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

• Register: ClinicalTrials.gov
• Last refreshed on: 7 March 2022
• Main ID: NCT02682810
• Date of registration: 10/02/2016
• Prospective Registration: No
• Primary sponsor: University of North Carolina, Chapel Hill
• Public title: Point of Care Virologic Testing to Improve Outcomes of HIV-Infected Children
• Scientific title: Z 1303 - Point-of-Care Virologic Testing to Improve Outcomes of HIV-Infected Children
• Date of first enrolment: February 2016
• Target sample size: 4000
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02682810
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Screening. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Zambia

Contacts

• Name: Jeff Stringer, MD
• Affiliation: University of North Carolina, Chapel Hill

Key inclusion & exclusion 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



Age minimum: N/A
Age maximum: 12 Weeks
Gender: All

Health Condition(s) or Problem(s) studied

Early Infant HIV Diagnosis

Intervention(s)

Device: Alere Q

Device: DNA PCR HIV diagnostic test

Primary Outcome(s)

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(s)

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]

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]

Secondary ID(s)

5U01AI100053-03

12-1346

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

National Institute of Allergy and Infectious Diseases (NIAID)