Point-of-Care HIV Testing and Early Dolutegravir Use for Infants (Moso)

  • STATUS
    Recruiting
  • End date
    Aug 31, 2026
  • participants needed
    900
  • sponsor
    Harvard School of Public Health (HSPH)
Updated on 4 October 2022

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 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.

Details
Condition HIV
Treatment Point-of-Care Cepheid Xpert HIV-1, DTG/ABC/3TC
Clinical Study IdentifierNCT05393193
SponsorHarvard School of Public Health (HSPH)
Last Modified on4 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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

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
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