NCT07457411

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 5,000 (estimated)
• Sponsor: University of Washington · Academic / Other
• Sex: All
• Age: 16 Months
• Healthy volunteers: Accepted

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.

Detailed description

The two neurodevelopmental screening methods identified by healthcare workers at the beginning of the study 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. These screening tools will be administered to children age 16-24 months who come to the clinic for routine wellness check ups and will last about 5-20 minutes depending on the tool. The pilot tests of these screening method will take part at 5 clinics in Botswana and 5 clinics in Kenya, for 5 months per tool. The research study will collect information on whether the screening test was done, how long it took, the outcome of the screening test for each child, and the child's gender and age. No identifying information will be collected about the child. At the end of the clinic visit, caregivers will be provided with an information sheet about the study and whether and how to get any follow up evaluation or support for their child. Healthcare workers will be trained on how to administer the tool and provide follow up support to children and caregivers. Caregivers will also be asked to complete a brief survey about whether they found the screening method to be acceptable and if they were satisfied with clinic services. Healthcare workers will be trained on how to administer the screening tool to children. They will ask the caregiver to carry a time card throughout the visit so the study can measure how much time the screening tool took to administer in a real world setting. Healthcare workers will administer the tool, including recording information from the child's medical records to understand neurodevelopmental risk. Every two months, healthcare workers will be asked to complete a brief survey to indicate if the tool is usable, acceptable, and feasible. At the end of the five month pilot test of a tool, healthcare workers and health records officers will be asked to take part in an individual interview to better understand how their experience was using the tool, barriers to using the tool, and how the tool can be better implemented in their clinic. They will get a small amount of money as compensation for time and effort of participating in surveys and interviews. This study will provide critical, concrete guidance to policymakers to inform early, context-specific policies for implementing neurodevelopmental screening, diagnostics, and therapeutics within programmatic settings with high HIV prevalence.

Conditions

• Neurodevelpmental Delays
• Neurodevelopment
• Neurodevelopment Outcome

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2027-01-01
• Primary completion: 2028-01-01
• Completion: 2028-03-01
• First posted: 2026-03-09
• Last updated: 2026-03-09