Short Message Service (SMS)MINT-II/HKWNCT06024317
Leveraging Community Health Workers and a Digital Health System to Improve the Timeliness of Child Well Visits
A study testing Huduma Kwa Wakati - Knowledge Intervention, Huduma Kwa Wakati - Reminders and Huduma Kwa Wakati - Incentives in people with Short Message Service (SMS) and Incentives, run by University of South Carolina at 1 site in Tanzania.
Trial summary
The goal of this cluster-randomized type 1 effectiveness implementation hybrid trial is to evaluate whether a community health worker led, integrated digital health intervention (Huduma Kwa Wakati; "Timely Services" in Kiswahili) can improve rates of timely well visits and receipt of key recommended preventive… Read more about this study
- Who is it for?
- Ages 15 years and older, women only
- Conditions the study is for
- Short Message Service (SMS), Incentives, Knowledge, Attitudes, Practice
- What is being tested?
- Huduma Kwa Wakati - Knowledge Intervention, Huduma Kwa Wakati - Reminders and Huduma Kwa Wakati - Incentives
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 800 participants
- Where
- 1 siteTanzania
- Study dates
- Aug 2026to 31 Aug 2027
- 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 15 years and older
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- mothers of children ages 12-23 months
- residing in the sampling area
- pregnant women in their last trimester of pregnancy
- residing in the sampling area
- expected to reside in the sampling area until the child reaches age 1 year
Who cannot join
- Women who are not living in catchment areas of participating health facilities (which routinely provide maternal and child health services). Facilities must be operational, must have at least 2 community health workers, and must have reported at least 100 pregnancies or births in the year prior to study implementation.)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Lavanya Vasudevan, PhD contact
Tanzania1 site
National Institute for Medical Research
Dar es Salaam
Esther Ngadaya, MD, PhD
About this study
Official title: Leveraging Community Health Workers and a Responsive Digital Health System to Improve Rates and Timeliness of Child Well Visits in the First Year of Life
The goal of this cluster-randomized type 1 effectiveness implementation hybrid trial is to evaluate whether a community health worker led, integrated digital health intervention (Huduma Kwa Wakati; "Timely Services" in Kiswahili) can improve rates of timely well visits and receipt of key recommended preventive interventions among children in their first year of life. The hypothesis is that Huduma Kwa Wakati will improve the timeliness and rates of completion of child well visits and receipt of recommended preventive services before age 1 year, compared to the standard of care. Researchers will compare outcomes among children enrolled from intervention clusters and no-intervention comparison clusters. Outcomes will also be compared to a cross-sectional retrospective comparison sample. This study will address the lack of rigorous evidence on the effectiveness of a community-based digital health intervention for promoting rates and timeliness of preventive service receipt among children from sub-Saharan Africa, and identify implementation strategies to facilitate the deployment of integrated community-based digital health interventions in low- and middle-income country settings.
Read the detailed description
Background and Objective:
In Tanzania, only 68% of children receive key recommended preventive health interventions within their first year of life. Prior research identified substantial rural-urban disparities in rates and timeliness of preventive service receipt in Tanzania, with children in rural settings being more like to receive delayed or no services. This type 1 effectiveness implementation hybrid study will evaluate the effect of Huduma Kwa Wakati ("Timely Services" in Kiswahili), a community-based, integrated digital health intervention, on the timeliness of child well visits and receipt of recommended preventive services in children's first year of life. The intervention combines a knowledge intervention, mobile phone-based reminders, and incentives with the goal to promote timely service receipt.
Methods:
The study will be conducted in the catchment areas of 40 rural health facilities in two predominantly rural regions in Tanzania. From each catchment area, three cohorts of mother-child dyads, one retrospective cohort and two prospective cohorts, will be enrolled into the study. The prospective cohort, comprising mothers from eighty communities ("clusters") within these catchment areas, will be randomized to an intervention or control arm. The timeliness (primary outcome) and coverage (secondary outcome) of child well visits will be observed for 1200 children (800 prospective children and 400 retrospective children). Details of the clinical trial refer to the prospective cohort of 800 mother-child dyads. Study logs, fidelity checklists, quantitative surveys, child health records, and qualitative interviews with mothers and key informants will be used to inform the five constructs of the Reach, Effectiveness, Adoption, Implementation and Maintenance (RE-AIM) framework. Results will be used to develop an implementation blueprint that can guide future adaptations, sustainability, and scale-up of Huduma Kwa Wakati.
Hypothesis:
The hypothesis is that Huduma Kwa Wakati is effective for increasing the timeliness of child well visits and rates of preventive services receipt before age 1 year compared to the standard of care.
Expected impact:
This study will address the lack of rigorous evidence on the effectiveness of a community-based digital health intervention for promoting rates and timeliness of recommended health service receipt among children from sub-Saharan Africa, and identify implementation strategies to facilitate the deployment of integrated interventions in low- and middle-income country settings.
- Conditions
- Short Message Service (SMS), Incentives, Knowledge, Attitudes, Practice, Preventive Services
- Being tested
- Huduma Kwa Wakati - Knowledge Intervention, Huduma Kwa Wakati - Reminders, Huduma Kwa Wakati - Incentives, Huduma Kwa Wakati - Service notifications
- Keywords
- Timeliness, Digital Health, Community Health Workers, Tanzania, Low and middle-income country, SMS reminder, Conditional incentive, Preventive services, Children
- Medical subject headings
- Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Huduma Kwa Wakati - Knowledge InterventionBehavioural
Counseling scripts assessing and addressing child health-related knowledge gaps
Huduma Kwa Wakati - RemindersBehavioural
Reminders of upcoming well visit due dates, sent to the mother's mobile phone
Huduma Kwa Wakati - IncentivesBehavioural
Conditional incentives for timely service receipt, tailored to each child's well visit schedule
Huduma Kwa Wakati - Service notificationsBehavioural
Service notifications (e.g., related to stockouts or service non-availability), sent to the mother's mobile phone
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm (Huduma Kwa Wakati) | Experimental | Within the catchment areas of 40 health facilities, 40 communities ("clusters"; 1 per catchment area) will be assigned to the intervention arm. 40 communities ("clusters"; 1 per catchment area) will be assigned to the control arm. 10 pregnant women in their last trimester of pregnancy will be enrolled from each cluster. Women enrolled from intervention clusters will receive all components of the Huduma Kwa Wakati intervention. Receives: Behavioral: Huduma Kwa Wakati - Knowledge Intervention; Behavioral: Huduma Kwa Wakati - Reminders; Behavioral: Huduma Kwa Wakati - Incentives; Behavioral: Huduma Kwa Wakati - Service notifications |
| Control (Standard of care) | No intervention | Within the catchment areas of 40 health facilities, 40 communities ("clusters"; 1 per catchment area) will be assigned to the intervention arm. 40 communities ("clusters"; 1 per catchment area) will be assigned to the control arm. 10 pregnant women in their last trimester of pregnancy will be enrolled from each cluster. Women enrolled from control arm will receive baseline and follow-up assessments only. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Delay in days (continuous) for the child well visit due at age 14 weeks
The average number of days between the due date of the 14 week well visit and the date on which the child actually attends this visit. Dates abstracted from the child's health book.
Measured: Assessed during the endline survey, an average follow-up period of 1 year
Secondary outcomes (1)
Delay > 28 days (binary) for the child well visit due at age 14 weeks
The percentage of participants with a delay >28 days between the visit due date (at age 14 weeks) and the date on which the visit was attended. Dates abstracted from the child's health book.
Measured: Assessed during the endline survey, an average follow-up period of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2023
- Study startAug 2026 (estimated)
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Short Message Service (SMS)Studies of the same condition, open and under way.
- More trials run by University of South CarolinaThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This type 1 effectiveness-implementation hybrid study uses a cluster-randomized trial design to evaluate intervention effectiveness.
- Masking
- None (open label)
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- Duke University, Emory University, University of North Carolina, National Institute for Medical Research, Tanzania
- Responsible party
- Principal investigator, Jan Ostermann, University of South Carolina
- Investigators
- Jan Ostermann, PhD, Principal investigator, University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06024317
- Sponsor's protocol ID
- Pro00120675
- Acronym
- MINT-II/HKW
- Status last verified
- Jul 2026
- First submitted
- 28 Aug 2023
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data from this study will be available from the National Institute for Medical Research, Muhimbili Research Centre, Tanzania, but restrictions apply that are governed by consent forms and data transfer agreements. Data may be made available by the authors upon reasonable request and with permission of the National Medical Research Review Committee at the National Institute for Medical Research (NIMR) in Tanzania.
Publications
Yelverton V, Hair NL, Ghosh SH, Mfinanga SG, Ngadaya E, Baumgartner JN, Ostermann J, Vasudevan L. Beyond coverage: Rural-urban disparities in the timeliness of childhood vaccinations in Tanzania. Vaccine. 2022 Sep 2;40(37):5483-5493. doi: 10.1016/j.vaccine.2022.07.020. Epub 2022 Aug 10.
PubMed 35961796Vasudevan L, Baumgartner JN, Moses S, Ngadaya E, Mfinanga SG, Ostermann J. Parental concerns and uptake of childhood vaccines in rural Tanzania - a mixed methods study. BMC Public Health. 2020 Oct 20;20(1):1573. doi: 10.1186/s12889-020-09598-1.
PubMed 33081744Ostermann J, Vasudevan L, Baumgartner JN, Ngadaya E, Mfinanga SG. Do mobile phone-based reminders and conditional financial transfers improve the timeliness of childhood vaccinations in Tanzania? Study protocol for a quasi-randomized controlled trial. Trials. 2019 Jul 4;20(1):397. doi: 10.1186/s13063-019-3430-4.
PubMed 31272487Ostermann J, Hair NL, Moses S, Ngadaya E, Godfrey Mfinanga S, Brown DS, Noel Baumgartner J, Vasudevan L. Is the intention to vaccinate enough? Systematic variation in the value of timely vaccinations and preferences for monetary vs non-monetary incentives among pregnant women in southern Tanzania. Vaccine X. 2023 Jan 23;13:100266. doi: 10.1016/j.jvacx.2023.100266. eCollection 2023 Apr.
PubMed 36814594Vasudevan L, Ostermann J, Moses SM, Ngadaya E, Mfinanga SG. Patterns of Mobile Phone Ownership and Use Among Pregnant Women in Southern Tanzania: Cross-Sectional Survey. JMIR Mhealth Uhealth. 2020 Apr 8;8(4):e17122. doi: 10.2196/17122.
PubMed 32267240Vasudevan L, Ostermann J, Thielman N, Baumgartner JN, Solomon D, Mosses A, Hobbie A, Hair NL, Liang C, van Zwetselaar M, Mfinanga S, Ngadaya E. Leveraging Community Health Workers and a Responsive Digital Health System to Improve Vaccination Coverage and Timeliness in Resource-Limited Settings: Protocol for a Cluster Randomized Type 1 Effectiveness-Implementation Hybrid Study. JMIR Res Protoc. 2024 Jan 12;13:e52523. doi: 10.2196/52523.
PubMed 38214956
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Leveraging Community Health Workers and a Responsive Digital Health System to Improve Rates and Timeliness of Child Well Visits in the First Year of Life
- ClinicalTrials.gov ID
- NCT06024317
- Acronym / sponsor ID
- MINT-II/HKW / Pro00120675
- Conditions
- Short Message Service (SMS), Incentives, Knowledge, Attitudes, Practice, Preventive Services
- Keywords
- Timeliness, Digital Health, Community Health Workers, Tanzania, Low and middle-income country, SMS reminder, Conditional incentive, Preventive services
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- University of South CarolinaUniversity, hospital or other
- Collaborators
- Duke University, Emory University, University of North Carolina, National Institute for Medical Research, Tanzania
- Study start
- Aug 2026 (estimated)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 6 Sep 2023 (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 cluster-randomized type 1 effectiveness implementation hybrid trial is to evaluate whether a community health worker led, integrated digital health intervention (Huduma Kwa Wakati; "Timely Services" in Kiswahili) can improve rates of timely well visits and receipt of key recommended preventive interventions among children in their first year of life. The hypothesis is that Huduma Kwa Wakati will improve the timeliness and rates of completion of child well visits and receipt of recommended preventive services before age 1 year, compared to the standard of care. Researchers will compare outcomes among children enrolled from intervention clusters and no-intervention comparison clusters. Outcomes will also be compared to a cross-sectional retrospective comparison sample. This study will address the lack of rigorous evidence on the effectiveness of a community-based digital health intervention for promoting rates and timeliness of preventive service receipt among children from sub-Saharan Africa, and identify implementation strategies to facilitate the deployment of integrated community-based digital health interventions in low- and middle-income country settings.
Detailed description
Background and Objective:
In Tanzania, only 68% of children receive key recommended preventive health interventions within their first year of life. Prior research identified substantial rural-urban disparities in rates and timeliness of preventive service receipt in Tanzania, with children in rural settings being more like to receive delayed or no services. This type 1 effectiveness implementation hybrid study will evaluate the effect of Huduma Kwa Wakati ("Timely Services" in Kiswahili), a community-based, integrated digital health intervention, on the timeliness of child well visits and receipt of recommended preventive services in children's first year of life. The intervention combines a knowledge intervention, mobile phone-based reminders, and incentives with the goal to promote timely service receipt.
Methods:
The study will be conducted in the catchment areas of 40 rural health facilities in two predominantly rural regions in Tanzania. From each catchment area, three cohorts of mother-child dyads, one retrospective cohort and two prospective cohorts, will be enrolled into the study. The prospective cohort, comprising mothers from eighty communities ("clusters") within these catchment areas, will be randomized to an intervention or control arm. The timeliness (primary outcome) and coverage (secondary outcome) of child well visits will be observed for 1200 children (800 prospective children and 400 retrospective children). Details of the clinical trial refer to the prospective cohort of 800 mother-child dyads. Study logs, fidelity checklists, quantitative surveys, child health records, and qualitative interviews with mothers and key informants will be used to inform the five constructs of the Reach, Effectiveness, Adoption, Implementation and Maintenance (RE-AIM) framework. Results will be used to develop an implementation blueprint that can guide future adaptations, sustainability, and scale-up of Huduma Kwa Wakati.
Hypothesis:
The hypothesis is that Huduma Kwa Wakati is effective for increasing the timeliness of child well visits and rates of preventive services receipt before age 1 year compared to the standard of care.
Expected impact:
This study will address the lack of rigorous evidence on the effectiveness of a community-based digital health intervention for promoting rates and timeliness of recommended health service receipt among children from sub-Saharan Africa, and identify implementation strategies to facilitate the deployment of integrated interventions in low- and middle-income country settings.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This type 1 effectiveness-implementation hybrid study uses a cluster-randomized trial design to evaluate intervention effectiveness.
| Arm | Type | Receives |
|---|---|---|
| Intervention arm (Huduma Kwa Wakati) | Experimental | Behavioral: Huduma Kwa Wakati - Knowledge Intervention, Behavioral: Huduma Kwa Wakati - Reminders, Behavioral: Huduma Kwa Wakati - Incentives, Behavioral: Huduma Kwa Wakati - Service notificationsWithin the catchment areas of 40 health facilities, 40 communities ("clusters"; 1 per catchment area) will be assigned to the intervention arm. 40 communities ("clusters"; 1 per catchment area) will be assigned to the control arm. 10 pregnant women in their last trimester of pregnancy will be enrolled from each cluster. Women enrolled from intervention clusters will receive all components of the Huduma Kwa Wakati intervention. |
| Control (Standard of care) | No intervention | –Within the catchment areas of 40 health facilities, 40 communities ("clusters"; 1 per catchment area) will be assigned to the intervention arm. 40 communities ("clusters"; 1 per catchment area) will be assigned to the control arm. 10 pregnant women in their last trimester of pregnancy will be enrolled from each cluster. Women enrolled from control arm will receive baseline and follow-up assessments only. |
Who may qualify
- Ages
- 15 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- mothers of children ages 12-23 months
- residing in the sampling area
- pregnant women in their last trimester of pregnancy
- residing in the sampling area
- expected to reside in the sampling area until the child reaches age 1 year
Key exclusion criteria (1 listed)
- Women who are not living in catchment areas of participating health facilities (which routinely provide maternal and child health services). Facilities must be operational, must have at least 2 community health workers, and must have reported at least 100 pregnancies or births in the year prior to study implementation.)
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 |
|---|---|---|
| Huduma Kwa Wakati - Knowledge InterventionCounseling scripts assessing and addressing child health-related knowledge gaps | Behavioural | Intervention arm (Huduma Kwa Wakati) |
| Huduma Kwa Wakati - RemindersReminders of upcoming well visit due dates, sent to the mother's mobile phone | Behavioural | Intervention arm (Huduma Kwa Wakati) |
| Huduma Kwa Wakati - IncentivesConditional incentives for timely service receipt, tailored to each child's well visit schedule | Behavioural | Intervention arm (Huduma Kwa Wakati) |
| Huduma Kwa Wakati - Service notificationsService notifications (e.g., related to stockouts or service non-availability), sent to the mother's mobile phone | Behavioural | Intervention arm (Huduma Kwa Wakati) |
Primary outcome
Delay in days (continuous) for the child well visit due at age 14 weeks
Time frame: Assessed during the endline survey, an average follow-up period of 1 year
The average number of days between the due date of the 14 week well visit and the date on which the child actually attends this visit. Dates abstracted from the child's health book.
1 secondary outcome
Delay > 28 days (binary) for the child well visit due at age 14 weeks
Time frame: Assessed during the endline survey, an average follow-up period of 1 year
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 6 Jul 2026.
- Background: PubMed 35961796Yelverton V, Hair NL, Ghosh SH, Mfinanga SG, Ngadaya E, Baumgartner JN, Ostermann J, Vasudevan L. Beyond coverage: Rural-urban disparities in the timeliness of childhood vaccinations in Tanzania. Vaccine. 2022 Sep 2;40(37):5483-5493. doi: 10.1016/j.vaccine.2022.07.020. Epub 2022 Aug 10.
- Background: PubMed 33081744Vasudevan L, Baumgartner JN, Moses S, Ngadaya E, Mfinanga SG, Ostermann J. Parental concerns and uptake of childhood vaccines in rural Tanzania - a mixed methods study. BMC Public Health. 2020 Oct 20;20(1):1573. doi: 10.1186/s12889-020-09598-1.
- Background: PubMed 31272487Ostermann J, Vasudevan L, Baumgartner JN, Ngadaya E, Mfinanga SG. Do mobile phone-based reminders and conditional financial transfers improve the timeliness of childhood vaccinations in Tanzania? Study protocol for a quasi-randomized controlled trial. Trials. 2019 Jul 4;20(1):397. doi: 10.1186/s13063-019-3430-4.
- Background: PubMed 36814594Ostermann J, Hair NL, Moses S, Ngadaya E, Godfrey Mfinanga S, Brown DS, Noel Baumgartner J, Vasudevan L. Is the intention to vaccinate enough? Systematic variation in the value of timely vaccinations and preferences for monetary vs non-monetary incentives among pregnant women in southern Tanzania. Vaccine X. 2023 Jan 23;13:100266. doi: 10.1016/j.jvacx.2023.100266. eCollection 2023 Apr.
- Background: PubMed 32267240Vasudevan L, Ostermann J, Moses SM, Ngadaya E, Mfinanga SG. Patterns of Mobile Phone Ownership and Use Among Pregnant Women in Southern Tanzania: Cross-Sectional Survey. JMIR Mhealth Uhealth. 2020 Apr 8;8(4):e17122. doi: 10.2196/17122.
- Derived from this study: PubMed 38214956Vasudevan L, Ostermann J, Thielman N, Baumgartner JN, Solomon D, Mosses A, Hobbie A, Hair NL, Liang C, van Zwetselaar M, Mfinanga S, Ngadaya E. Leveraging Community Health Workers and a Responsive Digital Health System to Improve Vaccination Coverage and Timeliness in Resource-Limited Settings: Protocol for a Cluster Randomized Type 1 Effectiveness-Implementation Hybrid Study. JMIR Res Protoc. 2024 Jan 12;13:e52523. doi: 10.2196/52523.
- Individual participant dataSharing planned: No. The data from this study will be available from the National Institute for Medical Research, Muhimbili Research Centre, Tanzania, but restrictions apply that are governed by consent forms and data transfer agreements. Data may be made available by the authors upon reasonable request and with permission of the National Medical Research Review Committee at the National Institute for Medical Research (NIMR) in Tanzania.
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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.
Lavanya Vasudevan, PhD contact
Jan Ostermann, PhD principal investigator
University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Huduma Kwa Wakati - Knowledge Intervention, Huduma Kwa Wakati - Reminders and Huduma Kwa Wakati - Incentives in people with Short Message Service (SMS) and Incentives, run by University of South Carolina at 1 site in Tanzania.
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 5 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 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Tanzania. 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 Jan Ostermann, PhD (18037778747, jano@mailbox.sc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Delay in days (continuous) for the child well visit due at age 14 weeks (time frame: Assessed during the endline survey, an average follow-up period of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06024317, which also lists 6 linked publications.
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 6 Jul 2026.