ImmunizationMINTNCT03252288
mHealth-Assisted Conditional Cash Transfers to Improve Timeliness of Vaccinations (D0271)
A study testing Reminders and Conditional financial transfers in people with Immunization, run by Duke University at 1 site in Tanzania.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 16 years and older, women only
- Conditions the study is for
- Immunization
- What is being tested?
- Reminders and Conditional financial transfers
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 412 participants
- Where
- 1 siteTanzania
- Study dates
- 15 Aug 2017to 31 Dec 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Pregnant, last trimester
- Access to mobile phone
Who cannot join
- Cognitive impairment
- Unwillingness to receive study-related information and reminders via mobile phone
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Immunization
- Being tested
- Reminders, Conditional financial transfers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RemindersBehavioural
Text of phone-call based reminders to mobile phones
Conditional financial transfersBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| No intervention | No intervention | No intervention |
| Reminders only | Experimental | Reminders are sent 1 week and 1 day before each scheduled vaccination date Receives: Behavioral: Reminders |
| Reminders + Conditional financial transfer | Experimental | 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 Receives: Behavioral: Reminders; Behavioral: Conditional financial transfers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Timely Vaccinations Received
Number of vaccinations received within 4 weeks of scheduled vaccination dates. Note: Vaccinations are due at birth and at ages 6, 10, and 14 weeks. Delays in 6 and/or 10 week vaccinations result in corresponding shifts in subsequent vaccination due dates. Timeliness is calculated independently for each vaccination in relation to its scheduled due date: The vaccination is considered timely if it is received within 4 weeks of the scheduled due date, not timely otherwise. Observations beyond 6 months after birth are censored.
Measured: Up to 6 months after birth
Secondary outcomes (1)
Number of Vaccinations Received
Number of vaccinations received (range 0-4, for the vaccination due at birth, 6, 10, and 14 weeks) Note: Vaccinations are due at birth and at ages 6, 10, and 14 weeks. Delays in 6 and/or 10 week vaccinations result in corresponding shifts in subsequent vaccination due dates. Thus, some vaccinations may be due after the end of the observation period, which ends 6 months after birth).
Measured: Up to 6 months after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2017
- Study start15 Aug 2017
- Primary completion13 Oct 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ImmunizationStudies of the same condition, open and under way.
- More trials run by Duke 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A random event (scheduled vaccination date for a child based on date of birth) will determine whether a women does not receive an intervention (before a certain calendar date) or receives an intervention (after a certain calendar date).
- Masking
- None (open label)
- Enrolment
- 412 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Fogarty International Center of the National Institute of Health, University of South Carolina, National Institute for Medical Research, Tanzania
- Responsible party
- Sponsor
- Investigators
- Jan Ostermann, MD, PhD, Principal investigator, University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03252288
- Sponsor's protocol ID
- 2017-0591
- Other IDs
- 1R21TW010262
- Acronym
- MINT
- Status last verified
- Mar 2025
- First submitted
- 14 Aug 2017
- Last updated
- 7 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
Ostermann 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 36814594Ostermann 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 31272487
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- mHealth-Assisted Conditional Cash Transfers to Improve Timeliness of Childhood Vaccinations
- ClinicalTrials.gov ID
- NCT03252288
- Acronym / sponsor ID
- MINT / 2017-0591
- Conditions
- Immunization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 412 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Fogarty International Center of the National Institute of Health, University of South Carolina, National Institute for Medical Research, Tanzania
- Study start
- 15 Aug 2017 (actual)
- Primary completion
- 13 Oct 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 17 Aug 2017 (actual)
- Results
- Posted 7 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- A random event (scheduled vaccination date for a child based on date of birth) will determine whether a women does not receive an intervention (before a certain calendar date) or receives an intervention (after a certain calendar date).
| Arm | Type | Receives |
|---|---|---|
| No intervention | No intervention | –No intervention |
| Reminders only | Experimental | Behavioral: RemindersReminders are sent 1 week and 1 day before each scheduled vaccination date |
| Reminders + Conditional financial transfer | Experimental | Behavioral: Reminders, Behavioral: Conditional financial transfersReminders are sent 1 week and 1 day before each scheduled vaccination date; and conditional financial transfers are made for each on-time vaccination visit |
Who may qualify
- Ages
- 16 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Pregnant, last trimester
- Access to mobile phone
Key exclusion criteria (2 listed)
- Cognitive impairment
- Unwillingness to receive study-related information and reminders via mobile phone
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 |
|---|---|---|
| RemindersText of phone-call based reminders to mobile phones | Behavioural | Reminders + Conditional financial transfer, Reminders only |
| Conditional financial transfersFull 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 | Behavioural | Reminders + Conditional financial transfer |
Primary outcome
Number of Timely Vaccinations Received
Time frame: Up to 6 months after birth
Number of vaccinations received within 4 weeks of scheduled vaccination dates. Note: Vaccinations are due at birth and at ages 6, 10, and 14 weeks. Delays in 6 and/or 10 week vaccinations result in corresponding shifts in subsequent vaccination due dates. Timeliness is calculated independently for each vaccination in relation to its scheduled due date: The vaccination is considered timely if it is received within 4 weeks of the scheduled due date, not timely otherwise. Observations beyond 6 months after birth are censored.
1 secondary outcome
Number of Vaccinations Received
Time frame: Up to 6 months after birth
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: 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.
- Derived from this study: 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.
- Individual participant dataSharing planned: No. 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.
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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. This study is not recruiting at the moment.
Jan Ostermann, MD, 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 Reminders and Conditional financial transfers in people with Immunization, run by Duke University 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 2 inclusion and 2 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: finished, as of the sponsor's last update on 7 Mar 2025. 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?
Yes. Results are posted in the registry (first posted 7 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Timely Vaccinations Received (time frame: Up to 6 months after birth). 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 NCT03252288, which also lists 2 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 7 Mar 2025.