Facility-based HIV self-testing as an additional testing option in health facilities: A systematic review and meta-analysis

Facility-based HIV self-testing (FB-HIVST) has been used across settings to improve testing accessibility and achieve global testing and treatment targets by 2030. The effectiveness of FB-HIVST remains uncertain; thus, we conducted a review to assess the risk and benefits of FB-HIVST to inform global guidance. We searched across nine electronic databases covering the period up to February 01, 2022, and included publications that directly compared FB-HIVST to standard HIV testing services (SOC) or no intervention. Meta-analysis was conducted on comparable outcomes using random-effects model for relative risks (RR) and 95% confidence intervals. Other outcomes were summarized descriptively. Risk of bias was assessed using Cochrane’s Risk of Bias tool. Certainty of evidence was assessed using Grading of Recommendations, Assessment, Development and Evaluations (GRADE). After screening 2,203 articles, 11 studies were found eligible, including 4 randomized controlled trials (RCT), 2 cohort studies, 3 economic evaluations, and 2 qualitative studies. Meta-analyses of four RCTs demonstrated that FB-HIVST may increase testing uptake (RR=2.47; 95% CI= 0.96, 6.33) and may lead to greater HIV diagnosis (RR=3.77; 95% CI=0.81, 17.44). Overall GRADE certainty was low. Trials found FB-HIVST as acceptable and feasible to many users, with minimal risk of social harm. A single RCT reported on linkage to care and observed that, among total enrolled,  FB-HIVST compared to SOC may increase linkage to care threefold (RR= 3.26; 95% CI: 0.68, 15.62; low-certainty evidence). FB-HIVST was found to be cost-effective in a high-burden outpatient department, but determined to be quite variable. FB-HIVST is safe and may be an effective method to increase testing coverage and the diagnoses, particularly in high-burden HIV settings or sites with limited staff and resources. Findings from this review informed WHO’S guideline development process and its recommendation that FB-HIVST be offered as an additional testing option at facilities. ### Competing Interest Statement The authors have declared no competing interest. ### Clinical Protocols ### Funding Statement This systematic review was supported by Unitaid-WHO HIV and Co-Infections/Co-Morbidities Enabler Grant [HIV&COIMS], 541 no grant number; https://unitaid.org) ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable. Yes All relevant data are within the manuscript and its Supporting Information files.