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Recruiting NCT06703125

NCT06703125 The Alama Project: Autism Outcomes and Neurobehavioral Markers in Young Children Born to Mothers With HIV in Kenya

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Clinical Trial Summary
NCT ID NCT06703125
Status Recruiting
Phase
Sponsor Indiana University
Condition Autism
Study Type INTERVENTIONAL
Enrollment 850 participants
Start Date 2025-02-11
Primary Completion 2029-02-28

Eligibility & Interventions

Sex All sexes
Min Age 24 Months
Max Age 72 Months
Study Type INTERVENTIONAL
Interventions
Eyelink Portable Duo

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

This trial targets 850 participants in total. It began in 2025-02-11 with a primary completion date of 2029-02-28.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

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).

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. 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.

Contact & Investigator

Central Contact

Rebecca McNally Keehn, PhD, HSPP

✉ mcnallyr@iu.edu

📞 317-274-2121

Principal Investigator

Rebecca McNally Keehn

PRINCIPAL INVESTIGATOR

IU School of Medicine

Frequently Asked Questions

Who can join the NCT06703125 clinical trial?

This trial is open to participants of all sexes, aged 24 Months or older, up to 72 Months, studying Autism. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT06703125 currently recruiting?

Yes, NCT06703125 is actively recruiting participants. Contact the research team at mcnallyr@iu.edu for enrollment information.

Where is the NCT06703125 trial being conducted?

This trial is being conducted at Eldoret, Kenya.

Who is sponsoring the NCT06703125 clinical trial?

NCT06703125 is sponsored by Indiana University. The principal investigator is Rebecca McNally Keehn at IU School of Medicine. The trial plans to enroll 850 participants.

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