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Reaching the Joint United Nations Programme on HIV/AIDS (UNAIDS) 90-90-90 targets to end the HIV epidemic relies on effective interventions that engage untested HIV+ individuals and retain them in care. Evidence on community-based interventions through the lens of the targets has not yet been synthesized, reflecting a knowledge gap. We conducted a systematic review and meta-analysis to shed light on successful community-based interventions that have been effective in contributing, directly or indirectly, towards the UNAIDS 90-90-90 targets: knowledge of HIV status, linkage to care/on treatment, and viral suppression. Linkage to care was also included in this review due to the limitations of studies. We conducted a systematic review and meta-analysis of the period 2007-2018. Eleven databases were searched to identify community-based interventions designed to improve knowledge of HIV status (in particular HIV testing), linkage to care/on treatment, and/or viral suppression. Eligible studies were classified by intervention, population, country income level, outcomes and success. Success was defined as interventions demonstrating statistical significance between intervention and control group or that reached any target by proportion; 90% testing, 81% linked to care/on treatment and 73% viral suppression. Of 82 eligible studies, 51.2% (42/82) reported on HIV testing (first 90), 20.7% (17/82) on linkage to care/ on treatment (second 90), and 45.1% (37/82) on viral suppression (third 90). In all, 67.1% (55/82) of studies reported success; 21 studies on the first 90, 9 towards linkage to care/on treatment, and 25 towards the third. By strategies, 36.6% deployed community workers/peers, 22% used combined test and treat strategies, 12.2% used educational methods, 8.5% used mobile testing, 7.3% used campaigns and 13.4% used technology. For HIV testing/linkage, combined test/treat interventions were often used, for viral suppression, educational interventions and technologies were commonly deployed. Our pooled analysis suggested that deployment of community health care workers/peer workers significantly improved viral suppression (pooled OR: 1.40 95% CI 1.06-1.86). Of the studies published after 2014, 50.0% reported metrics aligned with UNAIDS targets. Data on linkage to care/on treatment (second target) remained weak, because many studies reported successes on the first and third targets. Stratification by targets and country income levels is informative and guides adaptation of successful interventions in comparable settings. Consistent reporting of clear metrics aligned with UNAIDS targets will aid in synergy of study data with programmatic data that will help reportage. Exploration of innovative interventions, for engagement and linkage and deployment of community/ peer workers is strongly encouraged.

Stigma, discrimination, lack of privacy, and long waiting times partly explain why six out of ten individuals living with HIV do not access facility-based testing. By circumventing these barriers, self-testing offers potential for more people to know their sero-status. Recent approval of an in-home HIV self test in the US has sparked self-testing initiatives, yet data on acceptability, feasibility, and linkages to care are limited. We systematically reviewed evidence on supervised (self-testing and counselling aided by a health care professional) and unsupervised (performed by self-tester with access to phone/internet counselling) self-testing strategies. Seven databases (Medline [via PubMed], Biosis, PsycINFO, Cinahl, African Medicus, LILACS, and EMBASE) and conference abstracts of six major HIV/sexually transmitted infections conferences were searched from 1st January 2000-30th October 2012. 1,221 citations were identified and 21 studies included for review. Seven studies evaluated an unsupervised strategy and 14 evaluated a supervised strategy. For both strategies, data on acceptability (range: 74%-96%), preference (range: 61%-91%), and partner self-testing (range: 80%-97%) were high. A high specificity (range: 99.8%-100%) was observed for both strategies, while a lower sensitivity was reported in the unsupervised (range: 92.9%-100%; one study) versus supervised (range: 97.4%-97.9%; three studies) strategy. Regarding feasibility of linkage to counselling and care, 96% (n = 102/106) of individuals testing positive for HIV stated they would seek post-test counselling (unsupervised strategy, one study). No extreme adverse events were noted. The majority of data (n = 11,019/12,402 individuals, 89%) were from high-income settings and 71% (n = 15/21) of studies were cross-sectional in design, thus limiting our analysis. Both supervised and unsupervised testing strategies were highly acceptable, preferred, and more likely to result in partner self-testing. However, no studies evaluated post-test linkage with counselling and treatment outcomes and reporting quality was poor. Thus, controlled trials of high quality from diverse settings are warranted to confirm and extend these findings. Please see later in the article for the Editors' Summary.

HIV self-testing has gained momentum following the approval of self-testing methods and novel technological advancements. Digital HIV self-testing involves completing an oral or blood-based HIV self-test with support from a digital innovation. We conducted a systematic review on the existing data analyzing digital HIV self-testing accuracy while updating research on digital HIV self-test acceptability, preference, feasibility, and impact. We searched Embase and PubMed for records on HIV self-testing with digital support. Included studies significantly incorporated a form of digital innovation throughout the HIV self-test process and reported quantitative data. For accuracy measures, the search spanned January 1, 2013, to October 15, 2024; for patient-centered and impact outcomes, we updated existing literature (June 16, 2021, to October 15, 2024) reported in a previous systematic review. Studies' quality was assessed using the QUADAS 2 Tool, Newcastle-Ottawa Scale, and Cochrane Risk of Bias Tool 2. Fifty-five studies (samples ranging 120-21,035, median 1267 participants) were summarized from 19 middle- to high-income countries. Seven studies reported on the accuracy of HIV self-testing with innovations from >5000 participants. Diagnostic performance metrics, including point estimates of specificity, sensitivity, positive predictive value, and negative predictive value were measured (n=3), and ranged from: 96.8% to 99.9%, 92.9% to 100.0%, 76.5% to 99.2%, and 99.2% to 100.0%, respectively. The percentage of invalid test results for oral and blood-based self-tests ranged from 0.2% to 12.7% (n=4). Fifty-one studies reported data on metrics beyond accuracy, including acceptability, preference, feasibility, and impact outcomes from >30,000 participants. Majority (38/51, 74.5%) were observational studies, while 25.5% (13/51) reported data from randomized controlled trials. Acceptability and preference outcomes varied from 64.5% to 99.0% (14/51) and 4.6% to 99.3% (8/51), respectively. Feasibility outcomes included test uptake (30.9% to 98.2%; 28/51), response rate (26.0% to 94.8%; 7/51), and visits to web-based providers (43.0% to 70.7%; n=4). Impact outcomes assessed new infections (0.0% to 25.8%; 31/51), first-time testers (2.0% to 53.0%; 26/51), result return proportions (22.1% to 100.0%; 24/51), linkage to care as both connections to confirmatory testing and counseling (53.0% to 100.0%; 16/51), and referrals for treatment initiation (44.4% to 98.1%; 8/51). The quality of studies varied, though they generally demonstrated low risk of bias. Digital innovations improved the accuracy of HIV self-test results, and were well-accepted and preferred by participants. Operationally, they were found to be feasible and reported impacting the HIV self-testing process. These findings are in favor of the use of digital HIV self-test innovations as a promising support tool and suggest that digital HIV self-tests' service delivery models hold promise in not only facilitating HIV testing but also impacting operational outcomes that are crucial to reaching Joint United Nations Program on HIV/AIDS targets in middle- to high-income countries. PROSPERO CRD42020205025; https://www.crd.york.ac.uk/prospero/CRD42020205025.

The focus on prevention strategies aimed at curbing the HIV epidemic is growing, and therefore screening for HIV has again taken centre stage. Our aim was to establish whether a convenient, non-invasive, HIV test that uses oral fluid was accurate by comparison with the same test with blood-based specimens. We did a systematic review and meta-analysis to compare the diagnostic accuracy of a rapid HIV-antibody-based point-of-care test (Oraquick advance rapid HIV-1/2, OraSure Technologies Inc, PA, USA) when used with oral versus blood-based specimens in adults. We searched five databases of published work and databases of five key HIV conferences. Studies we deemed eligible were those focused on adults at risk of HIV; we excluded studies in children, in co-infected populations, with self-reported inferior reference standards, and with incomplete reporting of key data items. We assessed the diagnostic accuracy of testing with oral and blood-based specimens with bivariate regression analysis. We computed positive predictive values (PPVs) in high-prevalence and low-prevalence settings with Bayesian methods. In a direct head-to-head comparison of studies, we identified a pooled sensitivity about 2% lower in oral (98·03%, 95% CI 95·85–99·08) than in blood-based specimens (99·68%, 97·31–99·96), but similar specificity (oral 99·74%, 99·47–99·88; blood 99·91%, 99·84–99·95). Negative likelihood ratios were small and similar (oral 0·019, 0.009–0·040; blood 0·003, 0·001–0·034), but positive likelihood ratios differed (oral 383·37, 183·87–799·31; blood 1105·16, 633·14–2004·37). Although in high-prevalence settings PPVs were similar (oral 98·65%, 95% credible interval 85·71–99·94; blood 98·50, 93·10–99·79), in low-prevalence settings PPVs were lower for oral (88·55%, 77·31–95·87) than blood (97·65%, 95·48–99·09) specimens. Although Oraquick had a high PPV in high-prevelence settings in oral specimens, the slightly lower sensitivity and PPV in low-prevalence settings in oral specimens should be carefully reviewed when planning worldwide expanded initiatives with this popular test. Canadian Institutes for Health Research (CIHR KRS 102067).

ObjectivesAcross Canada, in the last decade, incidence rates of sexually transmitted and blood-borne infections (STBBI) have peaked (syphilis) or plateaued (hepatitis C virus (HCV) and HIV). Key populations (gay, bisexual and other men who have sex with men, trans and gender-diverse people, and people who use injection drugs) are at greater risk for these STBBIs, so correctly predicting risk before screening potentially infected individuals is crucial. We developed and validated a diagnostic clinical risk prediction model (CRPM) estimating HIV, HCV and syphilis risk for two key populations in two Canadian provinces.MethodsWe used 20 variables and STBBI test results from a cross-sectional study evaluating multiplexed testing (detection of coinfections) in New Brunswick and Quebec (n=400) to develop our CRPM. We randomly split the data into development (n=300) and validation (n=100) datasets using clinic-stratified sampling. We used Bayesian predictive projection with development data to select ranked STBBI predictors. We obtained the ORs of the highest performing submodel measured as area under the receiver operating curve (AUC), sensitivity and specificity with 89% credible intervals (89% CrI) using validation data. Analyses were performed in R (≥V.4.2.3).ResultsOut of 400 participants, 73 were infected with HIV (n=16), HCV (n=60), and/or syphilis (n=5). An internally validated submodel with two predictors (past drug injection, type of past sexually transmitted infection) displayed the highest AUC (0.79; 89% CrI 0.66 to 0.79), sensitivity (0.85; 89% CrI 0.79 to 0.91) and specificity (0.30; 89% CrI 0.15 to 0.50). The predictor contributing most to STBBI risk was past drug injection (OR=7.62; 89% CrI 4.41 to 13.07).ConclusionsThis Bayesian-based CRPM is the first to identify high-risk individuals for HIV, HCV and syphilis with an overall good performance that minimises case missing. After additional validation, it could serve as a promising novel tool for prescreening key populations and improve Canadian STBBI multiplexed screening strategies.

Successful point-of-care testing, namely ensuring the completion of the test and treat cycle in the same encounter, has immense potential to reduce diagnostic and treatment delays, and impact patient outcomes. However, having rapid tests is not enough, as many barriers may prevent their successful implementation in point-of-care testing programs. Qualitative research on diagnostic practices may help identify such barriers across different points of care in health systems. In this exploratory qualitative study, we conducted 78 semi-structured interviews and 13 focus group discussions in an urban and rural area of Karnataka, India, with healthcare providers (doctors, nurses, specialists, traditional healers, and informal providers), patients, community health workers, test manufacturers, laboratory technicians, program managers and policy-makers. Participants were purposively sampled to represent settings of hospitals, peripheral labs, clinics, communities and homes, in both the public and private sectors. In the Indian context, the onus is on the patient to ensure successful point-of-care testing across homes, clinics, labs and hospitals, amidst uncoordinated providers with divergent and often competing practices, in settings lacking material, money and human resources. We identified three overarching themes affecting point-of-care testing: the main theme is 'relationships' among providers and between providers and patients, influenced by the cross-cutting theme of 'infrastructure'. Challenges with both result in 'modified practices' often favouring empirical (symptomatic) treatment over treatment guided by testing. Even if tests can be conducted on the spot and infrastructure challenges have been resolved, relationships among providers and between patients and providers are crucial for successful point-of-care testing. Furthermore, these barriers do not act in isolation, but are interlinked and need to be examined as such. Also, a test alone has only limited power to overcome those difficulties. Test developers, policy-makers, healthcare providers and funders need to use these insights in overcoming barriers to point-of-care testing programs.

With the need to expedite the detection of multiple sexually transmitted blood-borne infections (STBBIs), there is an increased demand for digital innovations and tests that improve the efficiency of point-of-care testing in outreach community settings. Multiplexed testing is being offered to at-risk populations by frontline health care professionals. With this in mind, we evaluated AideSmart! (for health aides or health care workers), an integrated app and platform solution that enables multiplexed STBBI screening at the point of care, for feasibility, preference, accuracy, and impact. With AideSmart!, we provided trained health care workers with the ability to perform rapid multiplexed tests; offer STBBI pre- or posttest counseling; maintain quality assurance of testing; facilitate linkages to care; and enhance health care provider-patient communication, data documentation, and patient engagement through the multiplexed STBBI screening and linkage process. We evaluated the performance of multiplexed tests. In a cross-sectional study conducted during the COVID-19 pandemic, we recruited at-risk populations in Canada from community-based organizations in Montreal, Quebec, and Saint John, New Brunswick, with unknown serostatus for HIV, hepatitis C virus (HCV), and syphilis. Following orientation and pretest counseling with AideSmart!, we performed multiplexed tests, simultaneously screening for HIV, HCV, and syphilis, using 2 rapid investigational multiplexed tests (Chembio for HIV and syphilis and MedMira for HIV, HCV, and syphilis) followed by confirmatory testing from local and national laboratories. Of the 401 participants, all (100%) accepted the AideSmart! multiplexed strategy: 59.4% (148/249) preferred multiplexed rapid tests over laboratory tests, and 56.6% (141/249) preferred receiving same-day test results. Rapid test results were obtained in 15 minutes (vs laboratory tests at 4-24 days). A total of 29 new infections (n=27, 93% HCV; n=1, 3% syphilis; and n=1, 3% HIV) were identified and treated within a week. Feasibility of the strategy (completion of testing and linkages to care) was at 76.1% (305/401). Health care professionals provided positive feedback and emphasized the importance of knowing one's negative or positive serostatus, especially during a pandemic. Multiplexed rapid tests' specificity (against laboratory reference standards) exceeded 98% (98.7%-100%) for all pathogens and devices. An electronic reader, used by the Chembio rapid test, enhanced sensitivity (HIV: 100%, 95% CI 79.4%-100%; syphilis: 86.8%, 95% CI 71.9%-95.6% [Chembio] vs HIV: 100%, 95% CI 78.2%-100%; HCV: 90.3%, 95% CI 80.1%-96.4%; and syphilis: 57.9%, 95% CI 40.8%-73.7% [MedMira]). The AideSmart! digital multiplexed rapid screening strategy for health care workers facilitated STBBI testing for multiple STBBIs and arranged for pre- or posttest counseling and rapid linkages with high feasibility and acceptability. Electronic readers enhanced the diagnostic performance of multiplexed biomarker tests. This study generated data in support of digital multiplexed strategies in digitally enabled settings for at-risk populations nationally and worldwide.

Adherence to antiretroviral therapy (ART) remains problematic. Regular monitoring of its barriers is clinically recommended, however, patient-provider communication around adherence is often inadequate. Our team thus decided to develop a new electronically administered patient-reported outcome measure (PROM) of barriers to ART adherence (the I-Score) to systematically capture this data for physician consideration in routine HIV care. To prepare for a controlled definitive trial to test the I-Score intervention, a pilot study was designed. Its primary objectives are to evaluate patient and physician perceptions of the I-Score intervention and its implementation strategy. This one-arm, 6-month study will adopt a mixed method type 3 implementation-effectiveness hybrid design and be conducted at the Chronic Viral Illness Service of the McGill University Health Centre (Montreal, Canada). Four HIV physicians and 32 of their HIV patients with known or suspected adherence problems will participate. The intervention will involve having patients complete the I-Score through a smartphone application (Opal), before meeting with their physician. Both patients and physicians will have access to the I-Score results, for consideration during the clinic visits at Times 1, 2 (3 months), and 3 (6 months). The implementation strategy will focus on stakeholder involvement, education, and training; promoting the intervention's adaptability; and hiring an Application Manager to facilitate implementation. Implementation, patient, and service outcomes will be collected (Times 1-2-3). The primary outcome is the intervention's acceptability to patients and physicians. Qualitative data obtained, in part, through physician focus groups (Times 2-3) and patient interviews (Times 2-3) will help evaluate the implementation strategy and inform any methodological adaptations. This study will help plan a definitive trial to test the efficacy of the I-Score intervention. It will generate needed data on electronic PROM interventions in routine HIV care that will help improve understanding of conditions for their successful implementation. ClinicalTrials.gov identifier: NCT04702412; https://clinicaltrials.gov/.

The Joint United Nations Programme on HIV/AIDS (UNAIDS) Fast-Track initiative seeks to eliminate AIDS as a health threat by 2030, with its focus on UNAIDS 90-90-90 targets. Effective policies and programs, if scaled nationally, have the potential to generate a greater impact on HIV control, yet a synthesis of successful HIV policies/programs aligned to the targets is currently unavailable. To fill this gap, we conducted a systematic review to evaluate successful HIV policies and programs to direct future interventions. For the period 2007-2018, we searched 8 databases and classified eligible studies by country income level, UNAIDS targets, intervention type, and reported outcomes. Study outcomes were classified as per UNAIDS targets; proportionally: 90% target 1, 81% target 2, and 73% target 3. We retrieved 5201 citations and a final set of eight studies on policies. Break up by income: three (38%) from high income, one (12%) from middle income and four (50%) from low income. Break up by outcomes reported: 36% (4/11) focused on HIV testing, 46% (5/11) on antiretroviral therapy initiation, and 18% (2/11) on viral suppression. Across studies, UNAIDS targets were met in high-income countries, where policies and guidelines were adhered to, whereas in low and middle-income countries, non-adherence led to failure to reach the targets. Targets were also met when country infrastructure supported a targeted program and stakeholders were actively engaged. From the studies identified, we deduced a clear, positive correlation between implementation of policies and programs that resulted in an increase in patient awareness and an increase in partner notification with services that encouraged them, and together these resulted in increasing testing rates, and deployment of linkage/retention programs that improved retention in care. An analysis of these studies also suggests that policies, combined with the scale-up incentives, are needed to change the status quo. Incentives to improve the targets must exist; performance incentives at the health care worker level and country level incentives that could transform the nature of care. Given the complexity in reporting of targets, a one size fits all model is not a feasible option. However, the policies created a strong framework to shape future interventions.