Infant HIV testing at birth using point-ofcare and conventional HIV DNA PCR: An implementation feasibility pilot study in Kenya

Pilot and Feasibility Studies

Volumn 5, Issue 1, 2019, Pages

  Sandbulte, Matthew R ^a   Gautney, Brad J ^b   Maloba, May ^c   Wexler, Catherine ^a   Brown, Melinda ^a   Mabachi, Natabhona ^a   Goggin, Kathy ^d,e   Lwembe, Raphael ^f   Nazir, Niaman ^g   Odeny, Thomas A ^e,f   Finocchario Kessler, Sarah ^a  

^a UNIVERSITY OF KANSAS SCHOOL OF MEDICINE   (United States)

^b Global Health Innovations   (United States)

^c Global Health Researcher   (Kenya)

^d CHILDREN S MERCY HOSPITAL   (United States)

^e UNIVERSITY OF MISSOURI KANSAS CITY SCHOOL OF MEDICINE   (United States)

^f KENYA MEDICAL RESEARCH INSTITUTE   (Kenya)

^g UNIVERSITY OF KANSAS MEDICAL CENTER   (United States)

Author keywords

Birth testing; Early infant diagnosis; HIV; Implementation; Point of care testing

Indexed keywords

DNA POLYMERASE; VIRUS DNA;

ARTICLE; ATTITUDE; BIRTH; BLOOD SAMPLING; CD4 LYMPHOCYTE COUNT; COMMUNITY; COMPARATIVE STUDY; CONTROLLED STUDY; DRIED BLOOD SPOT TESTING; FEASIBILITY STUDY; FEMALE; HEALTH CARE COST; HEALTH CARE PERSONNEL; HEALTH CARE QUALITY; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS INFECTED PATIENT; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; IMMUNE RESPONSE; INFANT; KENYA; MAJOR CLINICAL STUDY; MEDICATION COMPLIANCE; NEWBORN; PARENT; PILOT STUDY; POINT OF CARE TESTING; POLYMERASE CHAIN REACTION; QUALITATIVE ANALYSIS; RANDOMIZED CONTROLLED TRIAL; SCALE UP; VIRUS LOAD;

EID: 85073760485     PISSN: None     EISSN: 20555784     Source Type: Journal    
DOI: 10.1186/s40814-019-0402-0     Document Type: Article

References (34)

1. On the Fast-Track to an AIDS-Free Generation. The incredible journey of the global plan towards the elimination of new HIV infections among children by 2015 and keeping their mothers alive: Joint United Nations Programme on HIV/AIDS; 2016. http://www.unaids.org/en/resources/documents/2016/ GlobalPlan2016
2. Violari A, Cotton MF, Gibb DM, Babiker AG, Steyn J, Madhi SA, et al. Early antiretroviral therapy and mortality among HIV-infected infants. N Engl J Med. 2008;359(21):2233-44.
3. Global plan Kenya Country fact sheet: UNAIDS; 2016. http://www.unaids. org/sites/default/files/media/documents/UNAIDS_ GlobalplanCountryfactsheet_kenya_en.pdf
4. United Nations Children's Fund. UNICEF Data: Paediatric Care and Treatment, Early Infant HIV Diagnosis downloadable spreadsheet. 2018. https://data.unicef.org/topic/hivaids/paediatric-treatment-and-care/. Accessed 17 Jan 2019.
5. Ciaranello AL, Park JE, Ramirez-Avila L, Freedberg KA, Walensky RP, Leroy V. Early infant HIV-1 diagnosis programs in resource-limited settings: opportunities for improved outcomes and more cost-effective interventions. BMC Med. 2011;9:59.
6. Tiam A, Gill MM, Hoffman HJ, Isavwa A, Mokone M, Foso M, et al. Conventional early infant diagnosis in Lesotho from specimen collection to results usage to manage patients: where are the bottlenecks? PLoS One. 2017;12(10):e0184769.
7. Sutcliffe CG, van Dijk JH, Hamangaba F, Mayani F, Moss WJ. Turnaround time for early infant HIV diagnosis in rural Zambia: a chart review. PLoS One. 2014;9(1):e87028.
8. Lankowski AJ, Siedner MJ, Bangsberg DR, Tsai AC. Impact of geographic and transportation-related barriers on HIV outcomes in sub-Saharan Africa: a systematic review. AIDS Behav. 2014;18(7):1199-223.
9. Essajee S, Vojnov L, Penazzato M, Jani I, Siberry GK, Fiscus SA, et al. Reducing mortality in HIV-infected infants and achieving the 90-90-90 target through innovative diagnosis approaches. J Int AIDS Soc. 2015;18(Suppl 6):20299.
10. Gill MM, Mofenson LM, Phalatse M, Tukei V, Guay L, Nchephe M. Piloting very early infant diagnosis of HIV in Lesotho: acceptability and feasibility among mothers, health workers and laboratory personnel. PLoS One. 2018;13(2):e0190874.
11. Lilian RR, Kalk E, Bhowan K, Berrie L, Carmona S, Technau K, et al. Early diagnosis of in utero and intrapartum HIV infection in infants prior to 6 weeks of age. J Clin Microbiol. 2012;50(7):2373-7.
12. Lilian RR, Kalk E, Technau KG, Sherman GG. Birth diagnosis of HIV infection in infants to reduce infant mortality and monitor for elimination of motherto- child transmission. Pediatr Infect Dis J. 2013;32(10):1080-5.
13. Finocchario-Kessler S, Gautney BJ, Khamadi S, Okoth V, Goggin K, Spinler JK, et al. If you text them, they will come: using the HIV infant tracking system to improve early infant diagnosis quality and retention in Kenya. AIDS. 2014;28(Suppl 3):S313-21.
14. Kayumba K, Nsanzimana S, Binagwaho A, Mugwaneza P, Rusine J, Remera E, et al. TRACnet internet and short message service technology improves time to antiretroviral therapy initiation among HIV-infected infants in Rwanda. Pediatr Infect Dis J. 2016;35(7):767-71.
15. Phiri NA, Lee HY, Chilenga L, Mtika C, Sinyiza F, Musopole O, et al. Early infant diagnosis and outcomes in HIV-exposed infants at a central and a district hospital, northern Malawi. Public Health Action. 2017;7(2):83-9.
16. Bourne DE, Thompson M, Brody LL, Cotton M, Draper B, Laubscher R, et al. Emergence of a peak in early infant mortality due to HIV/AIDS in South Africa. AIDS. 2009;23(1):101-6.
17. International NBoS-KaI. 2014 Kenya demographic and health survey key findings. Rockville, Maryland: KNBS and ICF International. p. 2015. https:// www.dhsprogram.com/pubs/pdf/SR227/SR227.pdf
18. Consolidated guidelines on the use of antiretroviral drugs for treating and preventing HIV infection: recommendations for a public health approach - 2nd ed: World Health Organization; 2016. http://apps.who.int/iris/bitstream/ 10665/208825/1/9789241549684_eng.pdf
19. Ministry of Health NASCP. Guidelines on use of antiretroviral drugs for treating and preventing HIV infection in Kenya 2016. Nairobi: NASCOP; 2016. https://aidsfree.usaid.gov/sites/default/files/kenya_art_2016.pdf
20. Chiu A, Modi S, Rivadeneira ED, Koumans EH. Optimizing infant HIV diagnosis in resource-limited settings: modeling the impact of HIV DNA PCR testing at birth. J Acquir Immune Defic Syndr. 2016;73(4):454-62.
21. Celletti F, Sherman G, Mazanderani AH. Early infant diagnosis of HIV: review of current and innovative practices. Curr Opin HIV AIDS. 2017;12(2):112-6.
22. WHO Prequalification of In Vitro Diagnostics Public Report. Product: Xpert® HIV-1 Qual Assay WHO reference number: PQDx 0259-070-00: World Health Organization; 2016. http://www.who.int/diagnostics_laboratory/evaluations/ pq-list/hiv-vrl/160613PQPublicReport_0259-0700-00_XpertQualHIV_v2.pdf
23. WHO Prequalification of In Vitro Diagnostics Public Report. Product: Alere™ q HIV-1/2 Detect WHO reference number: PQDx 0226-032-00: World Health Organization; 2016. http://www.who.int/diagnostics_laboratory/evaluations/ pq-list/hiv-vrl/160613PQPublicReport_0226-032-00AlereHIVDetect_v2.pdf
24. Hsiao NY, Dunning L, Kroon M, Myer L. Laboratory evaluation of the Alere q pointof- care system for early infant HIV diagnosis. PLoS One. 2016;11(3):e0152672.
25. Ibrahim M, Moyo S, Mohammed T, Mupfumi L, Gaseitsiwe S, Maswabi K, et al. Brief report: high sensitivity and specificity of the Cepheid Xpert HIV-1 qualitative point-of-care test among newborns in Botswana. J Acquir Immune Defic Syndr. 2017;75(5):e128-e31.
26. Technau KG, Kuhn L, Coovadia A, Murnane PM, Sherman G. Xpert HIV-1 point-of-care test for neonatal diagnosis of HIV in the birth testing programme of a maternity hospital: a field evaluation study. Lancet HIV. 2017;4(10):e442-e8.
27. Murray TY, Sherman GG, Nakwa F, MacLeod WB, Sipambo N, Velaphi S, et al. Field evaluation of performance of Alere and Cepheid qualitative HIV assays for pediatric point-of-care testing in an academic Hospital in Soweto, South Africa. J Clin Microbiol. 2017;55(11):3227-35.
28. Jani IV, Meggi B, Mabunda N, Vubil A, Sitoe NE, Tobaiwa O, et al. Accurate early infant HIV diagnosis in primary health clinics using a point-of-care nucleic acid test. J Acquir Immune Defic Syndr. 2014;67(1):e1-4.
29. Dunning L, Kroon M, Hsiao NY, Myer L. Field evaluation of HIV point-of-care testing for early infant diagnosis in Cape Town, South Africa. PLoS One. 2017;12(12):e0189226.
30. Finocchario-Kessler S, Goggin K, Khamadi S, Gautney B, Dariotis JK, Bawcom C, et al. Improving early infant HIV diagnosis in Kenya: study protocol of a clusterrandomized efficacy trial of the HITSystem. Implement Sci. 2015;10:96.
31. National AIDS Control Council. Kenya AIDS Response Progress Report 2016. 2016.
32. Damschroder LJ, Aron DC, Keith RE, Kirsh SR, Alexander JA, Lowery JC. Fostering implementation of health services research findings into practice: a consolidated framework for advancing implementation science. Implement Sci. 2009;4:50.
33. Cost-effectiveness in health and medicine. Gold, MRS, J.E.; Russell, L.B.; Weinstein, M.C., editor. New York: Oxford University Press; 1996.
34. Dunning L, Kroon M, Fourie L, Ciaranello A, Myer L. Impact of birth HIV-PCR testing on the uptake of follow-up early infant diagnosis services in Cape Town, South Africa. Pediatr Infect Dis J. 2017;36(12):1159-64.