40 years old; all completed primary education and are mostly low-socioeconomic status. Risky sexual practices were common, but differed by peculiar individual and contextual factors. Older MSM often reported occasional sexual relations with women to avoid suspicion and social stigma. Younger MSM's risky sexual practices are mostly transactional and mediated by the need for social acceptance and support. Knowledge of STIs was poor, but prevalence, especially of HPV was high. The options for improving sexual wellbeing are limited and mostly clandestine.

Conclusion: Risky sexual behavior of Rwandan MSM has major implications for HIV/STI transmission. An environment of intense social stigma and social isolation makes it difficult to obtain information or services to improve sexual health. Effective interventions that address individual and contextual determinants of risk and access to health services are urgently needed to limit the consequence of MSM as a bridge for HIV transmission to the general population.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0211099PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6338414PMC
October 2019

PrEP in the Real World: Predictors of 6-Month Retention in a Diverse Urban Cohort.

AIDS Behav 2019 Jul;23(7):1797-1802

Division of General Internal Medicine, Albert Einstein College of Medicine, 3300 Kossuth Ave, Bronx, NY, 10467, USA.

The effectiveness of HIV pre-exposure prophylaxis (PrEP) depends on adherence, which requires retention in PrEP care. We sought to examine factors associated with six-month retention in PrEP care among individuals prescribed PrEP between 2011 and 2015 in a large, academic health system in the Bronx, New York. We used multivariable logistic regression to identify factors independently associated with six-month retention. Among 107 patients, retention at 6 months was 42%. In the multivariable analysis, heterosexual individuals were less likely to be retained in PrEP care at 6 months, but individuals who received prescriptions from attending physicians were more likely to be retained in care. Larger prospective studies are needed to better evaluate the individual and health system factors associated with long-term engagement in PrEP care.
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http://dx.doi.org/10.1007/s10461-018-2296-xDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6474829PMC
July 2019

Empowering With PrEP (E-PrEP), a Peer-Led Social Media-Based Intervention to Facilitate HIV Preexposure Prophylaxis Adoption Among Young Black and Latinx Gay and Bisexual Men: Protocol for a Cluster Randomized Controlled Trial.

JMIR Res Protoc 2018 Aug 28;7(8):e11375. Epub 2018 Aug 28.

Division of General Internal Medicine, Department of Medicine, Montefiore Health System / Albert Einstein College of Medicine, Bronx, NY, United States.

Background: Young black and Latinx, gay, bisexual, and other men who have sex with men (YBLGBM, aged 18-29 years) have among the highest rates of new HIV infections in the United States and are not consistently reached by existing prevention interventions. Preexposure prophylaxis (PrEP), an oral antiretroviral regimen taken daily by HIV-uninfected individuals to prevent HIV acquisition, is highly efficacious in reducing HIV acquisition and could help stop the HIV epidemic in YBLGBM. Use of social media (eg, Facebook, Twitter, online dating sites) is ubiquitous among young people, providing an efficient avenue to engage YBLGBM to facilitate PrEP adoption.

Objective: Our overall goal was to develop and pilot test a theoretically grounded, social media-based, peer-led intervention to increase PrEP uptake in YBLGBM. We used diffusion of innovation and information-motivation-behavioral skills frameworks to (1) identify potential factors associated with interest in and adoption of PrEP among YBLGBM; (2) develop Empowering with PrEP (E-PrEP), a social media-based, peer-led intervention to increase PrEP uptake in YBLGBM; and (3) pilot test the feasibility and acceptability of E-PrEP, and determine its preliminary efficacy for increasing adoption of PrEP by YBLGBM. We describe the development and protocol for E-PrEP.

Methods: Using a participatory research approach, we partnered with YBLGBM intervention development partners to develop a social media-based behavioral intervention to facilitate PrEP uptake, which involved an online messaging campaign disseminated by YBLGBM peer leaders to their existing online networks. We designed the 6-week campaign to provide education about PrEP, increase motivation to use PrEP, and facilitate access to PrEP. We then conducted a cluster-randomized trial of E-PrEP compared with an attention-matched general health control condition (E-Health) among YBLGBM aged 18 to 29 years to assess E-PrEP's feasibility, acceptability, preliminary efficacy for increasing self-reported intention to use PrEP, PrEP uptake, and impact on knowledge and attitudes about PrEP at 12-week follow-up (6 weeks after the end of the online campaign).

Results: From October 2016 to March 2017, we developed, pretested, and refined E-PrEP with 6 YBLGBM intervention development partners. From May to June 2017, we recruited, enrolled, and randomly assigned 10 peer leaders (n=5 for each condition). The 10 peer leaders then recruited and enrolled 152 participants from their existing online networks (range 3-33 per peer leader), during June and July 2017. Intervention follow-up was completed after 12 weeks, in November 2017, with analyses underway.

Conclusions: We hypothesize that, compared with E-Health, participants randomly assigned to E-PrEP will be more likely to express intention to use PrEP and greater PrEP uptake, and will also show changes in potential mediators of PrEP uptake (knowledge, attitudes, stigma, and access). A Web-based biobehavioral intervention model such as E-PrEP could be rapidly scaled even with limited resources and have significant population-level impact.

Trial Registration: ClinicalTrials.gov NCT03213366; https://clinicaltrials.gov/ct2/show/NCT03213366 (Archived by WebCite at http://www.webcitation.org/71onSdcXY).

Registered Report Identifier: RR1-10.2196/11375.
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http://dx.doi.org/10.2196/11375DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6134229PMC
August 2018

Authors' Response to Letter to the Editor: Adherence in ART: A Comment on Piña et al. (2017).

J Assoc Nurses AIDS Care 2018 May - Jun;29(3):355-356. Epub 2018 Mar 20.

Chief, Division of General Internal Medicine, Professor of Medicine, Psychiatry & Behavioral Sciences, Epidemiology & Population Health, Albert Einstein College of Medicine/Montefiore Health System, Bronx, New York, USA.

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http://dx.doi.org/10.1016/j.jana.2018.03.002DOI Listing
August 2019

Prevalence of and Factors Associated with the Use of HIV Serosorting and Other Biomedical Prevention Strategies Among Men Who Have Sex with Men in a US Nationwide Survey.

AIDS Behav 2018 Aug;22(8):2743-2755

The Center for HIV/AIDS Educational Studies and Training (CHEST), New York, NY, USA.

PrEP and treatment-as-prevention (TasP) are biomedical strategies to reduce HIV transmission. Some men who have sex with men (MSM) are combining biomedical strategies with HIV serosorting-termed "biomed matching" when both partners are either on PrEP or TasP, or "biomed sorting" when one partner is using PrEP and the other TasP. Nevertheless, there is limited data on the extent of biomed matching/sorting in large geographically diverse samples. In 2016-2017, 5021 MSM from across the US were surveyed about their HIV status and HIV viral load/PrEP use, as well as that of their recent casual male partners. For each participant, we calculated the proportion of his partners who were (1) HIV-positive and undetectable, (2) HIV-positive and detectable/unknown, (3) HIV unknown/undiscussed, (4) HIV-negative on PrEP, (5) HIV-negative, not on PrEP. In total, 66.6% (n = 3346) of participants were HIV-negative and not on PrEP, 11.9% (n = 599) on PrEP, 14.1% (n = 707) HIV-positive and undetectable, 1.1% (n = 55) HIV-positive and viral load detectable/unknown, and 6.2% (n = 313) HIV unsure/unknown. A participant's own HIV and PrEP status/was significantly associated with that of his partners (all p < 0.001), evincing evidence of both serosorting and biomed matching. Among men on PrEP and those who were HIV-undetectable, there was also some evidence to suggest these participants dually engaged in biomed matching as well as biomed sorting. We found evidence of biomed matching and sorting, which may compound its effectiveness for those using it (i.e., both partners bring biomedical protection). Unintended consequences of biomed matching/sorting include that men not using a biomedical strategy may be less likely to benefit from a partner's use of the strategy-potentially further driving disparities in HIV infections. Public health campaigns might be well served to highlight not only the benefits that biomedical HIV prevention strategies provide for their users (e.g., "being on PrEP protects me from getting HIV"), but also the benefits that a user brings to his partners (e.g., "my use of PrEP means my partners won't get HIV"), and the benefits of being with a partner who is using a biomedical strategy (e.g., "my partner's use of PrEP/TasP protects me from HIV").
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http://dx.doi.org/10.1007/s10461-018-2084-7DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6051908PMC
August 2018

The Use of Online Posts to Identify Barriers to and Facilitators of HIV Pre-exposure Prophylaxis (PrEP) Among Men Who Have Sex with Men: A Comparison to a Systematic Review of the Peer-Reviewed Literature.

AIDS Behav 2018 04;22(4):1080-1095

Albert Einstein College of Medicine and Montefiore Medical Center, Bronx, NY, USA.

Pre-exposure prophylaxis (PrEP) remains an under-utilized HIV prevention tool among men who have sex with men (MSM). To more comprehensively elucidate barriers and facilitators to PrEP use among US MSM, we conducted a systematic review of peer-reviewed published articles and content analysis of online posts about PrEP. We searched peer-reviewed databases (Medline, Web of Science, Google Scholar) using MESH headings and keywords about PrEP and/or HIV prevention from 2005 to 2015. We included original studies among MSM in the US that reported on barriers, facilitators, or other factors related to PrEP use. We also searched online posts and associated comments (news articles, opinion pieces, blogs and other social media posts) in diverse venues (Facebook, Slate Outward, Huffington Post Gay Voices, Queerty, and My PrEP Experience blog) to identify posts about PrEP. We used content analysis to identify themes and compare potential differences between the peer-reviewed literature and online posts. We identified 25 peer-reviewed articles and 28 online posts meeting inclusion criteria. We identified 48 unique barriers and 46 facilitators to using PrEP. These 94 themes fit into six overarching categories: (1) access (n = 14), (2) attitudes/beliefs (n = 24), (3) attributes of PrEP (n = 13), (4) behaviors (n = 11), (5) sociodemographic characteristics (n = 8), and (6) social network (n = 6). In all categories, analysis of online posts resulted in identification of a greater number of unique themes. Thirty-eight themes were identified in the online posts that were not identified in the peer-reviewed literature. We identified barriers and facilitators to PrEP in online posts that were not identified in a systematic review of the peer-reviewed literature. By incorporating data both from a systematic review of peer-reviewed articles and from online posts, we have identified salient and novel information about barriers to and facilitators of PrEP use. Traditional research approaches may not comprehensively capture current factors important for designing and implementing PrEP related interventions.
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http://dx.doi.org/10.1007/s10461-017-2011-3DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5991474PMC
April 2018

Outcomes Along the HIV Care Continuum Among Undocumented Immigrants in Clinical Care.

AIDS Res Hum Retroviruses 2017 Oct 22;33(10):1038-1044. Epub 2017 May 22.

3 Department of Epidemiology and Population Health, Albert Einstein College of Medicine , Bronx, New York.

HIV-infected undocumented immigrants face unique barriers to care yet little is known about their clinical outcomes. We performed a retrospective cohort study of HIV-infected adults in clinical care from 2006 to 2014 at a large academic medical center in a setting where medical insurance is available to HIV-infected undocumented immigrants. Undocumented status was assessed based on Social Security number and insurance status and verified through medical chart review. Using Poisson regression models, we compared undocumented and documented patients with respect to retention in care (≥2 HIV-related laboratory tests ≥90 days apart), antiretroviral therapy (ART) prescription (≥3 active antiretroviral agents prescribed in a year), and viral suppression (HIV RNA <200 copies/ml for the last measured viral load) for each year in care. Of 7,551 patients included in the analysis, we classified 173 (2.3%) as undocumented. For each year of the analysis, higher proportions of undocumented patients were retained in care, prescribed ART, and virally suppressed. In adjusted models, undocumented status was associated with increased probability of retention in care [risk ratio (RR) 1.05, confidence interval (95% CI) 1.01-1.09], ART prescription (RR 1.05, 95% CI 1.01-1.08), and viral suppression (RR 1.13, 95% CI 1.08-1.19) compared to documented status. Undocumented patients achieved clinical outcomes at modestly higher rates than documented patients, despite entering care with more advanced disease. In a setting where insurance is available to undocumented patients, similar outcomes along the HIV care continuum may be achieved regardless of immigration status.
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http://dx.doi.org/10.1089/AID.2017.0015DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5695751PMC
October 2017

Emerging from the database shadows: characterizing undocumented immigrants in a large cohort of HIV-infected persons.

AIDS Care 2017 12 27;29(12):1491-1498. Epub 2017 Mar 27.

a Division of General Internal Medicine, Department of Medicine , Montefiore Medical Center , Bronx , USA.

Little is known about how HIV affects undocumented immigrants despite social and structural factors that may place them at risk of poor HIV outcomes. Our understanding of the clinical epidemiology of HIV-infected undocumented immigrants is limited by the challenges of determining undocumented immigration status in large data sets. We developed an algorithm to predict undocumented status using social security number (SSN) and insurance data. We retrospectively applied this algorithm to a cohort of HIV-infected adults receiving care at a large urban healthcare system who attended at least one HIV-related outpatient visit from 1997 to 2013, classifying patients as "screened undocumented" or "documented". We then reviewed the medical records of screened undocumented patients, classifying those whose records contained evidence of undocumented status as "undocumented per medical chart" (charted undocumented). Bivariate measures of association were used to identify demographic and clinical characteristics associated with undocumented immigrant status. Of 7593 patients, 205 (2.7%) were classified as undocumented by the algorithm. Compared to documented patients, undocumented patients were younger at entry to care (mean 38.5 years vs. 40.6 years, p < 0.05), less likely to be female (33.2% vs. 43.1%, p < 0.01), less likely to report injection drug use as their primary HIV risk factor (3.4% vs. 18.0%, p < 0.001), and had lower median CD4 count at entry to care (288 vs. 339 cells/mm, p < 0.01). After medical record review, we re-classified 104 patients (50.7%) as charted undocumented. Demographic and clinical characteristics of charted undocumented did not differ substantially from screened undocumented. Our algorithm allowed us to identify and clinically characterize undocumented immigrants within an HIV-infected population, though it overestimated the prevalence of patients who were undocumented.
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http://dx.doi.org/10.1080/09540121.2017.1307921DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5617785PMC
December 2017

Pre-exposure prophylaxis prescribing and retention in care among heterosexual women at a community-based comprehensive sexual health clinic.

AIDS Care 2017 07 1;29(7):866-869. Epub 2017 Feb 1.

c Department of Medicine , Albert Einstein College of Medicine , Bronx , USA.

In the United States, heterosexual women account for 20% of new HIV infections. As a user-controlled HIV prevention method, pre-exposure prophylaxis (PrEP) has substantial potential to reduce new infections among women. However, among women, PrEP is vastly underutilized. To guide efforts to increase women-at-risk's PrEP use, we sought to describe the characteristics of women prescribed PrEP as well as their retention in PrEP care. We conducted a chart review of women who received care at a comprehensive sexual health clinic within a large urban health care system. Referral sources included the health care system's clinics and HIV testing program, as well as local community-based organizations. From 1 December 2014 to 5 August 2016, 554 women received care at the clinic. During this period, 21 heterosexual women (3.8%) received at least one prescription for daily oral PrEP. For women prescribed PrEP, median age was 35 years old (range: 20-52). The majority (66.7%) were either Latina or non-Latina Black and most (81.2%) had public health insurance. The most common PrEP indication was being in a known sero-discordant partnership (85.7%). Of women in such partnerships, 83.3% reported their male partner was currently taking antiretroviral medications (ARVs) and 16.7% reported trying to conceive with their partner (not mutually exclusive). Of women with ARV-using partners, 66.7% reported that their partners were virally suppressed. Retention in PrEP care at three months was 61.1% and, at six months, 37.5%. Further study is necessary to expand PrEP to women whose risk factors extend beyond being in a known sero-discordant partnership, and to understand the reasons for the observed drop-off in PrEP care visits in real-world settings.
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http://dx.doi.org/10.1080/09540121.2017.1286287DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5514312PMC
July 2017

Reaching Key Populations: PrEP Uptake in an Urban Health Care System in the Bronx, New York.

AIDS Behav 2017 May;21(5):1309-1314

Division of Infectious Diseases, Albert Einstein College of Medicine, Bronx, NY, USA.

Pre-exposure prophylaxis (PrEP) has been established as an effective HIV prevention tool, but real world studies are limited. To inform dissemination efforts, we sought to describe individuals prescribed PrEP in the largest health care system in the Bronx, New York, an urban region with a high burden of HIV. We used a clinical database and chart review to identify individuals prescribed PrEP between 2011 and 2015 (n = 108). A majority were Black and Hispanic, half were men who have sex with men, and nearly a third were cisgender women who have sex with men. Primary care settings were the most common site of PrEP prescription and PrEP prescription rates increased over time. Despite reaching a diverse patient population, PrEP prescribing rates were low, underscoring the urgent need for PrEP scale-up.
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http://dx.doi.org/10.1007/s10461-016-1663-8DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5380526PMC
May 2017