Trial Outcomes & Findings for mHealth-Assisted Conditional Cash Transfers to Improve Timeliness of Vaccinations (D0271) (NCT NCT03252288)
NCT ID: NCT03252288
Last Updated: 2025-03-07
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
412 participants
Primary outcome timeframe
Up to 6 months after birth
Results posted on
2025-03-07
Participant Flow
Participant milestones
| Measure |
No Intervention
No reminders or incentives
|
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
|
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
|
|---|---|---|---|
|
Overall Study
STARTED
|
239
|
67
|
106
|
|
Overall Study
COMPLETED
|
140
|
67
|
106
|
|
Overall Study
NOT COMPLETED
|
99
|
0
|
0
|
Reasons for withdrawal
| Measure |
No Intervention
No reminders or incentives
|
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
|
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
|
|---|---|---|---|
|
Overall Study
Death
|
11
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
79
|
0
|
0
|
|
Overall Study
Loss of baseline data on tablets
|
6
|
0
|
0
|
Baseline Characteristics
mHealth-Assisted Conditional Cash Transfers to Improve Timeliness of Vaccinations (D0271)
Baseline characteristics by cohort
| Measure |
No Intervention
n=140 Participants
No reminders or incentives
|
Reminders Only
n=67 Participants
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
|
Reminders + Conditional Financial Transfer
n=106 Participants
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
|
Total
n=313 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
15 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
125 Participants
n=5 Participants
|
65 Participants
n=7 Participants
|
105 Participants
n=5 Participants
|
295 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
140 Participants
n=5 Participants
|
67 Participants
n=7 Participants
|
106 Participants
n=5 Participants
|
313 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
140 Participants
n=5 Participants
|
67 Participants
n=7 Participants
|
106 Participants
n=5 Participants
|
313 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
Tanzania
|
140 participants
n=5 Participants
|
67 participants
n=7 Participants
|
106 participants
n=5 Participants
|
313 participants
n=4 Participants
|
|
Age
|
26.7 years
STANDARD_DEVIATION 7.56 • n=5 Participants
|
29.7 years
STANDARD_DEVIATION 6.57 • n=7 Participants
|
30.3 years
STANDARD_DEVIATION 6.67 • n=5 Participants
|
28.58 years
STANDARD_DEVIATION 7.24 • n=4 Participants
|
PRIMARY outcome
Timeframe: Up to 6 months after birthPopulation: Participants in follow-up survey without missing data on vaccinations and per-protocol study arm
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.
Outcome measures
| Measure |
No Intervention
n=139 Participants
No reminders or incentives
|
Reminders Only
n=67 Participants
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
|
Reminders + Conditional Financial Transfer
n=104 Participants
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
|
|---|---|---|---|
|
Number of Timely Vaccinations Received
Received 0 vaccinations within 28 days of target age
|
10 Participants
|
5 Participants
|
5 Participants
|
|
Number of Timely Vaccinations Received
Received 2 vaccinations within 28 days of target age
|
12 Participants
|
6 Participants
|
18 Participants
|
|
Number of Timely Vaccinations Received
Received 4 vaccinations within 28 days of target age
|
81 Participants
|
38 Participants
|
50 Participants
|
|
Number of Timely Vaccinations Received
Received 1 vaccination within 28 days of target age
|
9 Participants
|
6 Participants
|
12 Participants
|
|
Number of Timely Vaccinations Received
Received 3 vaccinations within 28 days of target age
|
27 Participants
|
12 Participants
|
19 Participants
|
SECONDARY outcome
Timeframe: Up to 6 months after birthNumber 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).
Outcome measures
| Measure |
No Intervention
n=139 Participants
No reminders or incentives
|
Reminders Only
n=67 Participants
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
|
Reminders + Conditional Financial Transfer
n=104 Participants
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
|
|---|---|---|---|
|
Number of Vaccinations Received
Received 0 vaccinations
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Vaccinations Received
Received 4 vaccinations
|
127 Participants
|
56 Participants
|
99 Participants
|
|
Number of Vaccinations Received
Received 1 vaccination
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Vaccinations Received
Received 2 vaccinations
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Vaccinations Received
Received 3 vaccinations
|
11 Participants
|
11 Participants
|
5 Participants
|
Adverse Events
No Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 12 deaths
Reminders Only
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Reminders + Conditional Financial Transfer
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place