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Clinical trial Recruiting at 1 site Interventional Ages 24 Months to 72 Months

Assessing autism outcomes in children born to mothers with HIV in Kenya

Official title: The Alama Project: Autism Outcomes and Neurobehavioral Markers in Young Children Born to Mothers With HIV in Kenya

Run by Indiana University · NCT06703125 · Data updated 2026-11-12

This study is testing if eye movement patterns in young children exposed to HIV can help identify signs of autism.

More Autism trials

Quick facts

Study typeInterventional
Ages24 Months to 72 Months
SexAll
Enrollment850 (estimated)
SponsorIndiana University
Academic / other
Locations1 site (Eldoret)
StatusRecruiting
StartedFebruary 11, 2025
Main results expectedFebruary 28, 2029
Study endsFebruary 28, 2029
Registry record updatedMay 26, 2026
Trial IDNCT06703125 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates include children aged 24-72 months who are either children exposed to HIV or unexposed, and whose caregivers speak Kiswahili or English.

Probably not a fit

Patients who are outside the age range of 24-72 months or do not meet the exposure criteria may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study utilizes a non-invasive eye-tracking system to evaluate eye movement patterns in children aged 24-72 months who are either exposed to HIV or not. By measuring metrics such as looking time and pupil diameter, the researchers aim to identify potential neurobehavioral markers that could predict autism diagnoses. Participants will be recruited from the ongoing Tabiri study, which focuses on neurodevelopmental outcomes in similar populations. The study seeks to enhance understanding of autism in the context of maternal HIV exposure.

Why it matters

Potential benefit: If successful, this study could lead to earlier and more accurate autism diagnoses in children affected by maternal HIV.

How similar studies have gone: While the use of eye-tracking for autism assessment is gaining traction, this specific approach in the context of maternal HIV exposure is relatively novel.

Who can join: the full rules

Show full inclusion / exclusion criteria 
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.

Where it's running

  • Moi Teaching and Referral Hospital
    Eldoret, Kenya     Recruiting

Study contacts

  • Principal investigator: Rebecca McNally Keehn — IU School of Medicine
  • Study coordinator: Rebecca McNally Keehn, PhD, HSPP
  • Email: mcnallyr@iu.edu
  • Phone: 317-274-2121

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.