Immunization
Conditions
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.
Interventions
Text of phone-call based reminders to mobile phones
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
Sponsors
Study design
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).
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Countries
Tanzania
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| No Intervention No reminders or incentives | 140 |
| Reminders Only Reminders are sent 1 week and 1 day before each scheduled vaccination date
Reminders: Text containing child name and vaccination due date sent via SMS to designated mobile phones | 67 |
| 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
Reminders: Text containing child name and vaccination due date sent via SMS to designated 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 | 106 |
| Total | 313 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Death | 1 | 0 | 0 |
| Overall Study | Loss of baseline data on tablets | 6 | 0 | 0 |
| Overall Study | Lost to Follow-up | 79 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 2 | 0 | 0 |
Baseline characteristics
| Characteristic | No Intervention | Reminders Only | Reminders + Conditional Financial Transfer | Total |
|---|---|---|---|---|
| Age | 26.7 years STANDARD_DEVIATION 7.56 | 29.7 years STANDARD_DEVIATION 6.57 | 30.3 years STANDARD_DEVIATION 6.67 | 28.58 years STANDARD_DEVIATION 7.24 |
| Age, Categorical <=18 years | 15 Participants | 2 Participants | 1 Participants | 18 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 125 Participants | 65 Participants | 105 Participants | 295 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 140 Participants | 67 Participants | 106 Participants | 313 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment Tanzania | 140 participants | 67 participants | 106 participants | 313 participants |
| Sex: Female, Male Female | 140 Participants | 67 Participants | 106 Participants | 313 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 12 / 239 | 0 / 67 | 0 / 106 |
| other Total, other adverse events | 0 / 239 | 0 / 67 | 0 / 106 |
| serious Total, serious adverse events | 0 / 239 | 0 / 67 | 0 / 106 |
Outcome results
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.
Time frame: Up to 6 months after birth
Population: Participants in follow-up survey without missing data on vaccinations and per-protocol study arm
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| No Intervention | Number of Timely Vaccinations Received | Received 0 vaccinations within 28 days of target age | 10 Participants |
| No Intervention | Number of Timely Vaccinations Received | Received 1 vaccination within 28 days of target age | 9 Participants |
| No Intervention | Number of Timely Vaccinations Received | Received 3 vaccinations within 28 days of target age | 27 Participants |
| No Intervention | Number of Timely Vaccinations Received | Received 2 vaccinations within 28 days of target age | 12 Participants |
| No Intervention | Number of Timely Vaccinations Received | Received 4 vaccinations within 28 days of target age | 81 Participants |
| Reminders Only | Number of Timely Vaccinations Received | Received 1 vaccination within 28 days of target age | 6 Participants |
| Reminders Only | Number of Timely Vaccinations Received | Received 4 vaccinations within 28 days of target age | 38 Participants |
| Reminders Only | Number of Timely Vaccinations Received | Received 2 vaccinations within 28 days of target age | 6 Participants |
| Reminders Only | Number of Timely Vaccinations Received | Received 3 vaccinations within 28 days of target age | 12 Participants |
| Reminders Only | Number of Timely Vaccinations Received | Received 0 vaccinations within 28 days of target age | 5 Participants |
| Reminders + Conditional Financial Transfer | Number of Timely Vaccinations Received | Received 3 vaccinations within 28 days of target age | 19 Participants |
| Reminders + Conditional Financial Transfer | Number of Timely Vaccinations Received | Received 1 vaccination within 28 days of target age | 12 Participants |
| Reminders + Conditional Financial Transfer | Number of Timely Vaccinations Received | Received 4 vaccinations within 28 days of target age | 50 Participants |
| Reminders + Conditional Financial Transfer | Number of Timely Vaccinations Received | Received 0 vaccinations within 28 days of target age | 5 Participants |
| Reminders + Conditional Financial Transfer | Number of Timely Vaccinations Received | Received 2 vaccinations within 28 days of target age | 18 Participants |
Number of Vaccinations Received
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).
Time frame: Up to 6 months after birth
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| No Intervention | Number of Vaccinations Received | Received 3 vaccinations | 11 Participants |
| No Intervention | Number of Vaccinations Received | Received 2 vaccinations | 1 Participants |
| No Intervention | Number of Vaccinations Received | Received 1 vaccination | 0 Participants |
| No Intervention | Number of Vaccinations Received | Received 4 vaccinations | 127 Participants |
| No Intervention | Number of Vaccinations Received | Received 0 vaccinations | 0 Participants |
| Reminders Only | Number of Vaccinations Received | Received 2 vaccinations | 0 Participants |
| Reminders Only | Number of Vaccinations Received | Received 0 vaccinations | 0 Participants |
| Reminders Only | Number of Vaccinations Received | Received 1 vaccination | 0 Participants |
| Reminders Only | Number of Vaccinations Received | Received 3 vaccinations | 11 Participants |
| Reminders Only | Number of Vaccinations Received | Received 4 vaccinations | 56 Participants |
| Reminders + Conditional Financial Transfer | Number of Vaccinations Received | Received 4 vaccinations | 99 Participants |
| Reminders + Conditional Financial Transfer | Number of Vaccinations Received | Received 3 vaccinations | 5 Participants |
| Reminders + Conditional Financial Transfer | Number of Vaccinations Received | Received 0 vaccinations | 0 Participants |
| Reminders + Conditional Financial Transfer | Number of Vaccinations Received | Received 2 vaccinations | 0 Participants |
| Reminders + Conditional Financial Transfer | Number of Vaccinations Received | Received 1 vaccination | 0 Participants |