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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: 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 [...]

Objective To present findings from implementation and scale-up of human immunodeficiency virus (HIV) self-testing programmes for female sex workers in Malawi and Zimbabwe, 2013-2018. Methods In Zimbabwe, we carried out formative research to assess the acceptability and accuracy of HIV self- testing. During implementation we evaluated sex workers' preferences for, and feasibility of, distribution of test kits before the programme was scaled-up. In Malawi, we conducted a rapid ethnographic assessment to explore the context and needs of female sex workers and resources available, leading to a workshop to define the distribution approach for test kits. Once distribution was implemented, we conducted a process evaluation and established a system for monitoring social harm. Findings In Zimbabwe, female sex workers were able to accurately self-test. The preference study helped to refine systems for national scale-up through existing services for female sex workers. The qualitative data helped to identify additional distribution strategies and mediate potential social harm to women. In Malawi, peer distribution of test kits was the preferred strategy. We identified some incidents of social harm among peer distributors and female sex workers, as well as supply-side barriers to implementation which hindered uptake of testing. Conclusion Involving female sex workers in planning and ongoing implementation of HIV self-testing is essential, along with strategies to mitigate potential harm. Optimal strategies for distribution and post-test support are context-specific and need to consider existing support for female sex workers and levels of trust and cohesion within their communities. Objectif Presenter les resultats de la mise en reuvre et de I'elargissement de programmes d'autodepistage du virus de l'immunodeficience humaine (VIH) pour les travailleuses du sexe au Malawi et au Zimbabwe entre 2013 et 2018. Methodes Au Zimbabwe, nous avons realise une recherche preparatoire pour evaluer l'acceptabilite et la precision de l'autotest du VIH. Au cours de la mise en reuvre, nous avons evalue la faisabilite et les preferences des travailleuses du sexe a l'egard de la distribution des trousses de depistage avant d'elargir le programme. Au Malawi, nous avons realise une evaluation ethnographique rapide pour etudier le contexte, les besoins des travailleuses du sexe et les ressources disponibles, ce qui a donne lieu a un atelier dont l'objectif etait de definir la methode de distribution des trousses de depistage. Une fois la distribution mise en place, nous avons evalue le processus et etabli un systeme de suivi des dommages sociaux. Resultats Au Zimbabwe, les travailleuses du sexe etaient en mesure de proceder a un autodepistage precis. Letude des preferences a permis de perfectionner les systemes en vue d'un developpement national par l'intermediaire des services existants pour les travailleuses du sexe. Les donnees qualitatives ont aide a definir d'autres strategies de distribution et les dommages sociaux indirects que peuvent subir les femmes. Au Malawi, la distribution de trousses de depistage par des pairs a ete la strategie privilegiee. Nous avons identifie quelques cas de dommages sociaux entre des travailleuses du sexe assurant la distribution et d'autres travailleuses du sexe, ainsi que des obstacles du cote de l'offre qui ont limite l'utilisation du test. Conclusion La participation des travailleuses du sexe a la planification et a la mise en reuvre continue de l'autodepistage du VIH est essentielle, de meme que les strategies visant a reduire les dommages potentiels. Pour etre optimales, les strategies en matiere de distribution et de soutien post-test doivent tenir compte du contexte, du soutien existant apporte aux travailleuses du sexe et du degre de confiance et de cohesion au sein de leurs communautes. Objetivo Presentar los resultados de la implementacion y ampliacion de los programas de autodiagnostico del virus de la inmunodeficiencia humana (VIH) para trabajadoras sexuales en Malawi y Zimbabwe, 2013-2018. Metodos En Zimbabwe, se llevo a cabo una investigacion formativa para evaluar la aceptabilidad y exactitud del autodiagnostico del VIH. Durante la implementacion, se evaluaron las preferencias de las trabajadoras sexuales y la viabilidad de la distribucion de los kits de pruebas antes de ampliar el programa. En Malawi, se realizo una evaluacion etnografica rapida para explorar el contexto y las necesidades de las trabajadoras sexuales y los recursos disponibles, que condujo a un taller para definir el enfoque de distribucion de los kits de pruebas. Una vez implementada la distribucion, se llevo a cabo una evaluacion del proceso y se establecio un sistema para el seguimiento de los danos sociales. Resultados En Zimbabwe, las trabajadoras sexuales pudieron autoevaluarse con precision. El estudio de preferencias contribuyo a perfeccionar los sistemas de ampliacion nacional mediante los servicios existentes para las trabajadoras sexuales. Los datos cualitativos ayudaron a identificar estrategias de distribucion adicionales y a mediar en posibles danos sociales para las mujeres. En Malawi, la estrategia preferida fue la distribucion de kits de pruebas entre pares. Se identificaron algunos incidentes de dano social entre distribuidores pares y trabajadoras sexuales, asi como barreras de suministro para la implementacion que dificultaban la realizacion de las pruebas. Conclusion Es esencial involucrar a las trabajadoras sexuales en la planificacion y la implementacion continua del autodiagnostico del VIH, junto con estrategias para reducir los danos potenciales. Las estrategias optimas para la distribucion y el apoyo posterior a las pruebas son especificas para cada contexto y deben tener en cuenta el apoyo existente a las trabajadoras sexuales y los niveles de confianza y cohesion dentro de sus comunidades., Introduction Female sex workers are a marginalized group who are disproportionately affected by human immunodeficiency virus (HIV) infection. (1) Despite reduction in HIV infections in the general population, the prevalence [...]

Introduction: The prevalence of undiagnosed HIV is declining in Africa, and various HIV testing approaches are finding lower positivity rates. In this context, the epidemiological impact and cost-effectiveness of community-based HIV self-testing (CB-HIVST) is unclear. We aimed to assess this in different sub-populations and across scenarios characterized by different adult HIV prevalence and antiretroviral treatment programmes in sub-Saharan Africa. Methods: The synthesis model was used to address this aim. Three sub-populations were considered for CB-HIVST: (i) women having transactional sex (WTS); (ii) young people (15 to 24 years); and (iii) adult men (25 to 49 years). We assumed uptake of CB-HIVST similar to that reported in epidemiological studies (base case), or assumed people use CB-HIVST only if exposed to risk (condomless sex) since last HIV test. We also considered a five-year time-limited CB-HIVST programme. Cost-effectiveness was defined by an incremental cost-effectiveness ratio (ICER; cost-per-disability-adjusted life-year (DALY) averted) below US$500 over a time horizon of 50 years. The efficiency of targeted CB-HIVST was evaluated using the number of additional tests per infection or death averted. Results: In the base case, targeting adult men with CB-HIVST offered the greatest impact, averting 1500 HIV infections and 520 deaths per year in the context of a simulated country with nine million adults, and impact could be enhanced by linkage to voluntary medical male circumcision (VMMC). However, the approach was only cost-effective if the programme was limited to five years or the undiagnosed prevalence was above 3%. CB-HIVST to WTS was the most cost-effective. The main drivers of cost-effectiveness were the cost of CB-HIVST and the prevalence of undiagnosed HIV. All other CB-HIVST scenarios had an ICER above US$500 per DALY averted. Conclusions: CB-HIVST showed an important epidemiological impact. To maximize population health within a fixed budget, CB-HIVST needs to be targeted on the basis of the prevalence of undiagnosed HIV, sub-population and the overall costs of delivering this testing modality. Linkage to VMMC enhances its cost-effectiveness. Keywords: HIV testing, community-based HIV self-testing; cost-effectiveness; mathematical modelling; HIV; benefits and cost, 1 | INTRODUCTION The ambitious UNAIDS targets, set in 2014, of diagnosing 90% of people living with HIV, having 90% of those diagnosed on antiretroviral treatment (ART) and having virological [...]

Introduction: HIV self-testing (HIVST) was first proposed as an additional option to standard HIV testing services in the 1980s. By 2015, two years after the first HIVST kit was approved for the American market and the year in which Unitaid invested in the 'HIV Self-Testing AfRica (STAR) Initiative,' HIVST remained unexplored with negligible access in low- and middle-income countries (LMIC). However, rapid progress had been made. This commentary outlines the interlinked market, regulatory and policy barriers that had inhibited product development and kept HIVST out of LMIC policy. We detail the components of STAR that enabled rapid HIVST scale-up, including critical investments in implementation, research, market forecasting, and engagement with manufacturers and regulators. Discussion: The STAR Initiative has generated crucial information about how to distribute HIVST products effectively, ethically and efficiently. Service delivery models range from clinic-based distribution to workplace and partner-delivered approaches to reach first-time male testers, to community outreach to sex workers and general population 'hotspots.' These data directly informed supportive policy, notably the 2016 WHO guidelines strongly recommending HIVST as an additiona testing approach, and regulatory change through support for WHO prequalification of the first HIVST kit in 2017. In July 2015, only two countries had national HIVST policies and were implementing HIVST. Three years later, 59 countries have policies, actively implemented in 28, with an additional 53 countries reporting policies under development. By end-November 2018 several quality-assured HIVST products had been registered, including two WHO prequalified tests. STAR Initiative countries have drafted regulations governing in vitro diagnostics, including HIVST products. With enabling policies, pre-qualification and regulations in place, donor procurement of kits has increased rapidly, to a forecasted estimate of 16 million HIVST kits procured by 2020. Conclusions: The STAR Initiative provided a strong foundation to introduce HIVST in LMICs and allow for rapid scale-up based on the wealth of multi-country evidence gathered. Together with sustained coordination and acceleration of market development work, HIVST can help address the testing gap and provide a focused and cost-effective means to expand access to treatment and prevention services. Keywords: HIV testing; HIV self-testing; market shaping; scale-up; prevention; linkage to care; cost effectiveness, 1 | INTRODUCTION HIV testing is the gateway to treatment and care and expanded prevention coverage. The first of the United Nations' 90-90-90 Fast Track targets to end the HIV [...]

BackgroundAntiretroviral drugs have been shown to reduce risk of mother-to-child transmission of human immunodeficiency virus (HIV) and are also widely used for post-exposure prophylaxis for parenteral and sexual exposures. Sexual transmission may be lower in couples in which one partner is infected with HIV and the other is not and the infected partner is on antiretroviral therapy (ART).ObjectivesTo determine if ART use in an HIV-infected member of an HIV-discordant couple is associated with lower risk of HIV transmission to the uninfected partner compared to untreated discordant couples.Search methodsWe used standard Cochrane methods to search electronic databases and conference proceedings with relevant search terms without limits to language.Selection criteriaRandomised controlled trials (RCT), cohort studies and case-control studies of HIV-discordant couples in which the HIV-infected member of the couple was being treated or not treated with ART DATA COLLECTION AND ANALYSIS: Abstracts of all trials identified by electronic or bibliographic scanning were examined independently by two authors. We initially identified 3,833 references and examined 87 in detail for study eligibility. Data were abstracted independently using a standardised abstraction form.Main resultsOne RCT and nine observational studies were included in the review. These ten studies identified 2,112 episodes of HIV transmission, 1,016 among treated couples and 1,096 among untreated couples. The rate ratio for the single randomised controlled trial was 0.04 [95% CI 0.00, 0.27]. All index partners in this study had CD4 cell counts at baseline of 350-550 cells/µL. Similarly, the summary rate ratio for the nine observational studies was 0.58 [95% CI 0.35, 0.96], with substantial heterogeneity (I(2)=64%). After excluding two studies with inadequate person-time data, we estimated a summary rate ratio of 0.36 [95% CI 0.17, 0.75] with substantial heterogeneity (I(2)=62%). We also performed subgroup analyses among the observational studies to see if the effect of ART on prevention of HIV differed by the index partner's CD4 cell count. Among couples in which the infected partner had ≥350 CD4 cells/µL, we estimated a rate ratio of 0.12 [95% CI 0.01, 1.99]. In this subgroup, there were 247 transmissions in untreated couples and 30 in treated couples.Authors' conclusionsART is a potent intervention for prevention of HIV in discordant couples in which the index partner has ≤550 CD4 cells/µL. A recent multicentre RCT confirms the suspected benefit seen in earlier observational studies and reported in more recent ones. Questions remain about durability of protection, the balance of benefits and adverse events associated with earlier therapy, long-term adherence and transmission of ART-resistant strains to partners. Resource limitations and implementation challenges must also be addressed.Counselling, support, and follow up, as well as mutual disclosure, may have a role in supporting adherence, so programmes should be designed with these components. In addition to ART provision, the operational aspects of delivering such programmes must be considered.

When HIV diagnostic tests first became available in 1985, HIV testing was offered with caution. No treatment was available, prevention options were limited, and stigma and discrimination against people with [...]

: Introduction: The HIV epidemic in Vietnam is concentrated in key populations and their partners – people who inject drugs, men who have sex with men, sex workers and partners of people living with HIV. These groups have poor access to and uptake of conventional HIV testing services (HTS). To address this gap, lay provider‐ and self‐testing and assisted partner notification (aPN) were introduced and delivered by the community. We explored the feasibility and effectiveness of implementing aPN as part of community testing services for key populations. Methods: Lay provider testing and self‐testing was started in January 2017, and targeted key populations and their partners. Since July 2017, aPN was introduced. HTS was offered at drop‐in houses or coffee shops in Thai Nguyen and Can Tho provinces. All self‐testing was assisted and observed by peer educators. Both in‐person and social network methods were used to mobilize key populations to test for HIV and offer HTS to partners of people living with HIV. Client‐level data, including demographic information and self‐reported risk behaviour, were collected on site by peer educators. Results: Between January 2017 and May 2018, 3978 persons from key populations were tested through community‐led HTS; 66.7% were first‐time testers. Of the 3978 clients, 3086 received HTS from a lay provider and 892 self‐tested in the presence of a lay provider. Overall, 245 (6.2% of tested clients) had reactive results, 231 (94.3%) were confirmed to be HIV positive; 215/231 (93.1%) initiated antiretroviral therapy (ART). Of 231 adult HIV‐positive clients, 186 (80.5%) were provided voluntary aPN, and 105 of their partners were contacted and received HTS. The ratio of partners who tested for HIV per index client was 0.56. Forty‐four (41.9%) partners of index clients receiving HTS were diagnosed with HIV, 97.7% initiated ART during the study period. No social harm was identified or reported. Conclusions: Including aPN as part of community‐led HTS for key populations and their partners is feasible and effective, particularly for reaching first‐time testers and undiagnosed HIV clients. Scale‐up of aPN within community‐led HTS for key populations is essential for achieving the United Nations 90‐90‐90 targets in Vietnam., Introduction In 2017, there were an estimated 250,000 people living with HIV (PLHIV) in Vietnam, a prevalence of 0.4% among adults aged 15 to 49 years. The majority of PLHIV [...]

: Introduction: Strategies employing a single rapid diagnostic test (RDT) such as HIV self‐testing (HIVST) or “test for triage” (T4T) are proposed to increase HIV testing programme impact. Current guidelines recommend serial testing with two or three RDTs for HIV diagnosis, followed by retesting with the same algorithm to verify HIV‐positive status before anti‐retroviral therapy (ART) initiation. We investigated whether clients presenting to HIV testing services (HTS) following a single reactive RDT must undergo the diagnostic algorithm twice to diagnose and verify HIV‐positive status, or whether a diagnosis with the setting‐specific algorithm is adequate for ART initiation. Methods: We calculated (1) expected number of false‐positive (FP) misclassifications per 10,000 HIV negative persons tested, (2) positive predictive value (PPV) of the overall HIV testing strategy compared to the WHO recommended PPV ≥99%, and (3) expected cost per FP misclassified person identified by additional verification testing in a typical low‐/middle‐income setting, compared to the expected lifetime ART cost of $3000. Scenarios considered were as follows: 10% prevalence using two serial RDTs for diagnosis, 1% prevalence using three serial RDTs, and calibration using programmatic data from Malawi in 2017 where the proportion of people testing HIV positive in facilities was 4%. Results: In the 10% HIV prevalence setting with a triage test, the expected number of FP misclassifications was 0.86 per 10,000 tested without verification testing and the PPV was 99.9%. In the 1% prevalence setting, expected FP misclassifications were 0.19 with 99.8% PPV, and in the Malawi 2017 calibrated setting the expected misclassifications were 0.08 with 99.98% PPV. The cost per FP identified by verification testing was $5879, $3770, and $24,259 respectively. Results were sensitive to assumptions about accuracy of self‐reported reactive results and whether reactive triage test results influenced biased interpretation of subsequent RDT results by the HTS provider. Conclusions: Diagnosis with the full algorithm following presentation with a reactive triage test is expected to achieve PPV above the 99% threshold. Continuing verification testing prior to ART initiation remains recommended, but HIV testing strategies involving HIVST and T4T may provide opportunities to maintain quality while increasing efficiency as part of broader restructuring of HIV testing service delivery., Introduction Substantial scale‐up of HIV testing services (HTS) has contributed to tremendous progress towards global targets to diagnose 90% of people with HIV by 2020. In 2017, PEPFAR alone conducted [...]

Background: Current rapid tests for syphilis and yaws can detect treponemal and non-treponemal antibodies. We aimed to critically appraise the literature for rapid diagnostic tests (RDTs) which can better distinguish an active infection of syphilis or yaws.Methods: We conducted a systematic review and meta-analysis, searching five databases between January 2010 and October 2021 (with an update in July 2022). A generalised linear mixed model was used to conduct a bivariate meta-analysis for the pooled sensitivity and specificity. Heterogeneity was assessed using the I2 statistic. We used the Quality Assessment of Diagnostic Accuracy Studies (QUADAS) to assess the risk of bias and Grading of Recommendations, Assessment, Development and Evaluations (GRADE) to evaluate the certainty of evidence.Results: We included 17 studies for meta-analyses. For syphilis, the pooled sensitivity and specificity of the treponemal component were 0.93 (95% CI: 0.86 to 0.97) and 0.98 (95% CI: 0.96 to 0.99), respectively. For the non-treponemal component, the pooled sensitivity and specificity were 0.90 (95% CI: 0.82 to 0.95) and 0.97 (95% CI: 0.92 to 0.99), respectively. For yaws, the pooled sensitivity and specificity of the treponemal component were 0.86 (95% CI: 0.66 to 0.95) and 0.97 (95% CI: 0.94 to 0.99), respectively. For the non-treponemal component, the pooled sensitivity and specificity were 0.80 (95% CI: 0.55 to 0.93) and 0.96 (95% CI: 0.92 to 0.98), respectively.Conclusions: RDTs that can differentiate between active and previously treated infections could optimise management by providing same-day treatment and reducing unnecessary treatment.Prospero Registration Number: CRD42021279587. [ABSTRACT FROM AUTHOR]

Background: Effective national and global HIV responses require a significant expansion of HIV testing and counselling (HTC) to expand access to prevention and care. Facility-based HTC, while essential, is unlikely to meet national and global targets on its own. This article systematically reviews the evidence for community-based HTC. Methods and Findings: PubMed was searched on 4 March 2013, clinical trial registries were searched on 3 September 2012, and Embase and the World Health Organization Global Index Medicus were searched on 10 April 2012 for studies including community-based HTC (i.e., HTC outside of health facilities). Randomised controlled trials, and observational studies were eligible if they included a community-based testing approach and reported one or more of the following outcomes: uptake, proportion receiving their first HIV test, CD4 value at diagnosis, linkage to care, HIV positivity rate, HTC coverage, HIV incidence, or cost per person tested (outcomes are defined fully in the text). The following community-based HTC approaches were reviewed: (1) door-to-door testing (systematically offering HTC to homes in a catchment area), (2) mobile testing for the general population (offering HTC via a mobile HTC service), (3) index testing (offering HTC to household members of people with HIV and persons who may have been exposed to HIV), (4) mobile testing for men who have sex with men, (5) mobile testing for people who inject drugs, (6) mobile testing for female sex workers, (7) mobile testing for adolescents, (8) self-testing, (9) workplace HTC, (10) church-based HTC, and (11) school-based HTC. The Newcastle- Ottawa Quality Assessment Scale and the Cochrane Collaboration's 'risk of bias' tool were used to assess the risk of bias in studies with a comparator arm included in pooled estimates. 117 studies, including 864,651 participants completing HTC, met the inclusion criteria. The percentage of people offered community-based HTC who accepted HTC was as follows: index testing, 88% of 12,052 participants; self-testing, 87% of 1,839 participants; mobile testing, 87% of 79,475 participants; door-to-door testing, 80% of 555,267 participants; workplace testing, 67% of 62,406 participants; and school-based testing, 62% of 2,593 participants. Mobile HTC uptake among key populations (men who have sex with men, people who inject drugs, female sex workers, and adolescents) ranged from 9% to 100% (among 41,110 participants across studies), with heterogeneity related to how testing was offered. Community- based approaches increased HTC uptake (relative risk [RR] 10.65, 95% confidence interval [CI] 6.27-18.08), the proportion of first-time testers (RR 1.23, 95% CI 1.06-1.42), and the proportion of participants with CD4 counts above 350 cells/ml (RR 1.42, 95% CI 1.16-1.74), and obtained a lower positivity rate (RR 0.59, 95% CI 0.37-0.96), relative to facility-based approaches. 80% (95% CI 75%-85%) of 5,832 community-based HTC participants obtained a CD4 measurement following HIV diagnosis, and 73% (95% CI 61%-85%) of 527 community-based HTC participants initiated antiretroviral therapy following a CD4 measurement indicating eligibility. The data on linking participants without HIV to prevention services were limited. In low- and middle-income countries, the cost per person tested ranged from US$2-US$126. At the population level, community-based HTC increased HTC coverage (RR 7.07, 95% CI 3.52-14.22) and reduced HIV incidence (RR 0.86, 95% CI 0.73-1.02), although the incidence reduction lacked statistical significance. No studies reported any harm arising as a result of having been tested. Conclusions: Community-based HTC achieved high rates of HTC uptake, reached people with high CD4 counts, and linked people to care. It also obtained a lower HIV positivity rate relative to facility-based approaches. Further research is needed to further improve acceptability of community-based HTC for key populations. HIV programmes should offer community-based HTC linked to prevention and care, in addition to facility-based HTC, to support increased access to HIV prevention, care, and treatment. Review Registration: International Prospective Register of Systematic Reviews CRD42012002554 Please see later in the article for the Editors' Summary., Introduction HIV is a leading cause of morbidity and mortality globally [1]. Despite considerable progress in controlling the epidemic, there were approximately 2.2 million new HIV infections, 1.7 million HIV-related [...]