Early Infant HIV Diagnosis Clinical Trial
Official title:
Z 1303 - Point-of-Care Virologic Testing to Improve Outcomes of HIV-Infected Children
| Verified date | January 2022 |
| Source | University of North Carolina, Chapel Hill |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 4000 |
| Est. completion date | September 24, 2019 |
| Est. primary completion date | September 24, 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | N/A to 12 Weeks |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| 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 |
| Lead Sponsor | Collaborator |
|---|---|
| University of North Carolina, Chapel Hill | National Institute of Allergy and Infectious Diseases (NIAID) |
Zambia,
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* Note: There are 13 references in all — Click here to view all references
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | Proportion of HIV-infected children who start anti-retroviral therapy (ART) within 6 months of the initial diagnosis | Short-term benefit | time of initial diagnosis through 6 months post diagnosis | |
| Secondary | Proportion of children starting ART who remain in care for 12 months following the initial diagnosis | Long-term retention benefit | time of initial diagnostic blood draw through 12 months post diagnosis |