Neurodevelpmental DelaysIMPLEMENTNCT07457411
Implementation Outcomes and Cost-effectiveness of Developmental Monitoring for Children Exposed to HIV
A study testing Neurodevelopmental screening in people with Neurodevelpmental Delays and Neurodevelopment, run by University of Washington.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 months and olderHealthy volunteers can take part
- Conditions the study is for
- Neurodevelpmental Delays, Neurodevelopment, Neurodevelopment Outcome
- What is being tested?
- Neurodevelopmental screening
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5,000 participants
- Where
- No sites listed yet
- Study dates
- Jan 2027to Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 months and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- None
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read the 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.
- Being tested
- Neurodevelopmental screening
- Keywords
- Implementation science, Neurodevelpment, Neurodevelopmental delays, Neurodevelopmental screening, Neurodevelopmental outcome, High HIV prevalence settings
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neurodevelopmental screeningOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Neurodevelomental risk score | Experimental | 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. Receives: Other: Neurodevelopmental screening |
| Neurodevelopmental screening method | Experimental | Neurodevelopmental screening may use the Global Scale for Early Development (GSED), Developmental Screen Questionnaire (DSQ), or another appropriate method identified by in-country experts. Receives: Other: Neurodevelopmental screening |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Over each of two 5-month pilot tests
Implementation outcomes for screening methods: Acceptability
Acceptability questionnaire
Measured: 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
Measured: Over each of two 5-month pilot tests
Implementation outcomes for screening methods: Feasibility
Feasibility questionnaire
Measured: Over each of two 5-month pilot tests
Implementation outcomes for screening methods: Fidelity
Questionnaires on fidelity of screening method
Measured: Over each of two 5-month pilot tests
Secondary outcomes (3)
Risk score
Results from neurodevelopmental risk score; range from 0-1 as a decimal; higher numbers indicate higher risk of poor neurodevelopmental outcome
Measured: 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
Measured: At each routine clinic appointment, over each of two 5-month pilot tests
Caregiver satisfaction
Questionnaire on caregiver satisfaction with experience of screening method
Measured: Day 1 (at routine clinic visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2026
- Study startJan 2027 (estimated)
- Primary completionJan 2028 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurodevelpmental DelaysStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Two sequential pilot tests will be conducted of two neurodevelopmental screening methods. There will not be a comparison arm.
- Masking
- None (open label)
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Anjuli Wagner, University of Washington
- Investigators
- Anjuli D Wagner, PhD, MPH, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07457411
- Sponsor's protocol ID
- STUDY00022215
- Other IDs
- U19HD118601-01
- Acronym
- IMPLEMENT
- Status last verified
- Mar 2026
- First submitted
- 23 Feb 2026
- Last updated
- 9 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation Outcomes and Cost-effectiveness of Developmental Monitoring for Children Exposed to HIV
- ClinicalTrials.gov ID
- NCT07457411
- Acronym / sponsor ID
- IMPLEMENT / STUDY00022215
- Keywords
- Implementation science, Neurodevelpment, Neurodevelopmental delays, Neurodevelopmental screening, Neurodevelopmental outcome, High HIV prevalence settings
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- Jan 2027 (estimated)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 9 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two sequential pilot tests will be conducted of two neurodevelopmental screening methods. There will not be a comparison arm.
| Arm | Type | Receives |
|---|---|---|
| Neurodevelomental risk score | Experimental | Other: Neurodevelopmental screeningNeurodevelopmental 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. |
| Neurodevelopmental screening method | Experimental | Other: Neurodevelopmental screeningNeurodevelopmental screening may use the Global Scale for Early Development (GSED), Developmental Screen Questionnaire (DSQ), or another appropriate method identified by in-country experts. |
Who may qualify
- Ages
- 16 months and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neurodevelopmental screeningThe 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. | Other | Neurodevelomental risk score, Neurodevelopmental screening method |
Primary outcome
Screening method coverage
Time frame: Over each of two 5-month pilot tests
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
Implementation outcomes for screening methods: Acceptability
Time frame: Over each of two 5-month pilot tests
Acceptability questionnaire
Cost of using screening method
Time frame: Over each of two 5-month pilot tests
Costing data from budgets, records, time-and-motion direct observation, time-and-motion clinic visit time cards
Implementation outcomes for screening methods: Feasibility
Time frame: Over each of two 5-month pilot tests
Feasibility questionnaire
Implementation outcomes for screening methods: Fidelity
Time frame: Over each of two 5-month pilot tests
Questionnaires on fidelity of screening method
3 secondary outcomes
Risk score
Time frame: At each routine clinic appointment, over each of two 5-month pilot tests
GSED screening tool
Time frame: At each routine clinic appointment, over each of two 5-month pilot tests
Caregiver satisfaction
Time frame: Day 1 (at routine clinic visit)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2026.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Anjuli D Wagner, PhD, MPH principal investigator
University of Washington
Questions about this trial
What is this clinical trial studying?
A study testing Neurodevelopmental screening in people with Neurodevelpmental Delays and Neurodevelopment, run by University of Washington.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Katy Sharrock, MS (8472350168, sharrock@uw.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Screening method coverage (time frame: Over each of two 5-month pilot tests). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2026.