Implementation Outcomes and Cost-effectiveness of Developmental Monitoring for Children Exposed to HIV
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age16+
SponsorUniversity of Washington
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
None
Trial design
Design model
Sequential
Treatments tested in this trial
Neurodevelopmental screening
Other interventionThe 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.
Treatment groups
5,000 Participants
are divided into 2 treatment groupsGroup A: Neurodevelomental risk scoreExperimental treatment 1 intervention
Group B: Neurodevelopmental screening methodExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
Over each of two 5-month pilot tests2
Implementation outcomes for screening methods: Acceptability
Acceptability questionnaire
Time frame
Over each of two 5-month pilot tests3
Cost of using screening method
Costing data from budgets, records, time-and-motion direct observation, time-and-motion clinic visit time cards
Time frame
Over each of two 5-month pilot tests4
Implementation outcomes for screening methods: Feasibility
Feasibility questionnaire
Time frame
Over each of two 5-month pilot testsSecondary outcomes
1
Risk score
Results from neurodevelopmental risk score; range from 0-1 as a decimal; higher numbers indicate higher risk of poor neurodevelopmental outcome
Time frame
At each routine clinic appointment, over each of two 5-month pilot tests2
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
Time frame
At each routine clinic appointment, over each of two 5-month pilot tests3
Caregiver satisfaction
Questionnaire on caregiver satisfaction with experience of screening method
Time frame
Day 1 (at routine clinic visit)Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Washington
Lead sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: