Comparison of practicability and effectiveness between unassisted HIV self-testing and directly assisted HIV self-testing in the Democratic Republic of the Congo: a randomized feasibility trial.

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.

Capillary whole-blood IgG-IgM COVID-19 self-test as a serological screening tool for SARS-CoV-2 infection adapted to the general public.

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.

Predictors of AIDS-related death among adult HIV-infected inpatients in Kisangani, the Democratic Republic of Congo.

INTRODUCTION: Human Immunodeficiency Virus (HIV) infection continues to be a major public health concern in sub-Saharan Africa. We aimed to evaluate potential factors associated with AIDS-related death among adult HIV-infected inpatients in Kisangani, the Democratic Republic of the Congo (DRC). METHODS: this is a hospital-based retrospective, observational analysis carried out between 1st January 2019 and 31st March 2020 among inpatients HIV, at 12 facilities integrating the HIV prevention and care packages in Kisangani. Factors associated with AIDS-related death were analyzed using the logistic regression models. RESULTS: a total of 347 HIV-infected inpatients were included. Among those, the rate of AIDS-related death was 25.1% (95% CI: 20.8-29.9). The rates of AIDS-related death were lower among patients with a university education (aOR: 0.03 [95% CI: 0.00-1.0]) and higher among patients in WHO clinical stage 4 (aOR: 15.4 [6.8-27.8]), patients with poor highly active antiretroviral therapy (HAART) observance (aOR: 14.5 [2.3-40.4), and patients suffering from opportunistic infections (aOR: 9.3 [95% CI: 3.4-25.1]), including cryptococcal meningitis (aOR: 27 [95% CI: 6.0-125.7]) and viral infections associated with zona and Kaposi sarcoma (aOR: 4.8 [95% CI: 2.2-10.4]). CONCLUSION: in our retrospective study on a large sample of inpatients hospitalized in Kisangani, classic causes of death were found. The association with the low level of education suggests that the economic level of the patients who die is a determining factor, difficult to correct. The identification of a limited number of other factors will allow a better medical management.

Acceptability of HIV self-testing in African students: a cross-sectional survey in the Democratic Republic of Congo.

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.

Acceptability, feasibility, and individual preferences of blood-based HIV self-testing in a population-based sample of adolescents in Kisangani, Democratic Republic of the Congo.

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% CI: 0.004-0.03]). In the hands of adolescents at home, the sensitivity of the Exacto Test HIV Self-test was estimated at 100%, while its specificity was 96.0%. The majority of participants (68.0%) affirmed that post-test counseling was essential, and that face-to-face counseling (78.9%) was greatly preferred. CONCLUSIONS: Home-based, supervised HIVST using a blood-based self-test and peer-based approach can be used with a high degree of acceptability and feasibility by adolescents living in Kisangani, DRC. Misinterpretation of test results is challenging to obtaining good feasibility of HIVST among adolescents with poor educational level. Face-to-face post-test counseling seems to be preferred among Kisangani's adolescents.

Insufficient education is a key factor of incorrect interpretation of HIV self-test results by female sex workers in Democratic Republic of the Congo: A multicenter cross-sectional study.

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.