Autism Spectrum DisorderNCT07821619
Pilot of an AI-Enabled Autism Caregiver Support Tool in Indiana and Kenya
A study testing AI-Enabled Autism Caregiver Support Tool in people with Autism Spectrum Disorder, run by Indiana University at 2 sites in 2 countries.
Trial summary
This prospective pilot study will evaluate an AI-enabled autism caregiver support tool for caregivers of children with autism in Indiana and Kenya. The tool is designed to provide evidence-based autism information, caregiver emotional support, and local service-navigation guidance, with safety guardrails and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- AI-Enabled Autism Caregiver Support Tool
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Jan 2028to Jan 2030
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult caregiver aged 18 years or older.
- Parent or primary caregiver of a child with autism spectrum disorder.
- Resides within the study catchment area in Indiana, United States or western Kenya.
- Able to provide informed consent.
- Has access to a mobile phone, tablet, or computer capable of accessing the AI-enabled caregiver support tool.
- Able to communicate in a study-supported language.
- Willing to use the AI-enabled caregiver support tool and complete study assessments.
Who cannot join
- Younger than 18 years of age.
- Unable or unwilling to provide informed consent.
- Unable to access the AI-enabled caregiver support tool using an internet-connected device.
- Unable to complete study procedures or assessments due to cognitive, communication, or other limitations that preclude participation.
- Currently participating in another study that, in the opinion of the investigators, would interfere with study participation or interpretation of study findings.
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
United States1 site
Indiana University
Indianapolis, Indiana, 46202
Kristen Cunningham, MPH, MS, 317-278-5675, kricunn@iu.edu
About this study
Official title: A Prospective Pilot Study of an AI-Enabled Autism Caregiver Support Tool to Assess Feasibility, Acceptability, Safety, Engagement, and Clinical-Trial Readiness in Indiana and Kenya
This prospective pilot study will evaluate an AI-enabled autism caregiver support tool for caregivers of children with autism in Indiana and Kenya. The tool is designed to provide evidence-based autism information, caregiver emotional support, and local service-navigation guidance, with safety guardrails and escalation pathways for high-risk concerns. Caregivers will receive access to the tool and complete baseline and follow-up assessments. The primary purpose of the study is to assess feasibility, acceptability, safety, engagement, and clinical-trial readiness. Exploratory caregiver outcomes include autism knowledge, caregiver self-efficacy, emotional distress and well-being, resource navigation, unmet needs, service engagement, satisfaction, and preparedness to take next steps after diagnosis. Findings will inform the design of a future fully powered effectiveness-implementation trial.
Read the detailed description
Families of children with autism often face significant challenges following diagnosis, including difficulty accessing reliable information, navigating complex systems of care, identifying appropriate services, and managing the emotional demands associated with caregiving. These challenges may be particularly pronounced in rural, underserved, and resource-constrained settings where access to specialty autism services and family navigation support is limited.
This study will evaluate an AI-enabled autism caregiver support tool designed to provide evidence-based autism information, caregiver emotional support, and service-navigation guidance for caregivers of children with autism in Indiana, United States, and western Kenya. The intervention was developed through a reciprocal innovation approach involving partners in both settings and was informed by caregiver, clinician, educator, and community stakeholder input. The tool is designed to provide plain-language information about autism, answer frequently asked caregiver questions, help caregivers identify relevant services and resources, and provide supportive coping guidance. Safety guardrails are incorporated to address crisis, medical, diagnostic, treatment-related, and other high-risk questions. The tool is not intended to diagnose autism, replace clinical care, or provide emergency services.
The study will use a prospective single-arm pre-post pilot design. Approximately 60 caregivers of children with autism will be recruited in Indiana and Kenya and provided access to the AI-enabled caregiver support tool. Participants will complete baseline and follow-up assessments and will have access to the intervention throughout the study period. Usage data, including engagement with the tool, use of resource-navigation features, and safety-related interactions, will also be collected.
The primary focus of the study is to evaluate feasibility, acceptability, safety, engagement, and clinical-trial readiness. Specific outcomes will include recruitment, retention, assessment completion, intervention uptake, participant engagement, safety events and escalations, usability, and implementation outcomes such as acceptability, feasibility, and appropriateness.
Additional exploratory outcomes will include autism knowledge, caregiver self-efficacy, access to reliable information, emotional well-being, service navigation, unmet caregiver needs, service engagement, preparedness to take next steps following diagnosis, satisfaction with the intervention, and trust in the AI-enabled caregiver support tool. These outcomes will be used to estimate outcome variability and inform selection of measures for a future fully powered effectiveness-implementation study.
By evaluating an AI-enabled caregiver support intervention in both Indiana and Kenya, this study will generate important information regarding implementation, safety, usability, engagement, and caregiver support needs across diverse cultural and resource settings. Findings will inform future efforts to develop scalable approaches for improving access to autism information, caregiver support, and service navigation for families of children with autism.
- Conditions
- Autism Spectrum Disorder
- Being tested
- AI-Enabled Autism Caregiver Support Tool
- Keywords
- Neurodevelopmental Condition, Autism Spectrum Disorder, Autism Caregiver, Caregiver Support, Artificial Intelligence, Digital Health, Family Navigation, Implementation Science, Autism Services, Caregiver Well-Being
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AI-Enabled Autism Caregiver Support ToolBehavioural
Participants will receive access to an AI-enabled autism caregiver support tool adapted for their local setting. The tool provides plain-language, evidence-based information about autism; answers caregiver questions; supports caregiver coping; helps families identify relevant services and resources; and includes safety guardrails for crisis, medical, diagnostic, behavioral, and treatment-related questions. The tool is not intended to diagnose autism, replace clinical care, or provide emergency services.
| Study group | Role | What they receive |
|---|---|---|
| AI-Enabled Autism Caregiver Support Tool | Experimental | Caregivers of children with autism will receive access to an AI-enabled caregiver support tool that provides evidence-based autism information, resource navigation support, and caregiver emotional support. Participants will use the tool during the study period and complete baseline and follow-up assessments to evaluate feasibility, acceptability, safety, engagement, and preliminary caregiver outcomes. Receives: Behavioral: AI-Enabled Autism Caregiver Support Tool |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment rate
Recruitment feasibility measured as the proportion of eligible participants who enroll in the study, calculated as the number of enrolled participants divided by the number of eligible participants approached for study participation.
Measured: Study enrollment period (up to 12 months)
Retention rate
Participant retention measured as the proportion of enrolled participants who complete the final study follow-up assessment.
Measured: Baseline to 6-month follow-up
Assessment completion rate
Assessment feasibility measured as the proportion of participants who complete all required baseline and follow-up study assessments, including caregiver-reported outcome measures and implementation assessments.
Measured: 6 months
Intervention Uptake
Intervention uptake measured as the proportion of enrolled participants who initiate at least one interaction with the AI-Enabled Autism Caregiver Support Tool following onboarding and activation.
Measured: 6 months
Intervention Engagement
Participant engagement with the AI-Enabled Autism Caregiver Support Tool measured using platform analytics, including number of sessions, active use days, questions submitted, conversations completed, and use of resource navigation and caregiver-support features.
Measured: 6 months
Safety Events and Escalations
Safety of the intervention measured by the number and proportion of high-risk prompts, safety escalations, adverse events, and interactions requiring referral to clinical, crisis, or emergency resources.
Measured: Baseline through 6 months
Acceptability of the Intervention
Acceptability of the AI-Enabled Autism Caregiver Support Tool measured using the Acceptability of Intervention Measure (AIM), with higher scores indicating greater perceived acceptability.
Measured: 6 months
Feasibility of the Intervention
Feasibility of the AI-Enabled Autism Caregiver Support Tool measured using the Feasibility of Intervention Measure (FIM), with higher scores indicating greater perceived feasibility.
Measured: 6 months
Appropriateness of the Intervention
Perceived appropriateness of the AI-Enabled Autism Caregiver Support Tool measured using the Intervention Appropriateness Measure (IAM), with higher scores indicating greater perceived fit, relevance, and suitability for caregiver support.
Measured: 6 months
Secondary outcomes (11)
System Usability Scale (SUS)
Usability of the AI-Enabled Autism Caregiver Support Tool measured using the System Usability Scale (SUS), a validated measure of perceived usability and ease of use.
Measured: 6 months
Participant Satisfaction With the Intervention
Participant satisfaction with the AI-Enabled Autism Caregiver Support Tool measured using study-specific satisfaction items assessing overall satisfaction, perceived usefulness, and likelihood of future use.
Measured: 6 months
Autism Knowledge
Change in caregiver autism knowledge measured using the Autism Spectrum Knowledge Questionnaire (ASKQ-2), with higher scores indicating greater autism-related knowledge.
Measured: Baseline and 6 months
Unmet Caregiver Needs
Change in caregiver-reported unmet information, emotional support, service-navigation, and autism-related care needs using study-specific caregiver needs assessment items.
Measured: Baseline and 6 months
Trust in the AI-Enabled Autism Caregiver Support Tool
Participant-reported trust in the information, guidance, and recommendations provided by the AI-Enabled Autism Caregiver Support Tool using study-specific trust measures.
Measured: 6 months
Preparedness to Take Next Steps Following Autism Diagnosis
Change in caregiver-reported preparedness to make decisions regarding autism-related services, supports, educational planning, and care coordination.
Measured: Baseline and 6 months
Service Engagement
Change in caregiver-reported engagement with autism-related clinical, educational, behavioral, and community-based services, measured using study-specific service utilization questionnaires documenting referral completion, service initiation, attendance, and ongoing participation in recommended services.
Measured: Baseline and 6 months
Resource Navigation
Change in caregiver ability to identify, access, and utilize autism-related services and supports, measured using service-navigation items adapted from the National Survey of Children's Health (NSCH), referral completion, service access, and follow-up engagement indicators.
Measured: Baseline and 6 months
Caregiver Well-Being
Change in caregiver well-being measured using the World Health Organization-Five Well-Being Index (WHO-5), with higher scores indicating greater psychological well-being.
Measured: Baseline and 6 months
Perceived Access to Reliable Information
Change in caregiver-reported access to trustworthy, understandable, and evidence-based autism-related information, measured using study-specific items assessing confidence in locating, understanding, and using autism-related information for decision-making and service navigation.
Measured: Baseline and 6 months
Caregiver Self-Efficacy
Change in caregiver self-efficacy and empowerment measured using the Family Empowerment Scale, including confidence in managing autism-related needs, navigating services, and advocating for their child.
Measured: Baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2026
- Study startJan 2028 (estimated)
- Primary completionJan 2029 (estimated)
- Study completionJan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a prospective, single-arm pre-post pilot study. Caregivers of children with autism in Indiana and Kenya will receive access to an AI-enabled caregiver support tool that provides evidence-based autism information, resource navigation, and supportive guidance. Participants will complete assessments at baseline and follow-up to evaluate feasibility, acceptability, usability, safety, engagement, and preliminary caregiver outcome measures.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- Moi University, Audere
- Responsible party
- Principal investigator, Megan Song McHenry, Indiana University
- Investigators
- Eren Oyungu, MBChB, MMED, Principal investigator, Moi UniversityMegan McHenry, MD, MS, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07821619
- Sponsor's protocol ID
- AI Autism Caregiver Support
- Status last verified
- Sep 2026
- First submitted
- 27 Aug 2026
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified quantitative data may be shared in accordance with participant consent, IRB approvals, data-use agreements, and applicable U.S. and Kenyan regulations. Raw conversational transcripts will not be publicly shared because they may contain sensitive caregiver, child, clinical, or location-specific information.
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Pilot Study of an AI-Enabled Autism Caregiver Support Tool to Assess Feasibility, Acceptability, Safety, Engagement, and Clinical-Trial Readiness in Indiana and Kenya
- ClinicalTrials.gov ID
- NCT07821619
- Acronym / sponsor ID
- AI Autism Caregiver Support
- Conditions
- Autism Spectrum Disorder
- Keywords
- Neurodevelopmental Condition, Autism Spectrum Disorder, Autism Caregiver, Caregiver Support, Artificial Intelligence, Digital Health, Family Navigation, Implementation Science
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- Moi University, Audere
- Study start
- Jan 2028 (estimated)
- Primary completion
- Jan 2029 (estimated)
- Study completion
- Jan 2030 (estimated)
- First posted
- 16 Sep 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.
This prospective pilot study will evaluate an AI-enabled autism caregiver support tool for caregivers of children with autism in Indiana and Kenya. The tool is designed to provide evidence-based autism information, caregiver emotional support, and local service-navigation guidance, with safety guardrails and escalation pathways for high-risk concerns. Caregivers will receive access to the tool and complete baseline and follow-up assessments. The primary purpose of the study is to assess feasibility, acceptability, safety, engagement, and clinical-trial readiness. Exploratory caregiver outcomes include autism knowledge, caregiver self-efficacy, emotional distress and well-being, resource navigation, unmet needs, service engagement, satisfaction, and preparedness to take next steps after diagnosis. Findings will inform the design of a future fully powered effectiveness-implementation trial.
Detailed description
Families of children with autism often face significant challenges following diagnosis, including difficulty accessing reliable information, navigating complex systems of care, identifying appropriate services, and managing the emotional demands associated with caregiving. These challenges may be particularly pronounced in rural, underserved, and resource-constrained settings where access to specialty autism services and family navigation support is limited.
This study will evaluate an AI-enabled autism caregiver support tool designed to provide evidence-based autism information, caregiver emotional support, and service-navigation guidance for caregivers of children with autism in Indiana, United States, and western Kenya. The intervention was developed through a reciprocal innovation approach involving partners in both settings and was informed by caregiver, clinician, educator, and community stakeholder input. The tool is designed to provide plain-language information about autism, answer frequently asked caregiver questions, help caregivers identify relevant services and resources, and provide supportive coping guidance. Safety guardrails are incorporated to address crisis, medical, diagnostic, treatment-related, and other high-risk questions. The tool is not intended to diagnose autism, replace clinical care, or provide emergency services.
The study will use a prospective single-arm pre-post pilot design. Approximately 60 caregivers of children with autism will be recruited in Indiana and Kenya and provided access to the AI-enabled caregiver support tool. Participants will complete baseline and follow-up assessments and will have access to the intervention throughout the study period. Usage data, including engagement with the tool, use of resource-navigation features, and safety-related interactions, will also be collected.
The primary focus of the study is to evaluate feasibility, acceptability, safety, engagement, and clinical-trial readiness. Specific outcomes will include recruitment, retention, assessment completion, intervention uptake, participant engagement, safety events and escalations, usability, and implementation outcomes such as acceptability, feasibility, and appropriateness.
Additional exploratory outcomes will include autism knowledge, caregiver self-efficacy, access to reliable information, emotional well-being, service navigation, unmet caregiver needs, service engagement, preparedness to take next steps following diagnosis, satisfaction with the intervention, and trust in the AI-enabled caregiver support tool. These outcomes will be used to estimate outcome variability and inform selection of measures for a future fully powered effectiveness-implementation study.
By evaluating an AI-enabled caregiver support intervention in both Indiana and Kenya, this study will generate important information regarding implementation, safety, usability, engagement, and caregiver support needs across diverse cultural and resource settings. Findings will inform future efforts to develop scalable approaches for improving access to autism information, caregiver support, and service navigation for families of children with autism.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a prospective, single-arm pre-post pilot study. Caregivers of children with autism in Indiana and Kenya will receive access to an AI-enabled caregiver support tool that provides evidence-based autism information, resource navigation, and supportive guidance. Participants will complete assessments at baseline and follow-up to evaluate feasibility, acceptability, usability, safety, engagement, and preliminary caregiver outcome measures.
| Arm | Type | Receives |
|---|---|---|
| AI-Enabled Autism Caregiver Support Tool | Experimental | Behavioral: AI-Enabled Autism Caregiver Support ToolCaregivers of children with autism will receive access to an AI-enabled caregiver support tool that provides evidence-based autism information, resource navigation support, and caregiver emotional support. Participants will use the tool during the study period and complete baseline and follow-up assessments to evaluate feasibility, acceptability, safety, engagement, and preliminary caregiver outcomes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Adult caregiver aged 18 years or older.
- Parent or primary caregiver of a child with autism spectrum disorder.
- Resides within the study catchment area in Indiana, United States or western Kenya.
- Able to provide informed consent.
- Has access to a mobile phone, tablet, or computer capable of accessing the AI-enabled caregiver support tool.
Key exclusion criteria (5 listed)
- Younger than 18 years of age.
- Unable or unwilling to provide informed consent.
- Unable to access the AI-enabled caregiver support tool using an internet-connected device.
- Unable to complete study procedures or assessments due to cognitive, communication, or other limitations that preclude participation.
- Currently participating in another study that, in the opinion of the investigators, would interfere with study participation or interpretation of study findings.
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 |
|---|---|---|
| AI-Enabled Autism Caregiver Support ToolParticipants will receive access to an AI-enabled autism caregiver support tool adapted for their local setting. The tool provides plain-language, evidence-based information about autism; answers caregiver questions; supports caregiver coping; helps families identify relevant services and resources; and includes safety guardrails for crisis, medical, diagnostic, behavioral, and treatment-related questions. The tool is not intended to diagnose autism, replace clinical care, or provide emergency services. | Behavioural | AI-Enabled Autism Caregiver Support Tool |
Primary outcome
Recruitment rate
Time frame: Study enrollment period (up to 12 months)
Recruitment feasibility measured as the proportion of eligible participants who enroll in the study, calculated as the number of enrolled participants divided by the number of eligible participants approached for study participation.
Retention rate
Time frame: Baseline to 6-month follow-up
Participant retention measured as the proportion of enrolled participants who complete the final study follow-up assessment.
Assessment completion rate
Time frame: 6 months
Assessment feasibility measured as the proportion of participants who complete all required baseline and follow-up study assessments, including caregiver-reported outcome measures and implementation assessments.
Intervention Uptake
Time frame: 6 months
Intervention uptake measured as the proportion of enrolled participants who initiate at least one interaction with the AI-Enabled Autism Caregiver Support Tool following onboarding and activation.
Intervention Engagement
Time frame: 6 months
Participant engagement with the AI-Enabled Autism Caregiver Support Tool measured using platform analytics, including number of sessions, active use days, questions submitted, conversations completed, and use of resource navigation and caregiver-support features.
Safety Events and Escalations
Time frame: Baseline through 6 months
Safety of the intervention measured by the number and proportion of high-risk prompts, safety escalations, adverse events, and interactions requiring referral to clinical, crisis, or emergency resources.
Acceptability of the Intervention
Time frame: 6 months
Acceptability of the AI-Enabled Autism Caregiver Support Tool measured using the Acceptability of Intervention Measure (AIM), with higher scores indicating greater perceived acceptability.
Feasibility of the Intervention
Time frame: 6 months
Feasibility of the AI-Enabled Autism Caregiver Support Tool measured using the Feasibility of Intervention Measure (FIM), with higher scores indicating greater perceived feasibility.
Appropriateness of the Intervention
Time frame: 6 months
Perceived appropriateness of the AI-Enabled Autism Caregiver Support Tool measured using the Intervention Appropriateness Measure (IAM), with higher scores indicating greater perceived fit, relevance, and suitability for caregiver support.
11 secondary outcomes
System Usability Scale (SUS)
Time frame: 6 months
Participant Satisfaction With the Intervention
Time frame: 6 months
Autism Knowledge
Time frame: Baseline and 6 months
Unmet Caregiver Needs
Time frame: Baseline and 6 months
Trust in the AI-Enabled Autism Caregiver Support Tool
Time frame: 6 months
Preparedness to Take Next Steps Following Autism Diagnosis
Time frame: Baseline and 6 months
Service Engagement
Time frame: Baseline and 6 months
Resource Navigation
Time frame: Baseline and 6 months
Caregiver Well-Being
Time frame: Baseline and 6 months
Perceived Access to Reliable Information
Time frame: Baseline and 6 months
Caregiver Self-Efficacy
Time frame: Baseline and 6 months
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 16 Sep 2026.
- Individual participant dataSharing planned: Yes. De-identified quantitative data may be shared in accordance with participant consent, IRB approvals, data-use agreements, and applicable U.S. and Kenyan regulations. Raw conversational transcripts will not be publicly shared because they may contain sensitive caregiver, child, clinical, or location-specific information.
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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.
Eren Oyungu, MBChB, MMED principal investigator
Moi University
Megan McHenry, MD, MS principal investigator
Indiana University
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AI-Enabled Autism Caregiver Support Tool in people with Autism Spectrum Disorder, run by Indiana University at 2 sites in 2 countries.
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 7 inclusion and 5 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 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Kenya. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Ananda Ombitsa (+254 718 748 223, rananda@ampath.or.ke), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment rate (time frame: Study enrollment period (up to 12 months)). The study lists 9 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 16 Sep 2026; AzTrials last refreshed its copy on 7 Nov 2026.