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

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.

• Reminders (Behavioral): Text of phone-call based reminders to mobile phones
• 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

Primary outcomes

• Number of Timely Vaccinations Received [Up to 6 months after birth]: 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.

Secondary outcomes

• Number of Vaccinations Received [Up to 6 months after birth]: 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).

Sex: Female, ages: 16 Years to any

Inclusion Criteria:

* Pregnant, last trimester
* Access to mobile phone

Exclusion Criteria:

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

Participant flow

Outcome results

• Number of Timely Vaccinations Received (Primary), Count of participants, Participants: No Intervention 10; Reminders Only 5; Reminders + Conditional Financial Transfer 5
• Number of Vaccinations Received (Secondary), Count of participants, Participants: No Intervention 0; Reminders Only 0; Reminders + Conditional Financial Transfer 0

Adverse events

Time frame: Through study completion, an average of 1 year.

• Results publication: 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
• Results publication: 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

• Study Protocol (PDF, 2017-08-11)
• Statistical Analysis Plan (PDF, 2017-08-11)
• Informed Consent Form (PDF, 2017-08-11)

• Jan Ostermann, MD, PhD, Principal investigator, University of South Carolina

NIH grants: R21TW010262