OBJECTIVE: To review HIV testing services (HTS) costs in sub-Saharan Africa.
METHODS: A systematic literature review of studies published from January 2006 to October 2020.
METHODS: We searched ten electronic databases for studies that reported estimates for cost per person tested ($pptested) and cost per HIV-positive person identified ($ppositive) in sub-Saharan Africa. We explored variations in incremental cost estimates by testing modality (health facility-based, home-based, mobile-service, self-testing, campaign-style, and stand-alone), by primary or secondary/index HTS, and by population (general population, people living with HIV, antenatal care male partner, antenatal care/postnatal women and key populations). All costs are presented in 2019US$.
RESULTS: Sixty-five studies reported 167 cost estimates. Most reported only $pptested (90%), while (10%) reported the $ppositive. Costs were highly skewed. The lowest mean $pptested was self-testing at $12.75 (median = $11.50); primary testing at $16.63 (median = $10.68); in the general population, $14.06 (median = $10.13). The highest costs were in campaign-style at $27.64 (median = $26.70), secondary/index testing at $27.52 (median = $15.85), and antenatal male partner at $47.94 (median = $55.19). Incremental $ppositive was lowest for home-based at $297.09 (median = $246.75); primary testing $352.31 (median = $157.03); in the general population, $262.89 (median: $140.13).
CONCLUSIONS: While many studies reported the incremental costs of different HIV testing modalities, few presented full costs. Although the $pptested estimates varied widely, the costs for stand-alone, health facility, home-based, and mobile services were comparable, while substantially higher for campaign-style HTS and the lowest for HIV self-testing. Our review informs policymakers of the affordability of various HTS to ensure universal access to HIV testing.

UNASSIGNED: The management of warfarin therapy presents clinical challenges due to its narrow therapeutic index. We aimed to evaluate the comparative effectiveness of different management strategies in patients using warfarin.
UNASSIGNED: PubMed, Embase, Cochrane CENTRAL, CINAHL, and EBSCO Open Dissertation were searched from inception to 8 May 2024. Randomized controlled trials that compared the following interventions: patient self-management (PSM), patient self-testing (PST), anticoagulation management services (AMS), and usual care in patients prescribed warfarin for any indication were included. Risk ratios (RR) with 95% confidence interval (CI) were estimated using a random-effects model. Surface under the cumulative ranking curves (SUCRA) were used to rank different interventions. The certainty of evidence was assessed using the Confidence in Network Meta-Analysis (CINeMA) online platform. This study is registered with PROSPERO (CRD42023491978).
UNASSIGNED: Twenty-eight trials involving 8100 participants were included, with follow-up periods of 1-24 months. Mean warfarin dosages were 4.9-7.2 mg/day. Only PSM showed a significant reduction of major TE risk compared with usual care (RR = 0.41; 95% CI: 0.24, 0.71; I2 = 0.0%) with moderate certainty of evidence. The 97.6% SUCRA also supported the beneficial effects of PSM over other interventions. The combined direct and indirect evidence showed significantly higher TTR in PSM compared with usual care (MD = 7.39; 95% CI: 2.39, 12.39), with very low certainty. However, direct evidence showed non-significant TTR improvement (MD = 6.49; 95% CI: -3.09, 16.07, I2 = 96.1%). No differences across various strategies were observed in all-cause mortality, major bleeding, stroke, transient ischemic attack, and hospitalization.
UNASSIGNED: PSM reduces the risk of major TE events compared with usual care, tends to improve anticoagulation control, and should be considered where appropriate.
UNASSIGNED: Agency for Healthcare Research and Quality (grant ID 5R18HS027960).

BACKGROUND: Social network strategies, in which social networks are utilized to influence individuals or communities, are increasingly being used to deliver human immunodeficiency virus (HIV) interventions to key populations. We summarized and critically assessed existing research on the effectiveness of social network strategies in promoting HIV self-testing (HIVST).
METHODS: Using search terms related to social network interventions and HIVST, we searched five databases for trials published between 1st January 2010 and 30th June 2023. Outcomes included uptake of HIV testing, HIV prevalence and linkage to antiretroviral therapy (ART) or HIV care. We used network meta-analysis to assess the uptake of HIV testing through social network strategies compared with control methods. A pairwise meta-analysis of studies with a comparison arm that reported outcomes was performed to assess relative risks (RR) and their corresponding 95% confidence intervals (CI).
RESULTS: Among the 4496 manuscripts identified, 39 studies fulfilled the inclusion criteria, including one quasi-experimental study, 22 randomized controlled trials and 16 observational studies. Networks HIVST testing was organized by peers (distributed to known peers, 15 studies), partners (distributed to their sexual partners, 16 studies) and peer educators (distributed to unknown peers, 8 studies). Among social networks, simulating the possibilities of ranking position, peer distribution had the highest uptake of HIV testing (84% probability), followed by partner distribution (80% probability) and peer educator distribution (74% probability). Pairwise meta-analysis showed that peer distribution (RR 2.29, 95% CI 1.54-3.39, 5 studies) and partner distribution (RR 1.76, 95% CI 1.50-2.07, 10 studies) also increased the probability of detecting HIV reactivity during testing within the key population when compared to the control.
CONCLUSIONS: All of the three social network distribution strategies enhanced the uptake of HIV testing compared to standard facility-based testing. Linkage to ART or HIV care remained comparable to facility-based testing across the three HIVST distribution strategies.
CONCLUSIONS: Network-based HIVST distribution is considered effective in augmenting HIV testing rates and reaching marginalized populations compared to facility-based testing. These strategies can be integrated with the existing HIV care services, to fill the testing gap among key populations globally.
UNASSIGNED: CRD42022361782.

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.

HIV self-testing (HIVST) is where individuals collect their specimens and perform the HIV test privately. HIVST has improved testing uptake and coverage, especially among vulnerable groups of sub-Saharan Africa (SSA). Vulnerable groups include key populations such as men who have sex with men, sex workers, people who inject drugs, lesbian, gay, bisexual and transgender persons and young women. However, little is known about the determinants and acceptability of HIVST among these groups in SSA. Therefore, this scoping review aims to explore the determinants and acceptability of HIVST among vulnerable groups in SSA.
A scoping review will be conducted using the Arksey and O\'Malley framework and further refined by Levac framework. The review will follow a six-step approach: (1) identifying the research question, (2) identifying relevant studies, (3) study selection eligibility, (4) charting the data, (5) collating, summarising and reporting the results and (6) consultation. A comprehensive search strategy will be developed, and the following electronic databases will be searched: MEDLINE, Embase, Global Health and the Cochrane Library. Grey literature will also be searched, including conference abstracts and reports. Eligibility criteria will include studies conducted in SSA, published between 2010 and 2023, focusing on vulnerable groups and exploring the determinants and acceptability of HIVST. Two independent reviewers will screen identified studies\' titles, abstracts and full texts. Any disagreements will be resolved through discussion or consultation with a third reviewer. Data extraction will be conducted using a standardised form.
This review, not requiring ethical approval, aims to inform policy and intervention design to boost HIV testing adoption within vulnerable communities. We plan to disseminate our findings via a peer-reviewed journal, policy briefs, conference presentations and stakeholder engagement.

BACKGROUND: Counseling supporting HIV self-testing (HIVST) is helpful in facilitating linkage to care and promoting behavior changes among men who have sex with men (MSM). Different levels of counseling support for MSM HIVST users may lead to variance in the linkage to care.
OBJECTIVE: This study aims to synthesize evidence on counseling supporting MSM HIVST users and to conduct a meta-analysis to quantify the proportion of MSM HIVST users who were linked to care.
METHODS: A systematic search was conducted using predefined eligibility criteria and relevant keywords to retrieve studies from the MEDLINE, Global Health, Web of Science, Embase, APA PsycINFO, and Scopus databases. This search encompassed papers and preprints published between July 3, 2012, and June 30, 2022. Studies were eligible if they reported counseling supporting HIVST or quantitative outcomes for linkage to care among MSM and were published in English. The screening process and data extraction followed the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines. The quality of the included studies was assessed by the National Institutes of Health quality assessment tool. Data were extracted using random effects models to combine the proportion of HIVST users who were linked to care. Subgroup analyses and metaregression were conducted to assess whether linkage to care varied according to study characteristics. All analyses were performed with R (version 4.2.1; R Foundation for Statistical Computing) using the metafor package.
RESULTS: A total of 55 studies published between 2014 and 2021, including 43 observational studies and 12 randomized controlled trials, were identified. Among these studies, 50 (91%) provided active counseling support and 5 (9%) provided passive counseling support. In studies providing active counseling support, most MSM HIVST users were linked to various forms of care, including reporting test results (97.2%, 95% CI 74.3%-99.8%), laboratory confirmation (92.6%, 95% CI 86.1%-96.2%), antiretroviral therapy initiation (90.8%, 95% CI 86.7%-93.7%), and referral to physicians (96.3%, 95% CI 85%-99.2%). In studies providing passive counseling support, fewer MSM HIVST users were linked to laboratory confirmation (78.7%, 95% CI 17.8%-98.4%), antiretroviral therapy initiation (79.1%, 95% CI 48.8%-93.7%), and referral to physicians (79.1%, 95% CI 0%-100%). Multivariate metaregression indicated that a higher number of essential counseling components, a smaller sample size (<300), and the use of mobile health technology to deliver counseling support were associated with better linkage to care. The quality of the studies varied from fair to good with a low to high risk of bias.
CONCLUSIONS: Proactively providing counseling support for all users, involving a higher number of essential components in the counseling support, and using mobile health technology could increase the linkage to care among MSM HIVST users.
BACKGROUND: PROSPERO CRD42022346247; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=346247.

Self-testing is an effective tool to bridge the testing gap for several infectious diseases; however, its performance in detecting SARS-CoV-2 using antigen-detection rapid diagnostic tests (Ag-RDTs) has not been systematically reviewed. This study aimed to inform WHO guidelines by evaluating the accuracy of COVID-19 self-testing and self-sampling coupled with professional Ag-RDT conduct and interpretation. Articles on this topic were searched until November 7th, 2022. Concordance between self-testing/self-sampling and fully professional-use Ag-RDTs was assessed using Cohen\'s kappa. Bivariate meta-analysis yielded pooled performance estimates. Quality and certainty of evidence were evaluated using QUADAS-2 and GRADE tools. Among 43 studies included, twelve reported on self-testing, and 31 assessed self-sampling only. Around 49.6% showed low risk of bias. Overall concordance with professional-use Ag-RDTs was high (kappa 0.91 [95% confidence interval (CI) 0.88-0.94]). Comparing self-testing/self-sampling to molecular testing, the pooled sensitivity and specificity were 70.5% (95% CI 64.3-76.0) and 99.4% (95% CI 99.1-99.6), respectively. Higher sensitivity (i.e., 93.6% [95% CI 90.4-96.8] for Ct < 25) was estimated in subgroups with higher viral loads using Ct values as a proxy. Despite high heterogeneity among studies, COVID-19 self-testing/self-sampling exhibits high concordance with professional-use Ag-RDTs. This suggests that self-testing/self-sampling can be offered as part of COVID-19 testing strategies.Trial registration: PROSPERO: CRD42021250706.

HIV self-testing (HIVST) has been proposed as an innovative strategy to diagnose human immunodeficiency virus (HIV). While HIVST offers the potential to broaden accessibility of early HIV diagnosis and treatment initiation, this testing strategy incurs additional cost and requires confirmatory testing and treatment. We have conducted the first systematic review to summarize the current economic literature for HIVST in low- and middle-income countries (LMICs).
A search strategy was developed including key terms for HIV, self-testing and cost-effectiveness and was conducted in Medline and Embase databases. Studies were included that reported costs per outcome and included both cost-effectiveness and cost-utility outcome measures. The search strategy identified publications up until August 15, 2023 were included. Abstract and full text screening was conducted and a standardized data abstraction form was used for included studies. Costs are reported in USD, 2020.
Our search strategy identified 536 total titles from the search strategy, which were screened down to 25 relevant studies that provided both cost and outcome data on HIVST. There was significant heterogeneity in the HIVST intervention, study population, costs and outcomes reported among included studies. Cost per person tested ranged from $1.09-155. Cost per case diagnosed ranged from $20-1,277. Cost-utility estimates ranged from cost-saving to $1846 per DALY averted. Higher cost-effectiveness estimates were associated with more expensive testing algorithms with increased support for linkage to care and post-test counseling.
All studies considered HIVST cost-effective although major drivers were identified included underlying HIV prevalence, testing cost and linkage to care. HIVST is likely to be cost-effective in a LMIC context, however policy makers should be aware of the drivers of cost-effectiveness when implementing HIVST programs as these underlying factors can impact the overall cost-effectiveness of HIVST.

Usage of self-screening tests has become increasingly relevant in public health perspective for early detection of SARS-CoV-2 infection in the transitioning era of the COVID-19 pandemic into an endemic. This study was designed to compare the diagnostic accuracy of self-conducted and health professional-conducted SARS-CoV-2 rapid antigen tests (Ag-RDTs) and whether the sample was taken from anterior nasal or nasal mid-turbinate. Eligible comparative Ag-RDTs accuracy studies were retrieved from electronic databases systematically, in accordance with PRISMA. Selected studies were assessed for risk of bias using QUADAS-2 and QUADAS-C. In total, we selected five out of 1952 studies retrieved using the keywords. The overall sensitivity for the self-collected nasal swab method and healthcare worker-collected nasopharyngeal swab method was 79% (95% CI 68-87; I2  = 62%) and 83% (95% CI 75-89; I2  = 32%), respectively, which was not statistically different (p = 0.499). Nasal mid-turbinate swabs have a significantly higher sensitivity compared to anterior nasal swabs (p < 0.01). Both sampling methods represent high and comparable specificity values of 98% (95% CI 97-99; I2  = 0%) and 99% (95% CI 98-99; I2  = 0%). Positive predictive value (range 90%-99%) and negative predictive value (range 87%-98%) were equivalent for both methods. Our findings indicated the accuracy of self-collected Ag-RDT on nasal swabs was comparable to those performed by healthcare worker-collected on nasopharyngeal swabs. Self-collected Ag-RDT could be considered as a transmission prevention method in the transition of COVID-19 pandemic.

OBJECTIVE: To review evaluations of the diagnostic accuracy of coronavirus disease 2019 (COVID-19) rapid antigen tests (RATs) approved by the Therapeutic Goods Administration (TGA) for self-testing by ambulatory people in Australia; to compare these estimates with values reported by test manufacturers.
METHODS: Systematic review of publications in any language that reported cross-sectional, case-control, or cohort studies in which the participants were ambulatory people in the community or health care workers in hospitals in whom severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection was suspected, and the results of testing self-collected biological samples with a TGA-approved COVID-19 RAT were compared with those of reverse transcription-polymerase chain reaction (RT-PCR) testing for SARS-CoV-2. Estimates of diagnostic accuracy (sensitivity, specificity) were checked and compared with manufacturer estimates published on the TGA website.
METHODS: Publications (to 1 September 2022) identified in the Cochrane COVID-19 Study Register and the World Health Organization COVID-19 research database. Information on manufacturer diagnostic accuracy evaluations was obtained from the TGA website.
RESULTS: Twelve publications that reported a total of eighteen evaluations of eight RATs approved by the TGA for self-testing (manufacturers: All Test, Roche, Flowflex, MP Biomedicals, Clungene, Panbio, V-Chek, Whistling) were identified. Five studies were undertaken in the Netherlands, two each in Germany and the United States, and one each in Denmark, Belgium, and Canada; test sample collection was unsupervised in twelve studies, and supervised by health care workers or researchers in six. Estimated sensitivity with unsupervised sample collection ranged from 20.9% (MP Biomedicals) to 74.3% (Roche), and with supervised collection from 7.7% (V-Chek) to 84.4% (Panbio); the estimates were between 8.2 and 88 percentage points lower than the values reported by the manufacturers. Test specificity was high for all RATs (97.9-100%).
CONCLUSIONS: The risk of false negative results when using COVID-19 RATs for self-testing may be considerably higher than apparent in manufacturer reports on the TGA website, with implications for the reliability of these tests for ruling out infection.