Clinical trial NCT02682810: Point of Care Virologic Testing to Improve Outcomes of HIV-Infected Children
Official title: Z 1303 - Point-of-Care Virologic Testing to Improve Outcomes of HIV-Infected Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Early Infant HIV Diagnosis
Keywords: HIV
point-of-care HIV diagnosis
Alere Q
diagnostic
children
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: National Institute of Allergy and Infectious Diseases (NIAID)
First posted: 2016-02-15
Enrollment: 4000
Sex: ALL
Minimum age (years): 4
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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.

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.

Eligibility 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

Primary outcomes:
measure: 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
timeFrame: time of initial diagnosis through 12 months post diagnosis
Secondary outcomes:
measure: Proportion of HIV-infected children who start anti-retroviral therapy (ART) within 6 months of the initial diagnosis
timeFrame: time of initial diagnosis through 6 months post diagnosis
measure: Proportion of children starting ART who remain in care for 12 months following the initial diagnosis
timeFrame: time of initial diagnostic blood draw through 12 months post diagnosis
Other outcomes:
Locations:
city: Lusaka
country: Zambia
facility: Chawama Health Centre
city: Lusaka
country: Zambia
facility: Chelstone Health Centre
city: Lusaka
country: Zambia
facility: Chilenje Health Centre
city: Lusaka
country: Zambia
facility: Chipata Health Centre
city: Lusaka
country: Zambia
facility: Kanyama Health Centre
city: Lusaka
country: Zambia
facility: Mtendere Health Centre
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Jeff Stringer, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: 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.
citation: 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.