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

Abstract 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

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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

BMC Infectious Diseases ◽

10.1186/s12879-020-05554-x ◽

2020 ◽

Vol 20 (1) ◽

Author(s):

Serge Tonen-Wolyec ◽

Charles Kayembe Tshilumba ◽

Salomon Batina-Agasa ◽

Roland Marini Djang’eing’a ◽

Marie-Pierre Hayette ◽

...

Keyword(s):

High Risk ◽

Hiv Infection ◽

Democratic Republic ◽

Linkage To Care ◽

Feasibility Trial ◽

Test Results ◽

Self Testing ◽

Willingness To Buy ◽

Republic Of The Congo ◽

Self Test

Abstract 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

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Practicability and effectiveness of the unassisted HIV self-testing compared to the directly assisted HIV self-testing in the Democratic Republic of the Congo: A Randomized Implementation Trial

10.21203/rs.3.rs-19502/v1 ◽

2020 ◽

Author(s):

Serge Tonen-Wolyec ◽

Charles Kayembe Tshilumba ◽

Salomon Batina-Agasa ◽

Roland Marini Djang’eing’a ◽

Marie-Pierre Hayette ◽

...

Keyword(s):

Democratic Republic ◽

Linkage To Care ◽

Correct Interpretation ◽

Successful Performance ◽

Self Testing ◽

Willingness To Buy ◽

Significant Difference ◽

Republic Of The Congo ◽

Self Test ◽

Additional Support

Abstract Background. HIV self-testing (HIVST) may be use free or assisted by health care workers. The aim of this trial was to assess the practicability and effectiveness of unassisted HIVST (UH) versus directly assisted HIVST (DAH) in field settings in the Democratic Republic of the Congo (DRC). Methods. A non-inferiority evaluation using a blood-based HIV self-test was conducted in Kisangani, DRC. Participants were randomized in a 1:1 ratio to UH or DAH. Practicability was defined as the successful performance and the correct interpretation of the result. The linkage to care and the willingness to buy self-test constituted the outcome for HIVST effectiveness. Results. The rate of successful performance of the test was same (93.2%) in UH and DAH. The rate of correct interpretation of the results was 86.9% in UH versus 93.2% in DAH yielding the difference of -6.3% (95% CI: -10.8 to 2.5). UH significantly decreased the rate of correct interpretation of results as compared to DAH (aRR: 0.60 [95% CI: 0.36 to 0.98]; P=0.019). None significant difference was found between two arms in evaluating the linkage to care. Willingness to buy HIV self-test was higher in UH as compared to DAH (92.3% versus 74.1%; aRR: 4.20 [95% CI: 2.42 to 7.32]; P<0.001). Conclusion. This study demonstrates that both UH and DAH show high level of practicability and effectiveness for HIVST. However, additional support tools will be need to improve the practicability of the test in UH. Taken together, UH as well as DAH should improve access to HIV testing in DRC. Trial registration: PACTR201904546865585. Registered 03 April 2019 - Retrospectively registered, https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=6032

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Uptake of HIV/AIDS Services Following a Positive Self-Test Is Lower in Men Than Women in the Democratic Republic of the Congo

Frontiers in Medicine ◽

10.3389/fmed.2021.667732 ◽

2021 ◽

Vol 8 ◽

Author(s):

Serge Tonen-Wolyec ◽

Charles Kayembe Tshilumba ◽

Salomon Batina-Agasa ◽

Alliance Tagoto Tepungipame ◽

Laurent Bélec

Keyword(s):

Positive Result ◽

Democratic Republic ◽

Secondary Analysis ◽

Linkage To Care ◽

Sub Saharan Africa ◽

Hiv Care ◽

Self Testing ◽

Republic Of The Congo ◽

Self Test ◽

Linkage To Hiv Care

As far as HIV self-testing (HIVST) is concerned, proving the link to HIV care for users with a positive result contributes to understanding the implementation of HIVST. We sought to examine whether there were differences by sex in the uptake of HIV services following a positive self-test in the Democratic Republic of the Congo (DRC). This was a mixed-methods study exploring linkage to care for HIVST through a secondary analysis of collected data from three pilot surveys recently conducted in three cities (Kinshasa, Kisangani, and Kindu) during 2018 and 2020 in the DRC. Linkage to HIV care was defined as delayed when observed beyond 1 week. A total of 1,652 individuals were self-tested for HIV. Overall, the proportion of linkage to HIV care was high (n = 258; 82.2%) among individuals having a positive result with HIV self-test (n = 314), but it was significantly lower in men (65.2%) than women (89.2%). Furthermore, linkage to HIV care of men was significantly delayed as compared with that of women (40.0 vs. 20.7%). These findings show a lower uptake of care following a positive self-test in men than women. This trend already previously observed in sub-Saharan Africa shed light on the need to increase linkages to care among men newly diagnosed through HIV self-testing.

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Analytical Performance of the Exacto Test HIV Self-Test: A Cross-Sectional Field Study in the Democratic Republic of the Congo

Open Forum Infectious Diseases ◽

10.1093/ofid/ofaa554 ◽

2020 ◽

Vol 7 (12) ◽

Author(s):

Serge Tonen-Wolyec ◽

Jérémie Muwonga Masidi ◽

Luc Ferdinand Kamanga Lukusa ◽

Gaetan Nsiku Dikumbwa ◽

Angèle Sarassoro ◽

...

Keyword(s):

Field Study ◽

Democratic Republic ◽

Analytical Performance ◽

Viable Option ◽

Excellent Performance ◽

Cross Sectional ◽

Performance Sensitivity ◽

Self Testing ◽

Republic Of The Congo ◽

Self Test

Abstract The Democratic Republic of the Congo (DRC) has begun implementing HIV self-testing to boost the first “95” of the UNAIDS 95-95-95 targets by 2025. This study aims to assess the performance and usability of the Exacto Test HIV (Biosynex, Strasbourg, France) self-test in the lab and in the field. The Exacto Test HIV self-test demonstrated high virological performance (sensitivity, 99.6%; specificity, 100%) in the lab and in the field in the hand of untrained users (sensitivity, 100%; specificity, 98.9%). Taken together, the excellent performance and usability characteristics of the Exacto Test HIV (Biosynex) self-test make the kit a viable option for HIV self-testing in the DRC.

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Insufficient education is a key factor of incorrect interpretation of HIV self-test results by female sex workers in Democratic Republic of the Congo

Medicine ◽

10.1097/md.0000000000014218 ◽

2019 ◽

Vol 98 (6) ◽

pp. e14218 ◽

Cited By ~ 6

Author(s):

Serge Tonen-Wolyec ◽

Salomon Batina-Agasa ◽

Jean De Dieu Longo ◽

Ralph-Sydney Mboumba Bouassa ◽

Laurent Bélec

Keyword(s):

Sex Workers ◽

Female Sex Workers ◽

Democratic Republic ◽

Test Results ◽

Female Sex ◽

Key Factor ◽

Republic Of The Congo ◽

Self Test

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A systematic review of qualitative evidence on factors enabling and deterring uptake of HIV self-testing in Africa

BMC Public Health ◽

10.1186/s12889-019-7685-1 ◽

2019 ◽

Vol 19 (1) ◽

Cited By ~ 13

Author(s):

Bernard Njau ◽

Christopher Covin ◽

Esther Lisasi ◽

Damian Damian ◽

Declare Mushi ◽

...

Keyword(s):

Systematic Review ◽

Hiv Testing ◽

Linkage To Care ◽

Ease Of Use ◽

Sub Saharan Africa ◽

Care Providers ◽

African Countries ◽

Qualitative Evidence ◽

Self Testing ◽

Self Test

Abstract Background More than 40% of adults in Sub-Saharan Africa are unaware of their HIV status. HIV self-testing (HIVST) is a novel approach with a potential to increase uptake of HIV testing and linkage to care for people who test HIV positive. We explored HIV stakeholder’s perceptions about factors that enable or deter the uptake of HIV self-testing and experiences of self-testing of adult users in Africa. Methods This systematic review of qualitative evidence included articles on qualitative studies published or made available between January 1998 to February 2018 on perspectives of key stakeholders, including HIV policymakers, HIV experts, health care providers, and adult men and women (18 years and above) about factors that enable or deter the uptake of HIV self-testing and experiences of self-testing among adult users. We searched CINAHL, MEDLINE in Pubmed, EMBASE, AJOL, PsycINFO, Social Science Citation Index (SSCI), and Web of Science for articles in English on HIVST with qualitative data from different African countries. Results In total, 258 papers were retrieved, and only nine (9) studies conducted in 5 African countries were eligible and included in this synthesis. Perceived facilitators of the uptake of HIVST were autonomy and self-empowerment, privacy, confidentiality, convenience, opportunity to test, including couples HIV testing, and ease of use. The perceived barriers included the cost of buying self-test kits, perceived unreliability of test results, low literacy, fear and anxiety of a positive test result, and potential psychological and social harms. HIV stakeholder’s concerns about HIVST included human right issues, lack of linkage to care, lack of face-to-face counseling, lack of regulatory and quality assurance systems, and quality of self-test kits. Actual HIVST users expressed preference of oral-fluid self-testing because of ease of use, and that it is less invasive and painless compared to finger-stick/whole blood-based HIV tests. Lack of clear instructions on how to use self-test kits, and existing different products of HIVST increases rates of user errors. Conclusions Overcoming factors that may deter HIV testing, and HIVST, in particular, is complex and challenging, but it has important implications for HIV stakeholders, HIVST users, and public health in general. Research is warranted to explore the actual practices related to HIVST among different populations in Africa.

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Persons Newly Diagnosed with HIV Infection are at High Risk for Depression and Poor Linkage to Care: Results from the Steps Study

AIDS and Behavior ◽

10.1007/s10461-010-9778-9 ◽

2010 ◽

Vol 15 (6) ◽

pp. 1161-1170 ◽

Cited By ~ 96

Author(s):

Ramona Bhatia ◽

Christine Hartman ◽

Michael A. Kallen ◽

James Graham ◽

Thomas P. Giordano

Keyword(s):

High Risk ◽

Hiv Infection ◽

Linkage To Care ◽

Newly Diagnosed ◽

Risk For Depression

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Findings of Feasibility for Serial Testing Using Over-the-Counter SARS-CoV-2 Test with the Assistance of a Digital Smartphone App (Preprint)

10.2196/preprints.35426 ◽

2021 ◽

Author(s):

Carly Herbert ◽

John Broach ◽

William Heetderks ◽

Felicia Qashu ◽

Laura Gibson ◽

...

Keyword(s):

United States ◽

Disease Transmission ◽

Smartphone Application ◽

The United States ◽

Test Results ◽

Kappa Score ◽

Self Testing ◽

Self Test ◽

Testing Schedule ◽

Gender Groups

BACKGROUND The ongoing pandemic necessitates the development of accurate, rapid, and affordable diagnostics to help curb SARS-CoV-2 disease transmission, morbidity, and mortality, as well as safely navigate social re-engagement. OBJECTIVE To describe the feasibility and acceptability of serial self-testing for SARS-CoV-2, including need for assistance and reliability of self-interpretation. METHODS A total of 206 adults in the United States with Smartphones were enrolled in this single-arm feasibility study during February and March 2021. All participants were asked to self-test for Covid-19 at home daily using an antigen-detection rapid diagnostic test over a 14-day period and use a smartphone application for testing assistance and to report their results. The main outcomes were adherence to the testing schedule, acceptability of testing and Smartphone application experiences, and reliability of participant versus study team interpretation of test results. RESULTS Among the 206 participants, 52% of study participants were women, the average age was 40.7 years, 34.43% were non-White, and half the sample (56.8%) had received a Bachelor’s degree or higher. Most participants (64.6%) showed high testing adherence. Participants’ interpretations of test results demonstrated high agreement (98.9%) with the study verified results, with a kappa score of 0.29 (p<0.001). Participants reported high satisfaction with self-testing and the smartphone application, with greater than 98% of participants reporting they would recommend the self-test and smartphone application to others. These results were consistent across age, race/ethnicity, and gender groups. CONCLUSIONS Participant’s high adherence to the recommended testing schedule, significant reliability between participant and study staff test interpretation, and acceptability of the smartphone application and self-test indicate that self-tests for SARS-CoV-2 with a smartphone application for assistance and reporting is highly feasible among a diverse population of adults in the United States.

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