Point of Care Virologic Testing to Improve Outcomes of HIV-Infected Children
NCT ID: NCT02682810
Last Updated: 2022-02-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
4000 participants
INTERVENTIONAL
2016-02-29
2019-09-24
Brief Summary
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Detailed Description
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HIV-infected infants will be followed for 12 months. The acceptability of point-of-care testing for EID will also be determined through the use of cross-sectional surveys of clinicians, laboratory personnel, and parents/guardians.
The feasibility will be assessed by a time-in-motion (TIM) and value stream mapping (VSM) analyses will also be conducted to compare the Alere Q to two additional testing technologies.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SCREENING
NONE
Study Groups
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DNA PCR HIV diagnostic test
SOC or control arm through existing PMTCT program, with DBS samples sent to an off-site laboratory for DNA PCR testing.
DNA PCR HIV diagnostic test
standard of care
Alere Q POC nucleic acid-based platform
POC test to provide same-day diagnosis
Alere Q
POC diagnostic Alere Q qualitative test (along with a DBS drawn for confirmatory DNA PCR)
Interventions
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DNA PCR HIV diagnostic test
standard of care
Alere Q
POC diagnostic Alere Q qualitative test (along with a DBS drawn for confirmatory DNA PCR)
Eligibility Criteria
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Inclusion Criteria
* documented HIV exposure through seropositive maternal or infant HIV antibody test
* with a parent or guardian will and able to provide written informed consent and to have the participant followed for 12 months after study enrolment
Exclusion Criteria
4 Weeks
12 Weeks
ALL
No
Sponsors
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National Institute of Allergy and Infectious Diseases (NIAID)
NIH
University of North Carolina, Chapel Hill
OTHER
Responsible Party
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Principal Investigators
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Jeff Stringer, MD
Role: PRINCIPAL_INVESTIGATOR
University of North Carolina, Chapel Hill
Locations
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Chawama Health Centre
Lusaka, , Zambia
Chelstone Health Centre
Lusaka, , Zambia
Chilenje Health Centre
Lusaka, , Zambia
Chipata Health Centre
Lusaka, , Zambia
Kanyama Health Centre
Lusaka, , Zambia
Mtendere Health Centre
Lusaka, , Zambia
Countries
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References
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Violari A, Cotton MF, Gibb DM, Babiker AG, Steyn J, Madhi SA, Jean-Philippe P, McIntyre JA; CHER Study Team. Early antiretroviral therapy and mortality among HIV-infected infants. N Engl J Med. 2008 Nov 20;359(21):2233-44. doi: 10.1056/NEJMoa0800971.
UNAIDS. 2014 Progress Report on The Global Plan: http://www.unaids.org/sites/default/files/documents/JC2681_2014-Global-Plan-progress_en.pdf. Accessed: 01 February 2015.
Stringer EM, Ekouevi DK, Coetzee D, Tih PM, Creek TL, Stinson K, Giganti MJ, Welty TK, Chintu N, Chi BH, Wilfert CM, Shaffer N, Dabis F, Stringer JS; PEARL Study Team. Coverage of nevirapine-based services to prevent mother-to-child HIV transmission in 4 African countries. JAMA. 2010 Jul 21;304(3):293-302. doi: 10.1001/jama.2010.990.
Stringer JS, Sinkala M, Maclean CC, Levy J, Kankasa C, Degroot A, Stringer EM, Acosta EP, Goldenberg RL, Vermund SH. Effectiveness of a city-wide program to prevent mother-to-child HIV transmission in Lusaka, Zambia. AIDS. 2005 Aug 12;19(12):1309-15. doi: 10.1097/01.aids.0000180102.88511.7d.
Antiretroviral Therapy for HIV Infection in Infants and Children: Towards Universal Access: Recommendations for a Public Health Approach: 2010 Revision. Geneva: World Health Organization; 2010. Available from http://www.ncbi.nlm.nih.gov/books/NBK138576/
Braun M, Kabue MM, McCollum ED, Ahmed S, Kim M, Aertker L, Chirwa M, Eliya M, Mofolo I, Hoffman I, Kazembe PN, van der Horst C, Kline MW, Hosseinipour MC. Inadequate coordination of maternal and infant HIV services detrimentally affects early infant diagnosis outcomes in Lilongwe, Malawi. J Acquir Immune Defic Syndr. 2011 Apr 15;56(5):e122-8. doi: 10.1097/QAI.0b013e31820a7f2f.
Newell ML, Coovadia H, Cortina-Borja M, Rollins N, Gaillard P, Dabis F; Ghent International AIDS Society (IAS) Working Group on HIV Infection in Women and Children. Mortality of infected and uninfected infants born to HIV-infected mothers in Africa: a pooled analysis. Lancet. 2004 Oct 2-8;364(9441):1236-43. doi: 10.1016/S0140-6736(04)17140-7.
Laursen L. Point-of-care tests poised to alter course of HIV treatment. Nat Med. 2012 Aug;18(8):1156. doi: 10.1038/nm0812-1156. No abstract available.
UNITAID. HIV/AIDS diagnostic technology landscape.Tech. Rep., WHO, Geneva, Switzerland, 2012.
Jani IV, Meggi B, Mabunda N, Vubil A, Sitoe NE, Tobaiwa O, Quevedo JI, Lehe JD, Loquiha O, Vojnov L, Peter TF. Accurate early infant HIV diagnosis in primary health clinics using a point-of-care nucleic acid test. J Acquir Immune Defic Syndr. 2014 Sep 1;67(1):e1-4. doi: 10.1097/QAI.0000000000000250.
Yusuf S, Collins R, Peto R. Why do we need some large, simple randomized trials? Stat Med. 1984 Oct-Dec;3(4):409-22. doi: 10.1002/sim.4780030421. No abstract available.
Palumbo P, Lindsey JC, Hughes MD, Cotton MF, Bobat R, Meyers T, Bwakura-Dangarembizi M, Chi BH, Musoke P, Kamthunzi P, Schimana W, Purdue L, Eshleman SH, Abrams EJ, Millar L, Petzold E, Mofenson LM, Jean-Philippe P, Violari A. Antiretroviral treatment for children with peripartum nevirapine exposure. N Engl J Med. 2010 Oct 14;363(16):1510-20. doi: 10.1056/NEJMoa1000931.
Bolton-Moore C, Mubiana-Mbewe M, Cantrell RA, Chintu N, Stringer EM, Chi BH, Sinkala M, Kankasa C, Wilson CM, Wilfert CM, Mwango A, Levy J, Abrams EJ, Bulterys M, Stringer JS. Clinical outcomes and CD4 cell response in children receiving antiretroviral therapy at primary health care facilities in Zambia. JAMA. 2007 Oct 24;298(16):1888-99. doi: 10.1001/jama.298.16.1888.
Chibwesha CJ, Mollan KR, Ford CE, Shibemba A, Saha PT, Lusaka M, Mbewe F, Allmon AG, Lungu R, Spiegel HML, Mweni E, Mwape H, Kankasa C, Chi BH, Stringer JSA. A Randomized Trial of Point-of-Care Early Infant Human Immunodeficiency Virus (HIV) Diagnosis in Zambia. Clin Infect Dis. 2022 Aug 25;75(2):260-268. doi: 10.1093/cid/ciab923.
Chibwesha CJ, Ford CE, Mollan KR, Stringer JS. Point-of-Care Virologic Testing to Improve Outcomes of HIV-Infected Children in Zambia: A Clinical Trial Protocol. J Acquir Immune Defic Syndr. 2016 Aug 1;72 Suppl 2(Suppl 2):S197-201. doi: 10.1097/QAI.0000000000001050.
Related Links
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University of North Carolina website
Other Identifiers
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12-1346
Identifier Type: -
Identifier Source: org_study_id
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