Clinical trial NCT03252288: mHealth-Assisted Conditional Cash Transfers to Improve Timeliness of Vaccinations (D0271)
Official title: mHealth-Assisted Conditional Cash Transfers to Improve Timeliness of Childhood Vaccinations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Immunization
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Fogarty International Center of the National Institute of Health
name: University of South Carolina
name: National Institute for Medical Research, Tanzania
First posted: 2017-08-17
Enrollment: 412
Sex: FEMALE
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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).
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Number of Timely Vaccinations Received
timeFrame: Up to 6 months after birth
Secondary outcomes:
measure: Number of Vaccinations Received
timeFrame: Up to 6 months after birth
Other outcomes:
Locations:
city: Dar es Salaam
country: Tanzania
facility: National Institute for Medical Research
Study officials:
affiliation: University of South Carolina
name: Jan Ostermann, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.