NCT02682810

Brief Summary

This is a two-arm, unmasked, randomized, controlled trial to test the effectiveness of the Alere Q point-of-care (POC) HIV diagnostic assay for use in resource-poor settings.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2016

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

February 10, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 15, 2016

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 24, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 24, 2019

Completed
Last Updated

February 28, 2022

Status Verified

January 1, 2022

Enrollment Period

3.6 years

First QC Date

February 10, 2016

Last Update Submit

February 24, 2022

Conditions

Early Infant HIV Diagnosis

Keywords

HIVpoint-of-care HIV diagnosisAlere Qdiagnosticchildren

Outcome Measures

Primary Outcomes (1)

  • Proportion of HIV-infected children in each arm who remain alive, in care, and with no HIV circulating in their bloodstream 12 months after initial diagnosis

    time of initial diagnosis through 12 months post diagnosis

Secondary Outcomes (2)

  • Proportion of HIV-infected children who start anti-retroviral therapy (ART) within 6 months of the initial diagnosis

    time of initial diagnosis through 6 months post diagnosis

  • Proportion of children starting ART who remain in care for 12 months following the initial diagnosis

    time of initial diagnostic blood draw through 12 months post diagnosis

Study Arms (2)

DNA PCR HIV diagnostic test

ACTIVE COMPARATOR

SOC or control arm through existing PMTCT program, with DBS samples sent to an off-site laboratory for DNA PCR testing.

Device: DNA PCR HIV diagnostic test

Alere Q POC nucleic acid-based platform

EXPERIMENTAL

POC test to provide same-day diagnosis

Device: Alere Q

Interventions

DNA PCR HIV diagnostic testDEVICE

standard of care

DNA PCR HIV diagnostic test
Alere QDEVICE

POC diagnostic Alere Q qualitative test (along with a DBS drawn for confirmatory DNA PCR)

Alere Q POC nucleic acid-based platform

Eligibility Criteria

Age4 Weeks - 12 Weeks
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • to 12 weeks of life
  • 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

You may not qualify if:

  • Infants will be excluded from participation if they have major congenital anomalies or other medical conditions that would require management at a referral facility or otherwise interfere with study procedures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Chawama Health Centre

Lusaka, Zambia

Location

Chelstone Health Centre

Lusaka, Zambia

Location

Chilenje Health Centre

Lusaka, Zambia

Location

Chipata Health Centre

Lusaka, Zambia

Location

Kanyama Health Centre

Lusaka, Zambia

Location

Mtendere Health Centre

Lusaka, Zambia

Location

Related Publications (15)

  • 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.

    PMID: 19020325BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    PMID: 20639563BACKGROUND

  • 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.

    PMID: 16052086BACKGROUND

  • 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/

    PMID: 23741772BACKGROUND

  • 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.

    PMID: 21224736BACKGROUND

  • 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.

    PMID: 15464184BACKGROUND

  • 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.

    PMID: 22869167BACKGROUND

  • UNITAID. HIV/AIDS diagnostic technology landscape.Tech. Rep., WHO, Geneva, Switzerland, 2012.

    BACKGROUND

  • 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.

    PMID: 24933096BACKGROUND

  • 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.

    PMID: 6528136BACKGROUND

  • 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.

    PMID: 20942667BACKGROUND

  • 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.

    PMID: 17954540BACKGROUND

  • 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.

    PMID: 34718462DERIVED

  • 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.

    PMID: 27355509DERIVED

Related Links

MeSH Terms

Conditions

Disease

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Jeff Stringer, MD

    University of North Carolina, Chapel Hill

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 10, 2016

First Posted

February 15, 2016

Study Start

February 1, 2016

Primary Completion

September 24, 2019

Study Completion

September 24, 2019

Last Updated

February 28, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Locations

ZA(6)