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Eye-Tracking test could spot autism in toddlers

NCT ID NCT06703125

Diagnosis Sponsor: Indiana University Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study is testing whether a simple, non-invasive eye-tracking test can help diagnose autism in young children (ages 24-72 months) born to mothers with HIV in Kenya. Researchers will compare eye-tracking results with standard clinical autism evaluations in 850 children. If the eye-tracking test proves accurate, it could offer a faster, more accessible way to identify autism early.

What this could mean

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

What this could lead to
If successful, this could provide a simple, non-invasive tool to help diagnose autism earlier in children, especially in resource-limited settings.
What could go wrong
This is an observational study, not a treatment trial. The eye-tracking test may not accurately predict autism in all children, and results may not apply to other populations.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 850 people

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

Started

Feb 2025

Expected to finish

Feb 2029

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

24 to 72 months

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: * Children enrolled in the Tabiri study (R01HD104552) * CHEU or CHUU * Children ages 24-72 months * Caregivers of children must speak Kiswahili (local language) or English. Exclusion Criteria: * There will be no specific exclusion criteria. We anticipate that a small number of CHEU and CHUU will develop HIV prior to enrollment in the current study; these children will be included and will follow all general study procedures.

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Conditions

The condition(s) this trial relates to.

autism

As listed by the trial registrant

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

Autism

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Moi Teaching and Referral Hospital

    RECRUITING

    Eldoret, Kenya

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