Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Point of Care Virologic Testing to Improve Outcomes of HIV-Infected Children

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02682810
Recruitment Status : Completed
First Posted : February 15, 2016
Last Update Posted : September 27, 2019
Sponsor:
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

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.

Condition or disease Intervention/treatment Phase
Early Infant HIV Diagnosis Device: DNA PCR HIV diagnostic test Device: Alere Q Not Applicable

Detailed Description:

At public sector clinics in Lusaka, Zambia, approximately 4,000 HIV-exposed infants between 4 and 12 weeks of life will be randomized in this trial of point-of-care virologic testing to improve outcomes of HIV-infected children in Zambia. There is a standard of care (SOC) or control arm and an intervention arm known as the Alere arm. In both study arms, early infant diagnosis (EID) will be provided at 6 weeks of life. Infants randomized to the SOC arm will receive EID through the existing prevention of mother-to-child-transmission (PMTCT) program, with samples sent to an off-site laboratory for DNA PCR testing. Infants randomized to the intervention arm will receive POC diagnostic Alere Q qualitative test (along with a dried blood spot (DBS) drawn for confirmatory DNA PCR).

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Z 1303 - Point-of-Care Virologic Testing to Improve Outcomes of HIV-Infected Children
Actual Study Start Date : February 2016
Actual Primary Completion Date : September 24, 2019
Actual Study Completion Date : September 24, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Active Comparator: 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.
Device: DNA PCR HIV diagnostic test
standard of care

Experimental: Alere Q POC nucleic acid-based platform
POC test to provide same-day diagnosis
Device: Alere Q
POC diagnostic Alere Q qualitative test (along with a DBS drawn for confirmatory DNA PCR)




Primary Outcome Measures :
  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 Frame: time of initial diagnosis through 12 months post diagnosis ]

Secondary Outcome Measures :
  1. Proportion of HIV-infected children who start anti-retroviral therapy (ART) within 6 months of the initial diagnosis [ Time Frame: time of initial diagnosis through 6 months post diagnosis ]
    Short-term benefit

  2. Proportion of children starting ART who remain in care for 12 months following the initial diagnosis [ Time Frame: time of initial diagnostic blood draw through 12 months post diagnosis ]
    Long-term retention benefit



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   up to 12 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 4 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02682810


Locations
Layout table for location information
Zambia
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
Sponsors and Collaborators
University of North Carolina, Chapel Hill
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
Layout table for investigator information
Principal Investigator: Jeff Stringer, MD University of North Carolina, Chapel Hill

Additional Information:
Publications:
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.
World Health Organization. Antiretroviral Therapy for HIV Infection in Infants and Children: Towards Universal Access (2010 Revision): http://www.who.int/hiv/pub/paediatric/infants2010/en/index.html Accessed 2011.
UNITAID. HIV/AIDS diagnostic technology landscape.Tech. Rep., WHO, Geneva, Switzerland, 2012.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT02682810     History of Changes
Other Study ID Numbers: 12-1346
5U01AI100053-03 ( U.S. NIH Grant/Contract )
First Posted: February 15, 2016    Key Record Dates
Last Update Posted: September 27, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by University of North Carolina, Chapel Hill:
HIV
point-of-care HIV diagnosis
Alere Q
diagnostic
children