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

Not Applicable

Recruiting

• Conditions: Autism

• Registration Number: NCT06703125
• Lead Sponsor: Indiana University

Brief 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.

Study Timeline

• Study First Submitted: 2024-11-21
• Study First Submitted QC: 2024-11-21
• Study First Posted: 2024-11-25
• Study Start: 2025-02-11
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-10
• Last Update Posted: 2025-04-11
• Primary Completion: 2029-02-28
• Study Completion: 2029-02-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 850

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Agreement between eye-tracking biomarker score and autism diagnosis	Day 1	The composite eye-tracking biomarker score, a consolidated measure based on eye-tracking indices that predict autism outcome, will be compared to the categorical autism diagnosis (autism presence/absence). Clinical diagnosis is obtained based upon a standard clinical evaluation. The evaluation will include 1) a semi-structured caregiver(s) clinical interview to gather information about developmental history and autism symptoms and 2) a battery of standardized child clinical observational measures. The evaluation will be conducted over a one-time 2- to 3-hour clinical autism evaluation. Eye-tracking will be recorded immediately following the clinical evaluation.

Trial Locations

Locations (1)

Moi Teaching and Referral Hospital; 🇰🇪 Eldoret, Kenya