DETECTION OF NEW HIV CASES UNDER EPIDEMIC CONTROL - WHEN IS IT THE RIGHT TIME TO REVIEW HIV TESTING ALGORITHMS FOR COUNTRIES NEARING THE 95-95-95 MILESTONES? CASE STUDY -BOTSWANA
DOI:
https://doi.org/10.21010/Ajid%20v19i1.8Keywords:
HIV epidemic control, 2-test strategy, 3-test strategy, WHO 2019 HIV Testing Services, HIV testing algorithmAbstract
Background: Accurate diagnosis of human immunodeficiency virus (HIV) infection is dependent on using established national HIV testing algorithm. The purpose of this study was to review published articles to identify, and apply lessons learned to determine factors affecting transition of HIV testing algorithm for countries that have attained HIV epidemic control.
Materials and methods: We systematically searched peer-reviewed articles from online scientific databases; PubMed and Google Scholar from January 2019 to March 2024, using defined search phrases to extract articles. The defined search terms targeted articles focusing on issues of attained epidemic control and transitioning of HIV testing algorithm. Descriptive analysis was used to develop themes to answer the research question.
Results: The findings show that countries should consider the following areas before changing their HIV testing algorithm: (i) evaluate the current national HIV testing algorithm to determine the Positive Predictive Value (PPV), which should be ≥99%, (ii) evaluate test kits bearing both CE and FDA certification and are WHO pre-qualified (iii) 4th generation Rapid Diagnostic Tests (RDTs) are less sensitive than laboratory-based 4th generation assays, (iv) pilot the proposed algorithm before country-wide roll-out, (v) country specific policies, and framework are required to guide transition, and (vi) a combination of 4th and 3rd generation RDTs can achieve desired PPV.
Conclusion: Transitioning HIV testing algorithm for countries reaching HIV epidemic control is a multistep process which considers the PPV of the current algorithms, considers policies and framework to guide the process and, evaluates a combination of 4th and 3rd generation RDTs.
References
Adetunji, A. A., Adewumi, M. O., Michael, O. S., Fayemiwo, S. A., Ogunniyi, A., and Taiwo, B. O. (2019). Rapid HIV antigen–antibody assays and detection of acute HIV infection in Sub-Saharan Africa. The American Journal of Tropical Medicine and Hygiene, 101(2), 285.
Ali, H., Amoyaw, F., Baden, D., Durand, L., Bronson, M., Kim, A., and Swaminathan, M. (2019). Ghana’s HIV epidemic and PEPFAR’s contribution towards epidemic control. Ghana medical journal, 53(1), 59-62.
Augusto, Â. D. R., Iriemenam, N. C., Kohatsu, L., De Sousa, L., Maueia, C., Hara, C., ... and Parekh, B. S. (2020). High level of HIV false positives using EIA-based algorithm in survey: Importance of confirmatory testing. PLoS One, 15(10), e0239782.
Bangalee, A., Bhoora, S., and Punchoo, R. (2021). Evaluation of serological assays for the diagnosis of HIV infection in adults. South African Family Practice, 63(4).
Barr, B. A. T., Lowrance, D., Johnson, C. C., Baggaley, R. C., Rogers, J. H., Balachandra, S. K., and Jahn, A. (2021). Treatment-adjusted prevalence to assess HIV testing programmes. Bulletin of the World Health Organization, 99(12), 874.
Demir, T., Yalcin, S., and Kilic, S. (2020). Evaluation of the diagnostic performance and optimal cutoff value of a fourth-generation ELISA, VIDAS HIV-1/2 Duo Ultra assay, in a low-prevalence country. Diagnostic Microbiology and Infectious Disease, 97(1), 115011.
Duong, Y. T., Mavengere, Y., Patel, H., Moore, C., Manjengwa, J., Sibandze, D., and Parekh, B. S. (2014). Poor performance of the determine HIV-1/2 Ag/Ab combo fourth-generation rapid test for detection of acute infections in a National Household Survey in Swaziland. Journal of Clinical Microbiology, 52(10), 3743-3748.
Dupwa, B., Kumar, A. M., Tripathy, J. P., Mugurungi, O., Takarinda, K. C., Dzangare, J., and Mukeredzi, I. (2019). Retesting for verification of HIV diagnosis before antiretroviral therapy initiation in Harare, Zimbabwe: Is there a gap between policy and practice? Transactions of The Royal Society of Tropical Medicine and Hygiene, 113(10), 610-616.
Eaton, J. W., Sands, A., Barr-DiChiara, M., Jamil, M. S., Baggaley, R., Tippett Barr, B. A., and Johnson, C. C. (2021). Accuracy and performance of the WHO 2015 and WHO 2019 HIV testing strategies across epidemic settings. medRxiv, 2021-03.
Fajardo, E., Lastrucci, C., Bah, N., Mingiedi, C. M., Ba, N. S., Mosha, F., and Johnson, C. (2023). Country adoption of WHO 2019 guidance on HIV testing strategies and algorithms: a policy review across the WHO African region. BMJ open, 13(12), e071198.
Ford, N., Eshun-Wilson, I., Ameyan, W., Newman, M., Vojnov, L., Doherty, M., andGeng, E. (2021). Future directions for HIV service delivery research: Research gaps identified through WHO guideline development. PLoS medicine, 18(9), e1003812.
Fonner, V. A., Sands, A., Figueroa, C., Baggaley, R., Quinn, C., Jamil, M. S., and Johnson, C. (2020). Country adherence to WHO recommendations to improve the quality of HIV diagnosis: a global policy review. BMJ Global Health, 5(5), e001939.
Human Sciences Research Council (HSRC), 27 NOVEMBER 2023. New HIV Survey Highlights Progress and Ongoing Disparities in South Africa’s HIV Epidemic. Human Sciences Research Council. https://hsrc.ac.za/press-releases/hsc/new-hiv-survey-highlights-progress-and-ongoing-disparities-in-south-africas-hiv-epidemic/. Accessed May 30, 2024.
Huang, Y., Liu, H., Dai, S., Lan, X., Liu, S., Ren, X., and Hong, G. (2023). Evaluation of a two-test strategy for HIV screening in a low-prevalence setting and the indications for optimizing clinical management. Heliyon, 9(9).
Johnson, L. F., van Rensburg, C., Govathson, C., and Meyer-Rath, G. (2019). Optimal HIV testing strategies for South Africa: a model-based evaluation of population-level impact and cost-effectiveness. Scientific reports, 9(1), 12621.
Joulaei, H., Shooshtarian, S., and Dianatinasab, M. (2018). Is UNAIDS 90-90-90 target a Dream or a Reality for Middle East and North Africa Region on Ending the AIDS Epidemic? A Review Study. AIDS reviews, 20(2).
Krasowski, M. D., Wier, D., Smith, S., Riedel, A., Lauseker-Hao, Y., Kelner, M., and Wang, S. (2021). Real-world clinical performance evaluation of a fourth-generation HIV antigen/antibody differentiation test. The Journal of Applied Laboratory Medicine, 6(6), 1417-1432.
Livant, E., Heaps, A., Kelly, C., Maharaj, R., Samsunder, N., Nhlangulela, L., and VOICE Study Team. (2017). The fourth generation AlereTM HIV Combo rapid test improves detection of acute infection in MTN-003 (VOICE) samples. Journal of Clinical Virology, 94, 15-21.
Lo, N. C., Lowe, A., and Bendavid, E. (2016). Abstinence funding was not associated with reductions in HIV risk behavior in sub-Saharan Africa. Health affairs, 35(5), 856-863.
Maheu-Giroux, M., and Mishra, S. (2024). Evidence with 95-95-95 that ambitious is feasible. The Lancet HIV, 11(4), e203-e204.
Manjate, A., Nilsson, C., Axelsson, M., Lindroth, S., Sirbu, D., Sacarlal, J., and Unemo, M. (2024). Laboratory-based evaluation of the 4th-generation AlereTM HIV Combo rapid point-of-care test. Plos one, 19(2), e0298912
Martin, E. G., Cornett, J., Mohammed, D. Y., and Salaru, G. (2020). Rapid testing algorithm performance in a low-prevalence environment. Sexually transmitted diseases, 47(5S), S35-S40.
Masciotra, S., Luo, W., Youngpairoj, A. S., Kennedy, M. S., Wells, S., Ambrose, K., and Owen, S. M. (2013). Performance of the Alere Determine™ HIV-1/2 Ag/Ab Combo Rapid Test with specimens from HIV-1 seroconverters from the US and HIV-2 infected individuals from Ivory Coast. Journal of Clinical Virology, 58, e54-e58.
Mashishi, B. R., Makatini, Z., and Adu-Gyamfi, C. G. (2021). The evolving HIV epidemic and its impact on the HIV testing algorithm: is it time to change the HIV testing algorithm in South Africa?. Journal of Clinical Virology, 144, 104990.
Merrick, T., Radix, A. E., Gonzalez, C. J., Hoffmann, C. J., and Ganjhu, L. (2022). Prevention and Management of Hepatitis B Virus Infection in Adults With HIV. MEDICAL CARE, 2.
Ministry of Health- Republic of Botswana. 2016. Botswana National HIV Testing Services guidelines. Ministry of Health, Gaborone. Botswana.
Mishra, S. (2017). FDA, CE mark or something else?—thinking fast and slow. Indian heart journal, 69(1), 1-5.
Molinaro, A. M. (2015). Diagnostic tests: how to estimate the positive predictive value. Neuro-Oncology Practice, 2(4), 162-166.
Murphy, E. M., Greene, M. E., Mihailovic, A., and Olupot-Olupot, P. (2006). Was the “ABC” approach (abstinence, being faithful, using condoms) responsible for Uganda's decline in HIV?. PLoS medicine, 3(9), e379.
National AIDS and Health Promotion Agency (NAHPA). August 2023 Government of Botswana: Botswana AIDS Impact Survey V 2021 (BAIS V): Report. Gaborone, Botswana.
Okware, S., Kinsman, J., Onyango, S., Opio, A., and Kaggwa, P. (2005). Revisiting the ABC strategy: HIV prevention in Uganda in the era of antiretroviral therapy. Postgraduate medical journal, 81(960), 625-628.
Patel, H. K., Ikpe, S., Bronson, M., Birhanu, S., Abimiku, A. L., Jahun, I., and Parekh, B. (2022). Performance of HIV rapid testing algorithm in Nigeria: findings from a household-based Nigeria HIV/AIDS indicator and impact survey (NAIIS). PLOS Global Public Health, 2(7), e0000466.
Parker, J., Carrasco, A. F., and Chen, J. (2019). BioRad BioPlex® HIV Ag-Ab assay: incidence of false positivity in a low-prevalence population and its effects on the current HIV testing algorithm. Journal of Clinical Virology, 116, 1-3.
Petersen, J., Monteiro, M., Dalal, S., and Jhala, D. (2021). Reducing false-positive results with fourth-generation HIV testing at a veterans affairs medical center. Federal Practitioner, 38(5), 232.
Parekh, B. S., Ou, C. Y., Fonjungo, P. N., Kalou, M. B., Rottinghaus, E., Puren, A., and Nkengasong, J. N. (2018). Diagnosis of human immunodeficiency virus infection. Clinical microbiology reviews, 32(1), 10-1128.
Patel, H. K., Ikpe, S., Bronson, M., Birhanu, S., Abimiku, A. L., Jahun, I., and Parekh, B. (2022). Performance of HIV rapid testing algorithm in Nigeria: findings from a household-based Nigeria HIV/AIDS indicator and impact survey (NAIIS). PLOS Global Public Health, 2(7), e0000466.
PEPFAR. 2021.Latest Global Results - United States Department of State [Internet]. June 2021. [cited 2022Nov19]. Available from: https://www.state.gov/wp-content/uploads/2021/06/PEPFAR-Latest-Global-Results_JUNE-2021-1.pdf
Petersen, J., Monteiro, M., Dalal, S., & Jhala, D. (2021). Reducing false-positive results with fourth-generation HIV testing at a veterans affairs medical center. Federal Practitioner, 38(5), 232.
UNAIDS. The path that ends AIDS. 2023. https://www.unaids.org/en/resources/documents/2023/global-aids-update-2. (Accessed, May 2nd, 2024)
UNAIDS. 2023.Fact Sheet- Global HIV statistics. [cited May1, 2024]. Available from .https://www.unaids.org/sites/default/files/media_asset/UNAIDS_FactSheet_en.pdf.
UNAIDS. 2022. Fact sheet - latest global and regional statistics on the status of the AIDS epidemic.[cited Dec15, 2022]. Available from: https://www.unaids.org/en/resources/documents/2022/UNAIDS_FactSheet
UNAIDS. 2021, 06, September. Update- Global roll-out of HIV treatment has saved millions of lives. [cited Dec15, 2022]. Available from:
UNAIDS. 2016. UNAIDS 2016–2021 Strategy On the Fast-Track to end AIDS [Internet]. [cited 2022 Nov19]. Available from: https://unaids.org/sites/default/files/media_asset/20151027_UNAIDS_PCB37_15_18_EN_rev1.pdf
Qiu, X., Sokoll, L., Ly, T. D., Coignard, C., Eshleman, S. H., Mohr, P., and Hackett Jr, J. (2021). An improved HIV antigen/antibody prototype assay for earlier detection of acute HIV infection. Journal of Clinical Virology, 145, 105022.
Robertson ML. An Annotated Chronology of the History of AIDS in Toronto: The First Five Years, 1981–1986. Canadian Bulletin of Medical History. 2005 Oct;22(2):313-51.
Sirivichayakul, S., Pankam, T., Pattanachaiwit, S., Phancharoen, K., Barisri, N., Areeyolwattana, S., ... and Phanuphak, P. (2021). Ability of Alere™ HIV Combo to diagnose acute HIV infection is based mainly on HIV-1 p24 antigen detection. Asian Pac J Allergy Immunol.
Skovdal, M., Beckmann, N., Maswera, R., Nyamukapa, C., and Gregson, S. (2022). The (in) visibility of misdiagnosis in point-of-care HIV testing in Zimbabwe. Medical anthropology, 41(4), 404-417.
Statistics South Africa. 2024.Government of South Africa. Available from https://www.statssa.gov.za/. Accessed May 30, 2024.
Vogus, A., and Graff, K. (2015). PEPFAR transitions to country ownership: review of past donor transitions and application of lessons learned to the Eastern Caribbean. Global Health: Science and Practice, 3(2), 274-286.
Wang, J. S., Sim, H. J., Park, S. J., Park, G. R., Kang, C., and Chung, Y. S. (2021). Effect of a confirmatory testing algorithm on early acute HIV diagnosis in Korea. Medicine, 100(17), e25632.
World Health Organization. 19 April, 2024.WHO list of prequalified in vitro diagnostic products. Accessed: May 10, 2024. Available from https://extranet.who.int/prequal/sites/default/files/document_files/240418_List_of_Prequalified_In_Vitro_Diagnostic_Products.pdf
World Health Organization. November, 2021a. Optimizing HIV testing algorithms: a generic verification protocol for selecting appropriate HIV serology assays and assessing the level of shared false-reactivity. Accessed: May 12, 2024. Available from: https://www.who.int/publications/i/item/9789240039162.
World Health Organization. July ,2021b. Consolidated guidelines on HIV prevention, testing, treatment, service delivery and monitoring: recommendations for a public health approach.
World Health Organization. 2019a. Consolidated guidelines on HIV testing. Accessed December 2021. Available from: https://iris.who.int/bitstream/handle/10665/336323/9789241550581-eng.pdf?sequence=1
World Health Organization. 2019b. Policy brief- Consolidated guidelines for a changing epidemic. Accessed: December 15, 2022. Available https://iris.who.int/bitstream/handle/10665/329966/WHO-CDS-HIV-19.31-eng.pdf?sequence=
World Health Organization. 2016. Consolidated guidelines on the use of antiretroviral drugs for treating and preventing HIV infection: recommendations for a public health approach. World Health Organization.
World Health Organization. July 2015. Consolidated Guidelines on HIV Testing Services: 5Cs: Consent, Confidentiality, Counselling, Correct Results and Connection. Geneva. PMID: 26378328
Wratil, P. R., Rabenau, H. F., Eberle, J., Stern, M., Münchhoff, M., Friedrichs, I., and Keppler, O. T. (2020). Comparative multi-assay evaluation of Determine™ HIV-1/2 Ag/Ab Combo rapid diagnostic tests in acute and chronic HIV infection. Medical microbiology and immunology, 209, 139-150.
Yoo, S. J. (2020). Clinical utility of HIV-1/2 Ab immunochromatographic assay as an additive test for HIV screen-positive patients. Annals of Clinical & Laboratory Science, 50(2), 274
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