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Preexposure prophylaxis (PrEP) with emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) reduced HIV acquisition in the iPrEx trial among men who have sex with men and transgender women. Self-reported sexual risk behavior decreased overall, but may be affected by reporting bias. We evaluated potential risk compensation using biomarkers of sexual risk behavior. Sexual practices were assessed at baseline and quarterly thereafter; perceived treatment assignment and PrEP efficacy beliefs were assessed at 12 weeks. Among participants with ≥1 follow-up behavioral assessment, sexual behavior, syphilis, and HIV infection were compared by perceived treatment assignment, actual treatment assignment, and perceived PrEP efficacy. Overall, acute HIV infection and syphilis decreased during follow-up. Compared with participants believing they were receiving placebo, participants believing they were receiving FTC/TDF reported more receptive anal intercourse partners prior to initiating drug (12.8 vs. 7.7, P = 0.04). Belief in receiving FTC/TDF was not associated with an increase in receptive anal intercourse with no condom (ncRAI) from baseline through follow-up (risk ratio [RR] 0.9, 95% confidence interval [CI]: 0.6-1.4; P = 0.75), nor with a decrease after stopping study drug (RR 0.8, 95% CI: 0.5-1.3; P = 0.46). In the placebo arm, there were trends toward lower HIV incidence among participants believing they were receiving FTC/TDF (incidence rate ratio [IRR] 0.8, 95% CI: 0.4-1.8; P = 0.26) and also believing it was highly effective (IRR 0.5, 95% CI: 0.1-1.7; P = 0.12). There was no evidence of sexual risk compensation in iPrEx. Participants believing they were receiving FTC/TDF had more partners prior to initiating drug, suggesting that risk behavior was not a consequence of PrEP use.

Transgender people with sex recorded male at birth desiring feminization commonly use cyproterone acetate or spironolactone as antiandrogens with estradiol, but the optimal antiandrogen is unclear. We aimed to assess the effect of antiandrogens on breast development. We hypothesized this would be greater in those treated with cyproterone acetate than spironolactone due to more potent androgen receptor antagonism and suppression of serum total testosterone concentrations. A randomized clinical trial was conducted between 2020-2022 at an outpatient endocrinology clinic. Transgender people aged 18+ years old commencing feminizing gender affirming hormone therapy were included. The intervention was standardized estradiol therapy plus either spironolactone 100 mg daily or cyproterone acetate 12.5 mg daily for 6 months. The primary outcome was breast development as measured by the breast-chest distance. Secondary outcomes included estimated breast volume, suppression of serum total testosterone concentration <2 nmol/L, and Gender Preoccupation and Stability Questionnaire (GPSQ). Sixty-three people (median age 25 years) were enrolled, randomized, and included in intention to treat analysis (cyproterone acetate n = 32, spironolactone n = 31). At 6 months, there was no between-group difference in breast-chest distance (mean difference 0.27 cm, 95% CI -0.82 to 1.35, P = .6) or estimated breast volume (mean difference 17.26 mL, 95% CI -16.94 to 51.47, P = .3). Cyproterone acetate was more likely to suppress serum testosterone concentration to <2 nmol/L (odds ratio 9.01, 95% CI 1.83 to 4.44, P = .008). Changes in GPSQ were similar between groups. Antiandrogen choice should be based on clinician and patient preference with consideration of side effects. Further research is needed to optimize breast development in transgender people.

To date, no randomized controlled trials have specifically addressed behavior changes after HIV self-testing (HIVST) among transgender women. This study aims to evaluate the effects of HIVST on changes in HIV testing behavior, frequency of condomless sex, and partner numbers among transgender women in China. Participants were recruited from 2 Chinese cities using both online and offline methods. Transgender women were randomly assigned to receive an HIVST intervention. Data from the previous 3 months were collected at baseline, 3 months, and 6 months. The primary outcome was the mean change in the number of HIV tests among transgender women during the 6-month follow-up. An intention-to-treat analysis was conducted. The statistical analysis used analysis of covariance and linear mixed-effects models. From February to June 2021, and 255 transgender women were recruited, of which only 36.5% (93/255) had a steady job, and 27.1% (69/255) earned less than US $414.9 of income per month. They were randomly assigned to the intervention (n=127) and control (n=128) groups. At 6 months, the mean number of HIV tests was 2.14 (95% CI 1.80-2.48) in the intervention group and 1.19 (95% CI 0.99-1.40) in the control group (P<.001), with increases of 0.84 (95% CI 0.54-1.14) and 0.11 (95% CI -0.19-0.41) over 6 months, respectively. The net increase was 0.73 (95% CI 0.31-1.15; P<.001), with a similar adjusted result. No significant differences in the frequency of condomless sex or partner numbers were observed between the 2 groups. HIVST is an effective strategy for enhancing regular HIV testing behavior among transgender women in China. This strategy should be combined with measures to address the financial vulnerability of the transgender women community to reduce subsequent risk behaviors, including condomless sex. Chinese Clinical Trial Registry ChiCTR2000039766; https://www.chictr.org.cn/showproj.html?proj=61402.

TechStep was a technology-based trial, with a stepped care approach, to reduce sexual risks and increase PrEP uptake among transgender and gender expansive youth and young adults (15–24 years old). From October 2019 to September 2021, 254 participants were randomized into: 1) Text (n = 82), or 2) Webapp (n = 87), or 3) Control (n = 85). At the 3-month follow-up assessment, those randomized to Text and Webapp and did not demonstrate improvement on primary outcomes were re-randomized to receive virtual eCoaching (Text + or Webapp +), or to remain in their initial condition without eCoaching. Results showed no effect on condomless encounters at 6-month, the primary endpoint, when comparing the Webapp + (0.33 decrease; 95%CI: -0.01, 0.67, p-value = 0.057) or the Text + (0.27 decrease; 95%CI: -0.13, 0.68, p-value = 0.181) conditions to the Control condition. However, in secondary analyses, condomless encounters were significantly reduced for Text compared to Control. The rate of PrEP uptake was low for all study arms.Trial registration: Clinical Trials # NCT04000724 (registered June 26, 2019).

For maximum effect pre-exposure prophylaxis should be targeted to the subpopulations that account for the largest proportion of infections (population-attributable fraction [PAF]) and for whom the number needed to treat (NNT) to prevent infection is lowest. We aimed to estimate the PAF and NNT of participants in the iPrEx (Pre-Exposure Prophylaxis Initiative) trial. The iPrEx study was a randomised controlled efficacy trial of pre-exposure prophylaxis with coformulated tenofovir disoproxil fumarate and emtricitabine in 2499 men who have sex with men (MSM) and transgender women. Participants aged 18 years or older who were male at birth were enrolled from 11 trial sites in Brazil, Ecuador, Peru, South Africa, Thailand, and the USA. Participants were randomly assigned (1:1) to receive either a pill with active pre-exposure prophylaxis or placebo, taken daily. We calculated the association between demographic and risk behaviour during screening and subsequent seroconversion among placebo recipients using a Poisson model, and we calculated the PAF and NNT for risk behaviour subgroups. The iPrEx trial is registered with ClinicalTrials.gov, NCT00458393. Patients were enrolled between July 10, 2007, and Dec 17, 2009, and were followed up until Nov 21, 2010. Of the 2499 MSM and transgender women in the iPrEx trial, 1251 were assigned to pre-exposure prophylaxis and 1248 to placebo. 83 of 1248 patients in the placebo group became infected with HIV during follow-up. Participants reporting receptive anal intercourse without a condom seroconverted significantly more often than those reporting no anal sex without a condom (adjusted hazard ratio [AHR] 5·11, 95% CI 1·55–16·79). The overall PAF for MSM and transgender women reporting receptive anal intercourse without a condom was 64% (prevalence 60%). Most of this risk came from receptive anal intercourse without a condom with partners with unknown serostatus (PAF 53%, prevalence 54%, AHR 4·76, 95% CI 1·44–15·71); by contrast, the PAF for receptive anal intercourse without a condom with an HIV-positive partner was 1% (prevalence 1%, AHR 7·11, 95% CI 0·70–72·75). The overall NNT per year for the cohort was 62 (95% CI 44–147). NNTs were lowest for MSM and transgender women self-reporting receptive anal intercourse without a condom (NNT 36), cocaine use (12), or a sexually transmitted infection (41). Having one partner and insertive anal sex without a condom had the highest NNTs (100 and 77, respectively). Pre-exposure prophylaxis may be most effective at a population level if targeted toward MSM and transgender women who report receptive anal intercourse without a condom, even if they perceive their partners to be HIV negative. Substance use history and testing for STIs should also inform individual decisions to start pre-exposure prophylaxis. Consideration of the PAF and NNT can aid in discussion of the benefits and risks of pre-exposure prophylaxis with MSM and transgender women. National Institute of Allergy and Infectious Diseases and the Bill & Melinda Gates Foundation.

ObjectivesFor transgender and gender-diverse (TGD) people, it is known that there is a lack of healthcare professionals with experience in trans healthcare. This may result in either inadequate provision of healthcare or in an increased seeking of adequate trans healthcare. Little is known about healthcare services utilisation and resulting costs in treatment-seeking TGD people with gender incongruence or gender dysphoria (GIC/GD). Therefore, the aim of this study was to determine the excess costs associated with GIC/GD in Germany.DesignIn a secondary analysis, baseline data of a randomised controlled trial with a sample of TGD people with GIC/GD were combined with data of a telephone survey conducted in a representative sample of the general German population. The data sets were matched using entropy balancing. Self-reported healthcare services utilisation was valued by standardised unit costs for the German healthcare system, and absenteeism from work and unemployment were valued with the gross hourly wage of persons in manufacturing and services sectors.SettingsTGD people with GIC/GD living at least 50 km outside Hamburg in the federal state Bremen, Mecklenburg-Western Pomerania, Lower Saxony or Schleswig Holstein and the German general adult population.ParticipantsTreatment-seeking TGD people with GIC/GD (n=167) and people of the general German population (n=2811).Primary and secondary outcome measures6-month excess healthcare costs and indirect costs from a societal perspective were calculated for the year 2020 using two-part models with logit specification for the first part and a generalised linear model with gamma family and log link function for the second part.ResultsThe total 6-month excess costs associated with GIC/GD from a societal perspective were estimated to be €672 (95% CI: €−3315 to €4657; p=0.741) per person. The direct excess healthcare costs were estimated to be €2 (€−1115 to €1119; p=0.977) and the indirect excess costs due to absenteeism from work and unemployment were €669 (€−3031 to €4370; p=0.723) per person. The total excess costs associated with GIC/GD in trans men, trans women and non-binary people were estimated to be €−5572 (€−12 232 to €1088), €4238 (€−1694 to €10 170) and €3041 (€−4268 to €10 351) per person (all with p>0.05), respectively.ConclusionsThe total 6-month costs in TGD people with GIC/GD did not differ statistically significantly from the costs in the general German population. Indirect excess costs due to absenteeism from work accounted for the largest part of the excess costs associated with GIC/GD, yet with wide 95% CIs. Potential causes of absenteeism from work, such as experienced or expected discrimination, need to be identified and addressed so that TGD people can experience a healthy work environment.Trial registration numberNCT04290286.

Background Transgender women in the U.S. have an alarmingly high incidence rate of HIV infection; condomless anal and vaginal sex is the primary risk behavior driving transmission. Young transgender women are the subpopulation at the highest risk for HIV. Despite this, there are no published randomized controlled efficacy trials testing interventions to reduce sexual risk for HIV among this group. This paper describes the design of a group-based intervention trial to reduce sexual risk for HIV acquisition and transmission in young transgender women. Methods This study, funded by the National Institutes of Health, is a randomized controlled trial of a culturally-specific, empowerment-based, and group-delivered six-session HIV prevention intervention, Project LifeSkills, among sexually active young transgender women, ages 16-29 years in Boston and Chicago. Participants are randomized (2:2:1) to either the LifeSkills intervention, standard of care only, or a diet and nutrition time- and attention-matched control. At enrollment, all participants receive standardized HIV pre- and post-test counseling and screening for HIV and urogenital gonorrhea and chlamydia infections. The primary outcome is difference in the rate of change in the number of self-reported condomless anal or vaginal sex acts during the prior 4-months, assessed at baseline, 4-, 8-, and 12-month follow-up visits. Discussion Behavioral interventions to reduce sexual risk for HIV acquisition and transmission are sorely needed for young transgender women. This study will provide evidence to determine feasibility and efficacy in one of the first rigorously designed trials for this population. Trial registration ClinicalTrials.gov number, NCT01575938 , registered March 29, 2012.

Tenofovir alafenamide fumarate (F/TAF) pre-exposure prophylaxis (PrEP) is understudied in sub-Saharan Africa. The Tandika PrEP study was a randomized trial that evaluated same-day F/TAF initiation, the impact of drug-level feedback on PrEP adherence, and integrated PrEP and sexually transmitted infection (STI) services for HIV-negative transgender women (TGW) in Uganda (NCT04491422). From April 2022-February 2023, a qualitative sub-study of 30 in-depth interviews explored (1) perspectives on same-day initiation of F/TAF PrEP, (2) experiences of urine tenofovir testing and drug-level feedback, and (3) descriptions of self-collection of samples for STI testing. Qualitative data were analyzed using an inductive content analytic approach. Integrated PrEP/STI services were valued by TGW because the convenience of urine testing motivated adherence and allowed for tenofovir and STI detection. (1) Preferred characteristics: F/TAF-based PrEP was easy to take and not readily identifiable as an HIV-related medication, resulting in less stigma than the better-known tenofovir disoproxil fumarate (F/TDF). Weight gain associated with F/TAF use was viewed positively by TGW as a symbol of health and prosperity in African settings. (2) Adherence motivation: PrEP adherence was motivated by a desire not to disappoint healthcare workers; TGW reciprocated adherence support and drug-level feedback by taking PrEP. (3) Facilitating adherence and STI care: Urine testing enhanced STI detection and treatment. Utilization of urine for tenofovir and STI testing motivated the uptake of HIV/STI care, emphasizing the importance of integrated PrEP and STI services. Integrating PrEP/STI services into differentiated delivery models could increase prevention uptake in this vulnerable population.

Background Despite the critical importance of humanized healthcare for transgender individuals, no existing measures specifically assess care humanization for this population. The Transgender Health Care Humanization Scale (THcH Scale) was developed to address this gap, yet it initially lacked confirmatory validation. This study validates the Transgender THcH scale for evaluating healthcare providers’ sensitivity towards transgender patients. Methods This study involved 443 healthcare professionals and students from a public university and associated hospital. Participants were divided randomly into two groups for Exploratory Factor Analysis (EFA) and Confirmatory Factor Analysis (CFA). Using the Kaiser-Meyer-Olkin Measure of Sampling Adequacy and Bartlett’s Test of Sphericity, EFA confirmed data suitability for factor analysis. Factors were identified using parallel analysis with an oblique Promax rotation to allow for inter-factor correlations. The internal consistency of the factors was assessed using Cronbach’s alpha. CFA was performed using Maximum Likelihood estimation, with goodness-of-fit evaluated by multiple indices. The THcH Scale’s divergent validity was assessed through Spearman’s correlation analysis with the Duke University Religion Index (DUREL). Results Exploratory and Confirmatory Factor Analyses confirmed the scale’s two-factor structure with excellent psychometric properties, including high internal consistency (Cronbach’s alpha > 0.8) and good fit indices (χ²/df = 1.74, CFI = 0.972, TLI = 0.964, GFI = 0.989, RMSEA = 0.069, SRMR = 0.043). Divergent validity was established through moderate correlations with the DUREL index. Conclusions The THcH scale is a reliable and valid tool for promoting sensitivity and awareness among healthcare professionals, thereby enhancing healthcare access and quality for the transgender population. Further research should expand its application to primary care and diverse populations and settings.

In the United States, transgender men and transmasculine people who have sex with men (TMSM) face an increased risk of HIV and encounter unique barriers to HIV prevention services, including preexposure prophylaxis (PrEP). Peer-based, digitally delivered support interventions that address these barriers in 1-on-1 or small-group settings may be effective in increasing PrEP engagement. This study aims to compare the efficacy of digitally delivered individual and small-group peer-based strategies for improving PrEP uptake and adherence among at-risk adult TMSM without HIV. The Transmasculine One-on-One and Group Empowerment for Targeted HIV Reduction (TOGETHR) study was a digital, open-label, randomized 2×2 factorial trial (1:1:1:1 randomization) of peer-delivered HIV prevention strategies designed to increase PrEP engagement in 300 PrEP-indicated TMSM without HIV. Participants were randomized to 1 of 4 conditions: (A) standard of care (SOC) package (information and PrEP locator tools), (B) SOC + PrEP for TMSM (PrEP4T; individual peer-based HIV prevention intervention), (C) SOC + LifeSkills for TMSM (LS4TM; group peer-based HIV prevention intervention), or (D) SOC + PrEP4T and LS4TM (both individual and group interventions). Interventions were delivered over a 6-week period. The study enrolled adults 18 years or older who were \"transgender men or transmasculine,\" sexually active with 1 or more partners who had a penis and were assigned male sex at birth, living without HIV, behaviorally at risk for HIV acquisition, and residing in geographic hot spots identified in the US Ending the HIV Epidemic initiative. Study protocols and procedures were codeveloped with our community advisory board, including eligibility criteria, operationalization of geographic stratification, study branding, and detailed recruitment plans. Recruitment and enrollment began on April 1, 2024, and as of March 20, 2025, 103 TMSM had been enrolled. The median age was 26 (IQR 24-31) years. Among the 103 participants, 39 (37.9%) identified as Black, Indigenous, and People of Color, and 18 (17.5%) as Latine; 36 (35.0%) identified as \"transgender man or trans man\"; 31 (30.1%) as transmasculine; and 15 (14.6%) as nonbinary, genderqueer, or gender nonconforming. Additionally, 69 (67.0%) had at least a four-year college degree, and only 7 (6.8%) had no health insurance. Granger causality tests indicated that recruitment activities via social media (P=.006) and transgender-inclusive dating platforms (P=.02) were most effective and predicted higher baseline enrollment survey completion 2 weeks later. On March 21, 2025, the National Institutes of Health terminated the grant award, citing gender ideology and stating, \"it is the policy of NIH not to prioritize such research programs.\" This study was part of a critical research pathway to identify effective strategies for preventing HIV acquisition in TMSM, a group traditionally underserved in HIV prevention, and to inform prevention packages that incorporate peer-delivered interventions. Strong engagement with the TMSM community was central to the study's success and provided valuable insights for future HIV prevention research and practice. ClinicalTrials.gov NCT06182280; https://clinicaltrials.gov/ct2/show/NCT06182280. DERR1-10.2196/76831.