Assessing autism outcomes in children born to mothers with HIV in Kenya
The Alama Project: Autism Outcomes and Neurobehavioral Markers in Young Children Born to Mothers With HIV in Kenya
This study is testing if eye movement patterns in young children exposed to HIV can help identify signs of autism.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 850 (estimated) |
| Ages | 24 Months to 72 Months |
| Sex | All |
| Sponsor | Indiana University Academic / other |
| Locations | 1 site (Eldoret, Kenya) |
| Trial ID | NCT06703125 on ClinicalTrials.gov |
What this trial studies
This study utilizes a non-invasive eye-tracking system to evaluate eye movement patterns in children aged 24-72 months who are either exposed to HIV or not. By measuring metrics such as looking time and pupil diameter, the researchers aim to identify potential neurobehavioral markers that could predict autism diagnoses. Participants will be recruited from the ongoing Tabiri study, which focuses on neurodevelopmental outcomes in similar populations. The study seeks to enhance understanding of autism in the context of maternal HIV exposure.
Who should consider this trial
Good fit: Ideal candidates include children aged 24-72 months who are either children exposed to HIV or unexposed, and whose caregivers speak Kiswahili or English.
Not a fit: Patients who are outside the age range of 24-72 months or do not meet the exposure criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to earlier and more accurate autism diagnoses in children affected by maternal HIV.
How similar studies have performed: While the use of eye-tracking for autism assessment is gaining traction, this specific approach in the context of maternal HIV exposure is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Eldoret, Kenya
- Moi Teaching and Referral Hospital — Eldoret, Kenya, Kenya (Recruiting)
Study contacts
- Principal investigator: Rebecca McNally Keehn — IU School of Medicine
- Study coordinator: Rebecca McNally Keehn, PhD, HSPP
- Email: mcnallyr@iu.edu
- Phone: 317-274-2121
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.