Comparison of practicability and effectiveness between unassisted HIV selftesting and directly assisted HIV self-testing in the Democratic Republic of the Congo: a randomized feasibility trial
HIV; HIV self-testing; Unassisted HIV self-testing; Directly assisted HIV self-testing; Democratic Republic of the Congo
Abstract :
[en] 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 andeffectiveness 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.
Research Center/Unit :
UNIKIS - University of Kisangani
Disciplines :
Laboratory medicine & medical technology
Author, co-author :
Tonen-Wolyec, Serge; Ecole Doctorale Régionale D’Afrique Centrale en Infectiologie Tropicale, Franceville, Gabon ; University of Bunia, Bunia, Democratic Republic of the Congo ; University of Kisangani, Kisangani, Democratic Republic of the Congo
Kayembe Tshilumba, Charles; University of Kisangani, Kisangani, Democratic Republic of the Congo > Internal Medicine
Batina-Agasa, Salomon; University of Kisangani, Kisangani, Democratic Republic of the Congo > Internal Medicine
Hayette, Marie-Pierre ; Université de Liège - ULiège > Département des sciences biomédicales et précliniques > Bact., mycologie, parasitologie, virologie, microbio.
Belec, Laurent; Hôpital Européen Georges Pompidou, and University of Paris Descartes, Paris Sorbonne Cité, Paris, France > Laboratory of virology
Language :
English
Title :
Comparison of practicability and effectiveness between unassisted HIV selftesting and directly assisted HIV self-testing in the Democratic Republic of the Congo: a randomized feasibility trial
Alternative titles :
[fr] Comparaison de la faisabilité et de l'efficacité entre l'autotest du VIH non assisté et l'autotest du VIH assisté en RDC: un essai de faisabilité randomisé
Global AIDS Update 2018. Miles to go: closing gaps, breaking barriers, righting injustices. Geneva: Joint United Nations Programme on HIV/AIDS; 2018. Accessed February 21, 2020.
Stover J, Bollinger L, Izazola J, Loures L, DeLay P, Ghys P. What is required to end the AIDS epidemic as a public health threat by 2030? The cost and impact of the fast-track approach. PLoS One. 2016;11(6):e0158253. DOI: 10.1371/journal.pone.0158253
World Health Organisation. HIV self-testing strategic framework a guide for planning, introducing and scaling up HIV testing services. 2018.
Choko AT, Desmond N, Webb EL, Chavula K, Napierala-Mavedzenge S, Gaydos CA, et al. The uptake and accuracy of oral kits for HIV self-testing in high HIV prevalence setting: a cross-sectional feasibility study in Blantyre, Malawi. PLoS Med. 2011;8(10):e1001102. DOI: 10.1371/journal.pmed.1001102
Johnson CC, Kennedy C, Fonner V, Siegfried N, Figueroa C, Dalal S, et al. Examining the effects of HIV self-testing compared to standard HIV testing services: a systematic review and meta-analysis. J Int AIDS Soc. 2017;20(1):21594. DOI: 10.7448/IAS.20.1.21594
World Health Organisation. Guidelines on HIV self-testing and partner notification: supplement to consolidated guidelines on HIV testing services. 2016. Available at http://apps.who.int/iris/bitstream/handle/10665/251655/9789241549868-eng.pdf;jsessionid=B043673B59952F021C313F076554ABA6?sequence=1 Accessed February 04, 2020.
Sarkar A, Mburu G, Shivkumar PV, Sharma P, Campbell F, Behera J, et al. Feasibility of supervised self-testing using an oral fluid-based HIV rapid testing method: a cross-sectional, mixed method study among pregnant women in rural India. J Int AIDS Soc. 2016;19(1):20993. DOI: 10.7448/IAS.19.1.20993
Grésenguet G, Longo JD, Tonen-Wolyec S, Mboumba Bouassa RS, Belec L. Acceptability and usability evaluation of finger-stick whole blood HIV self-test as an HIV screening tool adapted to the general public in the Central African Republic. Open AIDS J. 2017;11:101–18. DOI: 10.2174/1874613601711010101
Figueroa C, Johnson C, Ford N, Sands A, Dalal S, Meurant R, et al. Reliability of HIV rapid diagnostic tests for self-testing performed by self-testers compared to health-care workers: a systematic review and meta-analysis. Lancet HIV. 2018;5(6):e277–90. DOI: 10.1016/S2352-3018(18)30044-4
Tonen-Wolyec S, Batina-Agasa S, Muwonga J, Fwamba N’kulu F, Mboumba Bouassa RS, Belec L. Evaluation of the practicability and virological performance of finger-stick whole-blood HIV self-testing in French-speaking sub-Saharan Africa. PLoS One. 2018;13:e0189475. DOI: 10.1371/journal.pone.0189475
Tonen-Wolyec S, Mboup S, Grésenguet G, Bouassa RB, Bélec L. Insufficient education is a challenge for HIV self-testing. Lancet HIV. 2018;5(7):e341. DOI: 10.1016/S2352-3018(18)30141-3
Ortblad KF, Musoke DK, Ngabirano T, Nakitende A, Haberer JE, McConnell M, et al. Female sex workers often incorrectly interpret HIV self-test results in Uganda. J Acquir Immune Defic Syndr. 2018;79(1):e42–5. DOI: 10.1097/QAI.0000000000001765
Tonen-Wolyec S, Batina-Agasa S, Longo JDD, Mboumba Bouassa RS, Bélec L. 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. Medicine. 2019;98(6):e14218. DOI: 10.1097/MD.0000000000014218
Devillé W, Tempelman H. Feasibility and robustness of an oral HIV self-test in a rural community in South-Africa: an observational diagnostic study. PLoS One. 2019;14(4):e0215353. DOI: 10.1371/journal.pone.0215353
Martínez Pérez G, Steele SJ, Govender I, Arellano G, Mkwamba A, Hadebe M, et al. Supervised oral HIV self-testing is accurate in rural KwaZulu Natal, South Africa. Trop Med Int Health. 2016;21:759–67. DOI: 10.1111/tmi.12703
Pant Pai N, Sharma J, Shivkumar S, Pillay S, Vadnais C, Joseph L, et al. Supervised and unsupervised self-testing for HIV in high- and low-risk populations: a systematic review. PLoS Med. 2013;10(4):e1001414. DOI: 10.1371/journal.pmed.1001414
Kurth AE, Cleland CM, Chhun N, Sidle JE, Were E, Naanyu V, et al. Accuracy and acceptability of oral fluid HIV self-testing in a general adult population in Kenya. AIDS Behav. 2016;20:870–9. DOI: 10.1007/s10461-015-1213-9
Asiimwe S, Oloya J, Song X, Whalen CC. Accuracy of un-supervised versus provider-supervised self-administered HIV testing in Uganda: a randomized implementation trial. AIDS Behav. 2014 December;18(12):2477–84. DOI: 10.1007/s10461-014-0765-4
Prazuck T, Karon S, Gubavu C, Andre J, Legall JM, Bouvet E, et al. A finger-stick whole-blood HIV selftest as an HIV screening tool adapted to the general public. PLoS One. 2016;11(2):e0146755. DOI: 10.1371/journal.pone.0146755
UNAIDS. HIV testing, Democratic Republic of the Congo. http://aidsinfo.unaids.org/ Accessed February 14, 2020.
Programme National de Lutte contre le Sida. Guide de prise en charge intégrée du VIH en République Démocratique du Congo. 2016. Available at http://www.pnmls.cd/doc/guide-de-prise-en-charge-integree-du-vih-en-republique-democratique-du-congo.pdf Accessed February 21, 2020.
Tonen-Wolyec S, Batina-Agasa S, Muwonga J, Mboumba Bouassa R-S, Kayembe Tshilumba C, Bélec L. Acceptability, feasibility, and individual preferences of bloodbased HIV self-testing in a population-based sample of adolescents in Kisangani, Democratic Republic of the Congo. PLoS One. e0218795;14(7).
Elie C, Touzé E. Les essais de non-infériorité. Sang Thrombose Vaisseaux. 2012;24(2):93–9. 10.1684/stv.2012.0682. DOI: 10.1684/stv.2012.0682
Landlis JR, Koch GG. The measurement of observer agreement for categorical data. Biometrics. 1977;33(1):159–74. DOI: 10.2307/2529310
Mircioiu C, Atkinson J. A comparison of parametric and non-parametric methods applied to a Likert scale. Pharmacy (Basel). 2017;5(2):26. DOI: 10.3390/pharmacy5020026
World Health Organization [WHO]. HIV Self-Testing Strategic Framework: A Guide For Planning, Introducing And Scaling Up HIV Testing Services. Geneva; 2018. Available at: https://apps.who.int/iris/bitstream/handle/10665/275521/9789241514859-eng.pdf?ua=1 Accessed February 14, 2020.
Steehler K, Siegler AJ. Bringing HIV self-testing to scale in the United States: a review of challenges, potential solutions, and future opportunities. J Clin Microbiol. 2019;57:e00257–19. DOI: 10.1128/JCM.00257-19
Estem KS, Catania J, Klausner JD. HIV Self-Testing: a Review of Current Implementation and Fidelity. Curr HIV/AIDS Rep. 2016;13(2):107–15. DOI: 10.1007/s11904-016-0307-y
Ng OT, Chow AL, Lee VJ, Chen MI, Win MK, Tan HH, et al. Accuracy and user-acceptability of HIV selftesting using an oral fluid-based HIV rapid test. PLoS One. 2012;7(9):e45168. DOI: 10.1371/journal.pone.0045168
World Bank Document. Republique Democratique du Congo, Etude sur le decoupage. 2010. http://documents.banquemondiale.org/curated/fr/915621468245668283/pdf/ 506750ESW0P1041Box353763B001PUBLIC1.pdf Accessed January 11, 2020.
Mokgatle MM, Madiba S. High acceptability of HIV self-testing among technical vocational education and training college students in Gauteng and north West Province what are the implications for the scale up in South Africa? PLoS One. 2017;12(1):e0169765. DOI: 10.1371/journal.pone.0169765
Watson V, Dacombe RJ, Williams C, Edwards T, Adams ER, Johnson CC. Re-reading of OraQuick HIV-1/2 rapid antibody test results: quality assurance implications for HIV self-testing programmes. J Int AIDS Soc. 2019;22(Suppl 1):e25234. DOI: 10.1002/jia2.25234
