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

NCT ID NCT05393193

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

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 900 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2022

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion criteria for point-of-care infant HIV testing: 1. Mother 18 years of age or older 2. Mother willing and able to provide verbal consent for infant testing 3. Infant birth weight ≥1.5kg 4. 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: 1. Mother 18 years of age or older 2. Mother willing and able to provide written informed consent for study participation for herself and her infant 3. Positive point-of-care HIV screening for infant (HIV DNA PCR pending or completed) 4. Infant eligible for ART treatment in accordance with the Botswana government program 5. Infant birth weight ≥1.5 kg Exclusion criteria for infant longitudinal treatment cohort: 1. Medical condition making it unlikely that the infant will survive to 24 months 2. Infant unable to start treatment-dose ART \< 168 hours of age 3. Infant unable to attend follow-up visits at a BHP study clinic in Gaborone or Francistown

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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

More trials for these conditions

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