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

Indiana University

Status: Enrolling

Conditions: Autism

Treatments: Diagnostic Test: Eyelink Portable Duo

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06703125

23171

1R01HD116441-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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).

Full 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.

Enrollment: 850 estimated patients

Sex: All

Ages: 24 to 72 months old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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850 participants in 1 patient group

Children Undergoing Developmental Evaluation for Autism

Experimental group

Description:

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.

Treatment:

Diagnostic Test: Eyelink Portable Duo