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BackgroundApproaches that allow easy access to pre-exposure prophylaxis (PrEP), such as over-the-counter provision at pharmacies, could facilitate risk-informed PrEP use and lead to lower HIV incidence, but their cost-effectiveness is unknown. We aimed to evaluate conditions under which risk-informed PrEP use is cost-effective.MethodsWe applied a mathematical model of HIV transmission to simulate 3000 setting-scenarios reflecting a range of epidemiological characteristics of communities in sub-Saharan Africa. The prevalence of HIV viral load greater than 1000 copies per mL among all adults (HIV positive and negative) varied from 1·1% to 7·4% (90% range). We hypothesised that if PrEP was made easily available without restriction and with education regarding its use, women and men would use PrEP, with sufficient daily adherence, during so-called seasons of risk (ie, periods in which individuals are at risk of acquiring infection). We refer to this as risk-informed PrEP. For each setting-scenario, we considered the situation in mid-2021 and performed a pairwise comparison of the outcomes of two policies: immediate PrEP scale-up and then continuation for 50 years, and no PrEP. We estimated the relationship between epidemic and programme characteristics and cost-effectiveness of PrEP availability to all during seasons of risk. For our base-case analysis, we assumed a 3-monthly PrEP cost of US$29 (drug $11, HIV test $4, and $14 for additional costs necessary to facilitate education and access), a cost-effectiveness threshold of $500 per disability-adjusted life-year (DALY) averted, an annual discount rate of 3%, and a time horizon of 50 years. In sensitivity analyses, we considered a cost-effectiveness threshold of $100 per DALY averted, a discount rate of 7% per annum, the use of PrEP outside of seasons of risk, and reduced uptake of risk-informed PrEP.FindingsIn the context of PrEP scale-up such that 66% (90% range across setting-scenarios 46-81) of HIV-negative people with at least one non-primary condomless sex partner take PrEP in any given period, resulting in 2·6% (0·9-6·0) of all HIV negative adults taking PrEP at any given time, risk-informed PrEP was predicted to reduce HIV incidence by 49% (23-78) over 50 years compared with no PrEP. PrEP was cost-effective in 71% of all setting-scenarios, and cost-effective in 76% of setting-scenarios with prevalence of HIV viral load greater than 1000 copies per mL among all adults higher than 2%. In sensitivity analyses with a $100 per DALY averted cost-effectiveness threshold, a 7% per year discount rate, or with PrEP use that was less well risk-informed than in our base case, PrEP was less likely to be cost-effective, but generally remained cost-effective if the prevalence of HIV viral load greater than 1000 copies per mL among all adults was higher than 3%. In sensitivity analyses based on additional setting-scenarios in which risk-informed PrEP was less extensively used, the HIV incidence reduction was smaller, but the cost-effectiveness of risk-informed PrEP was undiminished.InterpretationUnder the assumption that making PrEP easily accessible for all adults in sub-Saharan Africa in the context of community education leads to risk-informed use, PrEP is likely to be cost-effective in settings with prevalence of HIV viral load greater than 1000 copies per mL among all adults higher than 2%, suggesting the need for implementation of such approaches, with ongoing evaluation.FundingUS Agency for International Development, US President's Emergency Plan for AIDS Relief, and Bill & Melinda Gates Foundation.

: Introduction: In Viet Nam, key populations (KPs) face barriers accessing HIV services. Virtual platforms can be leveraged to increase access for KPs, including for HIV self‐testing (HIVST). This study compares reach and effectiveness of a web‐based HIVST intervention from pilot to scale‐up in Viet Nam. Methods: A mixed‐methods explanatory sequential design used cross‐sectional and thematic analysis. The pilot launched in Can Tho in November 2020, followed by Hanoi and Nghe An in April 2021. Scale‐up included Can Tho and Nghe An, with 21 novel provinces from April to December 2022. After risk assessment, participants registered on the website, receiving HIVST (OraQuick®) by courier, peer educator or self‐pick‐up. Test result reporting and completing satisfaction surveys were encouraged. Intervention reach was measured through numbers accessing the testing, disaggregated by demographics, and proportion of individuals reporting self‐testing post‐registration. Effectiveness was measured through numbers reporting self‐test results, testing positive and linking to care, and testing negative and using HIVST to manage pre‐exposure prophylaxis (PrEP) use. Thematic content analysis of free‐text responses from the satisfaction survey synthesized quantitative outcomes. Results: In total, 17,589 participants registered on the HIVST website; 11,332 individuals ordered 13,334 tests. Participants were generally young, aged 6.3% of all tests were reactive (pilot: 176/3129, 5.6% reactive compared to scale‐up: 385/5811, 6.6% reactive, p = 0.063); of which most linked to care (509/522, 97.5%). One‐fifth of participants with a negative test initiated or continued PrEP (pilot; 19.8%, scale‐up; 18.5%, p = 0.124). Thematic analysis suggested that community delivery models increased programmatic reach. Live chat may also be a suitable proxy for staff support to increase result reporting. Conclusions: Web‐based self‐testing in Viet Nam reached people at elevated risk of HIV, facilitating uptake of anti‐retroviral treatment and direct linkage to PrEP initiations. Further innovations such as the use of social‐network testing services and incorporating features powered by artificial intelligence could increase the effectiveness and efficiency of the approach., INTRODUCTION In December 2021, an estimated 230,000 people were living with HIV in Viet Nam. General population HIV prevalence was less than 0.3%, with the epidemic concentrated in three key [...]

: Introduction: Following HIV testing services (HTS), the World Health Organization recommends prompt linkage to prevention and treatment. Scale‐up of effective linkage strategies is essential to achieving the global 95‐95‐95 goals for maintaining low HIV incidence by 2030 and reducing HIV‐related morbidity and mortality. Whereas linkage to care including same‐day antiretroviral therapy (ART) initiation for all people with HIV is now routinely implemented in testing programmes, linkage to HIV prevention interventions including behavioural or biomedical strategies, for HIV‐negative individuals remains sub‐optimal. This review aims to evaluate effective post‐HTS linkage strategies for HIV overall, and highlight gaps specifically in linkage to prevention. Methods: Using the five‐step Arksey and O'Malley framework, we conducted a scoping review searching existing published and grey literature. We searched PubMed, Cochrane Library, CINAHL, Web of Science and EMBASE databases for English‐language studies published between 1 January 2010 and 30 November 2023. Linkage interventions included as streamlined interventions—involving same‐day HIV testing, ART initiation and point‐of‐care CD4 cell count/viral load, case management—involving linkage coordinators developing personalized HIV care and risk reduction plans, incentives—financial and non‐financial, partner services—including contact tracing, virtual—like social media, quality improvement—like use of score cards, and peer‐based interventions. Outcomes of interest were linkage to any form of HIV prevention and/or care including ART initiation. Results: Of 2358 articles screened, 66 research studies met the inclusion criteria. Only nine linkage to prevention studies were identified (n = 9/66, 14%)—involving pre‐exposure prophylaxis, voluntary medical male circumcision, sexually transmitted infection and cervical cancer screening. Linkage to care studies (n = 57/66, 86%) focused on streamlined interventions in the general population and on case management among key populations. Discussion: Despite a wide range of HIV prevention interventions available, there was a dearth of literature on HIV prevention programmes and on the use of messaging on treatment as prevention strategy. Linkage to care studies were comparatively numerous except those evaluating virtual interventions, incentives and quality improvement. Conclusions: The findings give insights into linkage strategies but more understanding of how to provide these effectively for maximum prevention impact is needed., INTRODUCTION Globally, linkage to HIV services, defined as a process to support people testing for HIV to engage with prevention, care, treatment and other relevant non‐HIV‐related services, is an important [...]

Pregnancy is a high-risk period for HIV acquisition in African women, and pregnant women who become acutely infected with HIV account for up to a third of vertical HIV transmission cases in African settings. To protect women and eliminate vertical transmission, WHO recommends offering oral pre-exposure prophylaxis (PrEP) based on tenofovir to HIV-negative pregnant and post-partum women with a substantial risk of HIV acquisition. PrEP implementation for pregnant and post-partum women lags behind implementation for other high-risk populations. Unique considerations for PrEP implementation arise during pregnancy and post partum, including the integration of provider training with clinical delivery and monitoring of PrEP exposure and outcomes within existing maternal health systems, yet scarce implementation data are available to generate evidence in this context.

BackgroundEconomic compensation interventions may help support higher voluntary medical male circumcision (VMMC) coverage in priority sub-Saharan African countries. To inform World Health Organization guidelines, we conducted a systematic review of economic compensation interventions to increase VMMC uptake.MethodsEconomic compensation interventions were defined as providing money or in-kind compensation, reimbursement for associated costs (e.g. travel, lost wages), or lottery entry. We searched five electronic databases and four scientific conferences for studies examining the impact of such interventions on VMMC uptake, HIV testing and safer-sex/risk-reduction counseling uptake within VMMC, community expectations about compensation, and potential coercion. We screened citations, extracted data, and assessed risk of bias in duplicate. We conducted random-effects meta-analysis. We also reviewed studies examining acceptability, values/preferences, costs, and feasibility.ResultsOf 2484 citations identified, five randomized controlled trials (RCTs) and three non-randomized controlled trials met our eligibility criteria. Studies took place in Kenya, Malawi, South Africa, Tanzania, Uganda, Zambia, and Zimbabwe. Meta-analysis of four RCTs showed significant impact of any economic compensation on VMMC uptake (relative risk: 5.23, 95% CI: 3.13 to 8.76). RCTs of food/transport vouchers and conditional cash transfers generally showed increases in VMMC uptake, but lotteries, subsidized VMMC, and receiving a gift appeared somewhat less effective. Three non-randomized trials showed mixed impact. Six additional studies suggested economic compensation interventions were generally acceptable, valued for addressing key barriers, and motivating to men. However, some participants felt they were insufficiently motivating or necessary; one study suggested they might raise community suspicions. One study from South Africa found a program cost of US$91 per additional circumcision and US$450-$1350 per HIV infection averted.ConclusionsEconomic compensation interventions, particularly transport/food vouchers, positively impacted VMMC uptake among adult men and were generally acceptable to potential clients. Carefully selected economic interventions may be a useful targeted strategy to enhance VMMC coverage.

BackgroundVoluntary medical male circumcision (VMMC) remains an essential component of combination HIV prevention services, particularly in priority countries in sub-Saharan Africa. As VMMC programs seek to maximize impact and efficiency, and to support World Health Organization guidance, specific uptake-enhancing strategies are critical to identify.MethodsWe systematically reviewed the literature to evaluate the impact of service delivery interventions (e.g., facility layout, service co-location, mobile outreach) on VMMC uptake among adolescent and adult men. For the main effectiveness review, we searched for publications or conference abstracts that measured VMMC uptake or uptake of HIV testing or risk reduction counselling within VMMC services. We synthesized data by coding categories and outcomes. We also reviewed studies assessing acceptability, values/preferences, costs, and feasibility.ResultsFour randomized controlled trials and five observational studies were included in the effectiveness review. Studies took place in South Africa, Tanzania, Uganda, Zambia, and Zimbabwe. They assessed a range of service delivery innovations, including community-, school-, and facility-based interventions. Overall, interventions increased VMMC uptake; some successfully improved uptake among age-specific subpopulations, but urban-rural stratification showed no clear trends. Interventions that increased adult men's uptake included mobile services (compared to static facilities), home-based testing with active referral follow-up, and facility-based HIV testing with enhanced comprehensive sexual education. Six acceptability studies suggested interventions were generally perceived to help men choose to get circumcised. Eleven cost studies suggested interventions create economies-of-scale and efficiencies. Three studies suggested such interventions were feasible, improving facility preparedness, service quality and quantity, and efficiencies.ConclusionsInnovative changes in male-centered VMMC services can improve adult men's and adolescent boys' VMMC uptake. Limited evidence on interventions that enhance access and acceptability show promising results, but evidence gaps persist due to inconsistent intervention definition and delivery, due in part to contextual relevance and limited age disaggregation.

IntroductionHIV 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.MethodsWe 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 discussionWe 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.ConclusionsExpanding 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.

IntroductionHIV 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.MethodsWe 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 discussionWe 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.ConclusionsExpanding 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.

Phylogenetic analysis of pathogens is an increasingly powerful way to reduce the spread of epidemics, including HIV. As a result, phylogenetic approaches are becoming embedded in public health and research programmes, as well as outbreak responses, presenting unique ethical, legal, and social issues that are not adequately addressed by existing bioethics literature. We formed a multidisciplinary working group to explore the ethical issues arising from the design of, conduct in, and use of results from HIV phylogenetic studies, and to propose recommendations to minimise the associated risks to both individuals and groups. We identified eight key ethical domains, within which we highlighted factors that make HIV phylogenetic research unique. In this Review, we endeavoured to provide a framework to assist researchers, public health practitioners, and funding institutions to ensure that HIV phylogenetic studies are designed, done, and disseminated in an ethical manner. Our conclusions also have broader relevance for pathogen phylogenetics.

Scale-up of human immunodeficiency virus (HIV) testing and antiretroviral therapy (ART) for people living with HIV has been increasing in sub-Saharan Africa. As a result, areas with high HIV prevalence are finding a declining proportion of people testing positive in their national testing programmes. In eastern and southern Africa, where there are settings with adult HIV prevalence of 12% and above, the positivity from national HIV testing services has dropped to below 5%. Identifying those in need of ART is therefore becoming more costly for national HIV programmes. Annual target-setting assumes that national testing positivity rates approximate that of population prevalence. This assumption has generated an increased focus on testing approaches which achieve higher rates of HIV positivity. This trend is a departure from the provider-initiated testing and counselling strategy used early in the global HIV response. We discuss a new indicator, treatment-adjusted prevalence, that countries can use as a practical benchmark for estimating the expected adult positivity in a testing programme when accounting for both national HIV prevalence and ART coverage. The indicator is calculated by removing those people receiving ART from the numerator and denominator of HIV prevalence. Treatment-adjusted prevalence can be readily estimated from existing programme data and population estimates, and in 2019, was added to the World Health Organization guidelines for HIV testing and strategic information. Using country examples from Kenya, Malawi, South Sudan and Zimbabwe we illustrate how to apply this indicator and we discuss the potential public health implications of its use from the national to facility level. Le depistage du virus de l'immunodeficience humaine (VIH) et le traitement antiretroviral (TAR) pour les personnes vivant avec le VIH ont connu un veritable essor en Afrique subsaharienne. Par consequent, les regions touchees par une forte prevalence du VIH detectent un pourcentage moins eleve de personnes testees positives dans leurs programmes de depistage nationaux. En Afrique orientale et australe, la ou certains endroits affichent une prevalence du VIH chez l'adulte egale ou superieure a 12%, le taux de positivite des services de depistage nationaux est passe sous la barre des 5%. Identifier les personnes necessitant un TAR devient donc plus couteux pour les programmes nationaux consacres au VIH. Pour definir les objectifs annuels, on part du principe que les taux de positivite nationaux se rapprochent du taux de prevalence au sein de la population. Cette supposition a oriente les demarches vers des methodes de depistage permettant d'obtenir des taux de positivite plus eleves; une tendance qui s'ecarte de la strategie des services de depistage et de conseil a l'initiative des prestataires, utilisee a l'aube de la lutte mondiale contre le VIH. Dans le present document, nous nous interessons a un nouvel indicateur, la prevalence ajustee sur le traitement. Cet indicateur peut servir de reference concrete pour les pays qui souhaitent evaluer le taux de positivite attendu chez l'adulte dans un programme de depistage, en tenant compte de la prevalence du VIH au niveau national ainsi que de la portee du TAR. Le calcul consiste a enlever les personnes recevant un TAR du numerateur et du denominateur de la prevalence du VIH. La prevalence ajustee sur le traitement peut aisement etre determinee en fonction des donnees de programme et estimations de population existantes. En 2019, elle a egalement ete ajoutee aux lignes directrices de l'Organisation mondiale de la Sante pour l'information strategique et le depistage du VIH. En nous inspirant d'exemples issus du Kenya, du Malawi, du Soudan du Sud et du Zimbabwe, nous expliquons comment employer cet indicateur et abordons les potentielles implications liees a son utilisation en matiere de sante publique, en partant du niveau national jusqu'aux etablissements. La ampliacion de las pruebas de deteccion del virus de la inmunodeficiencia humana (VIH) y del tratamiento antirretrovirico (TAR) para las personas infectadas por el VIH ha aumentado en el Africa subsahariana. En consecuencia, el porcentaje de personas que dan positivo en las pruebas de deteccion del VIH en los programas nacionales esta disminuyendo en las zonas con alta prevalencia del virus. En Africa meridional y oriental, donde hay entornos con una prevalencia del VIH en adultos del 12 % o superior, la tasa de positividad de los servicios nacionales de pruebas de deteccion del VIH ha descendido a menos del 5 %. Por lo tanto, la identificacion de las personas que necesitan TAR es cada vez mas costosa para los programas nacionales de VIH. El establecimiento de objetivos anuales supone que las tasas de positividad de las pruebas nacionales se aproximan a las de la prevalencia de la poblacion. Esta suposicion ha generado una mayor atencion a los enfoques de las pruebas que logran tasas mas altas de positividad del VIH. Esta tendencia se aleja de la estrategia del asesoramiento y las pruebas que iniciaron los proveedores y que se utilizo al principio de la respuesta mundial al VIH. Se analiza un nuevo indicador, la prevalencia ajustada segun el tratamiento, que los paises pueden emplear como punto de referencia practico para estimar la tasa de positividad esperada en adultos en un programa de pruebas de deteccion cuando se tiene en cuenta tanto la prevalencia nacional del VIH como la cobertura del TAR. El indicador se calcula eliminando del numerador y el denominador de la prevalencia del VIH a las personas que reciben TAR. La prevalencia ajustada segun el tratamiento se puede estimar con facilidad a partir de los datos de los programas existentes y de las estimaciones de poblacion, ademas, en 2019, se incluyo en las directrices de la Organizacion Mundial de la Salud para las pruebas de deteccion del VIH y en la informacion estrategica. A traves de ejemplos de paises como Kenia, Malaui, Sudan meridional y Zimbabue, se demuestra como aplicar este indicador y se discuten las posibles implicaciones para la salud publica de su uso desde el nivel nacional hasta el de los centros. [phrase omitted], Introduction Globally, there has been substantial scale-up of human immunodeficiency virus (HIV) testing services and antiretroviral therapy (ART), and it is now estimated that 78% (16 million) of the 20.6 [...]

: Introduction: Pre‐exposure prophylaxis (PrEP) is an important HIV prevention option. Two randomized trials have provided efficacy evidence for long‐acting injectable cabotegravir (CAB‐LA) as PrEP. In considering CAB‐LA as an additional PrEP modality for people at substantial risk of HIV, it is important to understand community response to injectable PrEP. We conducted a systematic review of values, preferences and perceptions of acceptability for injectable PrEP to inform global guidance. Methods: We searched nine databases and conference websites for peer‐reviewed and grey literature (January 2010−September 2021). There were no restrictions on location. A two‐stage review process assessed references against eligibility criteria. Data from included studies were organized by constructs from the Theoretical Framework of Acceptability. Results: We included 62 unique references. Most studies were observational, cross‐sectional and qualitative. Over half of the studies were conducted in North America. Men who have sex with men were the most researched group. Most studies (57/62) examined injectable PrEP, including hypothetical injectables (55/57) or placebo products (2/57). Six studies examined CAB‐LA specifically. There was overall interest in and often a preference for injectable PrEP, though there was variation within and across groups and regions. Many stakeholders indicated that injectable PrEP could help address adherence challenges associated with daily or on‐demand dosing for oral PrEP and may be a better lifestyle fit for individuals seeking privacy, discretion and infrequent dosing. End‐users reported concerns, including fear of needles, injection site pain and body location, logistical challenges and waning or incomplete protection. Discussion: Despite an overall preference for injectable PrEP, heterogeneity across groups and regions highlights the importance of enabling end‐users to choose a PrEP modality that supports effective use. Like other products, preference for injectable PrEP may change over time and end‐users may switch between prevention options. There will be a greater understanding of enacted preference as more end‐users are offered anti‐retroviral (ARV)‐containing injectables. Future research should focus on equitable implementation, including real‐time decision‐making and how trained healthcare providers can support choice. Conclusions: Given overall acceptability, injectable PrEP should be included as part of a menu of prevention options, allowing end‐users to select the modality that suits their preferences, needs and lifestyle., PROSPERO number: CRD42021285299 INTRODUCTION Despite the availability of HIV prevention tools, HIV remains a significant public health issue, with approximately 1.5 million people acquiring HIV in 2021 [1]. Pre‐exposure prophylaxis [...]

: Introduction: Data from two randomized controlled trials (RCTs) showed that injectable cabotegravir (CAB) for pre‐exposure prophylaxis (PrEP) was efficacious in reducing HIV acquisition. The US Food and Drug Administration approved CAB for PrEP in December 2021; Australia in August 2022; Zimbabwe in October 2022; South Africa in November 2022; Malawi in March 2023; and regulatory approvals are being sought in additional countries. The World Health Organization (WHO) recommended CAB be offered to people at substantial risk of HIV in July 2022. However, implementation experience beyond RCTs is limited. As countries consider CAB implementation, questions remain regarding delivery and involvement of populations excluded from the trials. A coordinated approach is needed to ensure these are addressed and CAB can be introduced in low‐ and middle‐income countries in timely, acceptable and effective ways. Discussion: Beginning in 2018, the Biomedical Prevention Implementation Collaborative (BioPIC) convened over 100 global health experts to develop a comprehensive introduction strategy for CAB. Using this roadmap, country landscaping for CAB introduction and lessons from oral PrEP implementation, AVAC and WHO co‐convened 50 researchers, donors, implementers and civil society in September 2021 to: (1) identify questions and evidence gaps related to CAB across contexts and partners; (2) define the implementation science agenda; and (3) agree on mechanism(s) for future coordination. As a result, CAB‐related questions were identified, including: defining optimal and feasible HIV testing strategies that expand access; delivery models; integration with a range of services, including family planning and antenatal care; and embedding CAB in demand generation for HIV prevention choices. Through convenings and mapping of implementation research, BioPIC identified gaps in populations, geographies and delivery approaches. Conclusions: The introduction strategy refined by BioPIC lays the groundwork for future HIV prevention products. Ongoing policy and implementation dialogue is critical to accelerate the design of CAB implementation studies that adequately address priority knowledge gaps. Additional long‐acting HIV prevention products may be available over the next 5 years, increasing choice, but potentially making delivery and stakeholder engagement more complex. Ongoing coordination with WHO will accelerate the adoption of evidence‐based policies and wide‐scale implementation, and lessons from BioPIC can inform introduction processes for long‐acting HIV prevention products., INTRODUCTION Injectable cabotegravir (CAB) is an integrase strand‐transfer inhibitor (INSTI) class antiretroviral. For use as HIV pre‐exposure prophylaxis (PrEP), it is administered to people who do not have HIV at [...]

Background HIV testing services (HTS) are the first steps in reaching the UNAIDS 95-95-95 goals to achieve and maintain low HIV incidence. Evaluating the effectiveness of different demand creation interventions to increase uptake of efficient and effective HTS is useful to prioritize limited programmatic resources. This review was undertaken to inform World Health Organization (WHO) 2019 HIV testing guidelines and assessed the research question, 'Which demand creation strategies are effective for enhancing uptake of HTS?' focused on populations globally. Methods and findings The following electronic databases were searched through September 28, 2021: PubMed, PsycInfo, Cochrane CENTRAL, CINAHL Complete, Web of Science Core Collection, EMBASE, and Global Health Database; we searched IAS and AIDS conferences. We systematically searched for randomized controlled trials (RCTs) that compared any demand creation intervention (incentives, mobilization, counseling, tailoring, and digital interventions) to either a control or other demand creation intervention and reported HTS uptake. We pooled trials to evaluate categories of demand creation interventions using random-effects models for meta-analysis and assessed study quality with Cochrane's risk of bias 1 tool. This study was funded by the WHO and registered in Prospero with ID CRD42022296947. We screened 10,583 records and 507 conference abstracts, reviewed 952 full texts, and included 124 RCTs for data extraction. The majority of studies were from the African (N = 53) and Americas (N = 54) regions. We found that mobilization (relative risk [RR]: 2.01, 95% confidence interval [CI]: [1.30, 3.09], p < 0.05; risk difference [RD]: 0.29, 95% CI [0.16, 0.43], p < 0.05, N = 4 RCTs), couple-oriented counseling (RR: 1.98, 95% CI [1.02, 3.86], p < 0.05; RD: 0.12, 95% CI [0.03, 0.21], p < 0.05, N = 4 RCTs), peer-led interventions (RR: 1.57, 95% CI [1.15, 2.15], p < 0.05; RD: 0.18, 95% CI [0.06, 0.31], p < 0.05, N = 10 RCTs), motivation-oriented counseling (RR: 1.53, 95% CI [1.07, 2.20], p < 0.05; RD: 0.17, 95% CI [0.00, 0.34], p < 0.05, N = 4 RCTs), short message service (SMS) (RR: 1.53, 95% CI [1.09, 2.16], p < 0.05; RD: 0.11, 95% CI [0.03, 0.19], p < 0.05, N = 5 RCTs), and conditional fixed value incentives (RR: 1.52, 95% CI [1.21, 1.91], p < 0.05; RD: 0.15, 95% CI [0.07, 0.22], p < 0.05, N = 11 RCTs) all significantly and importantly ([greater than or equal to]50% relative increase) increased HTS uptake and had medium risk of bias. Lottery-based incentives and audio-based interventions less importantly (25% to 49% increase) but not significantly increased HTS uptake (medium risk of bias). Personal invitation letters and personalized message content significantly but not importantly ( Conclusions Mobilization, couple- and motivation-oriented counseling, peer-led interventions, conditional fixed value incentives, and SMS are high-impact demand creation interventions and should be prioritized for programmatic consideration. Reduced duration counseling and video-based interventions are an efficient and effective alternative to address staffing shortages. Investment in demand creation activities should prioritize those with undiagnosed HIV or ongoing HIV exposure. Selection of demand creation interventions must consider risks and benefits, context-specific factors, feasibility and sustainability, country ownership, and universal health coverage across disease areas., Author(s): Anjuli D. Wagner 1,*, Irene N. Njuguna 1,2, Jillian Neary 3, Kendall A. Lawley 3, Diana K. N. Louden 4, Ruchi Tiwari 1, Wenwen Jiang 3, Ngozi Kalu 5, [...]

Author(s): Anna Grimsrud 1,*, Lynne Wilkinson 1,2, Peter Ehrenkranz 3, Stephanie Behel 4, Thato Chidarikire 5, Tina Chisenga 6, Rachel Golin 7,8, Cheryl Case Johnson 9, Maureen Milanga 10, Obinna [...]

Introduction: Social network‐based testing approaches (SNAs) encourage individuals ("test promoters") to motivate sexual partners and/or those in their social networks to test for HIV. We conducted a systematic review to examine the effectiveness, acceptability and cost‐effectiveness of SNA. Methods: We searched five databases from January 2010 to May 2023, and included studies that compared SNA with non‐SNA. We used random‐effects meta‐analysis to combine effect estimates. Certainty was assessed using the GRADE approach. Results: We identified 47 studies. SNA may increase uptake of HIV testing compared to non‐SNA (RR 2.04, 95% CI: 1.06–3.95, Low certainty). The proportion of first‐time testers was probably higher among partners or social contacts of test promoters using SNA compared to non‐SNA (RR 1.49, 95% CI: 1.22–1.81, Moderate certainty). The proportion of people who tested positive for HIV may be higher among partners or social contacts of test promoters using SNA compared to non‐SNA (RR 1.84, 95% CI: 1.01–3.35, Low certainty). There were no reports of any adverse events or harms associated with SNA. Based on six cost‐effectiveness studies, SNA was generally cheaper per person tested and per person diagnosed compared to non‐SNA. Based on 23 qualitative studies, SNA is likely to be acceptable to a variety of populations. Discussion: Our review collated evidence for SNA to HIV testing covering the key populations and the general population who may benefit from HIV testing. We summarized evidence for the effectiveness, acceptability and cost‐effectiveness of different models of SNA. While we did not identify an ideal model of SNA that could be immediately scaled up, for each setting and population targeted, we recommend various implementation considerations as our meta‐analysis showed the effectiveness might differ due to factors which include the testing modality (i.e. use of HIV self‐testing), type of test promoters, long or short duration of recruitment and use of financial incentives. Conclusions: Social network‐based approaches may enhance HIV testing uptake, increase the proportion of first‐time testers and those testing positive for HIV. Heterogeneity among studies highlights the need for context‐specific adaptations, but the overall positive impact of SNA on HIV testing outcomes could support its integration into existing HIV testing services. [ABSTRACT FROM AUTHOR]

To maximise the benefits of HIV self-testing (HIVST), it is critical to support self-testers in the testing process and ensure that they access appropriate prevention and care. To summarise systems and tools supporting HIVST (hereafter, 'support systems') and categorise them for future analysis, we synthesised the global data on HIVST support systems and proposed a typology. We searched five databases for articles reporting on one or more HIVST support systems and included 314 publications from 224 studies. Across 189 studies, there were 539 reports of systems supporting HIVST use; while across 115 studies, there were 171 reports of systems supporting result interpretation. Most commonly, these were pictorial instructions, followed by in-person demonstrations and in-person assistance while self-testing or reading self-test results. Less commonly, virtual interventions were also identified, including online video conferencing and smartphone apps. Smartphone-based automated result readers have been used in the USA, China, and South Africa. Across 173 studies, there were 987 reports of systems supporting post-test linkage to care; most commonly, these were in-person referrals/counselling, written referrals, and phone helplines. In the USA, Bluetooth beacons have been trialled to monitor self-test use and facilitate follow-up. We found that, globally, HIVST support systems use a range of methods, including static media, virtual tools, and in-person engagement. In-person and printed approaches were more common than virtual tools. Other considerations, such as linguistic and cultural appropriateness, may also be important in the development of effective HIVST programs. The success of HIV self-testing requires the user to accurately use the self-test, interpret the result, and be linked to relevant follow-up services. We summarised the systems and tools that have been used to support users through the self-testing process ('support systems'), and found a diverse range of support systems, including pictorial instructions, in-person support, and virtual tools. We have developed a typology to categorise these support systems, which can be used as a framework for further research. [ABSTRACT FROM AUTHOR]

Introduction: HIV retesting during late pregnancy and breastfeeding can help detect new maternal infections and prevent mother-to-child HIV transmission (MTCT), but the optimal timing and cost-effectiveness of maternal retesting remain uncertain. Methods: We constructed deterministic models to assess the health and economic impact of maternal HIV retesting on a hypothetical population of pregnant women, following initial testing in pregnancy, on MTCT in four countries: South Africa and Kenya (high/intermediate HIV prevalence), and Colombia and Ukraine (low HIV prevalence). We evaluated six scenarios with varying retesting frequencies from late in antenatal care (ANC) through nine months postpartum. We compared strategies using incremental cost-effectiveness ratios (ICERs) over a 20-year time horizon using country-specific thresholds. Results: We found maternal retesting once in late ANC with catch-up testing through six weeks postpartum was cost-effective in Kenya (ICER = $166 per DALY averted) and South Africa (ICER=$289 per DALY averted). This strategy prevented 19% (Kenya) and 12% (South Africa) of infant HIV infections. Adding one or two additional retests postpartum provided smaler benefits (1 to 2 percentage point increase in infections averted versus one retest). Adding three retests during the postpartum period averted additional infections (1 to 3 percentage point increase in infections averted versus one retest) but ICERs ($7639 and in Kenya and $11 985 in South Africa) greatly exceeded the cost-effectiveness thresholds. In Colombia and Ukraine, all retesting strategies exceeded the cost-effectiveness threshold and prevented few infant infections (up to 31 and 5 infections, respectively). Conclusions: In high HIV burden settings with MTCT rates similar to those seen in Kenya and South Africa, HIV retesting once in late ANC, with subsequent intervention, is the most cost-effective strategy for preventing infant HIV infections. In these settings, two HIV retests postpartum marginally reduced MTCT and were less costly than adding three retests. Retesting in low-burden settings with MTCT rates similar to Colombia and Ukraine was not cost-effective at any time point due to very low HIV prevalence and limited breastfeeding. Keywords: maternal HIV retesting; elimination of maternal-to-child HIV transmission; EMTCT; prevention of maternal-to-child HIV transmission; PMTCT; cost-effectiveness analysis; maternal and child health, 1 | INTRODUCTION Despite successful scale-up of prevention of mother-to-child HIV transmission (PMTCT) programmes, an estimated 160 000 children worldwide became infected with HIV in 2018, with approximately 30% of [...]

Introduction: Given the synergistic relationship between HIV and sexually transmitted infections (STI), the integration of services has the potential to reduce the incidence of both HIV and STIs. We explored the extent to which STI testing has been offered within HIV pre-exposure prophylaxis (PrEP) programmes worldwide. Methods: We conducted a systematic review of PrEP programmes implementing STI testing services in nine databases. We approached PrEP implementers for additional unpublished data and implementation details. Descriptive statistics were used to present the characteristics of STI testing within PrEP programmes. Content analysis of the input from PrEP implementers was conducted to summarize the barriers to and facilitators of STI testing. Results: Of 9,161 citations, 91 studies conducted in 32 countries were included: 69% from high-income countries (HICs) and 64% from programmes targeting men who have sex with men (MSM) and transgender women (TGW) only. The majority of programmes (70%, 64/91) conducted STI testing before the initiation of PrEP. The most common STIs tested were gonorrhoea (86%, 78/91), chlamydia (84%, 76/91) and syphilis (84%, 76/91).The majority provided STI testing at three-month intervals (70%, 53/76, for syphilis; 70% 53/78, for chlamydia; 68%, 53/78, for gonorrhoea). Relative to low- and middle-income countries (LMICs), a higher proportion of PrEP programmes in HICs offered testing for gonorrhoea (92% vs. 71%, p < 0.05), chlamydia (92% vs. 64%, p < 0.01), syphilis (87% vs. 75%, p < 0.05), hepatitis A (18% vs. 4%, p < 0.05) and hepatitis C (43% vs. 21%, p < 0.05); offered testing for a higher number of STIs (mean 3.75 vs. 3.04, p < 0.05); and offered triple (throat, genital/urine and anorectal) anatomical site screening (54% vs. 18%, p < 0.001). Common implementation challenges included costs, access to STI diagnostics, programme logistics of integrating STI testing into PrEP delivery models and lack of capacity building for staff involved in PrEP provision. Conclusions: Significant gaps and challenges remain in the provision of STI testing services within HIV PrEP programmes. We recommend more active integration of STI testing and management into PrEP programmes, supported by standardized practice guidelines, staff capacity building training and adequate funding. This could lead to improved sexual health and HIV outcomes in key populations. Keywords: sexually transmitted infections; HIV; pre-exposure prophylaxis; sexual health; STI testing; systematic review, 1 | INTRODUCTION Pre-exposure prophylaxis (PrEP) is a safe and effective approach to prevent HIV infection when adherence is high [1-4]. PrEP was first approved for use as an HIV [...]

ObjectivePreexposure prophylaxis (PrEP) offers a promising new approach to HIV prevention. This systematic review and meta-analysis evaluated the evidence for use of oral PrEP containing tenofovir disoproxil fumarate as an additional HIV prevention strategy in populations at substantial risk for HIV based on HIV acquisition, adverse events, drug resistance, sexual behavior, and reproductive health outcomes.DesignRigorous systematic review and meta-analysis.MethodsA comprehensive search strategy reviewed three electronic databases and conference abstracts through April 2015. Pooled effect estimates were calculated using random-effects meta-analysis.ResultsEighteen studies were included, comprising data from 39 articles and six conference abstracts. Across populations and PrEP regimens, PrEP significantly reduced the risk of HIV acquisition compared with placebo. Trials with PrEP use more than 70% demonstrated the highest PrEP effectiveness (risk ratio = 0.30, 95% confidence interval: 0.21-0.45, P

Introduction: Learning one's HIV status through HIV testing services (HTS) is an essential step toward accessing treatment and linking to preventive services for those at high HIV risk. HTS may impact subsequent sexual behaviour, but the degree to which this varies by population or is true in the setting of contemporary HIV prevention activities is largely unknown. As part of the 2019 World Health Organization Consolidated Guidelines on HTS, we undertook a systematic review and meta-analysis to determine the effect of HTS on sexual behaviour. Methods: We searched nine electronic databases for studies published between July 2010 and December 2019. We included studies that reported on at least one outcome (condom use [defined as the frequency of condom use or condom-protected sex], number of sex partners, HIV incidence, STI incidence/prevalence). We included studies that prospectively assessed outcomes and that fit into one of three categories: (1) those evaluating more versus less-intensive HTS, (2) those of populations receiving HTS versus not and (3) those evaluating outcomes after versus before HTS. We conducted meta-analyses using random-effects models. Results and discussion: Of 29 980 studies screened, 76 studies were included. Thirty-eight studies were randomized controlled trials, 36 were cohort studies, one was quasi-experimental and one was a serial cross-sectional study. There was no significant difference in condom use among individuals receiving more-intensive HTS compared to less-intensive HTS (relative risk [RR]=1.03; 95% CI: 0.99 to 1.07). Condom use was significantly higher after receiving HTS compared to before HTS for individuals newly diagnosed with HIV (RR = 1.65; 95% CI: 1.36 to 1.99) and marginally significantly higher for individuals receiving an HIV-negative diagnosis (RR = 1.63; 95% CI: 1.01 to 2.62). Individuals receiving more-intensive HTS reported fewer sex partners at follow-up than those receiving less-intensive HTS, but the finding was not statistically significant (mean difference = -0.28; 95% CI: -3.66, 3.10). Conclusions: Our findings highlight the importance of using limited resources towards HTS strategies that focus on early HIV diagnosis, treatment and prevention services rather than resources dedicated to supplementing or enhancing HTS with additional counselling or other interventions. Keywords: HIV testing; sexual behaviour change; condom-protected sex; number of sexual partners; systematic review; meta-analysis, 1 | INTRODUCTION HIV testing and knowledge of one's status is an essential first step towards linkage to HIV treatment, prevention and care [1] . Early linkage to antiretroviral therapy [...]

The World Health Organization (WHO) estimated that in 2016 the global annual incidence of chlamydia, gonorrhoea, trichomoniasis and syphilis among people 15 to 49 years of age was 376.4 million [...]

Introduction: WHO/UNAIDS recommended Voluntary Medical Male Circumcision in 2007 based on systematic review of observational studies prior to 1999 and three randomized controlled trials (RCTs). To inform updated WHO guidance, we conducted a systematic review and meta-analysis of impact of circumcision on the risk of HIV infection among heterosexual men. Methods: Studies in PubMed of HIV incidence and changes in prevalence in heterosexual men by circumcision status were identified. Pooled incidence rate ratios were computed using fixed- and random-effects meta-analysis and risk of bias was assessed using the ROBINS-I tool. Results and Discussion: In three RCTs, the pooled incidence ratio was 0.41 (95% CI 0.30 to 0.56), with risk difference 10 (8 to 12) fewer infections per 1000 person-years (py). Pooled incidence ratios were 0.34 (0.24 to 0.49) in two post-RCT follow-up studies, 0.29 (0.19 to 0.43) in men at high HIV risk (five cohorts), 0.48 (0.33 to 0.70) in four community-based cohorts before circumcision scale-up, and 0.56 (0.49 to 0.64) (7 [6 to 8] fewer per 1000 py) in six community-based cohorts during circumcision and antiretroviral treatment scale-up. Heterogeneity between studies was low except in men at high HIV risk. We estimated 520,000 (425,000 to 605,000) fewer infections occurred in men by end of 2018 from 22.7 million circumcisions performed since 2008 and increasing by 155,000 (125,000 to 180,000) annually if epidemic conditions remain similar. After exclusion of studies with high risk of bias and those conducted outside Africa, pooled incidence ratios were similar. There was no evidence of confounding nor changes in risk behaviour following circumcision. In post-hoc exploratory analyses we observed a trend of decreasing effectiveness of circumcision in cohorts with lower HIV incidence. Conclusions: Efficacy of medical male circumcision on HIV incidence from randomized controlled trials was supported by effectiveness from observational studies in populations with diverse HIV risk and changing epidemic contexts. Voluntary Medical Male Circumcision remains an important evidence-based intervention for control of generalized HIV epidemics. Keywords: circumcision male; HIV incidence; HIV prevention; meta-analysis; review, 1 | INTRODUCTION Data suggesting a potential link between male circumcision and HIV infection at the individual and population levels were published in 1988 [1] and 1989 [2]. A meta-analysis [...]