SummaryBackgroundThe ability of individuals to use HIV self-tests correctly is debated. To inform the 2016 WHO recommendation on HIV self-testing, we assessed the reliability and performance of HIV rapid diagnostic tests when used by self-testers.MethodsIn this systematic review and meta-analysis, we searched PubMed, PopLine, and Embase, conference abstracts, and additional grey literature between Jan 1, 1995, and April 30, 2016, for observational and experimental studies reporting on HIV self-testing performance. We excluded studies evaluating home specimen collection because patients did not interpret their own test results. We extracted data independently, using standardised extraction forms. Outcomes of interest were agreement between self-testers and health-care workers, sensitivity, and specificity. We calculated κ to establish the level of agreement and pooled κ estimates using a random-effects model, by approach (directly assisted or unassisted) and type of specimen (blood or oral fluid). We examined heterogeneity with the I2 statistic.Findings25 studies met inclusion criteria (22 to 5662 participants). Quality assessment with QUADAS-2 showed studies had low risk of bias and incomplete reporting in accordance with the STARD checklist. Raw proportion of agreement ranged from 85·4% to 100%, and reported κ ranged from fair (κ 0·277, p<0·001) to almost perfect (κ 0·99, n=25). Pooled κ suggested almost perfect agreement for both types of approaches (directly assisted 0·98, 95% CI 0·96–0·99 and unassisted 0·97, 0·96–0·98; I2=34·5%, 0–97·8). Excluding two outliers, sensitivity and specificity was higher for blood-based rapid diagnostic tests (4/16) compared with oral fluid rapid diagnostic tests (13/16). The most common error that affected test performance was incorrect specimen collection (oral swab or finger prick). Study limitations included the use of different reference standards and no disaggregation of results by individuals taking antiretrovirals.InterpretationSelf-testers can reliably and accurately do HIV rapid diagnostic tests, as compared with trained health-care workers. Errors in performance might be reduced through the improvement of rapid diagnostic tests for self-testing, particularly to make sample collection easier and to simplify instructions for use.FundingThe Bill & Melinda Gates Foundation and Unitaid.

UN Population Fund (through Zimbabwe's Integrated Support Fund funded by UK Department for International Development, Irish Aid, and Swedish International Development Cooperation Agency).

Point-of-care (POC) CD4 testing was implemented at a stand-alone HIV voluntary testing and counseling centre in Harare, Zimbabwe. To validate the use of this new technology, paired blood samples were collected from 165 patients either by a nurse or a laboratory technician and tested using POC and conventional laboratory CD4 machines. Finger prick (capillary) blood was collected directly into the PIMA POC CD4 Analyzer cartridges and tested immediately, whereas venous blood collected into evacuated tubes was used for CD4 enumeration on a Becton Dickinson FACSCalibur. There was no significant difference in mean absolute CD4 counts between the POC PIMA and Becton Dickinson FACSCalibur platforms (+7.6 cells/microL; P = 0.72). Additionally, there was no significant difference in CD4 counts between the platforms when run by either a nurse (+18.0 cells/microL; P = 0.49), or a laboratory technicians (-3.1 cells/microL; P = 0.93). This study demonstrates that POC CD4 testing can be conducted in a voluntary testing and counseling setting for staging HIV-positive clients. Both nurses and laboratory technicians performed the test accurately, thereby increasing the human resources available for POC CD4 testing. By producing same-day results, POC CD4 facilitates immediate decision-making, patient management and referral and may help improve patient care and retention. POC CD4 may also alleviate testing burdens at traditional central CD4 laboratories, hence improving test access in both rural and urban environments.

Introduction Social, structural and systems barriers inhibit uptake of HIV testing. HIV self‐testing ( HIVST ) has shown promising uptake by otherwise underserved priority groups including men, young people and first‐time testers. Here, we use characteristics of HIVST kit recipients to investigate delivery to these priority groups during HIVST scale‐up in three African countries. Methods Kit distributors collected individual‐level age, sex and testing history from all clients. These data were aggregated and analysed by country (Malawi, Zambia and Zimbabwe) for five distribution models: local community‐based distributor ( CBD : door‐to‐door, street and local venues), workplace distribution ( WD ), integration into HIV testing services ( IHTS ), or public health facilities ( IPHF ) and during demand creation for voluntary male medical circumcision ( VMMC ). Used kits were collected and re‐read from CBD and IHTS recipients. Results Between May 2015 and July 2017, 628,705 HIVST kits were distributed in Malawi (172,830), Zambia (190,787) and Zimbabwe (265,091). Community‐based models, the first to be established, accounted for 519,658 (82.7%) of kits distributed, with 275,419 (53.0%) used kits returned. Subsequent model diversification delivered 54,453 (8.7%) test‐kits through IHTS , 23,561 (3.7%) through VMMC , 21,183 (3.4%) through IPHF and 9850 (1.7%) through WD . Men took 294,508 (48.2%) kits, and 263,073 (43.1%) went to young people (16 to 24 years). A higher proportion of male self‐testers (65,577; 22.3%) were first‐time testers than women (54,096; 17.1%) with this apparent in Zimbabwe (16.2% vs. 11.4%), Zambia (25.4% vs. 17.7%) and Malawi (27.9% vs. 25.9%). The highest proportions of first‐time testers were in young (16 to 24 years) and older (>50 years) men (country‐ranges: 18.7% to 35.9% and 13.8% to 26.8% respectively). Most IHTS clients opted for HIVST in preference to standard HTS in each of 12 delivery sites, with those selecting HIVST having lower HIV prevalence, potentially due to self‐selection. Conclusions HIVST delivered at scale using several different models reached a high proportion of men, young people and first‐time testers in Malawi, Zambia and Zimbabwe, some of whom may not have tested otherwise. As men and young people have limited uptake under s...

Rashida Ferrand and colleagues combine quantitative and qualitative methods to investigate HIV prevalence among older children receiving primary care in Harare, Zimbabwe, and reasons why providers did not pursue testing. Please see later in the article for the Editors' Summary