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Quick HIV test at birth could get infants on better meds faster

NCT ID NCT05393193

Ongoing Disease control Sponsor: Harvard School of Public Health (HSPH) Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jul 14, 2026 · Updated 2 times

Summary

This study looks at whether testing high-risk newborns for HIV right after birth using a point-of-care test can speed up diagnosis and treatment. Infants who test positive will start on a dolutegravir-based drug regimen. Researchers will track how quickly the virus becomes undetectable and monitor safety over 96 weeks. About 900 infants in Botswana are expected to take part.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance
dolutegravir (DTG) combined with abacavir and lamivudine (ABC/3TC)
What this could lead to
If successful, this could show that early testing and dolutegravir-based treatment helps HIV-infected infants achieve faster viral suppression and better long-term outcomes.
What could go wrong
This is a Phase 4 study, but it's observational for testing and compares outcomes to another cohort, not a randomized trial. Results may not apply broadly, and risks include side effects from antiretroviral drugs.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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Conditions

The condition(s) this trial relates to.

HIV infectious disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

HIV

Contacts and locations

Locations

  • Botswana Harvard Health Partnership

    Gaborone, Botswana

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