Background No data are available on the feasibility of pre-exposure prophylaxis (PrEP) delivered by trained key population (KP) community health workers. Herein we report data from the KP-led Princess PrEP program serving men who have sex with men (MSM) and transgender women (TGW) in Thailand. Methods: From January 2016 to December 2017, trained MSM and TGW community health workers delivered same-day PrEP service in community health centres, allowing clients to receive one PrEP bottle to start on the day of HIV-negative testing. Visits were scheduled at Months 1 and 3, and every 3 months thereafter. Uptake, retention and adherence to PrEP services and changes in risk behaviours over time are reported. Results: Of 1467 MSM and 230 TGW who started PrEP, 44.1% had had condomless sex in the past 3 months. At Months 1, 3, 6, 9 and 12, retention was 74.2%, 64.0%, 56.2%, 46.7% and 43.9% respectively (lower in TGW than MSM at all visits; P<0.001), with adherence to at least four PrEP pills per week self-reported by 97.4%, 96.8%, 96.5%, 97.5% and 99.5% of respondents respectively (no difference between MSM and TGW). Logistic regression analysis identified age >25 years, being MSM and having at least a Bachelors degree significantly increased retention. Condomless sex did not change over the 12-month period (from 47.2% to 45.2%; P=0.20). New syphilis was diagnosed in 4.9% and 3.0% of PrEP clients at Months 6 and 12 (cf. 7.0% at baseline; P=0.007). Among PrEP adherers and non-adherers, there were one and six HIV cases of seroconversion respectively, which resulted in corresponding HIV incidence rates (95% confidence interval) of 0.27 (0.04–1.90) and 1.36 (0.61–3.02) per 100 person-years. Conclusion: Our KP-led PrEP program successfully delivered PrEP to MSM and TGW. Innovative retention supports are needed, especially for TGW and those who are young or with lower education levels. To scale-up and sustain KP-led PrEP programs, strong endorsement from international and national guidelines is necessary.

Introduction Concerns over potential drug‐drug interactions (DDI) between feminizing hormone therapy (FHT) and pre‐exposure prophylaxis (PrEP) have hampered uptake and adherence of PrEP among transgender women (TGW). To determine DDI between FHT and PrEP, we measured the pharmacokinetic (PK) parameters of blood plasma estradiol (E2) and tenofovir (TFV) in Thai TGW. Methods Twenty TGW who never underwent orchiectomy and had not received injectable FHT within six months were enrolled between January and March 2018. FHT (E2 valerate and cyproterone acetate) were prescribed to participants at baseline until week 5, and then from week 8 until the end of study. Daily PrEP (tenofovir disoproxil fumarate/emtricitabine) was initiated at week 3 and continued without interruption. Intensive E2 PK parameters and testosterone concentration at 24 hours (C24) were measured at weeks 3 (without PrEP) and 5 (with PrEP), and intensive TFV PK parameters were measured at weeks 5 (with FHT) and 8 (without FHT). Results Median (interquartile range) age, body mass index, and creatinine clearance were 21.5 (21–26) years, 20.6 (19.0‐22.4) kg/m2, and 116 (101‐126.5) mL/min, respectively. The geometric mean (%CV) of area under curve from time zero to 24 hours (AUC0‐24), maximum concentration (Cmax), and C24 of E2 at weeks 3 and 5 were 775.13 (26.2) pg h/mL, 51.47 (26.9) pg/mL, and 15.15 (42.0) pg/mL; and 782.84 (39.6), 55.76 (32.9), and 14.32 (67.4), respectively. The geometric mean (%CV) of TFV AUC0‐24, Cmax, and C24 at weeks 5 and 8 were 2242.1 (26.5) ng h/mL, 353.9 (34.0) ng/mL, and 40.9 (31.4) ng/mL; and 2530.2 (31.3), 311.4 (30.0), and 49.8 (29.6), respectively. The geometric mean of TFV AUC0‐24 and C24 at week 5 were significantly less than that at week 8 by 12% (p = 0.03) and 18% (p < 0.001), respectively. There were no significant changes in E2 PK parameters and median C24 of bioavailable testosterone between week 3 and week 5. Conclusions Our study demonstrated lower blood plasma TFV exposure in the presence of FHT, suggesting that FHT may potentially affect PrEP efficacy among TGW; but E2 exposure was not affected by PrEP. Further studies are warranted to determine whether these reductions in TFV are clinically significant. Clinical Trial Number: NCT03620734.

No abstract

Men who have sex with men (MSM) and Transgender Women (TGW) in Thailand contribute to more than half of all new HIV infections annually. This cross-sectional study describes epidemiologic profiles of these key populations (KP) in Key Population-led Test and Treat study. Baseline data were collected using self-administered questionnaires and HIV/STI testing from MSM and TGW aged ≥18 years enrolled in a cohort study in six community sites in Thailand between October 2015 and February 2016. Factors associated with HIV prevalence were determined by logistic regression. TGW in the cohorts had lower education and income levels than MSM. TGW also engaged in sex work more, though similar proportions between MSM and TGW reported to have multiple sexual partners and STI diagnosis at baseline. HIV prevalence was 15.0% for MSM and 8.8% for TGW in the cohorts. HIV prevalence among TGW was more associated with sociodemographic characteristics, whereas factors related to behavioral risks were determined to be associated with HIV prevalence among MSM. TGW and MSM in the cohorts also had high prevalence of STI. Key Population-driven HIV services are able to capture harder-to-reach key populations who are at heightened risk for HIV.

IntroductionMen who have sex with men (MSM) and transgender women (TGW) are two key populations (KPs) in Thailand at high risk for HIV. Uptake and scale‐up of pre‐exposure prophylaxis (PrEP) among them has been slow. We used data from Princess PrEP, Thailand’s largest KP‐led PrEP programme, to operationalize PrEP service cascades. We identified gaps and pointed out where additional data are needed to inform a larger HIV prevention cascade.MethodsNumbers of people tested for HIV, tested HIV negative, eligible for PrEP (defined as any of the following in the past three months: condomless sex with partners of unknown/uncertain HIV status or antiretroviral treatment or viral load status, multiple partners, engaging in sex work, sexually transmitted infections, injecting drugs, using amphetamine‐type stimulants, or repeated use of post‐exposure prophylaxis), offered PrEP and accepted PrEP during January to November 2019 were retrieved from Princess PrEP database to inform PrEP service cascades for MSM and TGW. Reasons for not accepting PrEP were documented.ResultsOf 6287 MSM who received HIV testing in Princess PrEP, 92.3% were HIV negative and 70.2% of them were eligible for PrEP. PrEP was offered to 94.7% of those eligible and 48.0% of those offered accepted it. Among 900 TGW who had HIV testing, 95.3% tested HIV negative and 64.8% of them met PrEP eligibility criteria. Of these, 95.0% were offered PrEP and 43.9% of them accepted it. Among MSM and TGW who met PrEP eligibility criteria, no or low‐HIV‐risk perception was the most common reason provided (46.7% of 2007 MSM and 41.9% of 296 TGW) for not accepting PrEP.ConclusionsPrEP service cascades from the Princess PrEP programme identified no or low‐risk perception as key barrier to PrEP acceptance among MSM and TGW who met PrEP eligibility criteria. More implementation research studies are needed to explore PrEP motivation and access in larger communities outside of clinical services. This is to identify gaps and strategies to address them within motivation, access and effective use domains of the HIV prevention cascade.