Rupa Patel

Retention in care outcomes for HIV pre-exposure prophylaxis implementation programmes among men who have sex with men in three US cities.

Despite the efficacy of pre‐exposure prophylaxis (PrEP) in preventing HIV transmission, few studies have evaluated PrEP use and retention in care outcomes in real‐world settings outside of clinical trials.

Implementation of Preexposure Prophylaxis for Human Immunodeficiency Virus Prevention Among Men Who Have Sex With Men at a New England Sexually Transmitted Diseases Clinic.

Background Preexposure prophylaxis (PrEP) is efficacious in preventing human immunodeficiency virus (HIV) among men who have sex with men (MSM). We assessed PrEP uptake among MSM presenting for services at a sexually transmitted diseases (STD) clinic. Methods Men who have sex with men presenting to the Rhode Island STD Clinic between October 2013 and November 2014 were educated about, and offered, PrEP. We categorized PrEP engagement using an implementation cascade to describe gaps in uptake which described MSM who: (1) were educated about PrEP, (2) indicated interest, (3) successfully received follow-up contact, (4) scheduled an appointment, (5) attended an appointment, and (6) initiated PrEP (ie, received a prescription). Bivariate and multivariable logistic regression models were used to examine predictors of PrEP initiation. Results A total of 234 MSM were educated about PrEP; of these, 56% expressed interest. Common reasons for lack of interest were low HIV risk perception (37%), wanting more time to consider (10%), concern about side effects (7%), and financial barriers (3%). Among those interested, 53% followed up. Of those, 51% scheduled an appointment. The most common reason patients did not schedule an appointment was low HIV risk perception (38%). Seventy-seven percent of those with an appointment attended the appointment; of those, 93% initiated PrEP. Patients with higher HIV-risk perception (adjusted odds ratios, 2.17; 95% confidence interval, 1.29–3.64) and a history of sex with an HIV-positive partner (adjusted odds ratios, 7.08; 95% confidence interval, 2.35–21.34) had significantly higher odds of initiating PrEP. Conclusions Low HIV-risk perception was the most significant barrier to PrEP uptake among MSM attending a public STD clinic.

Adherence to Pre-Exposure Prophylaxis for HIV Prevention in a Clinical Setting

Background The HIV epidemic in the United States (US) disproportionately affects gay, bisexual, and other men who have sex with men (MSM). Pre-exposure prophylaxis (PrEP) using co-formulated tenofovir disoproxil fumarate (TDF) and emtricitabine (FTC) has demonstrated high efficacy in reducing HIV incidence among MSM. However, low adherence was reported in major efficacy trials and may present a substantial barrier to successful PrEP implementation. Rates of adherence to PrEP in “real-world” clinical settings in the US remain largely unknown. Methods We reviewed demographic and clinical data for the first 50 patients to enroll in a clinical PrEP program in Providence, Rhode Island. We analyzed self-reported drug adherence as well as drug concentrations in dried blood spots (DBS) from patients who attended either a three- or six-month follow-up appointment. We further assessed drug concentrations and the resistance profile of a single patient who seroconverted while taking PrEP. Results Of the first 50 patients to be prescribed PrEP, 62% attended a follow-up appointment at three months and 38% at six months. Of those who attended an appointment at either time point (70%, n = 35), 92% and 95% reported taking ±4 doses/week at three and six months, respectively. Drug concentrations were performed on a random sample of 20 of the 35 patients who attended a follow-up appointment. TDF levels consistent with ±4 doses/week were found in 90% of these patients. There was a significant correlation between self-reported adherence and drug concentrations (r = 0.49, p = 0.02). One patient who had been prescribed PrEP seroconverted at his three-month follow-up visit. The patient’s drug concentrations were consistent with daily dosing. Population sequencing and ultrasensitive allele-specific PCR detected the M184V mutation, but no other TDF- or FTC-associated mutations, including those present as minor variants. Conclusion In this clinical PrEP program, adherence was high, and self-reported drug adherence accurately reflected drug concentrations as measured by DBS.

A Latent Class Analysis of Risk Factors for Acquiring HIV Among Men Who Have Sex with Men: Implications for Implementing Pre-Exposure Prophylaxis Programs.

Current Centers for Disease Control and Prevention (CDC) guidelines for prescribing pre-exposure prophylaxis (PrEP) to prevent HIV transmission are broad. In order to better characterize groups who may benefit most from PrEP, we reviewed demographics, behaviors, and clinical outcomes for individuals presenting to a publicly-funded sexually transmitted diseases (STD) clinic in Providence, Rhode Island, from 2012 to 2014. Latent class analysis (LCA) was used to identify subgroups of men who have sex with men (MSM) at highest risk for contracting HIV. A total of 1723 individuals presented for testing (75% male; 31% MSM). MSM were more likely to test HIV positive than heterosexual men or women. Among 538 MSM, we identified four latent classes. Class 1 had the highest rates of incarceration (33%), forced sex (24%), but had no HIV infections. Class 2 had <5 anal sex partners in the previous 12 months, the lowest rates of drug/alcohol use during sex and lower HIV prevalence (3%). Class 3 had the highest prevalence of HIV (7%) and other STDs (16%), > 10 anal sex partners in the previous 12 months (69%), anonymous partners (100%), drug/alcohol use during sex (76%), and prior STDs (40%). Class 4 had similar characteristics and HIV prevalence as Class 2. In this population, MSM who may benefit most from PrEP include those who have >10 sexual partners per year, anonymous partners, drug/alcohol use during sex and prior STDs. LCA is a useful tool for identifying clusters of characteristics that may place individuals at higher risk for HIV infection and who may benefit most from PrEP in clinical practice.

Defining the HIV pre-exposure prophylaxis care continuum

Pre-exposure prophylaxis (PrEP) is an effective HIV prevention strategy. There is little scientific consensus about how to measure PrEP program implementation progress. We draw on several years of experience in implementing PrEP programs and propose a PrEP continuum of care that includes: (1) identifying individuals at highest risk for contracting HIV, (2) increasing HIV risk awareness among those individuals, (3) enhancing PrEP awareness, (4) facilitating PrEP access, (5) linking to PrEP care, (6) prescribing PrEP, (7) initiating PrEP, (8) adhering to PrEP, and (9) retaining individuals in PrEP care. We also propose four distinct categories of PrEP retention in care that include being: (1) indicated for PrEP and retained in PrEP care, (2) indicated for PrEP and not retained in PrEP care, (3) no longer indicated for PrEP, and (4) lost to follow-up for PrEP care. This continuum of PrEP care creates a framework that researchers and practitioners can use to measure PrEP awareness, uptake, adherence, and retention. Understanding each point along the proposed continuum of PrEP care is critical for developing effective PrEP interventions and for measuring public health progress in PrEP program implementation.

Actinobaculum schaalii bacteremia: A report of two cases

We report two cases of bacteremia with Actinobaculum schaalii, a rarely reported, anaerobic, Gram-positive bacterium. The first case was a patient with renal cancer who developed pyelonephritis after cryoablation, and the second was a patient who developed sepsis after a urogenital procedure. Bacteremia resolved after administration of empiric antibiotic therapy.

Impact of insurance coverage on utilization of pre-exposure prophylaxis for HIV prevention

Pre-exposure prophylaxis (PrEP) can reduce U.S. HIV incidence. We assessed insurance coverage and its association with PrEP utilization. We reviewed patient data at three PrEP clinics (Jackson, Mississippi; St. Louis, Missouri; Providence, Rhode Island) from 2014–2015. The outcome, PrEP utilization, was defined as patient PrEP use at three months. Multivariable logistic regression was performed to determine the association between insurance coverage and PrEP utilization. Of 201 patients (Jackson: 34%; St. Louis: 28%; Providence: 28%), 91% were male, 51% were White, median age was 29 years, and 21% were uninsured; 82% of patients reported taking PrEP at three months. Insurance coverage was significantly associated with PrEP utilization. After adjusting for Medicaid-expansion and individual socio-demographics, insured patients were four times as likely to use PrEP services compared to the uninsured (OR: 4.49, 95% CI: 1.68–12.01; p = 0.003). Disparities in insurance coverage are important considerations in implementation programs and may impede PrEP utilization.

Awareness and attitudes of pre-exposure prophylaxis for HIV prevention among physicians in Guatemala: Implications for country-wide implementation

Introduction HIV continues to be a major health concern with approximately 2.1 million new infections occurring worldwide in 2015. In Central America, Guatemala had the highest incident number of HIV infections (3,700) in 2015. Antiretroviral pre-exposure prophylaxis (PrEP) was recently recommended by the World Health Organization (WHO) as an efficacious intervention to prevent HIV transmission. PrEP implementation efforts are underway in Guatemala and success will require providers that are knowledgeable and willing to prescribe PrEP. We sought to explore current PrEP awareness and prescribing attitudes among Guatemalan physicians in order to inform future PrEP implementation efforts. Methods We conducted a cross-sectional survey of adult internal medicine physicians at the main teaching hospital in Guatemala City in March 2015. The survey included demographics, medical specialty, years of HIV patient care, PrEP awareness, willingness to prescribe PrEP, previous experience with post-exposure prophylaxis, and concerns about PrEP. The primary outcome was willingness to prescribe PrEP, which was assessed using a 5-point Likert scale for different at-risk population scenarios. Univariate and multivariate logistic regression was performed to identify predictors for willingness to prescribe PrEP. Results Eighty-seven physicians completed the survey; 66% were male, 64% were internal medicine residency trainees, and 10% were infectious disease (ID) specialists. Sixty-nine percent of physicians were PrEP aware, of which 9% had previously prescribed PrEP. Most (87%) of respondents were willing to prescribe PrEP to men who have sex with men (MSM), sex workers, injection drug users, or HIV-uninfected persons having known HIV-positive sexual partners. Concerns regarding PrEP included development of resistance (92%), risk compensation (90%), and cost (64%). Univariate logistic regression showed that younger age, being a resident trainee, and being a non-ID specialist were significant predictors for willingness to prescribe PrEP. In multivariate logistic regression, being a non-ID specialist was a significant predictor. Conclusions Guatemalan physicians at an urban public hospital were PrEP aware and willing to prescribe, but few have actually done so yet. Future education programs should address the concerns identified, including the low potential for the development of antiretroviral resistance. These findings can aid PrEP implementation efforts in Guatemala.

HIV Pre-exposure Prophylaxis Programs Incorporating Social Applications Can Reach At-Risk Men Who Have Sex With Men for Successful Linkage to Care in Missouri, USA

Rupa R. Patel, MD, MPH, is the PrEP Program Director and an Assistant Professor, Division of Infectious Diseases, Washington University in St. Louis, St. Louis, Missouri, USA. (*Correspondence to: rupapatel@wustl.edu). Laura C. Harrison, BA, is a Research Assistant, Division of Infectious Diseases, Washington University in St. Louis, St. Louis, Missouri, USA. Viraj V. Patel, MD, MPH, is an Assistant Professor of Medicine, Division of General Internal Medicine, Montefiore Health System and Albert Einstein College of Medicine, Bronx, New York, USA. Philip A. Chan, MD, MS, is an Assistant Professor of Medicine, Division of Infectious Diseases, Brown University, Providence, Rhode Island, USA. Kenneth H. Mayer, MD, is a Professor of Medicine, Harvard Medical School, a CoChair and Medical Research Director, The Fenway Institute, and an Attending Physician, Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA. Hilary E. Reno, MD, PhD, is an Assistant Professor, Division of Infectious Diseases, Washington University in St. Louis, St. Louis, Missouri, USA. Tyrell Manning, BA, is an HIV 360 Fellow for the Human Rights Campaign Foundation and a Regional Integration Specialist, Williams and Associates, Inc., St. Louis, Missouri, USA.

Evolving models and ongoing challenges for HIV pre-exposure prophylaxis implementation in the United States

Background: The use of preexposure prophylaxis (PrEP) for HIV prevention was approved by the Food and Drug Administration in 2012, but delivery to at-risk persons has lagged. This critical review analyzes the current state of PrEP implementation in the United States, by reviewing barriers and innovative solutions to enhance PrEP access and uptake. Setting: Clinical care settings, public health programs, and community-based organizations (CBOs). Methods: Critical review of recent peer-reviewed literature. Results: More than 100 papers were reviewed. PrEP is currently provided in diverse settings. Care models include sexually transmitted disease clinics, community health centers, CBOs, pharmacies, and private primary care providers (PCPs). Sexually transmitted disease clinics have staff trained in sexual health counseling and are linked to public health programs (eg, partner notification services), whereas PCPs and community health centers may be less comfortable counseling and feel time-constrained in managing PrEP. However, PCPs may be ideal PrEP providers, given their long-term relationships with patients, integrating PrEP into routine care. Collaborations with CBOs can expand PrEP care through adherence support and insurance navigation. Pharmacies can deliver PrEP, given their experience with medication dispensing and counseling, and may be more accessible for some patients, but to address other health concerns, liaisons with PCPs may be needed. Conclusions: PrEP implementation in the United States is moving forward with the development of diverse models of delivery. Optimal scale-up will require learning about the best features of each model and providing choices to consumers that enhance engagement and uptake.