Status:
ACTIVE_NOT_RECRUITING
POC HIV Testing and Early DTG Use for Infants
Lead Sponsor:
Harvard School of Public Health (HSPH)
Collaborating Sponsors:
Botswana Harvard AIDS Institute Partnership
Ragon Institute of MGH, MIT and Harvard
Conditions:
HIV
Eligibility:
All Genders
Phase:
PHASE4
Brief Summary
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 a...
Eligibility Criteria
Inclusion
- Inclusion criteria for point-of-care infant HIV testing:
- Mother 18 years of age or older
- Mother willing and able to provide verbal consent for infant testing
- Infant birth weight ≥1.5kg
- Presence of any of the following risk factors:
- \<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:
- Mother 18 years of age or older
- Mother willing and able to provide written informed consent for study participation for herself and her infant
- Positive point-of-care HIV screening for infant (HIV DNA PCR pending or completed)
- Infant eligible for ART treatment in accordance with the Botswana government program
- Infant birth weight ≥1.5 kg
- Exclusion criteria for infant longitudinal treatment cohort:
- Medical condition making it unlikely that the infant will survive to 24 months
- Infant unable to start treatment-dose ART \< 168 hours of age
- Infant unable to attend follow-up visits at a BHP study clinic in Gaborone or Francistown
Exclusion
Key Trial Info
Start Date :
July 4 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2026
Estimated Enrollment :
900 Patients enrolled
Trial Details
Trial ID
NCT05393193
Start Date
July 4 2022
End Date
August 31 2026
Last Update
December 19 2024
Active Locations (1)
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1
Botswana Harvard HIV/AIDS Institute Partnership
Gaborone, Botswana