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mHealth-Assisted Conditional Cash Transfers to Improve Timeliness of Vaccinations (D0271)

mHealth-Assisted Conditional Cash Transfers to Improve Timeliness of Childhood Vaccinations

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03252288
Acronym
MINT
Enrollment
412
Registered
2017-08-17
Start date
2017-08-15
Completion date
2018-12-31
Last updated
2025-03-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Immunization

Brief 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. 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.

Interventions

BEHAVIORALReminders

Text of phone-call based reminders to mobile phones

BEHAVIORALConditional financial transfers

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

Sponsors

Fogarty International Center of the National Institute of Health
CollaboratorNIH
University of South Carolina
CollaboratorOTHER
National Institute for Medical Research, Tanzania
CollaboratorOTHER_GOV
Duke University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Intervention 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).

Eligibility

Sex/Gender
FEMALE
Age
16 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Pregnant, last trimester * Access to mobile phone

Exclusion criteria

* Cognitive impairment * Unwillingness to receive study-related information and reminders via mobile phone

Design outcomes

Primary

MeasureTime frameDescription
Number of Timely Vaccinations ReceivedUp to 6 months after birthNumber 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.

Secondary

MeasureTime frameDescription
Number of Vaccinations ReceivedUp to 6 months after birthNumber 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).

Countries

Tanzania

Participant flow

Participants by arm

ArmCount
No Intervention
No reminders or incentives
140
Reminders Only
Reminders are sent 1 week and 1 day before each scheduled vaccination date Reminders: Text containing child name and vaccination due date sent via SMS to designated mobile phones
67
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 Reminders: Text containing child name and vaccination due date sent via SMS to designated mobile phones Conditional financial transfers: 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
106
Total313

Withdrawals & dropouts

PeriodReasonFG000FG001FG002
Overall StudyDeath100
Overall StudyLoss of baseline data on tablets600
Overall StudyLost to Follow-up7900
Overall StudyWithdrawal by Subject200

Baseline characteristics

CharacteristicNo InterventionReminders OnlyReminders + Conditional Financial TransferTotal
Age26.7 years
STANDARD_DEVIATION 7.56
29.7 years
STANDARD_DEVIATION 6.57
30.3 years
STANDARD_DEVIATION 6.67
28.58 years
STANDARD_DEVIATION 7.24
Age, Categorical
<=18 years
15 Participants2 Participants1 Participants18 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
125 Participants65 Participants105 Participants295 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
140 Participants67 Participants106 Participants313 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
0 Participants0 Participants0 Participants0 Participants
Region of Enrollment
Tanzania
140 participants67 participants106 participants313 participants
Sex: Female, Male
Female
140 Participants67 Participants106 Participants313 Participants
Sex: Female, Male
Male
0 Participants0 Participants0 Participants0 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
12 / 2390 / 670 / 106
other
Total, other adverse events
0 / 2390 / 670 / 106
serious
Total, serious adverse events
0 / 2390 / 670 / 106

Outcome results

Primary

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.

Time frame: Up to 6 months after birth

Population: Participants in follow-up survey without missing data on vaccinations and per-protocol study arm

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
No InterventionNumber of Timely Vaccinations ReceivedReceived 0 vaccinations within 28 days of target age10 Participants
No InterventionNumber of Timely Vaccinations ReceivedReceived 1 vaccination within 28 days of target age9 Participants
No InterventionNumber of Timely Vaccinations ReceivedReceived 3 vaccinations within 28 days of target age27 Participants
No InterventionNumber of Timely Vaccinations ReceivedReceived 2 vaccinations within 28 days of target age12 Participants
No InterventionNumber of Timely Vaccinations ReceivedReceived 4 vaccinations within 28 days of target age81 Participants
Reminders OnlyNumber of Timely Vaccinations ReceivedReceived 1 vaccination within 28 days of target age6 Participants
Reminders OnlyNumber of Timely Vaccinations ReceivedReceived 4 vaccinations within 28 days of target age38 Participants
Reminders OnlyNumber of Timely Vaccinations ReceivedReceived 2 vaccinations within 28 days of target age6 Participants
Reminders OnlyNumber of Timely Vaccinations ReceivedReceived 3 vaccinations within 28 days of target age12 Participants
Reminders OnlyNumber of Timely Vaccinations ReceivedReceived 0 vaccinations within 28 days of target age5 Participants
Reminders + Conditional Financial TransferNumber of Timely Vaccinations ReceivedReceived 3 vaccinations within 28 days of target age19 Participants
Reminders + Conditional Financial TransferNumber of Timely Vaccinations ReceivedReceived 1 vaccination within 28 days of target age12 Participants
Reminders + Conditional Financial TransferNumber of Timely Vaccinations ReceivedReceived 4 vaccinations within 28 days of target age50 Participants
Reminders + Conditional Financial TransferNumber of Timely Vaccinations ReceivedReceived 0 vaccinations within 28 days of target age5 Participants
Reminders + Conditional Financial TransferNumber of Timely Vaccinations ReceivedReceived 2 vaccinations within 28 days of target age18 Participants
Secondary

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).

Time frame: Up to 6 months after birth

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
No InterventionNumber of Vaccinations ReceivedReceived 3 vaccinations11 Participants
No InterventionNumber of Vaccinations ReceivedReceived 2 vaccinations1 Participants
No InterventionNumber of Vaccinations ReceivedReceived 1 vaccination0 Participants
No InterventionNumber of Vaccinations ReceivedReceived 4 vaccinations127 Participants
No InterventionNumber of Vaccinations ReceivedReceived 0 vaccinations0 Participants
Reminders OnlyNumber of Vaccinations ReceivedReceived 2 vaccinations0 Participants
Reminders OnlyNumber of Vaccinations ReceivedReceived 0 vaccinations0 Participants
Reminders OnlyNumber of Vaccinations ReceivedReceived 1 vaccination0 Participants
Reminders OnlyNumber of Vaccinations ReceivedReceived 3 vaccinations11 Participants
Reminders OnlyNumber of Vaccinations ReceivedReceived 4 vaccinations56 Participants
Reminders + Conditional Financial TransferNumber of Vaccinations ReceivedReceived 4 vaccinations99 Participants
Reminders + Conditional Financial TransferNumber of Vaccinations ReceivedReceived 3 vaccinations5 Participants
Reminders + Conditional Financial TransferNumber of Vaccinations ReceivedReceived 0 vaccinations0 Participants
Reminders + Conditional Financial TransferNumber of Vaccinations ReceivedReceived 2 vaccinations0 Participants
Reminders + Conditional Financial TransferNumber of Vaccinations ReceivedReceived 1 vaccination0 Participants

Source: ClinicalTrials.gov · Data processed: Feb 21, 2026