Suchergebnisse

IntroductionPre‐exposure prophylaxis (PrEP) is recommended by the World Health Organization as an effective method of HIV prevention for individuals at risk for infection. In this paper, we describe the unique role that Thailand has played in the global effort to combat the HIV epidemic, including its role in proving the efficacy of PrEP, and discuss the opportunities and challenges of implementing PrEP in a middle‐income country.DiscussionThailand was one of the first countries in the world to successfully reverse a generalized HIV epidemic. Despite this early success, HIV prevalence has remained high among people who inject drugs and has surged among men who have sex with men (MSM) and transgender women (TGW). Two pivotal trials that showed that the use of oral antiretroviral medication as PrEP can reduce HIV transmission were conducted partially or entirely at Thai sites. Demonstration projects of PrEP, as well as clinical trials of alternative PrEP regimens, began or will begin in 2014–2015 in Thailand and will provide additional data and experience on how to best implement PrEP for high‐risk individuals in the community. Financing of drug costs, the need for routine laboratory monitoring and lack of awareness about PrEP among at‐risk groups all present challenges to the wider implementation of PrEP for HIV prevention in Thailand.ConclusionsAlthough significant challenges to wider use remain, PrEP holds promise as a safe and highly effective method to be used as part of a combined HIV prevention strategy for MSM and TGW in Thailand.

IntroductionHIV epidemics in the Asia‐Pacific region are concentrated among men who have sex with men (MSM) and other key populations. Pre‐exposure prophylaxis (PrEP) is an effective HIV prevention intervention and could be a potential game changer in the region. We discuss the progress towards PrEP implementation in the Asia‐Pacific region, including opportunities and barriers.DiscussionAwareness about PrEP in the Asia‐Pacific is still low and so are its levels of use. A high proportion of MSM who are aware of PrEP are willing to use it. Key PrEP implementation barriers include poor knowledge about PrEP, limited access to PrEP, weak or non‐existent HIV prevention programmes for MSM and other key populations, high cost of PrEP, stigma and discrimination against key populations and restrictive laws in some countries. Only several clinical trials, demonstration projects and a few larger‐scale implementation studies have been implemented so far in Thailand and Australia. However, novel approaches to PrEP implementation have emerged: researcher‐, facility‐ and community‐led models of care, with PrEP services for fee and for free. The WHO consolidated guidelines on HIV testing, treatment and prevention call for an expanded access to PrEP worldwide and have provided guidance on PrEP implementation in the region. Some countries like Australia have released national PrEP guidelines. There are growing community leadership and consultation processes to initiate PrEP implementation in Asia and the Pacific.ConclusionsCountries of the Asia‐Pacific region will benefit from adding PrEP to their HIV prevention packages, but for many this is a critical step that requires resourcing. Having an impact on the HIV epidemic requires investment. The next years should see the region transitioning from limited PrEP implementation projects to growing access to PrEP and expansion of HIV prevention programmes.

AbstractIntroductionTransgender women (TGW) need a specific package of primary care services usually not available in the publicly funded healthcare system. In addition, little is known about HIV and syphilis prevalence and incidence in clinic‐based samples of TGW. Here we evaluate the uptake of a transgender‐specific package of primary care services by TGW in Bangkok, Thailand and assess HIV and syphilis prevalence and incidence among them.MethodsOpen cohort study of TGW attending services at the Tangerine Community Health Clinic from 2016 to 2019. Cross‐sectional and longitudinal analysis of routinely collected clinic data was performed to study trends in the number of clients, clinic visits and HIV and syphilis prevalence and incidence.ResultsDuring the study period, 2947 TGW clients made a total of 5227 visits to Tangerine. The number of clients significantly increased from 446 in 2016 to 1050 in 2019 (p < 0.001) and the number of visits from 616 to 2198 during the same period (p < 0.001). Prevalence of HIV at first visit was 10.8% and of syphilis 9.8%. HIV incidence was 1.03 per 100 person years (PY) and of syphilis 2.06 per 100 PY of follow‐up. From 2016 to 2019, significant decreases occurred in the annual prevalence of HIV from 14.6% to 9.9% (p < 0.01). The annual prevalence of syphilis significantly increased from 6.6% in 2016 to 14.6% in 2018, and then decreased to 7.3% in 2019 (p < 0.001). The annual HIV incidence decreased during 2016 to 2019, from 1.68 to 1.28 per 100 PY, but this reduction was not statistically significant. The annual incidence of treponemal test seroconversion significantly increased from zero in 2016 to 4.55 per 100 PY in 2019 (p < 0.001).ConclusionsThe increasing uptake of a transgender‐specific package of services, including co‐located gender affirmative hormone therapy, suggests this may be an effective model in engaging and retaining TGW in primary care. The decrease in HIV prevalence and low HIV incidence across calendar years point at a possible reduction of HIV acquisition among the TGW population served by Tangerine. The increasing prevalence of syphilis suggests ongoing high‐risk sexual behaviour and underscores the need for screening and treatment for this infection at the time of delivery of HIV services.

AbstractIntroductionQuestions about the implementation of evidence‐based intervention to treat and prevent HIV have risen to the top of the field's scientific priorities. Despite the availability of highly efficacious treatment and prevention interventions, impact has fallen short of targets because these interventions are used with insufficient reach, consistency, sustainability and equity in diverse real‐world settings. At present, substantial excitement for implementation science — defined as research methods and strategies to improve use of evidence‐based interventions — has focused on developing and disseminating methods to conduct rigorous research. Yet, impactful answers depend on a sometimes less visible, but even more important, step: asking good questions about implementation.DiscussionIn this commentary, we offer several considerations for researchers formulating implementation research questions based on several distinctive features of the field. First, as findings are used not only by other researchers but by implementers, scientific questions must incorporate a range of stakeholder and community perspectives to be most relevant. Second, real‐world settings are contextually diverse, and the most relevant scientific questions must position answers to make sense within these contexts (whether geographical, organizational and sociological), rather than apart from them. Third, implementation is complex and dynamic; consequently, research questions must make use of emerging standards in describing implementation strategies and their effects whenever possible. Finally, the field of implementation science continues to evolve, so framing problems with a diverse disciplinary lens will enable researchers to pose insightful and impactful questions.ConclusionsWe are now at a juncture marked by both rich evidence‐based interventions and a persistent global pandemic. To achieve continued scientific progress against the HIV epidemic, asking the right questions might be part of the answer itself.

AbstractIntroductionLong‐acting and extended delivery (LAED) regimens for HIV treatment and prevention offer unique benefits to expand uptake, effective use and adherence. To date, research has focused on basic and clinical science around the safety and efficacy of these products. This commentary outlines opportunities in HIV prevention and treatment programmes, both for the health system and clients, that could be addressed through the inclusion of LAED regimens and the vital role of differentiated service delivery (DSD) in ensuring efficient and equitable access.DiscussionThe realities and challenges within HIV treatment and prevention programmes are different. Globally, more than 28 million people are accessing HIV treatment—the vast majority on a daily fixed‐dose combination oral pill that is largely available, affordable and well‐tolerated. Many people collect extended refills outside of health facilities with clinical consultations once or twice a year. Conversely, uptake of daily oral pre‐exposure prophylaxis (PrEP) has consistently missed global targets due to limited access with high individual cost and lack of choice contributing to substantial unmet PrEP need. Recent trends in demedicalization, simplification, additional method options and DSD for PrEP have led to accelerated uptake as its availability has become more aligned with user preferences. How people currently receive HIV treatment and prevention services and their barriers to adherence must be considered for the introduction of LAED regimens to achieve the expected improvements in access and outcomes. Important considerations include the building blocks of DSD: who (provider), where (location), when (frequency) and what (package of services). Ideally, all LAED regimens will leverage DSD models that emphasize access at the community level and self‐management. For treatment, LAED regimens may address challenges with adherence but their delivery should provide clear advantages over existing oral products to be scaled. For prevention, LAED regimens expand a potential PrEP user's choice of methods, but like other methods, need to be delivered in a manner that can facilitate frequent re‐initiation.ConclusionsTo ensure that innovative LAED HIV treatment and prevention products reach those who most stand to benefit, service delivery and client considerations during development, trial and early implementation are critical.

AbstractIntroductionIn Thailand, where the HIV epidemic is concentrated among key populations (KPs), particularly men who have sex with men (MSM) and transgender women (TGW), an HIV service delivery model tailored to KPs was piloted. This study evaluated the acceptability and retention of clients who accepted and declined the KP‐led HIV treatment service.MethodsA retrospective cohort study was conducted using secondary data from three community‐based organizations (CBOs) and three hospitals in Thailand. KP lay providers were trained to lead HIV treatment service in which MSM and TGW living with HIV received counselling and a 3‐month antiretroviral therapy (ART) supply at CBOs. Thai MSM and TGW who were at least 18 years, on ART for at least 6–12 months, without co‐morbidities/co‐infections, and virally suppressed were eligible and offered the service. Those who declined received ART via other service models offered by the hospitals and served as a comparison group.ResultsOf 220 clients screened between February 2019 and February 2020, 72% (159/220) were eligible of which 146 were MSM and 13 were TGW. Overall, 45% (72/159) accepted the KP‐led service. Of those who declined, 98% (85/87) preferred to see the physician at the hospital. After 12 months of follow‐up, among those accepted, 57% were in care at the CBO, 32% were referred back to and in care in other service models offered by the hospital, 10% were successfully transferred out to other hospital and 1% were lost to follow‐up (LTFU); among those declined, 92% were in care in any service models offered by the hospital, 5% were successfully transferred out to other hospital, 2% were LTFU and 1% died (p‐value<0.001).ConclusionsDespite moderate acceptability and retention in care at the CBO among the clients accepting the KP‐led service, almost all clients were engaged in care overall. Multiple service models that meet the preferences and needs of KPs living with HIV should be available to optimize engagement in care.

AbstractIntroductionWHO has recommended rapid antiretroviral therapy (ART) initiation, including same‐day ART (SDART). However, data on the feasibility in real‐world settings are limited. We implemented a cohort study at a stand‐alone HIV testing centre to examine its applicability and effectiveness.MethodsData were collected from the Thai Red Cross Anonymous Clinic in Bangkok, Thailand, between July 2017 and July 2018 from clients who were ART‐naïve and could return for follow‐up visits. Baseline laboratory tests and chest X‐ray were performed according to national guidelines, and clinical eligibility was determined based on physical examination and chest X‐ray findings. Primary outcomes were retention in care and viral load suppression at 3, 6 and 12 months.ResultsDuring the study period, 2427 people tested HIV positive. Of these, 2107 (2207/2427, 86.8%) met logistical criteria, and 1904 (1904/2427, 78.5%) agreed to SDART. One thousand seven hundred and twenty‐nine (1729/2427, 71.2%) were placed on ART, with 1257 received same‐day initiation and 1576 initiated ART within 7 days; 1198 clients were successfully referred to free, sustained ART sites. Retention among eligible clients who accepted SDART service at months 3, 6 and 12 was 79.8%, 75.2% and 75.3%, respectively.ConclusionsSame‐day ART initiation hub model at a stand‐alone HIV testing centre in an urban setting in Bangkok, Thailand, is highly feasible and has a potential for scaling up.Clinical Trial NumberNCT04032028

AbstractIntroductionConcerns 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.MethodsTwenty 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).ResultsMedian (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.ConclusionsOur 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.

AbstractIntroduction: PrEP awareness and uptake among men who have sex with men (MSM) and transgender women (TG) in Thailand remains low. Finding ways to increase HIV testing and PrEP uptake among high‐risk groups is a critical priority. This study evaluates the effect of a novel Adam's Love Online‐to‐Offline (O2O) model on PrEP and HIV testing uptake among Thai MSM and TG and identifies factors associated with PrEP uptake.Methods: The O2O model was piloted by Adam's Love (www.adamslove.org) HIV educational and counselling website. MSM and TG reached online by PrEP promotions and interested in free PrEP and/or HIV testing services contacted Adam's Love online staff, received real‐time PrEP eCounseling, and completed online bookings for receiving services at one of the four sites in Bangkok based on their preference. Auto‐generated site‐ and service‐specific e‐tickets and Quick Response (QR) codes were sent to their mobile devices enabling monitoring and check‐in by offline site staff. Service uptake and participant's socio‐demographic and risk behaviour characteristics were analyzed. Factors associated with PrEP uptake were assessed using multiple logistic regression.Results: Between January 10th and April 11th, 2016, Adam's Love reached 272,568 people online via the PrEP O2O promotions. 425 MSM and TG received eCounseling and e‐tickets. There were 325 (76.5%) MSM and TG who checked‐in at clinics and received HIV testing. Nine (2.8%) were diagnosed with HIV infection. Median (IQR) time between receiving the e‐ticket and checking‐in was 3 (0–7) days. Of 316 HIV‐negative MSM and TG, 168 (53.2%) started PrEP. In a multivariate model, higher education (OR 2.30, 95%CI 1.14–4.66; p = 0.02), seeking sex partners online (OR 2.05, 95%CI 1.19–3.54; p = 0.009), being aware of sexual partners' HIV status (OR 2.37, 95%CI 1.29–4.35; p = 0.008), ever previously using post‐exposure prophylaxis (PEP) (OR 2.46, 95%CI 1.19–5.09; p = 0.01), and enrolment at Adam's Love clinic compared to the other three sites (OR 3.79, 95%CI 2.06–6.95; p < 0.001) were independently associated with PrEP uptake.Conclusions: Adam's Love O2O model is highly effective in linking online at‐risk MSM and TG to PrEP and HIV testing services, and has high potential to be replicated and scaled up in other settings with high Internet penetration among key populations.

ABSTRACTAnalytic treatment interruption (ATI) is scientifically necessary in HIV‐remission ("cure") studies to test the effects of new interventions. However, stopping antiretroviral treatment poses risks to research participants and their sexual partners. Ethical debate about whether and how to conduct such studies has largely centered on designing risk‐mitigation strategies and identifying the responsibilities of research stakeholders. In this paper, we argue that because the possibility of HIV transmission from research participants to partners during ATI cannot practicably be eliminated—that is, it is ineliminable—the successful conduct of such trials ultimately depends on relationships of trust and trustworthiness. We describe our experiences with conducting and studying HIV‐remission trials with ATI in Thailand to examine the strengths, complexities, and limitations of the risk‐mitigation and responsibility approaches and to explore ways in which the building of trust—and trustworthiness—may help enhance the scientific, practical, and ethical dimensions of these trials.