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

NCT ID: NCT06703125

Last Updated: 2025-04-11

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 850 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-11
• Study Completion Date: 2029-02-28

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.

Conditions

Autism

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Children Undergoing Developmental Evaluation for Autism

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.

Group Type: EXPERIMENTAL

Eyelink Portable Duo

Intervention Type: 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.

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility 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.

• Minimum Eligible Age: 24 Months
• Maximum Eligible Age: 72 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role: collaborator

Indiana University

OTHER

Sponsor Role: lead

Responsible Party

Rebecca McNally Keehn

Assistant Professor of Pediatrics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rebecca McNally Keehn

Role: PRINCIPAL_INVESTIGATOR

IU School of Medicine

Locations

Moi Teaching and Referral Hospital

Eldoret, Kenya, Kenya

Site Status: RECRUITING

Countries

Kenya

Central Contacts

Rebecca McNally Keehn, PhD, HSPP

Role: CONTACT

mcnallyr@iu.edu

317-274-2121

Brandon Keehn, PhD

Role: CONTACT

bkeehn@purdue.edu

765-496-0204

Facility Contacts

Eren Oyungu, MD

Role: primary

erenoyungu2002@yahoo.co.uk

254 722 344312

Other Identifiers

1R01HD116441-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

23171

Identifier Type: -

Identifier Source: org_study_id