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

NCT03252288 | Completed Results

• 2 other identifiers: 2017-05911R21TW010262
• Study Type: interventional
• Target: 412
• Locations: 1 country
• Sites: 1

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.

Conditions

Immunization

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Number of Vaccinations Received

  Up to 6 months after birth

Study Arms (3)

No intervention

NO INTERVENTION

No intervention

Reminders only

EXPERIMENTAL

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

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

Behavioral: Reminders; Behavioral: Conditional financial transfers

Interventions

Reminders BEHAVIORAL

Text of phone-call based reminders to mobile phones

Reminders + Conditional financial transfer; Reminders only

Conditional financial transfers 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

Reminders + Conditional financial transfer

Eligibility Criteria

• Age: 16 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Pregnant, last trimester
• Access to mobile phone

You may not qualify if:

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

Sponsors & Collaborators

• Duke University: lead
• Fogarty International Center of the National Institute of Health: collaborator
• University of South Carolina: collaborator
• National Institute for Medical Research, Tanzania: collaborator

Study Sites (1)

National Institute for Medical Research

Dar es Salaam, Tanzania

Location

Related Publications (2)

• 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.

  PMID: 36814594 DERIVED

• 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.

  PMID: 31272487 DERIVED

Results Point of Contact

• Title: Jan Ostermann
• Organization: University of South Carolina

jano@mailbox.sc.edu

+1803-777-8747

Study Officials

• Jan Ostermann, MD, PhD

  University of South Carolina

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: August 14, 2017
• First Posted: August 17, 2017
• Study Start: August 15, 2017
• Primary Completion: October 13, 2018
• Study Completion: December 31, 2018
• Last Updated: March 7, 2025
• Results First Posted: March 7, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

TA (1)