NCT06703125

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 850 (estimated)
• Sponsor: Indiana University · Academic / Other
• Sex: All
• Age: 24 Months – 72 Months
• Healthy volunteers: Accepted

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).

Detailed 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.

Conditions

• Autism

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Eyelink Portable Duo	Eye-tracking data will be collected using a commercially-available remote eye-tracking system (Eyelink Portable Duo). Eye movements and pupil diameter will be collected while participants view a series of developmentally appropriate pictures and movies. The eye-tracker consists of two cameras; one that monitors eye movements and a second scene camera that monitors head movements, which permits eye tracking to take place without any equipment touching the child. Children will be asked to sit in highchair or on their the lap of the caregiver and will face a computer monitor. After a sticker is applied to the forehead of the child and brief eye-movement calibration completed, next visual stimuli (i.e., pictures and videos) will be presented on a laptop computer monitor that is placed at approximately 60-80cm from the child. The eye tracking portion of the visit will last approximately 15 minutes or until the child is no longer able to attend to pictures/videos.

Timeline

• Start date: 2025-02-11
• Primary completion: 2029-02-28
• Completion: 2029-02-28
• First posted: 2024-11-25
• Last updated: 2025-04-11

Locations

1 site across 1 country: Kenya

Regulatory

• FDA-regulated device study