Demonstration project of oral TDF-containing PrEP, administered, once-daily orally to men having sex with men (MSM) and transgender women (TGW) in India: Study protocol.

India has successfully reduced Human Immuno-deficiency Virus (HIV) incidence, with a 66% decline since the year 2000 has been seen; however, control among Men having sex with Men (MSM) and transgender women (TGW) remains a critical challenge. Oral Pre-Exposure Prophylaxis (PrEP) may help close a critical HIV prevention gap for MSM and TGW in India; however, no studies to date have evaluated the feasibility of oral PrEP among MSM and TGW in India. The proposed study aims at understanding the implementation of the provision of daily oral-Tenofovir (TDF) containing PrEP among MSM and TGW through the clinic and community-based delivery models in Pune, Maharashtra, and Jalandhar, Punjab respectively in India. The study aims at estimating PrEP adherence, facilitators, and barriers to PrEP use, retention, acceptability, and willingness to pay for PrEP. After the screening, eligible participants (n = 600) will receive PrEP medicines and will be monitored quarterly for HIV, STIs, and renal and liver toxicity for 12 months as per the schedule of events. The primary outcomes of interest are PrEP acceptability, PrEP adherence, retention rate, adverse medical events, and sexual behavioural changes with PrEP use and breakthrough infections while on PrEP. The study will assess the feasibility of two service delivery models; however, the data from the two service delivery models will be analyzed independently and will not be compared for feasibility and other outcome indicators. The study has been initiated after obtaining appropriate regulatory approvals. PrEP is efficacious in preventing HIV among high-risk population however there are scarce data on providing PrEP to MSM and TGW. The study will provide critical evidence to programs and policymakers on the implementation of PrEP in a "real world" setting, among MSM and TGW in India including identifying populations that can benefit most from this additional HIV prevention intervention along with acceptable delivery strategies and means of support for adherence. Not applicable being a demonstration project. Efficacy is already proven.

Sahay S ，Bangar S ，Chandhiok N 《PLoS One》

Prepped for PrEP? Acceptability, continuation and adherence among men who have sex with men and transgender women enrolled as part of Vietnam's first pre-exposure prophylaxis program.

Green KE ，Nguyen LH ，Phan HTT ，Vu BN ，Tran MH ，Ngo HV ，Tieu VTT ，Van H ，Le TM ，Do KQ ，Nguyen PA ，Ngo TM ，Doan AH ，Bui DTN ，Nguyen TNN ，Hang LTX ，Tran TT ，Luong BQ ... -  《-》

High pre-exposure prophylaxis uptake and early adherence among men who have sex with men and transgender women at risk for HIV Infection: the PrEP Brasil demonstration project.

Hoagland B ，Moreira RI ，De Boni RB ，Kallas EG ，Madruga JV ，Vasconcelos R ，Goulart S ，Torres TS ，Marins LMS ，Anderson PL ，Luz PM ，Costa Leite ID ，Liu AY ，Veloso VG ，Grinsztejn B ，PrEP Brasil Study TeamClinical Trial Number 01989611 ... -  《Journal of the International AIDS Society》

Evaluation of a pre-exposure prophylaxis programme for men who have sex with men and transgender women in Thailand: learning through the HIV prevention cascade lens.

Men 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. Numbers 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. Of 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. PrEP 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.

Ramautarsing RA ，Meksena R ，Sungsing T ，Chinbunchorn T ，Sangprasert T ，Fungfoosri O ，Meekrua D ，Sumalu S ，Pasansai T ，Bunainso W ，Wongsri T ，Mainoy N ，Colby D ，Avery M ，Mills S ，Vannakit R ，Phanuphak P ，Phanuphak N ... -  《Journal of the International AIDS Society》

HIV prevalence and incidence in a cohort of South African men and transgender women who have sex with men: the Sibanye Methods for Prevention Packages Programme (MP3) project.

Men who have sex with men (MSM) and transgender women (TGW) are at increased risk for acquiring HIV, but there are limited HIV incidence data for these key populations in Africa. Understanding HIV prevalence and incidence provides important context for designing HIV prevention strategies, including pre-exposure prophylaxis (PrEP) programmes. We describe HIV prevalence, awareness of HIV infection, HIV incidence and associated factors for a cohort of MSM and TGW in Cape Town and Port Elizabeth, South Africa. From 2015 to 2016, MSM and TGW in Cape Town and Port Elizabeth were enrolled and prospectively followed for 12 months, receiving a comprehensive package of HIV prevention services. HIV testing was conducted at baseline and at follow-up visits (targeted for three, six and twelve months). All HIV-negative PrEP-eligible participants were offered PrEP enrolment during the first four months of study participation. We determined HIV prevalence among participants at baseline, and incidence by repeat screening of initially HIV-negative participants with HIV tests at three, six and twelve months. Among 292 participants enrolled, HIV prevalence was high (43%; 95% CI: 38 to 49) and awareness of HIV status was low (50%). The 167 HIV-negative participants who were followed prospectively for 144.7 person-years; nine incident HIV infections were documented. Overall annual incidence was 6.2% (CI: 2.8 to 11.8) and did not differ by city. Annual HIV incidence was significantly higher for younger (18 to 19 years) MSM and TGW (MSM: 21.8% (CI: 1.2 to 100); TGW: 31.0 (CI: 3.7, 111.2)). About half of participants started PrEP during the study; the annual incidence of HIV among 82 (49%) PrEP starters was 3.6% (CI: 0.4, 13.1) and among those who did not start PrEP was 7.8% (CI: 3.1, 16.1). HIV incidence was high among MSM and TGW in the context of receiving a comprehensive package of prevention interventions and offering of PrEP. PrEP uptake was high; the observed incidence of HIV in those who started PrEP was about half the incidence of HIV in those who did not. Future implementation-oriented studies should focus on decisions to start and continue PrEP for those at highest risk, including young MSM.

Sullivan PS ，Phaswana-Mafuya N ，Baral SD ，Valencia R ，Zahn R ，Dominguez K ，Yah CS ，Jones J ，Kgatitswe LB ，McNaghten AD ，Siegler AJ ，Sanchez TH ，Bekker LG ... -  《Journal of the International AIDS Society》