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

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: Immunization
• Intervention / Treatment: Behavioral: Reminders; Behavioral: Conditional financial transfers

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

Study Locations

• Tanzania
  • Dar es Salaam, Tanzania
    • National Institute for Medical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

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

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

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	Behavioral: Reminders; 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	Behavioral: Reminders; Text of phone-call based reminders to mobile phones; Behavioral: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to 6 months after birth

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Up to 6 months after birth

Collaborators and Investigators

• Sponsor: Duke University
• Collaborators: University of South Carolina; Fogarty International Center of the National Institute of Health; National Institute for Medical Research, Tanzania
• Investigators: Principal Investigator: Jan Ostermann, MD, PhD, University of South Carolina

Publications and helpful links

General Publications

• Ostermann 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.

Study record dates

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): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 4, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 2017-0591 (Other Identifier: M D Anderson Cancer Center); 1R21TW010262 (U.S. NIH Grant/Contract)

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