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Introduction: The COVID-19 pandemic reached the African continent in less than three months from when the first cases were reported from mainland China. As COVID-19 preparedness and response plans were rapidly instituted across sub-Saharan Africa, many governments and donor organizations braced themselves for the unknown impact the COVID-19 pandemic would have in under-resourced settings with high burdens of PLHIV. The potential negative impact of COVID-19 in these countries is uncertain, but is estimated to contribute both directly and indirectly to the morbidity and mortality of PLHIV, requiring countries to leverage existing HIV care systems to propel COVID-19 responses, while safeguarding PLHIV and HIV programme gains. In anticipation of COVID-19-related disruptions, PEPFAR promptly established guidance to rapidly adapt HIV programmes to maintain essential HIV services while protecting recipients of care and staff from COVID-19. This commentary reviews PEPFAR's COVID-19 technical guidance and provides country-specific examples of programme adaptions in sub-Saharan Africa. Discussion: The COVID-19 pandemic may pose significant risks to the continuity of HIV services, especially in countries with high HIV prevalence and weak and over-burdened health systems. Although there is currently limited understanding of how COVID-19 affects PLHIV, it is imperative that public health systems and academic centres monitor the impact of COVID-19 on PLHIV. The general principles of the HIV programme adaptation guidance from PEPFAR prioritize protecting the gains in the HIV response while minimizing in-person home and facility visits and other direct contact when COVID-19 control measures are in effect. PEPFAR-supported clinical, laboratory, supply chain, community and data reporting systems can play an important role in mitigating the impact of COVID-19 in sub-Saharan Africa. Conclusions: As community transmission of COVID-19 continues and the number of country cases rise, fragile health systems may be strained. Utilizing the adaptive, data-driven programme approaches in facilities and communities established and supported by PEPFAR provides the opportunity to strengthen the COVID-19 response while protecting the immense gains spanning HIV prevention, testing and treatment reached thus far. Keywords: COVID-19; SARS-CoV-2; HIV care continuum; PEPFAR; readiness; response, 1 | INTRODUCTION Less than three months from the first reported cases of COVID-19 in China, the pandemic reached Nigeria, the first sub-Saharan African country to report a confirmed case [...]

Introduction: HIV testing is a required part of delivery of pre-exposure prophylaxis (PrEP) for HIV prevention. However, repeat testing can be challenging in busy, under-staffed clinical settings, which could negatively impact PrEP uptake and continuation. We prospectively evaluated optional facility-based HIV self-testing (HIVST) among young women using PrEP in an implementation programme. Methods: Between February and November 2019, we collected data from young women receiving PrEP at two family planning facilities in Kisumu, Kenya. At each PrEP follow-up visit, women were given the option to choose between provider-initiated testing and HIVST. We assessed factors associated with HIVST uptake and compared satisfaction with HIV testing and clinic experience between acceptors and decliners of HIVST. Results: A total of 172 women were offered HIVST at 202 PrEP follow-up visits. The median age was 21 years, 27% had multiple partners and 15% reported previously using HIVST. HIVST was accepted at 34.7% (70/202) of visits. Age (adjusted relative risk (aRR) 1.09 per year, 95% CI (confidence interval) 1.01 to 1.18), never being married (aRR 1.81, 95% CI 1.11 to 2.95) and having more PrEP follow-up visits (aRR 1.13 per visit, 95% CI 1.04 to 1.23) were associated with HIVST uptake. Compared to HIVST decliners, HIVST acceptors were more likely to be very happy with their overall testing experience (73% vs. 47% of visits, p = 0.003) and were more likely to say they would use HIVST in the future (96% vs. 76%, p < 0.001). Women who accepted HIVST had shorter visits than those choosing standard provider-initiated HIV testing (median [IQR]: 33 [32, 38] vs. 54 [41.5, 81] minutes, p = 0.003). Conclusions: In this pilot evaluation in Kenya, about one-third of women using PrEP opted for HIVST over provider-initiated testing, and those choosing HIVST spent less time in the clinic and were generally satisfied with their experience. HIVST in PrEP delivery is feasible and has the potential to simplify PrEP delivery and give clients testing autonomy. Additional studies are needed to explore optimal HIV retesting strategies in PrEP delivery, including the use of HIVST in PrEP at a larger scale and in different settings. Keywords: PrEP; HIV testing; self-testing; counselling; standard of care; satisfaction, 1 | INTRODUCTION As the scale-up of pre-exposure prophylaxis (PrEP) increases globally, barriers to PrEP implementation still remain. At the healthcare system level, a significant barrier is the complexity of [...]

Introduction: The HIV epidemic in Tijuana, Mexico is concentrated in key populations, including people who inject drugs (PWID). However, HIV interventions among PWID are minimal, and federal funding was provided for compulsory abstinence programmes associated with HIV and overdose. Alternatively, opioid agonist therapy reduces overdose, reincarceration, HIV, while improving antiretroviral therapy (ART) outcomes. We assessed potential impact and synergies of scaled-up integrated ART and opioid agonist therapy, compared to scale-up of each separately, and potential harms of compulsory abstinence programmes on HIV and fatal overdose among PWID in Tijuana. Methods: We developed a dynamic model of HIV transmission and overdose among PWID in Tijuana. We simulated scale-up of opioid agonist therapy from zero to 40% coverage among PWID. We evaluated synergistic benefits of an integrated harm reduction and ART scale-up strategy (40% opioid agonist therapy coverage and 10-fold ART recruitment), compared to scale-up of each intervention alone or no scale-up of low coverage ART and no harm reduction). We additionally simulated compulsory abstinence programmes (associated with 14% higher risk of receptive syringe sharing and 76% higher odds of overdose) among PWID. Results: Without intervention, HIV incidence among PWID could increase from 0.72 per 100 person-years (PY) in 2020 to 0.92 per 100 PY in 2030. Over ten years, opioid agonist therapy scale-up could avert 31% (95% uncertainty interval (UI): 18%, 46%) and 22% (95% UI: 10%, 28%) new HIV infections and fatal overdoses, respectively, with the majority of HIV impact from the direct effect on HIV transmission due to low ART coverage. Integrating opioid agonist therapy and ART scale-up provided synergistic benefits, with opioid agonist therapy effects on ART recruitment/retention averting 9% more new infections compared to ART scale-up alone. The intervention strategy could avert 48% (95% UI: 26%, 68%) of new HIV infections and one-fifth of fatal overdoses over ten years. Conversely, compulsory abstinence programmes could increase HIV and overdoses. Conclusions: Integrating ART with opioid agonist therapy could provide synergistic benefits and prevent HIV and overdoses among PWID in Tijuana, whereas compulsory abstinence programmes could cause harm. Policymakers should consider the benefits of integrating harm reduction and HIV services for PWID. Keywords: inject drugs; opioid agonist therapy; HIV; integration; Mexico; overdose; drug treatment, 1 | INTRODUCTION As global funding for HIV prevention and treatment programmes declines, service providers will need to maximize the benefits of their programmes by integrating and identifying potential synergies [...]

Introduction: People living with HIV (PLHIV) have an elevated risk of atherosclerotic cardiovascular disease (CVD) compared to their HIV-negative peers. Expanding statin use may help alleviate this burden. However, the choice of statin in the context of antiretroviral therapy is challenging. Pravastatin and pitavastatin improve cholesterol levels in PLHIV without interacting substantially with antiretroviral therapy. They are also more expensive than most statins. We evaluated the cost-effectiveness of pravastatin and pitavastatin for the primary prevention of CVD among PLHIV in Thailand who are not currently using lipidlowering therapy. Methods: We developed a discrete-state microsimulation model that randomly selected (with replacement) individuals from the TREAT Asia HIV Observational Database cohort who were aged 40 to 75 years, receiving antiretroviral therapy in Thailand, and not using lipid-lowering therapy. The model simulated each individual's probability of experiencing CVD. We evaluated: (1) treating no one with statins; (2) treating everyone with pravastatin 20mg/day (drug cost 7568 Thai Baht ($US243)/year) and (3) treating everyone with pitavastatin 2 mg/day (drug cost 8182 Baht ($US263)/year). Direct medical costs and quality-adjusted life-years (QALYs) were assigned in annual cycles over a 20-year time horizon and discounted at 3% per year. We assumed the Thai healthcare sector perspective. Results: Pravastatin was estimated to be less effective and less cost-effective than pitavastatin and was therefore dominated (extended) by pitavastatin. Patients receiving pitavastatin accumulated 0.042 additional QALYs compared with those not using a statin, at an extra cost of 96,442 Baht ($US3095), giving an incremental cost-effectiveness ratio of 2,300,000 Baht ($US73,812)/QALY gained. These findings were sensitive to statin costs and statin efficacy pill burden, and targeting of PLHIV based on CVD risk. At a willingness-to-pay threshold of 160,000 Baht ($US5135)/QALY gained, we estimated that pravastatin would become cost-effective at an annual cost of 415 Baht ($US13.30)/year and pitavastatin would become cost-effective at an annual cost of 600 Baht ($US19.30)/year. Conclusions: Neither pravastatin nor pitavastatin were projected to be cost-effective for the primary prevention of CVD among PLHIV in Thailand who are not currently using lipid-lowering therapy. We do not recommend expanding current use of these drugs among PLHIV in Thailand without substantial price reduction. Keywords: HIV; cardiovascular disease; statin; cost-effectiveness; Thailand; antiretroviral therapy, 1 | INTRODUCTION People living with HIV (PLHIV) have an elevated risk of atherosclerotic cardiovascular disease (CVD) compared to their HIV-negative peers [1]. This is only partially explained by the [...]

Introduction: Existing biomedical HIV prevention options, though highly effective, present substantial adherence challenges. End-user input on early-stage design of new HIV prevention approaches is critical to yielding products that achieve high uptake and adherence. The iPrevent Study examined youths' preferences for key attributes of long-acting Pre-Exposure Prophylaxis (PrEP), with a focus on characteristics pertinent to product delivery alongside key modifiable product attributes. Methods: A discrete choice experiment was conducted with female and male youth aged 18 to 24 in two high-density communities in Cape Town, South Africa during the period July 2017 to January 2019. Sexually active, PrEP-naive youth were recruited using population-based sampling; targeted sampling was used to enrol men who have sex with men (MSM). In a series of nine questions, participants were asked to choose between two hypothetical products composed of five attributes (form, dosing frequency, access, pain, insertion site). We used a random-parameters logit model to estimate preference weights and trade-offs among product alternatives. We examined differences across three subgroups: females, men who have sex with only women (MSW) and MSM. Results: A total of 807 participants (401 female) were enrolled with a median age of 21 years. Males included 190 MSM. Most youth had tested for HIV (95%) and reported being HIV-negative (91%). Across all groups, duration of effectiveness was the most important attribute, with strong preference for less frequent dosing. Injections were favoured over implants, though these preferences were strongest for females and MSM. Females preferred a product offered at a health clinic and disliked pharmacy access; all groups preferred the arm as the insertion site. Youth were willing to trade their preferred product form for longer duration. Conclusions: Youth indicated strong preferences for longer duration products. Each attribute nonetheless influenced preferences, offering insight into trade-offs that inform long-acting PrEP development. Keywords: HIV prevention; long-acting pre-exposure prophylaxis; discrete choice experiment; acceptability; adolescent girls and young women; men who have sex with men, 1 | INTRODUCTION End-user input on early stage design of new HIV prevention approaches is critical to yielding products that achieve high uptake and adherence. As evidenced by multiple clinical [...]

Keywords: HIV prevention; research ethics; guidelines; stakeholders; HIV Prevention Trials Network, Despite existing effective antiretroviral treatments and means of prevention, the human immunodeficiency virus (HIV) epidemic persists globally [1]. While efforts to scale-up access to these modalities is critical, research is [...]

Introduction: Global guidelines emphasize the ethical obligation of investigators to help participants in HIV-endpoint trials reduce HIV risk by offering an optimal HIV prevention package. Oral pre-exposure prophylaxis (PrEP) has increasingly become part of state-of-the-art HIV prevention. Here we describe the process of integrating oral PrEP delivery into the HIV prevention package of the Evidence for Contraceptive Options and HIV Outcomes (ECHO) Trial. Methods: ECHO was an open-label randomized clinical trial that compared HIV incidence among women randomized to one of three effective contraceptives. In total, 7830 women aged 16 to 35 years from 12 sites in four African countries (Eswatini, Kenya, South Africa and Zambia) were enrolled and followed for 12 to 18 months, from 2015 to 2018. Part-way through the course of the trial, oral PrEP was provided to study participants either off-site via referral or on site via trained trial staff. PrEP uptake was compared between different contraceptive users using Chi-squared tests or t-tests. HIV seroincidence rates were compared between participants who never versus ever initiated PrEP using exact Poisson regression. Results: PrEP access in ECHO began through public availability in Kenya in May 2017 and was available at all sites by June 2018. When PrEP became available, 3626 (46.3%) eligible women were still in follow-up in the study, and of these, 622 (17.2%) initiated PrEP. Women initiating PrEP were slightly older; more likely to be unmarried, not living with their partner, having multiple partners; and less likely to be earning their own income and receiving financial support from partners (all p < 0.05). PrEP initiation did not differ across study randomized groups (p = 0.7). Two-thirds of PrEP users were continuing PrEP at study exit. Conclusions: There is a need for improved HIV prevention services in clinical trials with HIV endpoints, especially trials among African women. PrEP as a component of a comprehensive HIV prevention package provided to women in a large clinical trial is practical and feasible. Provision of PrEP within clinical trials with HIV outcomes should be standard of prevention. Keywords: pre-exposure prophylaxis; clinical trials; standard of care; women; HIV, 1 | INTRODUCTION Within the context of clinical trials in which incident HIV infection is a primary study outcome, global guidelines emphasize an ethical imperative to assist participants reduce HIV [...]

Keywords: HIV; ART; differentiated service delivery; children; stable; family-centred, In 2017, the World Health Organization (WHO), together with the United States Centers for Disease Control and Prevention, the United States President's Emergency Plan for AIDS Relief (PEPFAR), the United [...]

Introduction: Pre-exposure prophylaxis (PrEP) is a key HIV prevention technology, and is a pillar of a comprehensive HIV prevention approach for men who have sex with men (MSM). Because there have been no national data to characterize trends in the PrEP continuum in the United States, overall and for key demographic groups of MSM, we aimed to describe the extent to which PrEP awareness, willingness and use changed over time, overall and for specific groups of MSM critical for HIV prevention (e.g. Black and Hispanic MSM, younger MSM, MSM in rural areas and MSM without health coverage). Methods: The American Men's Internet Survey (AMIS) is an annual survey of US MSM conducted in the United States among MSM aged [greater than or equal to]15 years since 2013. We analysed data on trends in elements of the PrEP continuum (awareness, willingness and use of PrEP) in a sample of 37,476 HIV-negative/unknown status MSM from December 2013 through November 2017. We evaluated trends in continuum steps overall and among demographic subgroups using Poisson models with Generalized Estimating Equations. For 2017 data, we used logistic regression to compare the prevalence of PrEP use among demographic groups. Results: Overall, 51.4% (n = 19,244) of AMIS respondents were PrEP-eligible across study years. Between 2013 and 2017, PrEP awareness increased from 47.4% to 80.6% willingness to use PrEP increased from 43.9% to 59.5% and PrEP use in the past 12 months increased from 1.7% to 19.9%. In 2017, use of PrEP was lower for men who were younger, lived outside of urban areas, and lacked health insurance; PrEP use was not different among Black, Hispanic and white MSM. Conclusions: Our data show progress in use of PrEP among US MSM, but also reveal mismatches between PrEP use and epidemic need. We call for additional support of PrEP initiation, especially among young, non-urban and uninsured MSM. Black and Hispanic MSM report levels of PrEP use no different from white MSM, but given higher HIV incidence for Black and Hispanic MSM, parity in use is not sufficient for epidemic control or health equity. Keywords: PrEP; men who have sex with men; behavioural surveillance; health disparities; PrEP willingness; online surveys; trend analysis; biomedical prevention, 1 | INTRODUCTION Men who have sex with men (MSM) are disproportionately impacted by the HIV epidemic in the United States, accounting for about 2% of the US population [1] [...]

Introduction: In Myanmar, men who have sex with men (MSM) and transgender women (TW) are disproportionately affected by HIV, despite national HIV program scale-up. However, limited HIV surveillance capacity prevents monitoring of epidemic trends and program impact. This study aimed to estimate HIV prevalence and incidence and explore associated sexual risk behaviours among MSM and TW clients attending HIV testing clinics in Myanmar. Methods: An electronic data management system was implemented in two community-based, MSM and TW -tailored HIV testing clinics in Myanmar in August 2016. Unique client identifiers enabled prospective monitoring of service engagement, testing frequency and outcomes. We estimated HIV incidence and rate of HIV diagnosis at baseline testing visit among clients over a 15 month period. Correlates of HIV diagnoses were identified using multivariable logistic regression. Results: 2794 MSM and TW were tested for HIV. At their baseline test, 38% of clients reported any previous testing and 93% reported being sexually active over the previous three months, with 74% reporting sex with casual male partners and 28% reporting consistent condom use with casual partners. 291 clients tested positive for HIV for the first time at baseline (10.4%; 95% CI: 9.3 to 11.6). Twelve incident cases were detected among 279 clients receiving [greater than or equal to]2 tests (incidence = 10.1 per 100 person-years; 95% CI: 5.73 to 17.8). HIV diagnosis at baseline was significantly associated with being a transgender woman or a non-openly disclosing man who has sex with men, age 26 to 39 years, and reporting no testing history. Conclusions: High HIV incidence and new diagnoses being associated with reporting no testing history points to undiagnosed HIV driving transmissions in Myanmar. Repeat testing was uncommon. HIV programs in Myanmar must focus on promoting frequent HIV testing alongside adequate coverage of education and primary prevention interventions among MSM and TW. Keywords: HIV prevention; men who have sex with men; transgender women; Myanmar; HIV epidemiology; HIV testing, (1) | INTRODUCTION Evidence of emergent HIV epidemics and prevalence estimates greater than 10% point to a disproportionate burden of HIV among men who have sex with men (MSM) and [...]

Introduction: The HPTN 071 (PopART) trial evaluated the impact of an HIV combination prevention package that included 'universal testing and treatment' on HIV incidence in 21 communities in Zambia and South Africa during 2013-2018. The primary study endpoint was based on the results of laboratory-based HIV testing for> 48,000 participants who were followed for up to three years. This report evaluated the performance of HIV assays and algorithms used to determine HIV status and identify incident HIV infections in HPTN 071, and assessed the impact of errors on HIV incidence estimates. Methods: HIV status was determined using a streamlined, algorithmic approach. A single HIV screening test was performed at centralized laboratories in Zambia and South Africa (all participants, all visits). Additional testing was performed at the HPTN Laboratory Center using antigen/antibody screening tests, a discriminatory test and an HIV RNA test. This testing was performed to investigate cases with discordant test results and confirm incident HIV infections. Results: HIV testing identified 978 seroconverter cases. This included 28 cases where the participant had acute HIV infection at the first HIV-positive visit. Investigations of cases with discordant test results identified cases where there was a participant or sample error (mixups). Seroreverter cases (errors where status changed from HIV infected to HIV uninfected, 0.4% of all cases) were excluded from the primary endpoint analysis. Statistical analysis demonstrated that exclusion of those cases improved the accuracy of HIV incidence estimates. Conclusions: This report demonstrates that the streamlined, algorithmic approach effectively identified HIV infections in this arge cluster-randomized trial. Longitudinal HIV testing (all participants, all visits) and quality control testing provided usefu data on the frequency of errors and provided more accurate data for HIV incidence estimates. Keywords: HIV incidence; seroconverters; HIV testing; community-randomized; Zambia; South Africa, (1) | INTRODUCTION Universal testing and treatment (UTT) for HIV prevention is an important component of HIV prevention programmes [1,2]. The HIV Prevention Trials Network (HPTN) 071 (PopART) trial, the [...]

Introduction: Female sex workers (FSWs) experience overlapping burdens of HIV, sexually transmitted infections and unintended pregnancy. Pre-exposure prophylaxis (PrEP) is highly efficacious for HIV prevention. It represents a promising strategy to reduce HIV acquisition risks among FSWs specifically given complex social and structural factors that challenge consistent condom use. However, the potential impact on unintended pregnancy has garnered little attention. We discuss the potentia concerns and opportunities for PrEP to positively or negatively impact the sexual and reproductive health and rights (SRHR) of FSWs. Discussion: FSWs have high unmet need for effective contraception and unintended pregnancy is common in low- and middle-income countries. Unintended pregnancy can have enduring health and social effects for FSWs, including consequences of unsafe abortion and financial impacts affecting subsequent risk-taking. It is possible that PrEP could negatively impact condom and other contraceptive use among FSWs due to condom substitution, normalization, external pressures or PrEP provision by single-focus services. There are limited empirical data available to assess the impact of PrEP on pregnancy rates in real-life settings. However, pregnancy rates are relatively high in PrEP trials and modelling suggests a potential two-fold increase in condomless sex among FSWs on PrEP, which, given low use of non-barrier contraceptive methods, would increase rates of unintended pregnancy. Opportunities for integrating family planning with PrEP and HIV services may circumvent these concerns and support improved SRHR. Synergies between PrEP and family planning could promote uptake and maintenance for both interventions. Integrating family planning into FSW-focused community-based HIV services is likely to be the most effective model for improving access to non-barrier contraception among FSWs. However, barriers to integration, such as provider skills and training and funding mechanisms, need to be addressed. Conclusions: As PrEP is scaled up among FSWs, there is growing impetus to consider integrating family planning services with PrEP delivery in order to better meet the diverse SRHR needs of FSWs and to prevent unintended consequences. Programme monitoring combined with research can close data gaps and mobilize adequate resources to deliver comprehensive SRHR services respectful of all women's rights. Keywords: sex workers; Pre-Exposure Prophylaxis (PrEP); contraception; unplanned pregnancy; HIV infections, (1) | INTRODUCTION Female sex workers (FSWs) in low- and middle-income countries experience overlapping burdens of high HIV prevalence alongside high rates of sexually transmitted infections (STIs) and unintended pregnancy [...]

Introduction: Electronic and other new media technologies (eHealth) can facilitate large-scale dissemination of information and effective delivery of interventions for HIV care and prevention. There is a need to both monitor a rapidly changing pipeline of technology-based care and prevention methods and to assess whether the interventions are appropriately diversified. We systematically review and critically appraise the research pipeline of eHealth interventions for HIV care and prevention, including published studies and other funded projects. Methods: Two peer-reviewed literature databases were searched for studies describing the development, trial testing or implementation of new technology interventions, published from September 2014 to September 2018. The National Institutes of Health database of grants was searched for interventions still in development. Interventions were included if eHealth was utilized and an outcome directly related to HIV treatment or prevention was targeted. We summarized each intervention including the stage of development, eHealth mode of delivery, target population and stage of the HIV care and prevention continua targeted. Results and discussion: Of 2178 articles in the published literature, 113 were included with 84 unique interventions described. The interventions utilize a variety of eHealth technologies and target various points on the prevention and care continua, with greater emphasis on education, behaviour change and testing than linkage to medical care. There were a variety of interventions for HIV care support but none for PrEP care. Most interventions were developed for populations in high income countries. An additional 62 interventions with funding were found in the development pipeline, with greater emphasis on managing HIV and PrEP care. Conclusions: Our systematic review found a robust collection of eHealth interventions in the published literature as well as unpublished interventions still in development. In the published literature, there is an imbalance of interventions favouring education and behaviour change over linkage to care, retention in care, and adherence, especially for PrEP. The next generation of interventions already in the pipeline might address these neglected areas of care and prevention, but the development process is slow. Researchers need new methods for more efficient and expedited intervention development so that current and future needs are addressed. Keywords: eHealth; mobile applications; smartphones; social media; primary prevention; secondary prevention Additional information may be found under the Supporting Information tab for this article., 1 | INTRODUCTION Care and prevention interventions for HIV stand at the intersection of two important trends. First, the models of care for people living with HIV and those at [...]

Introduction: Tuberculosis (TB) is a leading cause of mortality among people living with HIV (PLHIV). An invigorated global END TB Strategy seeks to increase efforts in scaling up TB preventive therapy (TPT) as a central intervention for HIV programmes in an effort to contribute to a 90% reduction in TB incidence and 95% reduction in mortality by 2035. TPT in PLHIV should be part of a comprehensive approach to reduce TB transmission, illness and death that also includes TB active case-finding and prompt, effective and timely initiation of anti-TB therapy among PLHIV However, the use and implementation of preventive strategies has remained deplorably inadequate and today TB prevention among PLHIV has become an urgent priority globally. Discussion: We present a summary of the current and novel TPT regimens, including current evidence of use with antiretroviral regimens (ART). We review challenges and opportunities to scale-up TB prevention within HIV programmes, including the use of differentiated care approaches and demand creation for effective TB/HIV services delivery. TB preventive vaccines and diagnostics, including optimal algorithms, while important topics, are outside of the focus of this commentary. Conclusions: A number of new tools and strategies to make TPT a standard of care in HIV programmes have become available. The new TPT regimens are safe and effective and can be used with current ART, with attention being paid to potentia drug-drug interactions between rifamycins and some classes of antiretrovirals. More research and development is needed to optimize TPT for small children, pregnant women and drug-resistant TB (DR-TB). Effective programmatic scale-up can be supported through context-adapted demand creation strategies and the inclusion of TPT in client-centred services, such as differentiated service delivery (DSD) models. Robust collaboration between the HIV and TB programmes represents a unique opportunity to ensure that TB, a preventable and curable condition, is no longer the number one cause of death in PLHIV. Keywords: TB; HIV care continuum; differentiated care; public health; co-infection; treatment, 1 INTRODUCTION Tuberculosis (TB) is a leading cause of mortality among people living with HIV (PLHIV). This population contributes substantially to the global TB burden, with a higher risk of [...]

Introduction: HIV incidence is high during pregnancy and breastfeeding with HIV acquisition risk more than doubling during pregnancy and the postpartum period compared to when women are not pregnant. The World Health Organization recommends offering pre-exposure prophylaxis (PrEP) to pregnant and postpartum women at substantial risk of HIV infection. However, maternal PrEP national guidelines differ and most countries with high maternal HIV incidence are not offering PrEP. We conducted a systematic review of recent research on PrEP safety in pregnancy to inform national policy and rollout. Methods: We used a standard Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) approach to conduct a systematic review by searching for completed, ongoing, or planned PrEP in pregnancy projects or studies from clinicaltrials.gov, PubMed and NIH RePORTER from 2014 to March 2019. We performed a systematic review of studies that assess tenofovir disoproxil fumarate (TDF)-based oral PrEP safety in pregnant and breastfeeding HIV-uninfected women. Results and discussion: We identified 14 completed (n = 5) and ongoing/planned (n = 9) studies that evaluate maternal and/or infant outcomes following PrEP exposure during pregnancy or breastfeeding. None of the completed studies found differences in pregnancy or perinatal outcomes associated with PrEP exposure. Nine ongoing studies, to be completed by 2022, will provide data on >6200 additional PrEP-exposed pregnancies and assess perinatal, infant growth and bone health outcomes, expanding by sixfold the data on PrEP safety in pregnancy. Research gaps include limited data on (1) accurately measured PrEP exposure within maternal and infant populations including drug levels needed for maternal protection; (2) uncommon perinatal outcomes (e.g. congenital anomalies); (3) infant outcomes such as bone growth beyond one year following PrEP exposure; (4) outcomes in HIV-uninfected women who use PrEP during pregnancy and/or lactation. Conclusions: Expanding delivery of PrEP is an essential strategy to reduce HIV incidence in pregnancy and breastfeeding women. Early safety studies of PrEP among pregnant women without HIV infection are reassuring and ongoing/planned studies will contribute extensive new data to bolster the safety profile of PrEP use in pregnancy. However, addressing research gaps is essential to expanding PrEP delivery for women in the context of pregnancy. Keywords: preexposure prophylaxis; PrEP; pregnancy; breastfeeding; PMTCT; prevention of mother to child transmission; HIV, 1 | INTRODUCTION HIV incidence is high during pregnancy and breastfeeding [1] with HIV acquisition risk more than doubling during pregnancy and the postpartum period compared to when women are [...]

Introduction: Transgender women may face the highest prevalence of HIV of any population, experiencing a disproportionate burden of disease frequently confirmed in surveys throughout the developing and developed world. However, few studies have been conducted specifically for transgender women in China. This study aimed to measure HIV prevalence and explore risk factors for infection in a diverse sample of Chinese transgender women to help advocate for prevention and care interventions for this population. Methods: From July 2018 to May 2019, we adapted a respondent-driven sampling (RDS) approach to recruit a diverse sample of 250 transgender women through chains of peer referrals in two cities of eastern China, Nanjing and Suzhou. Eligible participants (i.e. 18 years of age or older, living in Jiangsu province and assigned male sex at birth but currently self-identified as a gender different from male) completed a self-administered questionnaire on a mobile phone to collect demographic characteristics and risk behaviours and underwent HIV testing. Results and discussion: The survey sample was young (82% under age 35 years), with 28.8% having a university degree, 39.2% reporting work at entertainment venues, 47.6% ever having taken hormones and 6.4% being diagnosed with an STI in the last year. One in five (20.8%) reported having engaged in sex work. HIV prevalence was 14.8% (95% CI 10.6 to 19.8), with 75.6% of those testing HIV positive reporting they were already aware of their serostatus. In multivariate analysis, HIV prevalence was significantly higher among transgender women above the age of 24 years, those who work at entertainment venues, who never have taken hormones, and who had been diagnosed with an STI in the last year. Conclusions: The prevalence of HIV among transgender women in our study, at 14.8%, is among the highest detected in any population in eastern China. Chinese transgender women may therefore follow the disparity in the burden of HIV noted worldwide. Data support policies to prioritize transgender women for HIV testing outreach, for in-depth research to better understand the specific drivers of infection in this population, and for trans-friendly HIV care and prevention programmes to address their specific needs. Keywords: transgender women; HIV prevalence; risk factors; China; sex work; sexual behaviour, 1 | INTRODUCTION Transgender women, people who were assigned a 'male' sex at birth but identify as a gender other than man, bear the highest burden of HIV of any [...]

A number of highly potent and broadly neutralizing antibodies (bNAbs) against the human immunodeficiency virus (HIV) have recently been shown to prevent transmission of the virus, suppress viral replication, and delay plasma viral rebound following discontinuation of antiretroviral therapy in animal models and infected humans. However, the degree and extent to which such bNAbs interact with primary lymphocytes have not been fully delineated. Here, we show that certain glycan-dependent bNAbs, such as PGT121 and PGT151, bind to B, activated T, and natural killer (NK) cells of HIV-infected and -uninfected individuals. Binding of these bNAbs, particularly PGT121 and PGT151, to activated [CD4.sup.+] and [CD8.sup.+] T cells was mediated by complex-type glycans and was abrogated by enzymatic inhibition of N-linked glycosylation. In addition, a short-term incubation of PGT151 and primary NK cells led to degranulation and cellular death. Our data suggest that the propensity of certain bNAbs to bind uninfected/bystander cells has the potential for unexpected outcomes in passive-transfer studies and underscore the importance of antibody screening against primary lymphocytes., Introduction Recent advances in antibody cloning technologies have led to the isolation of a number of highly potent and broadly neutralizing antibodies (bNAbs) against the human immunodeficiency virus (HIV). Some [...]

Introduction: The search for an HIV cure involves important behavioural and social processes that complement the domains of biomedicine. However, the field has yet to tap into the full potential of behavioural and social sciences research (BSSR). In this article, we apply Gaist and Stirratt's BSSR Functional Framework to the field of HIV cure research. Discussion: The BSSR Functional Framework describes four key research domains: (1) basic BSSR (understanding basic behavioural and social factors), (2) elemental BSSR (advancing behavioural and social interventions), (3) supportive BSSR (strengthening biomedically focused clinical trials), and (4) integrative BSSR (building multi-disciplinary combination approaches for realworld implementation). In revisiting and applying the BSSR Functional Framework, we clarify the importance of BSSR in HIV cure research by drawing attention to such things as: how language and communication affect the meaning of 'cure' to people living with HIV (PLHIV) and broader communities; how cure affects the identity and social position of PLHIV; counselling and support interventions to address the psychosocial needs and concerns of study participants related to analytical treatment interruptions (ATIs); risk reduction in the course of ATI study participation; motivation, acceptability, and decision-making processes of potential study participants related to different cure strategies; HIV care providers' perceptions and attitudes about their patients' participation in cure research; potential social harms or adverse social events associated with cure research participation; and the scalability of a proven cure strategy in the context of further advances in HIV prevention and treatment. We also discuss the BSSR Functional Framework in the context of ATIs, which involve processes at the confluence of the BSSR domains. Conclusions: To move HIV cure regimens through the translational research pathway, attention will need to be paid to both biomedical and socio-behavioural elements. BSSR can contribute an improved understanding of the human and social dimensions related to HIV cure research and the eventual application of HIV cure regimens. The BSSR Functional Framework provides a way to identify advances, gaps and opportunities to craft an integrated, multi-disciplinary approach at all stages of cure research to ensure the real-world applicability of any strategy that shows promise. Keywords: Behavioural and Social Sciences Research (BSSR); functional framework; HIV cure research; HIV remission; analytica treatment interruption; people living with HIV, 1 | INTRODUCTION A cure for HIV infection has been a hoped-for goal since the virus was first identified. Despite tremendous scientific advances in preventing and treating HIV, there still [...]

Introduction: Until September 2019, pre-exposure prophylaxis (PrEP) with tenofovir disoproxil/emtricitabine for HIV prevention was not covered by health insurance plans in Germany, and was only available through private prescriptions with self-pay or through informal non-prescription sources. The objective of this study was to investigate the proportion of informal PrEP use among PrEP users and to identify factors of public health relevance that might be associated with informal PrEP use. Methods: We conducted a cross-sectional study recruiting PrEP users independent of their PrEP source. Clients from anonymous community testing checkpoints, users of three dating apps for men who have sex with men residing in Germany and users of a PrEP community website, were recruited to complete a short anonymous online survey. Participants were recruited between 24 July and 3 September 2018. The results were analysed using univariable and multivariable logistic regressions. Results: We recruited 2005 participants currently using PrEP. The median age was 38 years, and 80.3% of the participants identified themselves as male (missing: 19.1%). Overall, 71.6% obtained PrEP through medical services with a private prescription or a clinical trial, and 17.4% obtained PrEP through informal sources (missing: 11.0%). The most common informal sources were ordering online from another country (8.8%), travel abroad (3.6%), and friends (2.5%). Factors associated with informa PrEP use were on demand/intermittent dosing (adjusted OR: 3.5, 95% CI 2.5 to 5.0) and not receiving medical tests during PrEP use (adjusted OR: 3.2, 95% CI 2.0 to 5.2). In addition, informal PrEP users who did not take PrEP daily had a strongly increased risk of starting PrEP without prior medical tests (adjusted stratum-specific OR = 31.7, 95% CI 4.6 to 219.5). Conclusions: Informal PrEP use was associated with a higher risk of not getting tested before and during PrEP use, which could lead to HIV infections resistant to tenofovir and emtricitabine if people with undiagnosed HIV use PrEP. Health insurance plans that cover PrEP and the accompanying routine tests could ensure adequate medical supervision of PrEP users and reduce barriers to PrEP use. Our findings strongly support the implementation of PrEP programmes in countries with similar patterns of informal PrEP use. Keywords: PrEP; men who have sex with men; testing; informal PrEP; non-daily use; affordability, 1 | INTRODUCTION Pre-exposure prophylaxis (PrEP), with tenofovir disoproxil/emtricitabine, has been proven to be highly effective in preventing HIV infections in men who have sex with men (MSM) and other [...]

This article critically examines common understandings of sexuality and sexual agency among heterosexual Black men in Toronto. The findings are based on focus groups and in-depth interviews conducted for the qualitative arm of the broader weSpeak project, a mixed-methods study designed to engage and support heterosexual Black men in Ontario, Canada, in living more holistically healthy lives. Focus groups and in-depth interviews with 69 self-identified heterosexual Black men focused on vulnerability and resilience to HIV, but participants also shared their complex experiences and perspectives related to sexuality and sexual agency, especially in the context of systemic and structural conditions that affect their wellbeing. This article provides excerpts from their narratives to illustrate the complexities and emergent possibilities related to sexuality and sexual agency among heterosexual Black men, which may open up new ways of approaching HIV prevention and health promotion. Keywords: Black; African Canadians; Sexuality; Health; Masculinities; HIV Cet article examine d'un oeil critique les conceptions communes de la sexualite et de l'agentivite sexuelle chez les hommes noirs heterosexuels de Toronto. Les resultats sont fondes sur des groupes de discussion et des entrevues approfondies menees dans le cadre du volet qualitatif du projet weSpeak, une etude a methodes mixtes concue pour inciter et soutenir les hommes noirs heterosexuels de l'Ontario, au Canada, a mener une vie plus saine sur le plan holistique. Des groupes de discussion et des entrevues approfondies avec 69 hommes noirs heterosexuels auto-identifies axes sur la vulnerabilite et la resilience au VIH, mais les participants ont egalement partage leurs experiences et perspectives complexes liees a la sexualite et a l'agentivite sexuelle, en particulier dans le contexte des conditions systemiques et structurelles qui affectent leur bienetre. Cet article presente des extraits de leurs recits pour illustrer les complexites et les possibilites emergentes liees a la sexualite et a l'agentivite sexuelle chez les hommes noirs heterosexuels, ce qui pourrait ouvrir de nouvelles facons d>aborder la prevention du VIH et la promotion de la sante. Mots cles: Noirs; Afro-canadiens; Sexualite; Sante; Masculinites; VIH, INTRODUCTION Black people in Canada continue to experience disproportionately high rates of diagnosis for HIV For example, in Ontario in 2015-2016, Black men accounted for 17% of new diagnoses among [...]

Introduction: To adequately ascertain drug safety and efficacy drug trials need to include participants from all groups likely to receive the medication following approval. Pregnant women, however, are mostly excluded from trials, and women participating are often required to use highly effective contraception and taken off study product (even off study) if they conceive. There is little commercial incentive for including pregnant women in clinical trials, even when preclinical animal and human pharmacokinetic and safety data appear reassuring. With this conservative approach, large numbers of pregnant women are exposed to drug postlicensing with little known about drug safety and efficacy, and little done to systematically monitor outcomes of pregnancy exposure. Discussion: The article focuses on antiretrovirals for treating and preventing HIV, and presents potential approaches which could extend to other therapeutic areas, to obtaining adequate and timely data to inform use of these drugs in this population. Most importantly the pregnancy risk profile of investigational agents can be systematically stratified from low to high risk, based on guidelines from regulatory bodies. This stratification can determine the progress through preclinical work with animals and non-pregnant women to opportunistic studies among women who become pregnant on a clinical trial or within routine clinical treatment. Stratification can include pregnant women in clinical trials, concurrent with Phase II/III trials in nonpregnant adults, and ultimately to postmarketing surveillance for outcomes in pregnant women and their infants. Each step can be enabled by clear criteria from international and local regulatory bodies on progression through study phases, standardized protocols for collecting relevant data, collaborative data sharing, pregnancy outcomes surveillance systems supported by committed funding for these endeavours. Conclusions: A formalized step-wise approach to including pregnant women in antiretroviral drug research should become the new norm. Systematic implementation of this approach would yield more timely and higher quality pregnancy dosing, safety and efficacy data. Through more vigorous action, regulatory bodies could responsibly overcome reluctance to include pregnant women in drug trials. Funders, researchers and programme implementers need to be galvanized to progressively include pregnant women in research - the use of newer, more effective drugs in women is at stake (349). Keywords: HIV; teratogen; drug dosing; maternal health; child health; antiretroviral; pregnancy; dolutegravir; birth defects, 1 | INTRODUCTION Globally, antiretroviral (ARV) drug use in pregnancy has evolved from single and two-drug regimens for prevention of vertical infection, to three-drug regimens for all pregnant and breastfeeding [...]

Introduction: In 2011, Malawi implemented 'Option B+,' a test-and-treat strategy for the prevention of maternal to child transmission of HIV (PMTCT); however limited data on viral load (VL) suppression exist. We describe VL suppression in HIV-infected women at four to twenty-six weeks postpartum, factors associated with VL suppression and the impact of VL suppression levels on MTCT. Methods: HIV-positive mothers at four to twenty-six weeks postpartum were enrolled in a nested cross-sectional study within the 'National Evaluation of Malawi's PMTCT Programme' cohort study between October 2014 and May 2016. HIV-exposed infants received HIV-1 DNA testing and venous samples determined maternal VL, classified as unsuppressed (>1000 copies/mL), low-detectable (40 to 1000 copies/mL) or undetectable ( Conclusions: Unsuppressed and low-detectable VL was strongly predictive of MTCT among women on ART and associated with suboptimal adherence. This urges further consideration of optimal VL monitoring and target levels to reach elimination of paediatric infection. Keywords: viral load suppression; HIV; prevention of maternal to child transmission; antiretroviral therapy; HIV transmission; Option B+, 1 INTRODUCTION In 2011, Malawi implemented 'Option B+,' a universal test and treat strategy for all pregnant and breastfeeding women for the prevention of mother-to-child-transmission (PMTCT) of HIV [1,2]. Option [...]

Introduction: Young women in sub-Saharan Africa are disproportionately affected by HIV, accounting for 25% of all new infections in 2017. Several behavioural and biologicall factors are known to impact a young woman's vulnerability for acquiring HIV. One key but lesser understood, biologicall factor impacting vulnerability is the vaginal microbiome. This review describes the vaginal microbiome and examines its alterations, its influence on HIV acquisition as well as the efficacy of HIV prevention technologies, the role of the rectal microbiome in HIV acquisition, advandes in technologies to study the microbiome and some future research directions. Discussion: Although the composition of each woman's vaginal microbiome is unique, a microbiome dominated by Lactobacillus species is generally associated with a 'healthy' vagina. Disturbandes in the vaginal microbiota, characterized by a shift from a low-diversity, Lactobacillus-dominant state to a high-diversity non-Lactobacillus-dominant state, have been shown to be associated with a range of adverse reproductive health outcomes, including increasing the risk of genital inflammation and HIV acquisition. Gardnerella vaginalis and Prevotella bivia have been shown to contribute to both HIV risk and genital inflammation. In addition to impacting HIV risk, the composition of the vaginal microbiome affects the vaginal concentrations of some antiretroviral drugs, particularly those administered intravaginally and thereby their efficacy as pre-exposure prophylaxis (PrEP) for HIV prevention. Although the role of rectal microbiota in HIV acquisition in women is less well understood, the composition of this compartment's microbiome, particularly the presence of species of bacteria from the Prevotellaceae family likely contribute to HIV acquisition. Advandes in technologies have facilitated the study of the genital microbiome's structure and function. While next-generation sequencing advanded knowledge of the diversity and complexity of the vaginal microbiome, the emerging field of metaproteomics, which provides important information on vaginal bacterial community structure, diversity and function, is further shedding light on functionality of the vaginal microbiome and its relationship with bacterial vaginosis (BV), as well as antiretroviral PrEP efficacy. Conclusions: A better understanding of the composition, structure and function of the microbiome is needed to identify opportunities to alter the vaginal microbiome and prevent BV and reduce the risk of HIV acquisition. Keywords: HIV prevention; women; vaginal microbiome; rectal microbiome; genital inflammation; tenofovir ge, 1 | INTRODUCTION With 37 million people living with human immunodeficiency virus (HIV) and 1.8 million new infections in 2017, HIV remains a significant global public health problem. Sub-Saharan Africa [...]

HIV pre-exposure prophylaxis (PrEP) is the use of HIV medications by HIV-negative persons to prevent HIV acquisition from future potential or known exposures to this virus. Multiple studies have demonstrated [...]

Introduction: The Good Participatory Practice (GPP): Guidelines for Biomedical HIV Prevention Trials, second edition (2011) were developed to provide clinical trial sponsors and implementers with a formal stakeholder engagement framework. As one of the largest African research institutes, Wits Reproductive Health and HIV Institute (Wits RHI) became an early adopter of GPP by implementing its principles within large-scale national and regional clinical trials. This article examines Wits RHI's lessons learned from implementing GPP, its ongoing efforts to institutionalize GPP, and the yet to be realized potential in creating fully sustainable structures for meaningful stakeholder engagement in HIV prevention research, implementation science and beyond. Discussion: For the past seven years, Wits RHI has undertaken both centralized leadership roles in implementing GPP across multi-party regional research consortia as well as overseeing GPP for smaller investigator-driven trials. Through this iterative roll-out of GPP, key lessons have emerged. Obtaining upfront funding to support GPP activities throughout and between the research life cycle, and a trained multi-disciplinary team of GPP practitioners have helped facilitate an enabling environment for GPP implementation. We further recommend formally integrating stakeholder engagement into study documents, including monitoring and evaluation plans with indicators and performance metrics, to assist teams to track and refine their GPP strategies. Finally, institutionalizing resources and supporting organization-wide GPP along with ongoing support can help build efficiencies and maximize economies of scale toward a pragmatic and innovative application of the GPP Guidelines. Conclusions: Thanks to a growing global network of GPP practitioners and a burgeoning GPP Community of Practice, there has been substantive progress in making GPP an integral component of clinical HIV prevention research. The Wits RHI experience highlights the possibilities and the challenges to translating the GPP principles into concrete practices within specific clinical trials and across a research institute. Realizing the full potential of GPP, including direct and indirect--'collateral benefits' willrequire the collective buy-in and support from sponsors, implementers and community stakeholders across the research field. As the HIV prevention research field expands, however, a more conscious and systematic implementation of GPP is timely. Keywords: GPP; stakeholder engagement; HIV; prevention research; Africa, 1 | LOCATING GPP WITHIN HIV PREVENTION RESEARCH While clinical trials have long engaged with trial communities and other stakeholders as a matter of course, these efforts have often been [...]

Introduction: Clinical trials of biomedical HIV prevention modalities require the cooperation of multiple stakeholders. Key stakeholders, such as community members, may have stark vulnerabilities. Consequently, calls for HIV prevention researchers to implement 'stakeholder engagement' are increasingly common. Such engagement is held to benefit inter-stakeholder relations, stakeholders themselves and the research itself. The ethics review process presents a unique opportunity to strengthen stakeholder engagement practices in HIV prevention trials. However, this is not necessarily straightforward. In this article, we consider several complexities. First, is stakeholder engagement a legitimate component of what Research Ethics Committees (RECs) should review for HIV prevention trials? Second, what are the core features of engagement that should be under ethics review? Third, what are the key practices that should be highlighted in ethics review? Methods: To address these questions, we examined the international ethics guidelines specialized for such trials (UNAIDS 2012, UNAIDS-AVAC GPP 2011) and directly applicable to such trials (CIOMS 2016; WHO 2011). Thematic analysis was used to code and analyse these guidelines. Results and discussion: Ethics guidelines support REC review of engagement. Guidance recommends that engagement be broad and inclusive; early and sustained; and dynamic and responsive. Broad engagement practices include evaluating the context, planning in writing, and resourcing. RECs should assess engagement as part of a comprehensive review, and recommend revisions where necessary. Researchers should profile key elements of engagement valued in ethics guidance, when they draft ethics submissions. Importantly, the ethics review process should not undermine the 'dynamic responsiveness' required for excellent engagement in this field. Conclusions: As evidence-informed engagement strategies emerge, these should inform the ethics submission and review process. Both parties in the review process should strive to avoid a superficial, check-list type approach that caricatures what should be a thorough, nuanced ethics review of a rich, responsive engagement process. Keywords: Stakeholder engagement; community engagement; ethics review; Research Ethics Committee; Institutional Review Boards; HIV prevention trials, 1 | INTRODUCTION HIV prevention trials are complex endeavours. Ethics guidelines recognize several background complexities with such trials that trigger the need for stakeholder engagement. UNAIDS [1] notes the pragmatic [...]

Introduction: 'Sisters with a Voice', Zimbabwe's nationally scaled comprehensive programme for female sex workers (FSWs), intensified community mobilization activities in three sites to increase protective behaviours and utilization of clinical services. We compare indicators among FSWs at the beginning and after implementation. Methods: We used mixed methods to collect data at three sites: in-depth interviews (n = 22) in 2015, routine clinical data from 2010 to 2015, and two respondent driven sampling surveys in 2011 and 2015, in which participants completed an interviewer-administered questionnaire and provided a finger prick blood sample for HIV antibody testing. Estimates were weighted using RDS-1 and estimate convergence assessed in both years. We assessed differences in six indicators between 2011 and 2015 using logistic regression adjusted for age, duration in sex work and education. Results: 870 FSWs were recruited from the three sites in 2011 and 915 in 2015. Using logistic regression to adjust for socio-demographic differences, we found higher estimates of the proportion of HIV-positive FSWs and HIV-positive FSWs who knew their status and reported being on ART in Mutare and Victoria Falls in 2015 compared to 2011. Reported condom use with clients did not differ by year; however, condom use with regular partners was higher in 2015 in Mutare and Hwange. Reported HIV testing in the last six months among HIV-negative FSWs was higher in 2015 across sites: for instance, in Victoria Falls it was 13.4% (95% CI 8.7% to 19.9%) in 2011 and 80.8% (95% CI 74.0 to 87.7) in 2015. FSWs described positive perceptions of the Sisters programme, ease of engaging with health services, and improved solidarity among peers. Programme data showed increases in service use by 2015 across all sites. Conclusions: Improvements in key HIV care engagement indicators were observed among FSWs in two sites and in testing and prevention indicators across the three sites after implementation of an intensified community mobilization intervention. Engagement with services for FSWs is critical for countries to reach 90-90-90 targets. Keywords: Female sex workers; HIV; ART; peer education; community mobilization Additional Supporting Information may be found online in the Supporting information tab for this article., 1 | INTRODUCTION The World Health Organization and UNAIDS recommend that sex workers access comprehensive HIV prevention, testing, and treatment [1-3]. Female sex workers (FSWs) have a high burden of [...]

Introduction: British Columbia has made significant progress in the treatment and prevention of HIV since 1996, when Highly Active Antiretroviral Therapy (HAART) became available. However, we currently lack a historical summary of HIV prevention and care interventions implemented in the province since the introduction of HAART and how they have shaped the HIV epidemic. Guided by a socio-ecological framework, we present a historical review of biomedical and health services, community and structural interventions implemented in British Columbia from 1996-2015 to prevent HIV transmission or otherwise enhance the cascade of HIV care. Methods: We constructed a historical timeline of HIV interventions implemented in BC between 1996 and 2015 by reviewing publicly available reports, guidelines and other documents from provincial health agencies, community organizations and AIDS service organizations, and by conducting searches of peer-reviewed literature through PubMed and Ovid MEDLINE. We collected further programmatic information by administering a data collection form to representatives from BC's regional health authorities and an umbrella agency representing 45 AIDS Service organizations. Using linked population-level health administrative data, we identified key phases of the HIV epidemic in British Columbia, as characterized by distinct changes in HIV incidence, HAART uptake and the provincial HIV response. Results and Discussion: In total, we identified 175 HIV prevention and care interventions implemented in BC from 1996 to 2015. We identify and describe four phases in BC's response to HIV/AIDS: the early HAART phase (1996-1999); the harm reduction and health service scale-up phase (2000-2005); the early Treatment as Prevention phase (2006-2009); and the STOP HIV/AIDS phase (2010-present). In doing so, we provide an overview of British Columbia's universal and centralized HIV treatment system and detail the role of community-based and provincial stakeholders in advancing innovative prevention and harm reduction approaches, as well as 'seek, test, treat and retain' strategies. Conclusions: The review provides valuable insight into British Columbia's HIV response, highlights emerging priorities, and may inform future efforts to evaluate the causal impact of interventions. Keywords: British Columbia; historical review; cascade of care; treatment as prevention; quality of care; harm reduction To access the supplementary material to this article please see Supplementary Files under Article Tools online., Introduction British Columbia (BC) has made substantial progress treating and preventing HIV since the infection emerged in the early 1980s. The introduction of highly active antiretroviral therapy (HAART) in 1996 [...]

Background: Men who have sex with men (MSM) continue to be disproportionately affected by HIV in Malaysia. Recent success has been observed within demonstration projects examining the efficacy of HIV pre-exposure prophylaxis (PrEP), an antiretroviral -based medication taken by HIV-negative men to prevent sero-conversion. In order for such promising findings to be translated in real-world settings, it is important to understand the acceptability of PrEP, including perceived barriers to access or uptake. Methods: As part of a larger mixed-methods study exploring acceptability and willingness to use PrEP among MSM in Malaysia, 19 men took part in audio-recorded focus group discussions hosted by a community-based HIV organization and facilitated by a trained researcher. Discussions focussed on awareness and potential information management, general perceptions of PrEP and potential motivations or barriers to the use of PrEP, including those at the personal, social, health system or structural level. Data were transcribed verbatim and underwent a detailed thematic analysis. Results: Rather than perceiving PrEP as a replacement for condoms in terms of having safer sex, many participants viewed it as an additional layer protection, serving as a crucial barrier to infection on occasions where condom use was intended, but did not occur. It was also perceived as more valuable to 'at-risk' men, such as those in HIV sero-discordant relationships or those with a higher number of sexual partners. Elements of discussion tended to suggest that some men taking PrEP may be subject to stigma from others, on the assumption they may be promiscuous or engage in high-risk sexual behaviours. Conclusions: This qualitative study indicates that, broadly speaking, PrEP may be acceptable to MSM in Malaysia. However, in order for its potential to be realized, and uptake achieved, educative interventions are required to inform the target population as to the efficacy and potential, positive impact of PrEP. Given concerns for how those taking it may be stigmatized, it is crucial that the use of PrEP is presented as a responsible course of action, and one of a range of strategies that men can use to keep themselves safe from HIV. Keywords: MSM; PrEP; qualitative; Malaysia; risk reduction; HIV prevention, Background Pre-exposure prophylaxis (PrEP) is a significant development in the continuing global efforts to prevent transmission and acquisition of HIV [1,2]. In order to realize the potential of this antiretroviral [...]

Introduction: Male circumcision is a proven prevention strategy against the spread of HIV. The World Health Organization's new 2016-2021 strategic framework on voluntary medical male circumcision (VMMC) targets 90% of males aged 10-29 years to receive circumcision by 2021 in 14 priority sub-Saharan countries while anticipating an increase in the demand for infant circumcision. It also states that the use of circumcision devices is a safe and efficient innovation to accelerate attainment of these goals. The primary objective of this pilot study was to evaluate the safety and acceptability of the ShangRing, a novel circumcision device, in boys below 18 years of age. Methods: A total of 80 boys, 3 months to 17 years old, were circumcised using the no-flip ShangRing technique. All rings were removed 5-7 days later. Participants were evaluated weekly until the wound was completely healed. Data on procedure times, adverse events (AEs), time to clinical wound healing and satisfaction were recorded and analysed. Results: Nearly all (79/80, 98.8%) circumcisions were successfully completed using the no-flip ShangRing technique without complications. In one (1.2%) case, the outer ring slipped off after the foreskin was removed and the procedure was completed by stitching. The mean circumcision and ring removal times were 7.4 [+ or -] 3.2 and 4.4 [+ or -] 4.2 min, respectively. There were four (5%) moderate AEs, which were managed conservatively. No severe AEs occurred. The mean time to complete clinical healing was 29.8 [+ or -] 7.3 days. Participants or their parents liked ShangRing circumcision because it improved hygiene, was quick and possessed an excellent cosmetic appearance. Most (72/80, 94.7%) were very satisfied with the appearance of the circumcised penis, and all (100%) said they would recommend circumcision to others. Conclusions: Our results suggest that no-flip ShangRing VMMC is safe and acceptable in boys below 18 years of age. Our results are to be compared those seen following ShangRing VMMC in African men. Further study with larger sample sizes are needed to explore the scalability of the ShangRing in larger paediatric cohorts in Africa. We believe that the ShangRing has great potential for use in all age groups from neonates to adults, which would simplify device implementation. Keywords: Male circumcision; ShangRing; circumcision device; adolescents; infants, Introduction Male circumcision is one of the oldest surgical procedures. Its efficacy in reducing the spread of HIV was demonstrated in three randomized controlled trials (RCTs) conducted in Kenya, Uganda [...]

Keywords: African American; homosexual; community engagement; PrEP research, The sub-population at greatest risk for HIV infection in the United States is Black men who have sex with men (BMSM), and there is an urgent need for effective HIV [...]