Mental Health, Social Influences, and HIV Pre-exposure Prophylaxis (PrEP) Utilization Among Men and Transgender Individuals Screening for HIV Prevention Trials.

The effects of mental health comorbidities and social support on the HIV pre-exposure prophylaxis (PrEP) care continuum are unknown. We conducted a cross-sectional study of men and transgender individuals, ≥ 18 years-old, with ≥ 2 male or transgender partners, or recent condomless anal intercourse. Surveys assessed demographics, mental health treatment, depressive symptomatology, social support, and PrEP-related social contacts. Logistic regression assessed associations between these factors and PrEP uptake and persistence. Participants (n = 247) were 89% cis-male and 46% African-American. Median age was 27 (IQR:23-33). Thirty-seven percent had ever used PrEP, of whom 18% discontinued use. High depressive symptomology was identified in 11% and 9% were receiving mental health treatment. There were no significant associations between depressive symptoms or mental health treatment on the odds of PrEP uptake or discontinuation. Each additional PrEP contact conferred a greater odds of uptake (aOR:1.24, 95% CI: 1.09-1.42). Network-level targets may produce fruitful interventions to increase PrEP uptake.

Barriers and Facilitators of PrEP Adherence for Young Men and Transgender Women of Color.

We aimed to discover barriers and facilitators of HIV pre-exposure prophylaxis (PrEP) adherence in young men and transgender women of color who have sex with men (YMSM/TW). Short-term and sustained adherence were measured by urine tenofovir concentration and pharmacy refills, respectively. Optimal adherence was defined as having both urine tenofovir concentration consistent with dose ingestion within 48 h and pharmacy refills consistent with ≥ 4 doses per week use. Participants completed semi-structured interviews exploring adherence barriers and facilitators. Participants (n = 31) were primarily African-American (68%), mean age 22 years (SD: 1.8), and 48% had optimal adherence. Adherence barriers included stigma, health systems inaccessibility, side effects, competing stressors, and low HIV risk perception. Facilitators included social support, health system accessibility, reminders/routines, high HIV risk perception, and personal agency. Our findings identify targets for intervention to improve PrEP adherence in these populations, including augmenting health activation and improving accuracy of HIV risk perception.

Impact of store-and-forward (SAF) teledermatology on outpatient dermatologic care: A prospective study in an underserved urban primary care setting.

BACKGROUND: The clinical value of teledermatology in the primary care setting remains relatively unknown. OBJECTIVE: We sought to determine the impact of teledermatology on outpatient diagnosis, management, and access to dermatologic care in a resource-poor primary care setting. METHODS: We performed a prospective study of store-and-forward teledermatology consults submitted between January and November 2013 from 11 underserved clinics in Philadelphia to the University of Pennsylvania using mobile devices and the Internet. We assessed diagnostic and management concordance between primary care providers and dermatologists, time to consult completion, anticipated level of dermatology input in the absence of teledermatology, and number of consults managed with teledermatology alone. RESULTS: The study included 196 consults encompassing 206 dermatologic conditions. Diagnoses and management plans of primary care providers and dermatologists were fully concordant for 22% and 23% of conditions, respectively. The median time to consult completion was 14 (interquartile range 3-28) hours. At least 61% of consults would not otherwise have received dermatology input, and 77% of consults were managed with teledermatology alone. LIMITATIONS: Lack of a diagnostic gold standard, limited patient follow-up, and uncertain generalizability are limitations. CONCLUSION: Teledermatology is an innovative and impactful modality for delivering dermatologic care to outpatients in resource-poor primary care settings.

Screening for prostate cancer: a review of the evidence for the U.S. Preventive Services Task Force.

BACKGROUND: Screening can detect prostate cancer at earlier, asymptomatic stages, when treatments might be more effective. PURPOSE: To update the 2002 and 2008 U.S. Preventive Services Task Force evidence reviews on screening and treatments for prostate cancer. DATA SOURCES: MEDLINE (2002 to July 2011) and the Cochrane Library Database (through second quarter of 2011). STUDY SELECTION: Randomized trials of prostate-specific antigen-based screening, randomized trials and cohort studies of prostatectomy or radiation therapy versus watchful waiting, and large observational studies of perioperative harms. DATA EXTRACTION: Investigators abstracted and checked study details and quality using predefined criteria. DATA SYNTHESIS: Of 5 screening trials, the 2 largest and highest-quality studies reported conflicting results. One found that screening was associated with reduced prostate cancer-specific mortality compared with no screening in a subgroup of men aged 55 to 69 years after 9 years (relative risk, 0.80 [95% CI, 0.65 to 0.98]; absolute risk reduction, 0.07 percentage point). The other found no statistically significant effect after 10 years (relative risk, 1.1 [CI, 0.80 to 1.5]). After 3 or 4 screening rounds, 12% to 13% of screened men had false-positive results. Serious infections or urine retention occurred after 0.5% to 1.0% of prostate biopsies. There were 3 randomized trials and 23 cohort studies of treatments. One good-quality trial found that prostatectomy for localized prostate cancer decreased risk for prostate cancer-specific mortality compared with watchful waiting through 13 years of follow-up (relative risk, 0.62 [CI, 0.44 to 0.87]; absolute risk reduction, 6.1%). Benefits seemed to be limited to men younger than 65 years. Treating approximately 3 men with prostatectomy or 7 men with radiation therapy instead of watchful waiting would each result in 1 additional case of erectile dysfunction. Treating approximately 5 men with prostatectomy would result in 1 additional case of urinary incontinence. Prostatectomy was associated with perioperative death (about 0.5%) and cardiovascular events (0.6% to 3%), and radiation therapy was associated with bowel dysfunction. LIMITATIONS: Only English-language articles were included. Few studies evaluated newer therapies. CONCLUSION: Prostate-specific antigen-based screening results in small or no reduction in prostate cancer-specific mortality and is associated with harms related to subsequent evaluation and treatments, some of which may be unnecessary. PRIMARY FUNDING SOURCE: Agency for Healthcare Research and Quality.

Incidence of syphilis infection and syphilis-related care utilization among adolescents and young adults living with HIV.

BACKGROUND: Incidence of syphilis has been rising in recent years and disproportionately affects young adults, racial/ethnic minority men, and people living with HIV. This study describes patterns of syphilis infection and syphilis-related care utilization among adolescents and young adults living with HIV (AYALH) in Philadelphia. METHODS: We conducted a retrospective cohort study of AYALH receiving care at an adolescent-specialty clinic who received a syphilis test and/or benzathine penicillin for syphilis treatment from 2011 to 2018 (N = 335). Syphilis incidence rates were calculated by baseline demographic characteristics and by calendar year. Recurrent survival analysis was used to explore how demographic and neighborhood-level factors were associated with incident syphilis and syphilis-related care utilization. RESULTS: Syphilis-related care was provided 145 times and there were 109 episodes of confirmed syphilis among 83 unique participants between 2011 and 2018. The overall syphilis incidence rate was 13.50 (95% CI: 10.9-16.5) cases per hundred person-years. Participants assigned male sex at birth had higher hazards of infection (HR: 6.12, 95% CI: 1.53-24.48), while older participants (HR: 0.64, 95% CI: 0.58-0.72) and those living further from the clinic had lower hazards of infection (HR: 0.97, 95% CI: 0.94-1.00). Race, insurance status, neighborhood diversity index, and neighborhood social disadvantage index were not associated with hazard of infection or syphilis-related care utilization. CONCLUSIONS: Our study found high incidence of syphilis infection among a cohort of AYALH. Integrating comprehensive sexually transmitted infection prevention services into HIV care and improving syphilis prevention services in communities with high syphilis rates should be a priority in future intervention work.

Incorporating HIV Pre-Exposure Prophylaxis Care for Patients Seeking Induced Abortion and Pregnancy Loss Management.

BACKGROUND: Family planning clinical encounters are important opportunities for HIV prevention. Our objectives were to 1) estimate the proportion of patients seeking induced abortion and early pregnancy loss management eligible for HIV pre-exposure prophylaxis (PrEP) and 2) compare PrEP eligibility and uptake between patients with unintended and intended pregnancy. METHODS: We conducted a cross-sectional survey and a nested prospective cohort study of patients seeking an induced abortion or early pregnancy loss management. We assessed pregnancy intendedness, PrEP awareness, HIV risk and risk perception, desire for same-day PrEP start, and PrEP continuation at 30 days. We used the χ2 and Fisher's exact tests to assess differences between the participants with intended and unintended pregnancy. We had 80% power to detect a 14% difference in PrEP eligibility between the groups. RESULTS: We enrolled 250 women. Fifty-six percent (139) had an unintended pregnancy and 44% (110) had an intended pregnancy. PrEP eligibility did not differ significantly between the patients with intended and unintended pregnancy (16% vs. 10%; p = .18). More than one-half (54%, 135/250) were unaware of PrEP before their study visit, and 93% (232/250) considered themselves unlikely to acquire HIV. Of 33 women who were PrEP eligible, 11 accepted same-day start and 1 continued PrEP at 30 days. CONCLUSIONS: Intendedness of pregnancy was unrelated to PrEP eligibility in women seeking induced abortion and early pregnancy loss management. Most patients seeking these services are unaware of PrEP. Integrating PrEP into family planning care is likely to increase awareness and uptake of PrEP in women.

Performance of an automated electronic acute lung injury screening system in intensive care unit patients.

OBJECTIVE: Lung protective ventilation reduces mortality in patients with acute lung injury, but underrecognition of acute lung injury has limited its use. We recently validated an automated electronic acute lung injury surveillance system in patients with major trauma in a single intensive care unit. In this study, we assessed the system's performance as a prospective acute lung injury screening tool in a diverse population of intensive care unit patients. DESIGN: Patients were screened prospectively for acute lung injury over 21 wks by the automated system and by an experienced research coordinator who manually screened subjects for enrollment in Acute Respiratory Distress Syndrome Clinical Trials Network (ARDSNet) trials. Performance of the automated system was assessed by comparing its results with the manual screening process. Discordant results were adjudicated blindly by two physician reviewers. In addition, a sensitivity analysis using a range of assumptions was conducted to better estimate the system's performance. SETTING: The Hospital of the University of Pennsylvania, an academic medical center and ARDSNet center (1994-2006). PATIENTS: Intubated patients in medical and surgical intensive care units. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: Of 1270 patients screened, 84 were identified with acute lung injury (incidence of 6.6%). The automated screening system had a sensitivity of 97.6% (95% confidence interval, 96.8-98.4%) and a specificity of 97.6% (95% confidence interval, 96.8-98.4%). The manual screening algorithm had a sensitivity of 57.1% (95% confidence interval, 54.5-59.8%) and a specificity of 99.7% (95% confidence interval, 99.4-100%). Sensitivity analysis demonstrated a range for sensitivity of 75.0-97.6% of the automated system under varying assumptions. Under all assumptions, the automated system demonstrated higher sensitivity than and comparable specificity to the manual screening method. CONCLUSIONS: An automated electronic system identified patients with acute lung injury with high sensitivity and specificity in diverse intensive care units of a large academic medical center. Further studies are needed to evaluate the effect of automated prompts that such a system can initiate on the use of lung protective ventilation in patients with acute lung injury.

Tenofovir Urine Assay to Monitor Adherence to HIV Pre-exposure Prophylaxis.

Tenofovir Disoproxil Fumarate (TDF) and tenofovir Alafenamide (TAF) are prodrugs of tenofovir and have excellent long-term efficacy and tolerability for the treatment of HIV. An objective marker of adherence to tenofovir-based therapy could be clinically useful in supporting adherence to TDF-based HIV pre-Exposure Prophylaxis (PrEP) in populations in whom, self-report has been shown to be unreliable, and could play a role in resource-limited settings to support HIV and hepatitis B treatment adherence. A semi-quantitative high-performance liquid chromatographymass spectrometry method for tenofovir quantification of urine samples was developed. This assay detects tenofovir concentration in log10 levels between 1 and 10,000 ng/mL, and was shown to distinguish between recent adherence and low/non-adherence to both TDF and TAF, with a concentration of >1000 ng/mL, highly predictive of medication ingestion in the last 24-48 hours. This assay was validated relative to other markers of adherence including dried blood spot and selfreport in a highly adherent population of PrEP patients, and tenofovir was shown to be stable at room temperature in urine for at least 14 days. The assay was successfully used in a clinical setting to maintain high PrEP adherence and retention in care of 50 young men who have sex with men (MSM) over 48 weeks, to assess PrEP adherence in youth with mental health conditions, and to monitor drug levels relative to plasma levels in a case study of chewed TDF/FTC (tenofovir/emtricitabine) for PrEP. Further studies are underway to implement the tenofovir urine assay to monitor adherence and pre-exposure prophylaxis, nationally and internationally.

Social Support Networks Among Young Men and Transgender Women of Color Receiving HIV Pre-Exposure Prophylaxis.

PURPOSE: The aim of the study was to characterize perceived social support for young men and transgender women who have sex with men (YM/TWSM) taking HIV pre-exposure prophylaxis (PrEP). METHODS: Mixed-methods study of HIV-negative YM/TWSM of color prescribed oral PrEP. Participants completed egocentric network inventories characterizing their social support networks and identifying PrEP adherence support figures. A subset (n = 31) completed semistructured interviews exploring adherence support and qualities of PrEP support figures. We calculated proportions of role types (e.g., family), individuals disclosed to regarding PrEP use, and PrEP-supportive individuals within each participant network. Interviews were analyzed using an inductive approach. RESULTS: Participants (n = 50) were predominately African American men who have sex with men. Median age was 22 years (interquartile range: 20-23). Biologic family were the most common support figures, reported by 75% of participants (mean family proportion .37 [standard deviation (SD): .31]), followed by 67% reporting friends (mean friend proportion .38 [SD: .36]). Most network members were aware (mean disclosed proportion .74 [SD: .31]) and supportive (mean supportive proportion .87 [SD: .28]) of the participants' PrEP use. Nearly all (98%) participants identified ≥1 figure who provided adherence support; more often friends (48%) than family (36%). Participants characterized support as instrumental (e.g., transportation); emotional (e.g., affection); and social interaction (e.g., taking medication together). Key characteristics of PrEP support figures included closeness, dependability, and homophily (alikeness) with respect to sexual orientation. CONCLUSIONS: Although most YM/TWSM identified family in their support networks, friends were most often cited as PrEP adherence support figures. Interventions to increase PrEP adherence should consider integrated social network and family-based approaches.

I Am Men's Health: Generating Adherence to HIV Pre-Exposure Prophylaxis (PrEP) in Young Men of Color Who Have Sex with Men.

In 2012, the US Food and Drug Administration approved Truvada as a pre-exposure prophylaxis (PrEP) for adults at risk of HIV. PrEP is highly effective at preventing HIV when taken daily, but no gold standard exists for consistently administering PrEP to populations at highest risk. The "I Am Men's Health" program used an innovative methodology to generate adherence to PrEP in 23 mostly young men who have sex with men of color (yMSMc), during a 28-week period from February to September 2013. Adherence was measured using weekly medication pickup rates. The average age of the participants was 21 years, and the majority were black and lived below the poverty line. Time on PrEP ranged from 1 to 28 weeks (2723 person-days), and the weighted average adherence was 73%. The methodology used in this study was preliminarily effective at generating adherence to PrEP among high-risk yMSMc in a community setting and may help inform large-scale future HIV prevention interventions.

Vaccinating HIV patients: focus on human papillomavirus and herpes zoster vaccines.

Vaccination has been one of our most powerful tools to decrease morbidity and mortality from infectious diseases in the last century. It is critical to understand the evolving safety and efficacy data for vaccines in HIV-infected individuals as the number of people living with HIV in the United States and globally continues to increase. The quadrivalent human papillomavirus vaccine and the herpes zoster vaccine are newly licensed in the general population, and several studies have recently been published on the safety and efficacy of these vaccines in HIV populations. This manuscript reviews recent data for the vaccines most commonly administered in HIV patients and incorporates these data into our body of knowledge about the safety and efficacy of vaccines in this population. In addition, patient factors that predict response for each vaccine are discussed. Given the great burden of human papillomavirus and herpes zoster in HIV patients, we discuss the benefits and the challenges of vaccinating HIV patients with the human papillomavirus and herpes zoster vaccines. This review provides information that clinicians need to make real-time decisions in the absence of large-scale trials in the HIV population.

Application of the immunological disease continuum to study autoimmune and other inflammatory events after vaccination.

In vaccine safety monitoring, the evaluation of possible autoimmune events is challenging. Developing grouping systems based on pathophysiology, instead of organ systems, may enhance our ability to identify or verify associations between vaccines and adverse immunologically mediated events in clinical trials and post-licensure surveillance. Emerging data suggest that self-directed tissue inflammation occurs along a continuum from innate immune-driven diseases to adaptive immune-driven diseases. Herein, we develop this proposed classification for the vaccination setting in which inflammatory diseases are placed along a continuum according to the two major arms of the immune system, the innate immune arm (mediated by cells including neutrophils, macrophages and complement) and the adaptive immune arm (cell-mediated and humoral response). We incorporate hypersensitivity reactions and molecular mimicry vaccine-related reactions into this mechanistic scheme. We show how this could have important implications to assess mechanisms of potential immune-mediated adverse events following vaccination.