Point of Care Virologic Testing to Improve Outcomes of HIV-Infected Children
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| ClinicalTrials.gov Identifier: NCT02682810 |
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Recruitment Status :
Completed
First Posted : February 15, 2016
Last Update Posted : February 28, 2022
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Early Infant HIV Diagnosis | Device: DNA PCR HIV diagnostic test Device: Alere Q | Not Applicable |
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.
| 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 |
| Arm | Intervention/treatment |
|---|---|
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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.
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Device: DNA PCR HIV diagnostic test
standard of care |
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Experimental: Alere Q POC nucleic acid-based platform
POC test to provide same-day diagnosis
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Device: Alere Q
POC diagnostic Alere Q qualitative test (along with a DBS drawn for confirmatory DNA PCR) |
- 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 ]
- 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
- 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
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| Ages Eligible for Study: | 4 Weeks to 12 Weeks (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
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
| 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 | |
| Principal Investigator: | Jeff Stringer, MD | University of North Carolina, Chapel Hill |
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | University of North Carolina, Chapel Hill |
| ClinicalTrials.gov Identifier: | NCT02682810 |
| Other Study ID Numbers: |
12-1346 5U01AI100053-03 ( U.S. NIH Grant/Contract ) |
| First Posted: | February 15, 2016 Key Record Dates |
| Last Update Posted: | February 28, 2022 |
| Last Verified: | January 2022 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
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HIV point-of-care HIV diagnosis Alere Q diagnostic children |
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Disease Pathologic Processes |