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

NCT07457411 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 5000

Last updated 2026-03-09

No results posted yet for this study

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.

Conditions

  • Neurodevelpmental Delays
  • Neurodevelopment
  • Neurodevelopment Outcome

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.

Sponsors & Collaborators

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

    collaborator NIH

  • University of Washington

    lead OTHER

Principal Investigators

  • Anjuli D Wagner, PhD, MPH · University of Washington

Study Design

Allocation
NON_RANDOMIZED
Purpose
SCREENING
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
16 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2027-01-31
Primary Completion
2028-01-31
Completion
2028-03-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07457411 on ClinicalTrials.gov