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

NCT06703125 | Recruiting FDA Device

• 2 other identifiers: 231711R01HD116441-01
• Study Type: interventional
• Target: 850
• Locations: 1 country
• Sites: 1

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).

Conditions

Autism

Keywords

Autism; HIV; Eye tracker

Outcome Measures

Primary Outcomes (1)

• Agreement between eye-tracking biomarker score and autism diagnosis

  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.

  Day 1

Study Arms (1)

Children Undergoing Developmental Evaluation for Autism

EXPERIMENTAL

Young children (ages 24-72 month) who are HIV exposed but uninfected (CHEU) and young children who are HIV unexposed but uninfected (CHUU) undergoing a standard of care developmental evaluation will be enrolled into the study. After the completion of the developmental evaluation, research participation includes a one-time eye-tracking activity in which the child will view a series of different pictures and movies while their eye movements and pupil diameter are tracked and recorded.

Diagnostic Test: Eyelink Portable Duo

Interventions

Eyelink Portable Duo DIAGNOSTIC_TEST

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.

Children Undergoing Developmental Evaluation for Autism

Eligibility Criteria

• Age: 24 Months - 72 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

Sponsors & Collaborators

• Indiana University: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Moi Teaching and Referral Hospital

Eldoret, Kenya, Kenya

RECRUITING

MeSH Terms

Conditions

Autistic Disorder

Condition Hierarchy (Ancestors)

Autism Spectrum Disorder; Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Rebecca McNally Keehn

  IU School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rebecca McNally Keehn, PhD, HSPP

CONTACT

317-274-2121; mcnallyr@iu.edu

Brandon Keehn, PhD

CONTACT

765-496-0204; bkeehn@purdue.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Pediatrics

Study Record Dates

• First Submitted: November 21, 2024
• First Posted: November 25, 2024
• Study Start: February 11, 2025
• Primary Completion (Estimated): February 28, 2029
• Study Completion (Estimated): February 28, 2029
• Last Updated: April 11, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

KE (1)