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NOT YET RECRUITING
NCT07457411
NA

Implementation Outcomes and Cost-effectiveness of Developmental Monitoring for Children Exposed to HIV

Sponsor: University of Washington

View on ClinicalTrials.gov

Summary

The goal of this study is to learn about how to best carry out neurodevelopmental screening methods (tests to see if a young child can use support with brain development) in routine clinic visits in Botswana and Kenya among children age 16-24 months old. The main questions it aims to answer are: 1. when used in routine clinic visits by healthcare workers, how many children are able to get screened; 2. are the screening tools appropriate and how can they best be used; 3. how much time and money does it take to use the screening methods? The investigators will compare two screening methods chosen by healthcare workers at the beginning of the study. Children will undergo a brief test of their brain development to see if they need further evaluation and support. Caregivers will be asked to complete a short survey to see what they thought of the screening test. Healthcare workers will complete brief surveys and interviews to see what they thought of carrying out the screening tests and how use of the screening tests can be improved in their clinics.

Key Details

Gender

All

Age Range

16 Months - Any

Study Type

INTERVENTIONAL

Enrollment

5000

Start Date

2027-01

Completion Date

2028-03

Last Updated

2026-03-09

Healthy Volunteers

Yes

Interventions

OTHER

Neurodevelopmental screening

The two neurodevelopmental screening methods tested may include the Global Scale for Early Development (GSED), a new validated risk score, Developmental Screen Questionnaire (DSQ), or another appropriate method identified by in-country experts.