BackgroundOpportunities for HIV testing could be enhanced by offering HIV self-testing (HIVST) in populations that fear stigma and discrimination when accessing conventional HIV counselling and testing in health care facilities. Field experience with HIVST has not yet been reported in French-speaking African countries.MethodsThe practicability of HIVST was assessed using the prototype the Exacto® Test HIV (Biosynex, Strasbourg, France) self-test in 322 adults living in Kisangani and Bunia, Democratic Republic of the Congo, according to World Health Organization’s recommendations. Simplified and easy-to-read leaflet was translated in French, Lingala and Swahili.ResultsForty-nine percent of participants read the instructions for use in French, while 17.1% and 33.9% read the instructions in Lingala and Swahili, respectively. The instructions for use were correctly understood in 79.5% of cases. The majority (98.4%) correctly performed the HIV self-test; however, 20.8% asked for oral assistance. Most of the participants (95.3%) found that performing the self-test was easy, while 4.7% found it difficult. Overall, the results were correctly interpreted in 90.2% of cases. Among the positive, negative, and invalid self-tests, misinterpretation occurred in 6.5%, 11.2%, and 16.0% of cases, respectively (P<0.0001). The Cohen’s κ coefficient was 0.84. The main obstacle for HIVST was educational level, with execution and interpretation difficulties occurring among poorly educated people. The Exacto® Test HIV self-test showed 100.0% (95% CI; 98.8–100.0) sensitivity and 99.2% (95% CI; 97.5–99.8) specificity.ConclusionsOur field observations demonstrate: (i) the need to adapt the instructions for use to the Congolese general public, including adding educational pictograms as well as instructions for use in the local vernacular language(s); (ii) frequent difficulties understanding the instructions for use in addition to frequent misinterpretation of test results; and (iii) the generally good practicability of the HIV self-test despite some limitations. Supervised use of HIVST is recommended among poorly-educated people.

Background Adolescents living in sub-Saharan Africa constitute a vulnerable population at significant risk of HIV infection. This study aims to evaluate the acceptability, feasibility, and accuracy of home-based, supervised HIV self-testing (HIVST) as well as their predictors among adolescents living in Kisangani, Democratic Republic of the Congo (DRC). Methods A cross-sectional, door-to-door survey using a blood-based HIV self-test and a peer-based supervised HIVST approach was conducted from July to August 2018 in Kisangani, DRC. The acceptability and feasibility of HIVST were assessed among adolescents' consenting to use and interpret HIV self-test. The accuracy of HIVST was estimated by the sensibility and specificity of adolescent-interpreted HIV self-test. Factors associated with acceptability and feasibility of HIVST were analyzed with logistic regression. Results A total of 628 adolescents (including 369 [58.8%] females) aged between 15 and 19 years were enrolled. Acceptability of HIVST was high (95.1%); 96.1% of participants correctly used the self-test, and 65.2% asked for verbal instructions. The majority of adolescents (93.5%) correctly interpreted their self-test results. The Cohen's κ coefficient between the results read by adolescents and by supervisors was 0.62. The correct interpretation decreased significantly when adolescents had no formal education or attended primary school as compared to those currently attending university (37.0% versus 100%; adjusted OR: 0.01 [95%

We report on field interpretation of HIV self-testing among female sex workers (FSWs) and non-FSWs living in Democratic Republic of the Congo. Two hundred and eight participants [76 (36.5%) FSWs; 132 (63.5%) non-FSWs] were enrolled in Kisangani and Bunia to evaluate their ability to read and interpret the results of a prototype HIV self-test (Exacto Test HIV, Biosynex, Strasbourg, France), according to WHO recommendations. Thirteen standardized tests (6 positive, 5 negative, 2 invalid) were proposed after successive random selection. Two thousand seven hundred and four standardized tests (1248 positive, 1040 negative, 416 invalid) were interpreted; 2435 (90.1%) were correctly interpreted, whereas 269 (9.9%) were misinterpreted. In FSWs and non-FSWs, the test results were similarly correctly interpreted in 87.4% (864/988) and 91.6% (1571/1716), respectively. In multivariate logistic regression analysis, only the variable “educational level” remained strongly associated with the interpretation of positive, negative, and invalid HIV self-test results, but not the variables “commercial sex work” and “language chosen for instructions for use.” Incorrect interpretation was significantly higher in participants with insufficient educational level than in those with sufficient education level for positive (13.1% vs 2.6%; adjusted OR: 4.5), negative (22.3% vs 2.6%; adjusted OR: 5.3), and invalid test results (23.8% v 6.4%; adjusted OR: 3.6). Incorrect interpretation of HIV self-test was as common in FSWs and non-FSWs. The lower was the educational level, the greater was the difficulty to interpret results correctly. These observations point that insufficient education level, rather than commercial sex work by itself, constitutes a key factor of incorrect interpretation of HIV self-test.

Due to their ease-of-use, lateral flow assay SARS-CoV-2 antigen-detecting rapid diagnostic tests could be suitable candidates for antigen-detecting rapid diagnostic self-test (Ag-RDST). We evaluated the practicability of the Ag-RDST BIOSYNEX Antigen Self-Test COVID-19 Ag+ (Biosynex Swiss SA, Freiburg, Switzerland), using self-collected nasal secretions from the turbinate medium (NMT), in 106 prospectively included adult volunteers living in Paris, France. The majority of the participants correctly understood the instructions for use (94.4%; 95% confidence interval (CI): 88.3–97.4), showing a great ability to perform the entire self-test procedure to obtain a valid and interpretable result (100%; 95% CI: 96.5–100), and demonstrated the ability to correctly interpret test results (96.2%; 95% CI: 94.2–97.5) with a high level of general satisfaction. About one in eight participants (# 15%) needed verbal help to perform or interpret the test, and only 3.8% of test results were misinterpreted. By reference to multiplex real-time RT-PCR, the Ag-RDST showed 90.9% and 100% sensitivity and specificity, respectively, and high agreement (98.1%), reliability (0.94), and accuracy (90.9%) to detect SARS-CoV-2 antigen. Taken together, our study demonstrates the high usability and accuracy of BIOSYNEX Antigen Self-Test COVID-19 Ag+ for supervised self-collected NMT sampling in an unselected adult population living in France.

Introduction The empowerment of young people aged 15-24 years is a key component of an effective AIDS response. HIV self-testing (HIVST) is progressively being implemented in the Democratic Republic of Congo (DRC). Methods Socio-demographic and behavioural factors associated with acceptability of HIVST were evaluated among university students in Bunia, DRC. A representative cross-sectional study was conducted using a self-administered semi-structured questionnaire. Results A total of 1,012 students were recruited. Acceptability of unsupervised HIVST was higher in the group of young students as compared with older students and was markedly associated with prior knowledge on HIVST. Conclusion Adapted communication about HIVST appears likely essential to increase the supply and use of HIVST among students in DRC.

Background HIV self-testing (HIVST) is an additional approach to increasing uptake of HIV testing services. The practicability and accuracy of and the preference for the capillary blood self-test (Exacto Test HIV) versus the oral fluid self-test (OraQuick HIV self-test) were compared among untrained individuals in the Democratic Republic of the Congo (DRC). Methods This multicenter cross-sectional study (2019) used face-to-face, tablet-based, structured questionnaires in a facility-based HIVST approach. Volunteers from the general public who were at high risk of HIV infection, who were between 18 and 49 years of age, and who had signed an informed consent form were eligible for the study. The successful performance and correct interpretation of the self-test results were the main outcomes of the practicability evaluation. The successful performance of the HIV self-test was conditioned by the presence of the control band. The sensitivity and specificity of the participant-interpreted results compared to the laboratory results were estimated for accuracy. Preference for either type of self-test was assessed. Logistic regression models were used to examine factors associated with participants' preference. Results A total of 528 participants were included in this survey. The rate of successful performance of the HIV self-tests was high, with the blood test (99.6%) and the oral-fluid test (99.4%) yielding an absolute difference of 0.2%

The practicability of a prototype capillary whole-blood IgG-IgM COVID-19 self-test (Exacto ® COVID-19 self-test, Biosynex Swiss SA, Freiburg, Switzerland) as a serological screening tool for SARS-CoV-2 infection adapted to the general public was evaluated in a cross-sectional, general adult population study performed between April and May 2020 in Strasbourg, France, consisting of face-to-face, paper-based, semi-structured, and self-administrated questionnaires. Practicability was defined as the correct use of the self-test and the correct interpretation of the result. The correct use of self-test was conditioned by the presence of the control band after 15-min of migration. The correct interpretation of the tests was defined by the percent agreement between the tests results read and interpret by the participants compared to the expected results coded by the numbers and verified by trained observers. A total of 167 participants (52.7% female; median age, 35.8 years; 82% with post-graduate level) were enrolled, including 83 and 84 for usability and test results interpretation substudies, respectively. All participants (100%; 95% CI: 95.6–100) correctly used the self-test. However, 12 (14.5%; 95% CI: 8.5–23.6) asked for verbal help. The percent agreement between the tests results read and interpret by the participants compared to the expected results was 98.5% (95% CI: 96.5–99.4). However, misinterpretation occurred in only 2.3% of positive and 1.2% of invalid test results. Finally, all (100%) participants found that performing the COVID-19 self-test was easy; and 98.8% found the interpretation of the self-test results easy. Taken together, these pilot observations demonstrated for the first-time, high practicability and satisfaction of COVID-19 self-testing for serological IgG and IgM immune status, indicating its potential for use by the general public to complete the arsenal of available SARS-CoV-2 serological assays in the urgent context of the COVID-19 epidemic.

Background HIV self-testing (HIVST) can be performed using directly assisted and unassisted approaches in facilities or communities to reach different populations. The aim of this study was to compare the practicability and effectiveness of the two delivery approaches for HIVST, unassisted HIVST (UH) and directly assisted HIVST (DAH), in the field setting of Kisangani, the Democratic Republic of the Congo (DRC). Methods A randomized (1:1), non-blinded, non-inferiority trial using a blood-based and facility-based HIVST method was carried out in four facilities in Kisangani, the DRC, targeting populations at high risk for HIV infection. The primary outcome was the difference in the practicability of the HIV self-test between the two arms. Practicability was defined as successfully performing the test and correctly interpreting the result. Requests for assistance, positivity rate, linkage to care, and willingness to buy an HIV self-test kit constituted the secondary outcomes for HIVST effectiveness. The adjusted risk ratios (aRRs) were calculated using Poisson regression. Results The rate of successfully performing the test was same (93.2%) in the UH and DAH arms. The rate of correctly interpreting the results was 86.9% in the UH arm versus 93.2% in the DAH arm, for a difference of − 6.3%. After the follow-up 72 h later, participants in the UH arm had a significantly lower chance of correctly interpreting the test results than those in the DAH arm (aRR: 0.60; P = 0.019). Although the positivity rate was 3.4% among the participants in the DAH arm and 1.7% among those in the UH arm, no significant differences were found between the two arms in the positivity rate, requests for assistance, and linkage to care. Willingness to buy an HIV self-test was higher in the UH arm than in the DAH arm (92.3% versus 74.1%; aRR: 4.20; P < 0.001). Conclusion The results of this study indicate that UH is as practicable and effective as DAH among individuals at high risk for HIV infection in Kisangani, the DRC. However, additional support tools need to be assessed to improve the interpretation of the self-test results when using the UH approach. Trial registration PACTR201904546865585. Registered 03 April 2019 - Retrospectively registered, https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=6032