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Rapid HIV test for newborns could save lives by getting treatment started faster

NCT ID NCT03133728

Diagnosis Sponsor: University of Alabama at Birmingham 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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested a new rapid HIV test for infants in Zambia that gives results in under an hour, compared to standard lab tests that take weeks. Researchers wanted to see if faster diagnosis would lead to more babies starting treatment sooner. Over 1,600 HIV-exposed infants were enrolled, and the test was done at community clinics or homes. The goal was to improve survival and health outcomes for HIV-infected infants.

What this could mean

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

Active substance
Alere Q HIV-1/2 Detect Test (diagnostic test)
What this could lead to
If successful, this rapid test could help HIV-infected infants start treatment much sooner, reducing illness and death.
What could go wrong
The test may not be as accurate as standard lab tests, and results may vary in real-world settings. This study was completed, but broader use depends on further validation.

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.

Participants

1,682 people

The number who actually took part.

Started

May 2019

Finished

Sep 2020

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.

Who is studied

HIV-exposed infants and young children (up to 17 months of age)

Ages

1 minute to 17 months

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 include IYCs: 1. 0 days (at birth) - 17 months of age; 2. Probable or known HIV exposure documented through maternal sero-positivity or reactive infant HIV antibody test; 3. The IYC must be born to mothers who: 1. attended ≥1 ANC visits without HIV testing; or 2. delivered at home and did not return for post-natal care at a health facility, and thus the mother or their child were not tested for HIV; or 3. were documented as HIV-infected but never initiated ART; or 4. disengaged from HIV care after ART initiation/have not returned for ARV refills; or 5. have not returned to the facility with their infant for initial EID testing or follow-up EID testing (after a negative test at birth or 6 weeks); or 6. IYC not tested 6 weeks after cessation of breastfeeding. 4. With a parent/guardian ≥18 years of age, and willing and able to provide written informed consent in a study language (English, Nyanja, or Bemba). Exclusion criteria include IYCs: 1. With documented age-appropriate, guideline-adherent receipt of DBS-based EID HIV PCR testing; 2. Already known to be HIV-infected / receiving ART.

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Conditions

The condition(s) this trial relates to.

AIDS HIV infectious disease

As listed by the trial registrant

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

HIV HIV infections

Contacts and locations

Locations

  • George Primary Health Clinic

    Lusaka, Zambia

  • Kalingalinga Primary Health Clinic

    Lusaka, Zambia

  • Kamwala Primary Health Clinic

    Lusaka, Zambia

  • Makeni Primary Health Clinic

    Lusaka, Zambia

  • Matero Ref Primary Health Clinic

    Lusaka, Zambia

  • N'gombe Primary Health Clinic

    Lusaka, Zambia

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