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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Neurodevelopment; Neurodevelopment Outcome; Neurodevelpmental Delays
• Intervention / Treatment: Other: Neurodevelopmental screening

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.

• Study Type: Interventional
• Enrollment (Estimated): 5000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Katy Sharrock, MS; Phone Number: 8472350168; Email: sharrock@uw.edu
• Study Contact Backup: Name: Anjuli D Wagner, PhD, MPH; Phone Number: 978-460-2331; Email: anjuliw@uw.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Healthcare workers (HCW): age 18 years or older
• HCW: working at one of the clinics engaged in the study caring for children at routine clinic appointments
• Children: age 16-24 months
• Children: attending routine clinic appointment at one of the clinics engaged in the study
• Caregivers: age 18 years or older
• Caregivers: caregiver of child eligible for participation

Exclusion Criteria:

• None

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Neurodevelomental risk score; Neurodevelopmental screening will likely use a new validated risk score. In the event that the risk score is not deemed accurate or acceptable, neurodevelopmental screening will use the the Global Scale for Early Development (GSED), Developmental Screen Questionnaire (DSQ), or another appropriate method identified by in-country experts.	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.
Experimental: Neurodevelopmental screening method; Neurodevelopmental screening may use the Global Scale for Early Development (GSED), Developmental Screen Questionnaire (DSQ), or another appropriate method identified by in-country experts.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Screening method coverage	Number of eligible children who receive the screening method at their routine clinic appointment compared to number of total eligible children who have a routine clinic appointment	Over each of two 5-month pilot tests
Implementation outcomes for screening methods: Acceptability	Acceptability questionnaire	Over each of two 5-month pilot tests
Cost of using screening method	Costing data from budgets, records, time-and-motion direct observation, time-and-motion clinic visit time cards	Over each of two 5-month pilot tests
Implementation outcomes for screening methods: Feasibility	Feasibility questionnaire	Over each of two 5-month pilot tests
Implementation outcomes for screening methods: Fidelity	Questionnaires on fidelity of screening method	Over each of two 5-month pilot tests

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Risk score	Results from neurodevelopmental risk score; range from 0-1 as a decimal; higher numbers indicate higher risk of poor neurodevelopmental outcome	At each routine clinic appointment, over each of two 5-month pilot tests
GSED screening tool	Results from the Global Scales for Early Development; represented as a Developmental score (D-score), which is a z-score standardized to the child's age. Positive numbers indicate better than typical development for a child's age; negative numbers indicate poorer than typical development for a child's age	At each routine clinic appointment, over each of two 5-month pilot tests
Caregiver satisfaction	Questionnaire on caregiver satisfaction with experience of screening method	Day 1 (at routine clinic visit)

Collaborators and Investigators

• Sponsor: University of Washington
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Investigators: Principal Investigator: Anjuli D Wagner, PhD, MPH, University of Washington

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2027
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): March 1, 2028

Study Registration Dates

• First Submitted: February 23, 2026
• First Submitted That Met QC Criteria: March 2, 2026
• First Posted (Actual): March 9, 2026

Study Record Updates

• Last Update Posted (Actual): March 9, 2026
• Last Update Submitted That Met QC Criteria: March 2, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Implementation science; Neurodevelopmental outcome; Neurodevelopmental delays; Neurodevelpment; Neurodevelopmental screening; High HIV prevalence settings
• Other Study ID Numbers: STUDY00022215; U19HD118601-01 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No