Correlation Between H-Index, M-Index, and Academic Rank in Urology.

OBJECTIVES: To evaluate the h- and m-indices of academic urologists across all U.S. accredited urology residency programs to determine the relationship between these metrics and an author's academic rank, academic degrees, and gender. METHODS: A total of 136 urology residency programs with available faculty information on their websites were evaluated. The academic rank, academic degrees, and gender were recorded for each clinical and research faculty member. Each author's h-index was determined using the Scopus database. The m-indices for each author were then calculated. Statistical analysis was performed using the Wilcoxon rank-sum test. RESULTS: This study demonstrated that the h- and m-indices positively correlate with an author's academic rank. Among the 2,253 academic urologists evaluated, chairs/chiefs and professors had the highest median h- and m-indices (h-index 26, m-index 1.046 for chairs/chiefs; h-index 30, m-index 1.094 for professors). This was followed by associate professors (h-index 14, m-index 0.750), assistant professors (h-index 6, m-index 0.667), and clinical instructors (h-index 6, m-index 0.511). The median h- and m-indices were overall statistically higher for males than females. Faculty members with only a PhD were found to have the highest h- and m-indices followed by MD PhD, MD MBA, MD MPH, MD only, and DO only in descending order of index value. CONCLUSIONS: The h- and m-indices of academic urologists positively correlate with their academic rank. These metrics may serve as an additional tool in measuring an individual's academic productivity in consideration of job hirings, positional promotions, societal memberships, achievement awards, research grants, and more.

Microbial interactions among Gardnerella, Prevotella and Fannyhessea prior to incident bacterial vaginosis: protocol for a prospective, observational study.

INTRODUCTION: The aetiology of bacterial vaginosis (BV), a biofilm-associated vaginal infection, remains unknown. Epidemiologic data suggest that it is sexually transmitted. BV is characterised by loss of lactic acid-producing lactobacilli and an increase in facultative and strict anaerobic bacteria. Gardnerella spp are present in 95%-100% of cases; Gardnerella vaginalis has been found to be more virulent than other BV-associated bacteria (BVAB) in vitro. However, G. vaginalis is found in women with normal vaginal microbiota and colonisation is not sufficient for BV development. We hypothesise that Gardnerella spp initiate BV biofilm formation, but incident BV (iBV) requires incorporation of other key BVAB (ie, Prevotella bivia, Fannyhessea vaginae) into the biofilm that alter the transcriptome of the polymicrobial consortium. This study will investigate the sequence of microbiologic events preceding iBV. METHODS AND ANALYSIS: This study will enrol 150 women aged 18-45 years with normal vaginal microbiota and no sexually transmitted infections at a sexual health research clinic in Birmingham, Alabama. Women will self-collect twice daily vaginal specimens up to 60 days. A combination of 16S rRNA gene sequencing, qPCR for Gardnerella spp, P. bivia and F. vaginae, and broad range 16S rRNA gene qPCR will be performed on twice daily vaginal specimens from women with iBV (Nugent score 7-10 on at least 2 consecutive days) and controls (with comparable age, race, contraceptive method and menstrual cycle days) maintaining normal vaginal microbiota to investigate changes in the vaginal microbiota over time for women with iBV. Participants will complete daily diaries on multiple factors including sexual activity. ETHICS AND DISSEMINATION: This protocol is approved by the University of Alabama at Birmingham Institutional Review Board (IRB-300004547) and written informed consent will be obtained from all participants. Findings will be presented at scientific conferences and published in peer-reviewed journals as well as disseminated to providers and patients in communities of interest.

Prevalence and Predictors of Oral Treponema pallidum Detection by qPCR in Early Syphilis.

BACKGROUND: Treponema pallidum (T. pallidum) prevalence and burden at oral and lesion sites in adults with early syphilis were assessed by qPCR. Factors associated with oral shedding were also examined. METHODS: Pre-treatment oral and lesion swabs were collected from adults with early syphilis in a US multicenter syphilis treatment trial. Oral swabs were collected in the presence and absence of oral lesions. Following DNA extraction, qPCR and whole genome sequencing (WGS) were performed to assess burden and strain variability. RESULTS: All 32 participants were male, mean age was 35, and 90.6% were living with HIV. T. pallidum oral PCR positivity varied by stage: 16.7% primary, 44.4% secondary, and 62.5% in early latent syphilis. Median oral T. pallidum burden was highest in secondary syphilis at 63.2 copies/µL. Lesion PCR positivity was similar in primary (40.0%) and secondary syphilis (38.5%). Age 18-29 years was significantly associated with oral shedding (vs age 40+) in adjusted models. WGS identified two distinct strains. CONCLUSION: T. pallidum DNA was directly detected at oral and lesion sites in a high proportion of men with early syphilis. Younger age was associated with oral shedding. Ease of oral specimen collection and increased PCR availability suggest opportunities to improve syphilis diagnostic testing.

Impact of Converting from Immediate-Release Tacrolimus to Envarsus on BK Viremia Incidence in Kidney Transplant Patients with Rapid Metabolism.

BACKGROUND BK infections have been observed more frequently among people who are rapid metabolizers. The tacrolimus c/d ratio identifies rapid metabolizers after transplantation. Envarsus has a lower peak drug level exposure than tacrolimus and is more pronounced in rapid metabolizers. This study hypothesized that less exposure to high tacrolimus levels through use of Envarsus would reduce the incidence of BK infections. MATERIAL AND METHODS This study prospectively converted 43 consecutive kidney transplant recipients (identified as rapid metabolizers by c/d ratio of.

Characterization of Vaginal Microbial Community Dynamics in the Pathogenesis of Incident Bacterial Vaginosis, a Pilot Study.

BACKGROUND: Despite more than 60 years of research, the etiology of bacterial vaginosis (BV) remains controversial. In this pilot study, we used shotgun metagenomic sequencing to characterize vaginal microbial community changes before the development of incident BV (iBV). METHODS: A cohort of African American women with a baseline healthy vaginal microbiome (no Amsel criteria, Nugent score 0-3 with no Gardnerella vaginalis morphotypes) were followed for 90 days with daily self-collected vaginal specimens for iBV (≥2 consecutive days of a Nugent score of 7-10). Shotgun metagenomic sequencing was performed on select vaginal specimens from 4 women, every other day for 12 days before iBV diagnosis. Sequencing data were analyzed through Kraken2 and bioBakery 3 workflows, and specimens were classified into community state types. Quantitative polymerase chain reaction was performed to compare the correlation of read counts with bacterial abundance. RESULTS: Common BV-associated bacteria such as G. vaginalis , Prevotella bivia , and Fannyhessea vaginae were increasingly identified in the participants before iBV. Linear modeling indicated significant increases in G. vaginalis and F . vaginae relative abundance before iBV, whereas the relative abundance of Lactobacillus species declined over time. The Lactobacillus species decline correlated with the presence of Lactobacillus phages. We observed enrichment in bacterial adhesion factor genes on days before iBV. There were also significant correlations between bacterial read counts and abundances measured by quantitative polymerase chain reaction. CONCLUSIONS: This pilot study characterizes vaginal community dynamics before iBV and identifies key bacterial taxa and mechanisms potentially involved in the pathogenesis of iBV.

Impact of testosterone use on the vaginal microbiota of transgender men, including susceptibility to bacterial vaginosis: study protocol for a prospective, observational study.

INTRODUCTION: The effect of testosterone (T) therapy on the vaginal microbiota of transgender men (TGM) is not well characterised, although one cross-sectional study comparing the vaginal microbiota of cisgender women to TGM on T≥1 year found that, in 71% of the TGM, the vaginal microbiota was less likely to be Lactobacillus-dominated and more likely to be enriched with >30 other bacterial species, many associated with bacterial vaginosis (BV). This prospective study aims to investigate changes in the composition of the vaginal microbiota over time in TGM who retain their natal genitalia (ie, vagina) and initiate T. In addition, we will identify changes in the vaginal microbiota preceding incident BV (iBV) in this cohort while investigating behavioural factors, along with hormonal shifts, which may be associated with iBV. METHODS AND ANALYSIS: T-naïve TGM who have not undergone gender-affirming genital surgery with normal baseline vaginal microbiota (ie, no Amsel criteria, normal Nugent Score with no Gardnerella vaginalis morphotypes) will self-collect daily vaginal specimens for 7 days prior to initiating T and for 90 days thereafter. These specimens will be used for vaginal Gram stain, 16S rRNA gene sequencing and shotgun metagenomic sequencing to characterise shifts in the vaginal microbiota over time, including development of iBV. Participants will complete daily diaries on douching, menses and behavioural factors including sexual activity during the study. ETHICS AND DISSEMINATION: This protocol is approved through the single Institutional Review Board mechanism by the University of Alabama at Birmingham. External relying sites are the Louisiana State University Health Sciences Center, New Orleans Human Research Protection Program and the Indiana University Human Research Protection Program. Study findings will be presented at scientific conferences and peer-reviewed journals as well as shared with community advisory boards at participating gender health clinics and community-based organisations servicing transgender people. REGISTRATION DETAILS: Protocol # IRB-300008073.

Sexually transmitted infection screening to prevent adverse birth and newborn outcomes: study protocol for a randomized-controlled hybrid-effectiveness trial.

BACKGROUND: Sexually transmitted infections (STIs) during pregnancy are associated with adverse birth outcomes, including preterm birth, low birth weight, perinatal death, and congenital infections such as increased mother-to-child HIV transmission. Prevalence of STIs among pregnant women in South Africa remains high, with most women being asymptomatic for their infection(s). Unfortunately, most STIs remain undetected and untreated due to standard practice syndromic management in accordance with World Health Organization (WHO) guidelines. Although lab-based and point-of-care molecular tests are available, optimal screening strategies during pregnancy, their health impact, and cost-effectiveness are unknown. METHODS: We will implement a 3-arm (1:1:1) type-1 hybrid effectiveness-implementation randomized-controlled trial (RCT). We will enroll 2500 pregnant women attending their first antenatal care (ANC) visit for their current pregnancy at participating health facilities in Buffalo City Metro District, Eastern Cape Province, South Africa. Participants allocated to arms 1 and 2 (intervention) will receive GeneXpert® point-of-care diagnostic testing for Neisseria gonorrhoeae, Chlamydia trachomatis, and Trichomonas vaginalis, with same-day treatment for detected infection(s). Arm 1 will additionally receive a test-of-cure 3 weeks post-treatment, while Arm 2 will receive a repeat test at 30-34 weeks' gestation. Those allocated to Arm 3 will receive syndromic management (standard-of-care). The RE-AIM framework will be used to guide collection of implementation indicators to inform potential future scale up. Primary outcome measures include (1) frequency of adverse birth outcomes among study arms, defined by a composite measure of low birth weight and pre-term delivery, and (2) change in STI prevalence between baseline and birth outcome among intervention arms and compared to standard-of-care. Estimates and comparative costs of the different screening strategies relative to standard-of-care and the costs of managing adverse birth outcomes will be calculated. Cost-effectiveness will be assessed per STI and disability-adjusted life year averted. DISCUSSION: This trial is the first RCT designed to identify optimal, cost-effective screening strategies that decrease the burden of STIs during pregnancy and reduce adverse birth outcomes. Demonstrating the impact of diagnostic screening and treatment, compared to syndromic management, on birth outcomes will provide critical evidence to inform changes to WHO guidelines for syndromic management of STIs during pregnancy. TRIAL REGISTRATION: ClinicalTrials.gov NCT04446611 . Registered on 25 June 2020.

Safer in care: A pandemic-tested model of integrated HIV/OUD care.

BACKGROUND: Rural, poor, persons with HIV (PWH) and substance use are among the most vulnerable to SARS-CoV-2 and related health service disruptions. The objective of the study was to evaluate the health outcomes and utilization of PWH at an Outpatient-based Opioid Treatment (OBOT) Clinic. METHODS: We evaluated a clinic-based cohort at the University of Alabama at Birmingham HIV clinic from November 2018 to May 2021. We compared HIV outcomes of OBOT patients, who are highly vulnerable, to the overall clinic. We stratified OBOT patients according to comorbid stimulant use disorder and compared clinic utilization and viral load suppression in the 6 months before and after the safer at home mandate (May 2020) in Alabama. RESULTS: Of 3857 PWH, 57 were referred to OBOT, 48 attended, 45 were initiated on buprenorphine, and 35 had a VL< 200 in the last 6 months. Relative to the overall HIV clinic, OBOT patients were significantly less likely to remain VL suppressed (90% vs 78%, p = 0.01). More patients were suppressed after OBOT linkage (81%) than prior (73%). For those referred before May 2020, there was no change in viral suppression before and after the safer at home order (75%). Although new OBOT referrals did not increase during the pandemic, the number of visits attended per month did increase from a median of 3-4 per patient. CONCLUSIONS: Unlike many PWH who faced access barriers, PWH receiving care at OBOT did not fall out of care but increased healthcare utilization and maintained viral suppression despite the public health emergency.

Testing strategies for couple engagement in prevention of mother-to-child transmission of HIV and family health in Kenya: study protocol for a randomized controlled trial.

BACKGROUND: HIV-related maternal deaths and HIV infection among infants remain unacceptably high across sub-Saharan Africa despite increased antenatal care attendance and provision of antiretroviral therapy to pregnant women. In the Jamii Bora ("Better Family" in Swahili) Study, we seek to test the efficacy of an interdependence theory-based couple intervention. The intervention reaches pregnant women and male partners through home visits by male-female pairs of lay health workers. The aim is to increase access to home-based couples' HIV testing and counseling services to improve family health. METHODS: This is a three-arm randomized control trial among 1080 pregnant women 15 years of age or older, living with their male partners, and who have not undergone couples' HIV testing and counseling in Kisumu and Migori Counties in Kenya. Couples will be randomized into three groups: home-based couple visits, HIV self-testing kits for couple use, or standard care (male partner clinic invitation letters). Participants will be followed up to 18 months postpartum. The study has three aims: in aim 1, we will determine the effects of the intervention on our primary outcome of couple HIV testing, compared to HIV self-testing kits and standard care; in aim 2, we will examine the intervention impact on HIV prevention behaviors, facility delivery, and postnatal healthcare utilization, as well as secondary health outcomes of maternal viral suppression and HIV-free child survival up to 18 months for couples living with HIV; and in aim 3, we will compare the cost-effectiveness of the home-based couple intervention to the less resource-intensive strategies used in the other two study arms. Assessments with couples are conducted at baseline, late pregnancy, and at months 3, 6, 12, and 18 after birth. DISCUSSION: The results from this study will inform decision-makers about the cost-effective strategies to engage pregnant couples in the prevention of mother-to-child transmission and family health, with important downstream benefits for maternal, paternal, and infant health. TRIAL REGISTRATION: ClinicalTrials.gov NCT03547739 . Registered on May 9, 2018.

Prevalence of and Factors Associated With Genital and Extragenital Chlamydia and Gonorrhea Among Transgender Women in HIV Care in the United States, 2005 to 2016.

BACKGROUND: Data on testing rates and prevalence of and factors associated with genital and extragenital chlamydia and gonorrhea among transgender women with HIV in the United States are limited. METHODS: This retrospective cohort analysis included transgender women living with HIV enrolled in the US Centers for AIDS Research Network of Integrated Clinical Systems cohort between January 2005 and December 2016 with chlamydia or gonorrhea testing performed in HIV clinic. The primary outcome was a positive test result for chlamydia or gonorrhea at urogenital or extragenital (rectal/pharyngeal) sites. Factors associated with infection were examined using logistic regression and generalized estimating equations to account for multiple tests per woman. RESULTS: Among 312 transgender women in HIV care, 252 (81%) were tested for chlamydia or gonorrhea at least once. Annual testing rates were low: 23% to 53% at genital sites and 24% to 47% at extragenital sites. A total of 88 infections were detected, and 22% of women (55/252) had at least one positive test result. Most infections occurred at extragenital sites (80% of chlamydia and 82% of gonorrhea positive test results). Factors associated with infection in an adjusted model were as follows: age 18 to 29 years compared with ≥50 years (adjusted odds ratio [aOR], 7.6; 95% confidence interval [CI], 1.8-31.2), CD4 count >350 compared with CD4 <200 (aOR, 5.5; 95% CI, 1.2-25.1), and higher engagement in HIV care (aOR, 2.2; 95% CI, 1.0-4.5). CONCLUSIONS: Among transgender women living with HIV, testing rates for chlamydia and gonorrhea are inadequate, particularly at extragenital sites where most infections occur.

Direct Acting Antivirals in Hepatitis C-Infected Kidney Transplant Recipients: Associations with Long-term Graft Failure and Patient Mortality.

BACKGROUND: Direct-acting antiviral (DAA) therapy among hepatitis C virus (HCV)-infected kidney transplant recipients is associated with short-term improvement in protein/creatinine (P/C) ratios, but how HCV cure affects long-term graft outcomes remains unknown. METHODS: This is a retrospective follow-up study of 59 HCV-infected patients who underwent kidney transplant at the University of Alabama at Birmingham between 2007-2015 who were followed until the end of 2017. We examined the association of DAA-induced HCV cure with graft failure or death by survival analyses (Kaplan-Meier, Cox regression). RESULTS: Mean age was 55 years, 73% were African American, and 68% were male. Median baseline creatinine was 1.4 mg/dL, P/C ratio was 0.5, and estimated glomerular filtration rate (eGFR) was 59 mL/min. Of those who received DAA, 24 (83%) achieved cure. The remaining 5 DAA patients (17%) did not have documented evidence of sustained virologic response (SVR). Overall, 19 (32%) patients experienced graft failure or death; with lower incidence in treated patients than untreated (4 vs 15 events; 2.6 vs 10.3 per 100 person-years [cHR 0.19, 95% CI: 0.06-0.66]). When adjusted for age, sex, race, and proteinuria, the association remained strong and invariant across time-varying (aHR 0.30, 95% CI: 0.08-1.10), time-averaged (aHR 0.28, 95% CI: 0.07-1.07), and time-varying-cumulative (aHR 0.32, 95% CI: 0.08-1.21) proteinuria metrics. CONCLUSIONS: DAAs therapy was associated with improved graft survival and reduced mortality. While not statistically significant, the association was strong, and these single-center findings warrant larger studies to demonstrate the benefits of HCV treatment in this population.

An Updated Conceptual Model on the Pathogenesis of Bacterial Vaginosis.

Bacterial vaginosis (BV) is the most common cause of vaginal discharge. It is associated with an increased risk of preterm delivery, pelvic inflammatory disease, and an increased risk of acquisition of sexually transmitted infections including human immunodeficiency virus (HIV). The epidemiology of BV supports sexual transmission. However, its etiology remains unknown. At the center of the debate is whether BV is caused by a primary pathogen or a polymicrobial consortium of microorganisms that are sexually transmitted. We previously published a conceptual model hypothesizing that BV is initiated by sexual transmission of Gardnerella vaginalis. Critics of this model have iterated that G. vaginalis is found in virginal women and in sexually active women with a normal vaginal microbiota. In addition, colonization does not always lead to BV. However, recent advances in BV pathogenesis research have determined the existence of 13 different species within the genus Gardnerella. It may be that healthy women are colonized by nonpathogenic Gardnerella species, whereas virulent strains are involved in BV development. Based on our results from a recent prospective study, in addition to an extensive literature review, we present an updated conceptual model for the pathogenesis of BV that centers on the roles of virulent strains of G. vaginalis, as well as Prevotella bivia and Atopobium vaginae.

Brief Report: Kidney Dysfunction Does Not Contribute Significantly to Antiretroviral Therapy Modification in Treatment-Naive PLWH Receiving Initial ART.

BACKGROUND: Antiretroviral therapy (ART) durability, time to modification or cessation, has declined. The study objective was to determine whether kidney dysfunction is contributing to reduced durability. METHODS: This retrospective follow-up study of CNICS evaluated treatment-naive PLWH initiating ART between 2007 and 2014. Regimen modification was defined as cessation/modification of any part of the 3-drug ART regimen. We evaluated the role of kidney dysfunction in initial regimen modification as both a mediator and effect measure modifier. Associations of the variables with the ART modification were examined using univariable and multivariable Cox proportional hazard models. RESULTS: Of 4515 PLWH included in the analysis, 1967 modified their ART. Of those receiving TDF-based ART (n = 3888), 1580 (41%) modified their regimen compared with 387 (62%) receiving other regimens. Overall, the median eGFR decreased by 5 mL/min/1.73 m (quartiles: first = -16, third = 0) from baseline to follow-up. Of the 128 patients with low baseline eGFR (<60 mL/min/1.73 m), the final eGFR remained low in 73% while it increased to above 60 mL/min/1.73 m in 27%. Of the 4387 with normal baseline eGFR, only 135 (3%) had a final eGFR <60 mL/min/1.73 m. Those with low eGFR at the baseline and/or final visits were more likely to modify ART than others (hazards ratio = 1.75, 95% confidence interval: 1.39 to 2.19, P < 0.001). Relative to other regimens, TDF-based ART was less likely to be modified when accounting for numerous clinical and demographic traits. CONCLUSIONS: For patients in our study initiated on ART, including TDF-based ART, in the last decade, kidney dysfunction is not a major factor leading to regimen modification.

Erectile Dysfunction Medication Prescription: STI and Risk Behavior in Men with HIV.

INTRODUCTION: Erectile dysfunction (ED) is a common diagnosis in up to 50% of men with HIV and prescription of erectile dysfunction medication (EDM) has been variably associated with increased risk behaviors and acquisition of sexually transmitted infections (STIs). AIM: We measured the association of EDM prescription with bacterial STI testing, STI infection and sexual behavior among men engaged in HIV care. METHODS: A retrospective cohort study was conducted among HIV-infected men in care at an urban HIV clinic in Birmingham, Alabama between 2008 and 2016. Paired data analysis was used to compare STI testing and behavioral outcomes during the 12-month period before and after EDM prescription. MAIN OUTCOME MEASURES: Our study outcomes were STI testing and infection rates for Chlamydia trachomatis (CT), Neisseria gonorrhoeae (GC) and incident syphilis as well as risk behaviors before and after EDM prescription. RESULTS: Of 2924 HIV-infected men engaged in care, 589 (20%) initiated EDM with a new prescription from a clinic provider during the study period. During the year after EDM prescription, all STI testing rates decreased: CT (OR = 0.76; 95% CI: 0.58 - 1.01; P = .06), GC (OR = 0.76; 95% CI: 0.58 - 1.01; P = .06), and syphilis (OR = 0.28; 95% CI: 0.20 - 0.38; P < .001). A total of 43 STIs were detected in this study (10 CT, 8 GC, and 25 syphilis) and 42/43 occurred among men who have sex with men (MSM). Sexual activity rates were high before and after EDM (87.6% vs 82.9%; P = .08), and consistent condom use was rare (6.6% in both time periods). After EDM prescription, the median number of sexual partners in the past 6 months decreased from 2 to 1 among MSM and was stable at 1 among men who have sex with women. CLINICAL IMPLICATION: Management of ED in HIV clinic provides an excellent opportunity to discuss risk reduction, safer sex practices, and the importance of routine STI screening to prevent HIV/STI transmission. STRENGTH & LIMITATIONS: This study provides insight into a common but understudied clinical scenario-ED in men with HIV-in an urban clinic population that is representative of the Southeastern United States. Adherence for ED medication was not assessed and STI risk behaviors were self-reported. CONCLUSION: EDM prescription did not lead to any detectable change in risk behavior in this setting but bacterial STI was common among MSM who were tested. Heudebert JP, Tamhane A, Burkholder GA, Dionne-Odom J. Erectile Dysfunction Medication Prescription: STI and Risk Behavior in Men with HIV. J Sex Med 2019;16:691-700.

Incidence and predictors of reinfection with trichomoniasis based on nucleic acid amplification testing results in HIV-infected patients.

Trichomonas vaginalis infection contributes to HIV transmission. The study objective was to determine the incidence and predictors of T. vaginalis reinfection among HIV-infected women in Birmingham, Alabama. A retrospective cohort study of women at an urban HIV clinic from August 2014 to March 2016 with T. vaginalis by nucleic acid amplification test (NAAT) was conducted. Time to first episode of reinfection was evaluated using Kaplan-Meier survival curves. The association of various predictors was evaluated by univariate and multivariable Cox proportional hazards analyses. Of 612 HIV-infected women at the UAB HIV clinic tested for T. vaginalis by the Aptima TV assay, 110 (18.0%) were identified with prevalent T. vaginalis infection. Overall, 25/110 (22.7%) had a first episode of T. vaginalis reinfection by NAAT with a rate of 3.7 reinfections per 100 person-months (95% confidence interval [CI]: 2.3, 5.2). In univariate analysis, only an HIV viral load (VL) ≥200 copies/ml approached statistical significance (hazard ratio = 2.26; 95% CI: 0.97, 5.29, p = 0.06). After adjusting for age and race, the association of HIV VL ≥200 copies/ml remained strong (adjusted hazard ratio = 2.49; 95% CI: 0.99, 6.27, p = 0.05). T. vaginalis reinfection was high among HIV-infected women in this sample, necessitating enhanced disease control efforts in this high-risk population.

Short Communication: Association of Vitamin D Insufficiency and Protective Tenofovir Diphosphate Concentrations with Bone Toxicity in Adolescent Boys and Young Men Using Tenofovir Disoproxil Fumarate/Emtricitabine for HIV Pre-Exposure Prophylaxis.

We examined associations of 25-hydroxy vitamin D (25-OHD), tenofovir disoproxil fumarate (TDF), and bone toxicity. We studied TDF/emtricitabine (FTC) HIV pre-exposure prophylaxis (PrEP) in young men who have sex with men (YMSM). Bone toxicity was predefined using bone mineral density/content change from baseline to week 48. Baseline serum 25-OHD was dichotomized as <20 ng/mL (insufficient/deficient) versus ≥20 (sufficient), and week 48 dried blood spot tenofovir diphosphate (TFV-DP) as >700 fmol/punch (protective against HIV acquisition) versus ≤700. Associations were examined by univariate and multivariable logistic regression, reporting crude and adjusted odds ratios (ORs), with 95% confidence intervals (CIs). Of 101 enrolled, 69 had complete bone assessments and 25-OHD; of these, 59 had week 48 TFV-DP data. Median (Q1-Q3) age was 20 (18-21) years; 54% were black/African American. In univariate analysis, participants with baseline 25-OHD <20 ng/mL (OR = 5.4; 95% CI = 1.9-16.5) and blacks (OR = 4.9; 95% CI = 1.7-15.2) had greater odds of bone toxicity than those with 25-OHD ≥20 or other races. TFV-DP was not associated with bone toxicity (OR = 1.6; 95% CI = 0.5-5.5). In multivariable analysis, compared with those with 25-OHD ≥20 and TFV-DP ≤700, those with 25-OHD ≥20 and TFV-DP >700 (OR = 11.5; 95% CI = 1.4-169.6), 25-OHD <20 and TFV-DP ≤700 (OR = 19.4; 95% CI = 3.0-228.7), and 25-OHD <20 and TFV-DP >700 (OR = 32.3; 95% CI = 3.3-653.6) had greater odds of bone toxicity after adjusting for race. In multivariable models, 25-OHD insufficiency, protective TFV-DP concentrations, and black race were significantly associated with bone toxicity after 48 weeks of TDF/FTC PrEP in YMSM. Clinical Trials Registration: NCT01769469.

Racial disparities in the prevalence and control of hypertension among a cohort of HIV-infected patients in the southeastern United States.

BACKGROUND: African Americans are disproportionately affected by both HIV and hypertension. Failure to modify risk factors for cardiovascular disease and chronic kidney disease such as hypertension among HIV-infected patients may attenuate the benefits conferred by combination antiretroviral therapy. In the general population, African Americans with hypertension are less likely to have controlled blood pressure than whites. However, racial differences in blood pressure control among HIV-infected patients are not well studied. METHODS: We conducted a cross-sectional study evaluating racial differences in hypertension prevalence, treatment, and control among 1,664 patients attending the University of Alabama at Birmingham HIV Clinic in 2013. Multivariable analyses were performed to calculate prevalence ratios (PR) with 95% confidence intervals (CI) as the measure of association between race and hypertension prevalence and control while adjusting for other covariates. RESULTS: The mean age of patients was 47 years, 77% were male and 54% African-American. The prevalence of hypertension was higher among African Americans compared with whites (49% vs. 43%; p = 0.02). Among those with hypertension, 91% of African Americans and 93% of whites were treated (p = 0.43). Among those treated, 50% of African Americans versus 60% of whites had controlled blood pressure (systolic blood pressure <140 mmHg and diastolic blood pressure <90 mmHg) (p = 0.007). After multivariable adjustment for potential confounders, prevalence of hypertension was higher among African Americans compared to whites (PR 1.25; 95% CI 1.12-1.39) and prevalence of BP control was lower (PR 0.80; 95% CI 0.69-0.93). CONCLUSIONS: Despite comparable levels of hypertension treatment, African Americans in our HIV cohort were less likely to achieve blood pressure control. This may place them at increased risk for adverse outcomes that disproportionately impact HIV-infected patients, such as cardiovascular disease and chronic kidney disease, and thus attenuate the benefits conferred by combination antiretroviral therapy.

Mental health service utilization is associated with retention in care among persons living with HIV at a university-affiliated HIV clinic.

BACKGROUND: Mental health (MH) comorbidities reduce retention in care for persons living with HIV (PLWH) and are associated with poor health outcomes. Optimizing retention in primary care is vital, as poor retention is associated with delayed receipt of antiretroviral (ARV) therapy, ARV non-adherence, and poor health outcomes, including failure to suppress viral load, decreased CD4 counts, and clinically significant ARV drug resistance. We hypothesized that MH service utilization would be associated with improved retention in care for patients with HIV and MH comorbidities. METHODS: This is a retrospective analysis of PLWH initiating outpatient HIV health care at a university-affiliated HIV clinic between January 2007 and December 2013. We examined the association between MH service utilization and retention in care, the outcome of interest, using univariate and multivariable logistic regression. RESULTS: Overall, 627 (84.4%) out of 743 patients were retained in care using the Health Resources & Services Administration HIV/AIDS Bureau (HRSA/HAB) metric. A multivariable model adjusted for several sociodemographic factors, MH comorbidities, and MH service utilization. The results suggest that lack of health insurance (public ORadj = 0.3, p < 0.01; no insurance ORadj = 0.4, p < 0.01) and ≥ 3 MH comorbidities (ORadj = 0.3, P = 0.01) were associated with decreased retention in care. Conversely, older age (> 45 years, ORadj. = 1.6, p = 0.14) and ≥ 3 MH service utilization visits (ORadj. = 6.8, p < 0.01) were associated with increased retention in care. CONCLUSIONS: Even in the absence of documented MH comorbidities, improved retention in care was observed with increasing MH service utilization. In order to achieve the US-based National HIV/AIDS Strategy goal of 90% retention in care for PLWH, MH service utilization should be considered along with other evidence-based interventions to improve retention for PLWH newly engaged in care.

Trends in antiretroviral therapy prescription, durability and modification: new drugs, more changes, but less failure.

OBJECTIVE: To evaluate the real world durability of contemporary ART for treatment-naïve people living with HIV (PLWH). DESIGN: A retrospective follow-up study in a multisite cohort. METHODS: This study of the CNICS (CFAR Network of Integrated Clinical Systems) cohort integrates data from eight Center for AIDS Research (CFARs). PLWH initiating ART between 2007 and 2014 were included. Durability was defined as time from the initiation until discontinuation/modification using Kaplan-Meier survival curves. Cox Proportional Hazards measured associations with various sociodemographic and clinical characteristics. RESULTS: Among 5373 PLWH, the initial regimen was modified in 2285 (43%) patients. Efavirenz/emtricitabine/tenofovir (n = 2173, 40%) was the most commonly prescribed initial ART regimen; elvitegravir/cobicistat/emtricitabine/tenofovir became more common after 2012. Median durability for all regimens was 48.6 months. There were statistically significant differences in median durability for NNRTI, InSTI, and protease inhibitor-based regimens, which lasted 61, 44, and 32 months, respectively. Female sex (aHR = 1.4; 95% CI 1.2-1.6), intravenous drug use (aHR = 1.6; 95% CI 1.3-1.9), and CD4 cell count less than 200 cells/µl (aHR = 1.2; 95% CI 1.1-1.3) were significantly associated with regimen modification. Compared with InSTI, those receiving an InSTI/protease inhibitor (aHR = 2.7; 95% CI 2.0-3.7) or protease inhibitor-based ART (aHR = 1.9; 95% CI 1.6-2.2) were significantly more likely to be modified; but those receiving NNRTI (aHR = 1.1; 95% CI 0.9-1.3) were not. CONCLUSION: In treatment-naive PLWH, NNRTI and InSTI-based ART were most durable, relative to protease inhibitor and InSTI/protease inhibitor-based ART, and were least likely to be modified/discontinued. A greater understanding of reasons for regimen modification/discontinuation is needed to analyze contemporary regimen durability.