Transgender Women in Clinical Trials of Pre-Exposure Prophylaxis.

Lessons were learned with trans women who participated (as volunteers and investigators) in trials of HIV pre-exposure prophylaxis (PrEP). Trans women are not men. Compared with men who have sex with men, trans women trial participants were more likely to be involved with transactional sex, had more sexual partners, and were less likely to have PrEP medications detected in blood. Trans women define themselves differently in different cultures. One best practice is to ask at least 2 gender questions: sex assigned at birth and current gender. More information is needed to fully situate PrEP efficacy for trans women, including analysis of drug-drug interactions between PrEP medications and feminizing hormones and PrEP drug penetration into neovaginal tissues. Including trans women in studies is helpful only if their participation is specifically reported, as could occur in a table of baseline characteristics of the enrolled cohort. Gender-affirming care is important to foster appropriate uptake and use of PrEP. Such care includes use of preferred pronouns and names, safety to use the bathroom of choice, and access to gender-affirming hormone therapy and surgery. The consistent finding that PrEP works when taken across diverse populations having diverse practices related to gender, sexual intercourse, and hormone use provides a basis for offering PrEP to people at substantial risk of acquiring HIV although some subgroups may not have been fully represented in trials. Nonetheless, specific PrEP implementation science for trans women (and men) is essential to develop best practices for PrEP delivery and use

HIV pre-exposure prophylaxis in transgender women: a subgroup analysis of the iPrEx trial.

BackgroundPre-exposure prophylaxis (PrEP) with oral emtricitabine and tenofovir disoproxil fumarate is used to prevent the sexual acquisition of HIV in groups at high risk such as transgender women. We used data from the iPrEx study to assess PrEP efficacy, effectiveness, and adherence in transgender women.MethodsThe iPrEx trial was a randomised controlled trial of PrEP with oral emtricitabine plus tenofovir disoproxil fumarate compared with placebo in men who have sex with men (MSM) and transgender women, followed by an open-label extension. Drug concentrations were measured in blood by liquid chromatography and tandem mass spectroscopy. We did unplanned exploratory analyses to investigate differences in PrEP outcomes among transgender women and between transgender women and MSM.FindingsOf the 2499 participants enrolled in the randomised controlled trial, 29 (1%) identified as women, 296 (12%) identified as trans, 14 (1%) identified as men but reported use of feminising hormones, such that 339 (14%) reported one or more characteristics and are classified as transgender women for the purpose of this study. Compared with MSM, transgender women more frequently reported transactional sex, receptive anal intercourse without a condom, or more than five partners in the past 3 months. Among transgender women, there were 11 HIV infections in the PrEP group and ten in the placebo group (hazard ratio 1·1, 95% CI 0·5-2·7). In the PrEP group, drug was detected in none of the transgender women at the seroconversion visit, six (18%) of 33 seronegative transgender women (p=0·31), and 58 (52%) of 111 seronegative MSM (p<0·0001). PrEP use was not linked to behavioural indicators of HIV risk among transgender women, whereas MSM at highest risk were more adherent.InterpretationPrEP seems to be effective in preventing HIV acquisition in transgender women when taken, but there seem to be barriers to adherence, particularly among those at the most risk. Studies of PrEP use in transgender women populations should be designed and tailored specifically for this population, rather than adapted from or subsumed into studies of MSM.FundingUS National Institutes of Health and the Bill & Melinda Gates Foundation

Trends in obesity and associations with education and urban or rural residence in Thailand

Objective: To measure trends in the prevalence of overweight and obesity and the relationship with urban or rural residence and education in Thailand. Research Methods and Procedures: Data were from two nationally representative surveys of 38,323 individuals 18 years old (19,156 were 18 to 59 years old) in 2004 and 3375 individuals 18 to 59 years old in 1997. Overweight and obesity were defined using the World Health Organization’s Asian criteria. Results: Among those 18 years old in 2004, 17.8% of men (95% confidence interval, 16.6% to 19.0%) were overweight, 18.4% (17.3% to 19.5%) had Class I obesity, 4.8% (4.1% to 5.5%) had Class II obesity, and 15.9% (14.6% to 17.1%) had abdominal obesity. In women, 18.2% (17.1% to 19.2%) were overweight, 26.1% (24.9% to 27.3%) had Class I obesity, 9.3% (8.6% to 10.0%) had Class II obesity, and 37.3% (35.3% to 39.2%) had abdominal obesity. In those 18 to 59 years old, the prevalence of Class I obesity in men and all four categories in women significantly increased between 1997 and 2004. There was an inverse relationship in women but a positive relationship in men between education and the odds of being overweight or obese. In 2004, there were significantly lower odds of being overweight or obese in rural compared with urban men but similar odds between urban and rural women. Discussion: The prevalence of overweight and obesity in Thailand is high and increasing. Although the transition of overweight and obesity to those of lower socioeconomic status is not complete, it is well on the way