- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03252288
mHealth-Assisted Conditional Cash Transfers to Improve Timeliness of Vaccinations (MINT)
June 12, 2020 updated by: Duke University
mHealth-Assisted Conditional Cash Transfers to Improve Timeliness of Childhood Vaccinations
Vaccination is a cost-effective strategy for conferring immunity against a host of preventable diseases, however, rates of timely childhood vaccinations remain inadequate in resource-limited settings.
We propose to evaluate the feasibility and efficacy of mHealth-assisted conditional cash transfers as a means of overcoming individual barriers to timely vaccinations.
The study will form the basis for a pragmatic randomized controlled trial of the efficacy and cost-effectiveness of mHealth reminders and conditional cash transfers for improving rates of timely vaccinations among young children.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Vaccination is one of the most cost-effective strategies for conferring immunity against a host of preventable diseases.
The World Health Organization estimates that over 2.5 million child deaths are prevented annually worldwide due to vaccination efforts.
Infants must receive all recommended vaccinations in a timely manner to be fully protected from deadly infectious diseases such as tuberculosis, diphtheria, pertussis and polio.
A large body of evidence has shown that children living in socio-economically disadvantaged backgrounds are more likely to be vaccinated late, or not at all, compared to their counterparts from wealthier and more educated families.
While Tanzania has successfully achieved high national vaccination coverage, there remain substantial regional variations.
In this proposal we seek to evaluate the feasibility of combining two emerging types of interventions - mHealth and conditional cash transfers - to overcome individual barriers to timely vaccinations.
Researchers at Duke University and Tanzania's National Institute of Medical Research (NIMR) will collaborate to evaluate whether mobile phone (mHealth)-based vaccination reminders, combined with a financial incentive scheme for families with young children, may result in improved vaccination coverage and timeliness.
The specific aims of the proposal are to (1) conduct formative research to identify locally relevant client-side and provider-side barriers to timely vaccinations; (2) develop an mHealth system to facilitate and monitor timely vaccinations and conduct surveys with late-stage pregnant women to derive willingness-to-accept estimates and a feasible incentive structure; and (3) assess the efficacy of a combination intervention consisting of mHealth reminders and conditional cash transfers for improving the rates and timeliness of vaccinations among infants in their first 6 months of life.
Qualitative follow-up surveys with providers and a subset of clients will assess barriers to the acceptability and scalability of an mHealth supported conditional cash-transfer intervention for timely vaccination.
The study will be implemented with support from Tanzania's Ministry of Health and Social Welfare Immunization and Vaccine Development Programme.
The results of the proposed study will form the basis for a pragmatic randomized controlled trial of the efficacy and incremental cost-effectiveness of mHealth reminders and conditional cash transfers as means of improving timely vaccinations of young children.
Study Type
Interventional
Enrollment (Actual)
412
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Dar es Salaam, Tanzania
- National Institute for Medical Research
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (ADULT, OLDER_ADULT, CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Pregnant, last trimester
- Access to mobile phone
Exclusion Criteria:
- Cognitive impairment
- Unwillingness to receive study-related information and reminders via mobile phone
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: HEALTH_SERVICES_RESEARCH
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
NO_INTERVENTION: No intervention
|
|
EXPERIMENTAL: Reminders only
Reminders are sent 1 week and 1 day before each scheduled vaccination date
|
Text of phone-call based reminders to mobile phones
|
EXPERIMENTAL: Reminders + Conditional financial transfer
Reminders are sent 1 week and 1 day before each scheduled vaccination date; and conditional financial transfers are made for each on-time vaccination visit
|
Text of phone-call based reminders to mobile phones
Full amount paid if visit occurs within 1 week of the scheduled visit; partial amount is paid if visit occurs >1 week but within 4 weeks of the scheduled visit
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Timely vaccination visits
Time Frame: Up to 6 months after birth
|
Number of vaccination visits within 4 weeks of scheduled visit dates
|
Up to 6 months after birth
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of vaccinations received
Time Frame: Up to 6 months after birth
|
Number of vaccinations received
|
Up to 6 months after birth
|
Number of timely vaccinations received
Time Frame: Up to 6 months after birth
|
Number of vaccinations received within 4 weeks of scheduled vaccination dates
|
Up to 6 months after birth
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
August 15, 2017
Primary Completion (ACTUAL)
October 13, 2018
Study Completion (ACTUAL)
December 31, 2018
Study Registration Dates
First Submitted
August 14, 2017
First Submitted That Met QC Criteria
August 14, 2017
First Posted (ACTUAL)
August 17, 2017
Study Record Updates
Last Update Posted (ACTUAL)
June 16, 2020
Last Update Submitted That Met QC Criteria
June 12, 2020
Last Verified
June 1, 2020
More Information
Terms related to this study
Other Study ID Numbers
- D0271
- 1R21TW010262 (NIH)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Data from the proposed study will be stored in a data repository; this data will be de-identified so that they cannot be linked back to individuals.
Investigators wishing to use study data to answer new research questions may submit data analysis concept proposals for consideration by the Principal Investigators.
The Principal Investigators will review the proposal and will provide those submitting scientifically rigorous and promising proposals access to the data repository to address their research questions.
This will ensure that the data resources of the proposed study will provide the greatest possible benefit to the scientific community.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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