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Background Tenofovir disoproxil fumarate (TDF) decreases bone mineral density (BMD). We hypothesized that vitamin D3 (VITD3) would increase BMD in youth receiving TDF. Methods This was a randomized, double-blind, placebo-controlled trial of directly observed VITD3 vs placebo every 4 weeks for 48 weeks in youth aged 16-24 years with HIV, RNA load

Background: Young men who have sex with men (YMSM) in the United States have among the highest incidence of HIV and sexually transmitted infection (STI) and the lowest uptake of HIV and STI testing and pre-exposure prophylaxis (PrEP). Nearly universal mobile phone ownership among youth provides an opportunity to leverage mobile health apps to increase HIV/STI testing and PrEP uptake among YMSM. Objective: The goals of this project are to develop and refine LYNX, a novel mobile app to support linkage to HIV/STIs testing and PrEP services among YMSM in the United States, and to evaluate the acceptability and feasibility of LYNX in a pilot randomized controlled trial (RCT). Methods: This research protocol will be conducted in 3 phases: an iterative development phase with a series of 3 focus groups among 20 YMSM to refine the LYNX app; an open technical pilot among 15 YMSM to optimize usability of the app; and then a 6-month pilot RCT among 60 HIV-uninfected YMSM at risk for HIV acquisition. Developed using the Information, Motivation, and Behavioral skills theoretical model, the LYNX app includes an electronic diary to track sexual behaviors (information), a personalized risk score to promote accurate risk perception (information/motivation), testing reminders (motivation/behavioral skills), and access to home-based HIV/STI testing options and geospatial-based HIV/STI testing care sites (behavioral skills). Feasibility and acceptability will be assessed through app analytics of usage patterns and acceptability scales administered via computer-assisted self-interview at 3 and 6 months. We will also evaluate preliminary efficacy by comparing the proportion of YMSM who test at least once during the 6-month pilot and the proportion who successfully link to a PrEP provider in the intervention versus control groups. Results: Formative work is currently underway. The LYNX pilot RCT will begin enrollment in October 2018, with study results available in 2019. Conclusions: The LYNX app is one of the first mobile apps designed to increase HIV/STI testing and PrEP uptake among YMSM. As low-perceived risk is a barrier to HIV/STI testing and PrEP use among youth, the personalized risk assessment and interactive sexual diary in LYNX could assist YMSM in better understanding their HIV risk and providing motivation to test for HIV/STIs and initiate PrEP. Coupled with community-based recruitment, this novel mobile app has great potential to reach and engage YMSM not currently involved in care and increase rates of HIV/STI testing and PrEP uptake in this vulnerable population. Trial Registration: ClinicalTrials.gov NCT03177512; https://clinicaltrials.gov/ct2/show/NCT03177512 (Archived by WebCite at http://www.webcitation.org/73c917wAw) International Registered Report Identifier (IRRID): DERR1-10.2196/10659

BACKGROUND Chronic venous disorders (CVD) is estimated to affect 30% to 50% of women and 10% to 30% of men. The most widely prescribed treatment for CVD worldwide is micronized purified flavonoid fraction 500 mg (MPFF). The aim of this clinical trial was to develop a new once daily 1000-mg oral suspension of MPFF. METHODS In an international, randomized, double-blind, parallel-group study, symptomatic individuals classified CEAP C0s to C4s were randomized in either treatment arm and treated for 8 weeks. Lower limb symptoms (discomfort, pain and heaviness) were assessed using Visual Analog Scales (VAS), and quality of life (QoL) was measured with the CIVIQ-20 Questionnaire. RESULTS A total of 1139 patients were included in the study. Both MPFF treatment regimens were well tolerated and associated with a significant reduction in lower limb symptoms. A non-inferiority of MPFF 1000-mg oral suspension once daily compared to MPFF 500-mg tablet twice daily (P

Given the elevated potential for primary or transmitted drug resistance (TDR) among newly HIV-infected individuals, there is a need for a deeper understanding of the baseline resistance patterns present in young men of color who have sex with men.Genotypic data were collected for participants aged 13-24 who were enrolled from seven sites. Univariate and bivariate methods were used to describe the prevalence of TDR and characteristics associated with TDR.Of the 296 individuals participating in the substudy, 145 (49%) had baseline genotypes. The majority of the individuals were African American (65%) and gay-identified (70%). There was significant variation in genotype availability by site (p.001). Major surveillance drug resistance mutations were present in 28 subjects (19.3%); the majority were non-nucleoside reverse transcriptase inhibitor mutations (12.4%). Subjects with TDR were less likely to have used alcohol on 1 or more days in the prior 2 weeks. Location was not associated with acquisition of TDR.There was a high rate of TDR in a geographically and racially diverse sample of HIV-infected young men of color who have sex with men. This represents a serious public health concern given the young age of this sample and the potential need for long-term antiretroviral therapy. These findings underscore the critical roles of both early case identification and secondary prevention.

Este trabajo representa los resultados del Uso y Actitudes relacionando el alcohol, tabaco, Hojas de coca, tranquilizantes y anfetaminas en Estudiantes de Enfermería de la Universidad Mayor de San Andrés. El objetivo es analizar las actitudes mediante el uso de diferentes substancias con aquellos que no usan en los últimos 12 meses. Los datos fueron recolectados en Agosto del 2002, utilizando un cuestionario auto administrado y distribuido, garantizando el anonimato. Se obtuvieron estos resultados: Las actitudes relacionadas a las drogas aprueban el uso de hojas de coca, uso de alcohol, uso de tranquilizantes y desaprueban el uso de cocaína. El uso personal de drogas en los últimos 12 meses corresponde a: hojas de coca diariamente, alcohol menos que una vez por semana y tabaco diariamente. El principal motivo de uso de estas drogas vinculase a la práctica religiosa; los estudiantes son introducidos por primera vez por familiares y por amigos/enamorados. This study presents the results of a research that examined the Use and Attitudes about alcohol, tobacco, coca leaves, tranquilizers and amphetamines among Nursing Students at the Universidad Mayor de San Andrés who had not used these substances over the last 12 months. Data were collected in August 2002 by means of a self-administered and distributed questionnaire, which guaranteed anonymity. The following results were obtained: Attitudes related to drugs approve of coca leaf and tranquilizer use and disapprove of cocaine. Personal use of drugs during the last 12 months corresponds to: daily use of coca leaves, alcohol less than once per week and tobacco every day. The main reason for using these drugs is related to religious practice; the students' first contact with drugs occurs through family members and (girl or boy) friends. Este trabalho representa os resultados do Uso e Atitudes relacionados ao álcool, tabaco, folhas de coca, tranqüilizantes e anfetaminas em estudantes de enfermagem da Universidade Mayor de San Andrés. O objetivo é analisar as atitudes mediante o uso das diferentes substâncias com aqueles que usaram ou não drogas nos últimos 12 meses. Os dados da amostra estratificada e intencional foram coletados em agosto de 2002, utilizando um questionário auto administrado distribuído para preservar o anonimato. Obtiveram-se estes resultados: as atitudes relacionadas às drogas demonstram a aprovação do uso das folhas de coca, álcool, tranqüilizantes e desaprovam o uso da cocaína. O uso pessoal de drogas nos últimos 12 meses corresponde a: às folhas de coca diariamente, ao álcool menos que uma vez por semana, e tabaco diariamente. O principal motivo do uso destas drogas vincula-se a prática religiosa; os estudantes são introduzidos pela primeira vez pelos familiares, pelos amigos/enamorados.

To evaluate the feasibility of offering voluntary counseling and expedited human immunodeficiency virus (HIV) testing to women in labor, and to assess the characteristics of two rapid HIV assays compared with results from an expedited standard enzyme immunoassay (EIA), with Western blot confirmation, as indicated, we undertook a pilot study immediately prior to enactment of New York State regulations (August 1999) requiring expedited testing of laboring women (or newborns) with undocumented HIV status. From June 9, 1999 through July 2, 1999, we offered HIV counseling and testing (CT) to all medically stable women in active labor, 106 of 125 (85%) of whom accepted. One woman was confirmed HIV-1 seropositive. Rapid assay sensitivity and specificity were: SUDS 100 and 98%, and Multispot 100 and 100%, respectively in comparison with 100 and 99% for the standard EIA. The positive predictive values (PPV) were SUDS 33%; Multispot 100%; and EIA 50%. While our sample size was small, it appears that the accuracy of rapid and expedited HIV assays may be improved by requiring two different reactive assays before informing women of HIV-seropositive results or initiating antiretroviral treatment.

Objective. To describe the extent of adherence to the recommended neonatal zidovudine (ZDV) regimen administered to infants who have been exposed to the human immunodeficiency virus (HIV) to prevent mother-to-child transmission of HIV and to determine which maternal factors are associated with compliance. Methods. HIV-infected women (n = 87) who were participating in a larger study of perinatal transmission at 3 inner-city New York City hospitals were interviewed 2 to 6 weeks’ postpartum to assess adherence to neonatal prophylaxis, social support, social network factors, and depression. In addition, plasma samples of 45 of their infants were assayed for ZDV levels. Results. A majority of women (71%) administered all of the prescribed 4 daily doses in the previous week, as measured by interview; self-reported adherence was not associated with any maternal characteristics. In contrast, poor adherence, as measured by lower infant ZDV plasma levels, was associated with asymptomatic HIV illness in the mother and having 2 or more other children; good adherence, as indicated by higher ZDV levels, was associated with the presence of a maternal social support network, disclosure of HIV infection, and mothers’ adherence to their own ZDV regimens during pregnancy. In multivariate regression analyses, maternal asymptomatic status (β = −0.40) was associated with lower infant ZDV levels, and maternal adherence during pregnancy (β = 0.37) was associated with higher levels. Conclusions. Women who are HIV asymptomatic and lack a social support network are more likely not to comply with the recommended neonatal prophylactic regimen of antiretroviral therapy. Future studies should address the prenatal period and social network factors, such as disclosure of serostatus, and the custody of other children.