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

NCT ID: NCT03252288

Last Updated: 2025-03-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 412 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-08-15
• Study Completion Date: 2018-12-31

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.

Conditions

Immunization

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

No intervention

No intervention

Group Type: NO_INTERVENTION

No interventions assigned to this group

Reminders only

Reminders are sent 1 week and 1 day before each scheduled vaccination date

Group Type: EXPERIMENTAL

Reminders

Intervention Type: BEHAVIORAL

Text of phone-call based reminders to mobile phones

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

Group Type: EXPERIMENTAL

Reminders

Intervention Type: BEHAVIORAL

Text of phone-call based reminders to mobile phones

Conditional financial transfers

Intervention Type: BEHAVIORAL

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

Interventions

Reminders

Text of phone-call based reminders to mobile phones

Intervention Type: 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

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Pregnant, last trimester
• Access to mobile phone

Exclusion Criteria

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

• Minimum Eligible Age: 16 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Fogarty International Center of the National Institute of Health

NIH

Sponsor Role: collaborator

University of South Carolina

OTHER

Sponsor Role: collaborator

National Institute for Medical Research, Tanzania

OTHER_GOV

Sponsor Role: collaborator

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jan Ostermann, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of South Carolina

Locations

National Institute for Medical Research

Dar es Salaam, , Tanzania

Countries

Tanzania

References

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.

Reference Type: DERIVED

PMID: 36814594 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 31272487 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

1R21TW010262

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2017-0591

Identifier Type: -

Identifier Source: org_study_id