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

Last updated: April 10, 2025
Sponsor: Indiana University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Autism

Autism Spectrum Disorder (Asd)

Treatment

Eyelink Portable Duo

Clinical Study ID

NCT06703125
23171
1R01HD116441-01
  • Ages 24-72
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

The study will use a non-invasive remote eye-tracking system (Eyelink Portable Duo) to acquire a short series of eye-tracking measures to determine whether these can predict autism diagnoses in both children exposed to HIV and uninfected (CHEU) and children not exposed to HIV and uninfected (CHUU).

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  • There will be no specific exclusion criteria. We anticipate that a small number ofCHEU and CHUU will develop HIV prior to enrollment in the current study; thesechildren will be included and will follow all general study procedures.

Study Design

Total Participants: 850
Treatment Group(s): 1
Primary Treatment: Eyelink Portable Duo
Phase:
Study Start date:
February 11, 2025
Estimated Completion Date:
February 28, 2029

Study Description

The study will use a non-invasive remote eye-tracking system (Eyelink Portable Duo) to acquire a short series (less than 15 mins) of eye-tracking measures (e.g., looking time, pupil diameter, oculomotor dynamics), which may be associated with autism outcomes. Investigators will recruit children enrolled in the Tabiri study during or following their 24-month visit.

The Tabiri study is comparing neurodevelopmental (ND) outcomes between 24-month-old CHEU and CHUU.

Connect with a study center

  • Moi Teaching and Referral Hospital

    Eldoret,
    Kenya

    Active - Recruiting

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