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| ID | Type | Description | Link |
|---|---|---|---|
| P01HD107670 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Botswana Harvard AIDS Institute Partnership | OTHER |
| Ragon Institute of MGH, MIT and Harvard | OTHER |
| Botswana Ministry of Health | OTHER_GOV |
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
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This study is being conducted to explore the feasibility of implementing targeted birth HIV testing of high-risk neonates using facility-based point-of-care (POC) HIV diagnostics, and to improve the ability to implement the best standard-of-care treatment possible. Infants found to be HIV infected will be immediately offered enrollment into a dolutegravir (DTG) antiretroviral treatment study cohort (if maternal consent is granted) or referred for treatment at a government facility. Infants who enter the study treatment cohort will be prospectively followed through 96 weeks of age. ART will follow Botswana guidelines.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HIV-exposed neonates | Other | Point-of-care HIV testing at birth |
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| HIV-positive infants identified through birth HIV screening | Other | Early antiretroviral treatment per standard of care, including dolutegravir-based regimen beginning at 4 weeks of age for infants weighing at least 3.0kg. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Point-of-Care Cepheid Xpert HIV-1 | Diagnostic Test | Post-partum HIV-positive women with pre-determined risk factors for vertical HIV transmission will be offered point-of-care HIV testing for their newborns for early infant HIV diagnosis. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of high-risk HIV-exposed infants identified and tested | Analysis will largely be descriptive, highlighting the proportion of high-risk infants identified and tested at each facility. Proportions will be determined by populating actual numbers approached and screened matched against exact denominators obtained from surveillance data. | within 72 hours of life |
| Median time to HIV diagnosis and treatment-dose ART | We will describe the proportion of high-risk infants found to be HIV positive per risk category and compare this to findings from another cohort study of early-treated children. Average time to HIV diagnosis and treatment initiation will also be described. | 7 days |
| The proportion of children with HIV-1 RNA <40 copies/mL at 12 weeks on ART | We will compare time to viral suppression and the proportion with complete HIV-1 RNA suppression (<40 copies/mL) at 12 weeks from ART start between infants on early DTG with another cohort of children on early LPV/r. | 12 weeks on ART |
| The proportion of children with successful DTG-based treatment through 96 weeks on ART | We will compare the proportion with complete HIV-1 RNA suppression and no need for treatment modification at all visits through 96 weeks between infants on early DTG with another cohort of children on early LPV/r. | 96 weeks on ART |
| The proportion of infants with grade 3 or 4 adverse events/hospitalization/death | We will compare the proportion with grade 3 or 4 adverse events through 96 weeks between infants on early DTG with another cohort of children on early LPV/r. | 96 weeks on ART |
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Inclusion criteria for point-of-care infant HIV testing:
<12 weeks of ART prior to delivery (including no ART); Known HIV-1 viremia (above level of detection) for last test performed or at any time >24 weeks gestation in pregnancy; CD4 cell count known to be <350 cells/mm3 within the past year; Self-described poor adherence in pregnancy (1 or more complete days of missed ART)
Exclusion criteria for point-of-care infant HIV testing:
1) Medical condition making it unlikely that the infant will survive to 24 months
Inclusion criteria for infant longitudinal treatment cohort:
Exclusion criteria for infant longitudinal treatment cohort:
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| Name | Affiliation | Role |
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| Roger L Shapiro, MD, MPH | Harvard School of Public Health (HSPH) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
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| Botswana Harvard Health Partnership | Gaborone | Botswana |
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| NIH |
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| DTG/ABC/3TC | Drug | Infants will be started on a combination of NVP/ZDV/3TC. A switch to DTG/ABC/3TC will occur for all infants at or after 4 weeks (28 days) post-delivery for those weighing ≥3kg. Dosing of all ART will be weight-based by the Botswana treatment guidelines. |
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