mHealth-Assisted Conditional Cash Transfers to Improve Timeliness of Vaccinations

Immunization Clinical Trial

— MINT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03252288
• Other study ID #: D0271
• Secondary ID: 1R21TW010262
• Status: Completed
• Phase: N/A
• Start date: August 15, 2017
• Est. completion date: December 31, 2018

Study information

• Verified date: June 2020
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 412
• Est. completion date: December 31, 2018
• Est. primary completion date: October 13, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 16 Years and older

Eligibility

Inclusion Criteria:

• Pregnant, last trimester

• Access to mobile phone

Exclusion Criteria:

• Cognitive impairment

• Unwillingness to receive study-related information and reminders via mobile phone

Related Conditions & MeSH terms

• Immunization

Intervention

Behavioral:
• Reminders
Text of phone-call based reminders to 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

Locations

Country	Name	City	State
Tanzania	National Institute for Medical Research	Dar es Salaam

Sponsors (4)

Lead Sponsor	Collaborator
Duke University	John E. Fogarty International Center (FIC), National Institute for Medical Research, Tanzania, University of South Carolina

Country where clinical trial is conducted

Tanzania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Timely vaccination visits	Number of vaccination visits within 4 weeks of scheduled visit dates	Up to 6 months after birth
Secondary	Number of vaccinations received	Number of vaccinations received	Up to 6 months after birth
Secondary	Number of timely vaccinations received	Number of vaccinations received within 4 weeks of scheduled vaccination dates	Up to 6 months after birth