NCT03355989

Brief Summary

Like many developing countries, Pakistan faces a public health challenge of low and incomplete immunization rates of children, only 54% of children aged 12 to 24 months are fully immunized, which leaves children susceptible to vaccine-preventable diseases. The Expanded Program on Immunization (EPI) is a low-cost and effective health intervention, but the uptake is low, delayed, and completion rates are poor. Door-to-door campaigns can increase coverage, but are extremely expensive. Incentive-based approaches have been rigorously demonstrated to effectively increase take-up and completion rates of immunization, and there is substantial evidence that small incentives can have a large impact on the take up of preventative health behavior in general. There are two major constraints to scaling these findings, however. This study will attempt to find the most effective incentive design that helps increase the coverage of full immunization rates among children between the ages of 0 - 24 months in the city of Karachi, Pakistan. The study proposes to conduct a randomized control trial involving small conditional cash transfers (mCCTs) to determine the optimal CCT amount (high versus low), schedule (flat versus increasing) and design (lottery versus sure payment) that would lead to the highest increase in immunization rates. Interactive Research and Development's digital immunization registry will be used to enrol and randomize the study participants and generate CCTs disbursed through a mobile money transfer platform and mobile top - ups . The three year study will be conducted in Karachi, Pakistan enrolling a sample of 11,200 children, 0-2 years of age. The study aims to provide evidence regarding the most cost-effective way to structure incentives in terms of size, schedule, and design; and address the challenge of delivering small incentives in a way that is inexpensive, logistically simple, and not subject to leakage.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11,197

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 6, 2017

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

November 22, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 29, 2017

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 4, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 4, 2020

Completed
Last Updated

July 29, 2020

Status Verified

July 1, 2020

Enrollment Period

2.4 years

First QC Date

November 22, 2017

Last Update Submit

July 27, 2020

Conditions

Keywords

Conditional Cash TransferImmunization coverageImmunization reminder

Outcome Measures

Primary Outcomes (1)

  • Proportion of fully immunized children

    This will be the proportion of Fully immunized children under two years of age. A fully immunized child (FIC) will be one who received the entire series of EPI recommended vaccines by 2 years of age: one dose of BCG, 3 doses of each OPV, Pentavalent \& PCV immunizations, and 2 doses of Measles vaccines. This is a commonly used indicator in WUENIC, DHS reports and EPI survey reports.

    When the participants reach 2 years of age

Secondary Outcomes (5)

  • Penta3, Polio3, PCV3, or Measles1 coverage at 12 to 23 months

    Children vaccinated between the age of 12 to 23 months

  • Penta3, Polio3, PCV3, or Measles1 coverage at 12 months

    Children vaccinated by 12 months of age

  • Proportion of fully immunized children at 12 months

    When the children enroled reach 12 months of age

  • Proportion timely receipt of vaccine doses.

    Vaccination date within 4 weeks of the due date

  • Immunization system utilization (drop-out rate)

    This will be noted for when the child exceeds two years of age and remains unvaccinated

Study Arms (12)

Low Flat Rate without Lottery

EXPERIMENTAL

The intervention consists of receiving a small cash incentive of $0.80 on every vaccine along with 3 SMS reminders before, at and after the due date. The incentive will be sent via mobile top - up.

Other: Conditional Cash TransferOther: SMS Reminder

Low Flat Rate with Lottery

EXPERIMENTAL

The intervention consists of a 20% chance of receiving a small cash incentive of $4.00 on every vaccine along with 3 SMS reminders before, at and after the due date. The incentive will be sent via mobile top - up.

Other: Conditional Cash TransferOther: SMS Reminder

Low Sharp Rate without Lottery

EXPERIMENTAL

The intervention consists of receiving a small cash incentive of $0.75 on the BCG/Penta-1/Penta-2 vaccine and $1.00 on the Measles-1/Measles 2 vaccine along with 3 SMS reminders before, at and after the due date. The incentive will be sent via mobile top - up.

Other: Conditional Cash TransferOther: SMS Reminder

Low Sharp Rate with Lottery

EXPERIMENTAL

The intervention consists of a 20% chance of receiving a small cash incentive of $3.75 on the BCG/Penta-1/Penta-2 vaccine and $5.00 on the Measles-1/Measles 2 vaccine along with 3 SMS reminders before, at and after the due date. The incentive will be sent via mobile top - up.

Other: Conditional Cash TransferOther: SMS Reminder

High Flat Rate without Lottery

EXPERIMENTAL

The intervention consists of receiving a large cash incentive of $2.40 on every vaccine along with 3 SMS reminders before, at and after the due date. The incentive will be sent via mobile top - up.

Other: Conditional Cash TransferOther: SMS Reminder

High Flat Rate with Lottery

EXPERIMENTAL

The intervention consists of a 20% chance of receiving a large cash incentive of $12.00 on every vaccine along with 3 SMS reminders before, at and after the due date. The incentive will be sent via mobile top - up.

Other: Conditional Cash TransferOther: SMS Reminder

High Sharp Rate without Lottery

EXPERIMENTAL

The intervention consists of receiving a large cash incentive of $2.25 on the BCG/Penta-1/Penta-2 vaccine and $3.00 on the Measles-1/Measles 2 vaccine along with 3 SMS reminders before, at and after the due date. The incentive will be sent via mobile top - up.

Other: Conditional Cash TransferOther: SMS Reminder

High Sharp Rate with Lottery

EXPERIMENTAL

The intervention consists of a 20% chance of receiving a large cash incentive of $11.25 on the BCG/Penta-1/Penta-2 vaccine and $15.00 on the Measles-1/Measles 2 vaccine along with 3 SMS reminders before, at and after the due date. The incentive will be sent via mobile top - up.

Other: Conditional Cash TransferOther: SMS Reminder

Easypaisa Flat Rate without Lottery

EXPERIMENTAL

The intervention consists of receiving a large cash incentive of $2.40 on every vaccine along with 3 SMS reminders before, at and after the due date. The incentive will be sent via mobile money transfer i.e. easypaisa

Other: Conditional Cash TransferOther: SMS Reminder

Easypaisa Flat Rate with Lottery

EXPERIMENTAL

The intervention consists of a 20% chance of receiving a large cash incentive of $12.00 on every vaccine along with 3 SMS reminders before, at and after the due date. The incentive will be sent via mobile money transfer i.e. easypaisa

Other: Conditional Cash TransferOther: SMS Reminder

SMS Reminder Only

EXPERIMENTAL

The intervention consists of only sending 3 SMS reminders before, at and after the due date.

Other: SMS Reminder

Control

NO INTERVENTION

No intervention will be provided either in the form of cash incentive or reminder SMS. Vaccination facilities will be provided as per usual.

Interventions

Conditional cash transfer provided via mobile airtime and easypaisa along with SMS reminders to increase immunization coverage and timeliness

Easypaisa Flat Rate with LotteryEasypaisa Flat Rate without LotteryHigh Flat Rate with LotteryHigh Flat Rate without LotteryHigh Sharp Rate with LotteryHigh Sharp Rate without LotteryLow Flat Rate with LotteryLow Flat Rate without LotteryLow Sharp Rate with LotteryLow Sharp Rate without Lottery

Three SMS reminders for immunization provided before, at and after the due date respectively

Easypaisa Flat Rate with LotteryEasypaisa Flat Rate without LotteryHigh Flat Rate with LotteryHigh Flat Rate without LotteryHigh Sharp Rate with LotteryHigh Sharp Rate without LotteryLow Flat Rate with LotteryLow Flat Rate without LotteryLow Sharp Rate with LotteryLow Sharp Rate without LotterySMS Reminder Only

Eligibility Criteria

AgeUp to 23 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Children between 0 - 23 months of age visiting the EPI center for BCG/OPV-0 or Pentavalent-1/Polio-1/PCV-1 or Pentavalent-2/Polio-2/PCV-2 vaccination.
  • Children permanently residing within Korangi Town, Karachi and planto remain there for the next three years.
  • Caregiver accompanying the child can provide a valid mobile phone number at the time of enrolment

You may not qualify if:

  • Children visiting the EPI center for Pentavalent-2 or Measles-1 or Measles 2
  • Children born out of multiple births i.e twins or triplets
  • Children not residing or planning to move out of Korangi in the next three years
  • Children accompanied by caregivers unable to provide a phone number

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

BHU 51-B

Karachi, Sindh, Pakistan

Location

Related Publications (2)

  • Chandir S, Siddiqi DA, Abdullah S, Duflo E, Khan AJ, Glennerster R. Small mobile conditional cash transfers (mCCTs) of different amounts, schedules and design to improve routine childhood immunization coverage and timeliness of children aged 0-23 months in Pakistan: An open label multi-arm randomized controlled trial. EClinicalMedicine. 2022 Jun 25;50:101500. doi: 10.1016/j.eclinm.2022.101500. eCollection 2022 Aug.

  • Palmer MJ, Henschke N, Bergman H, Villanueva G, Maayan N, Tamrat T, Mehl GL, Glenton C, Lewin S, Fonhus MS, Free C. Targeted client communication via mobile devices for improving maternal, neonatal, and child health. Cochrane Database Syst Rev. 2020 Jul 14;8(8):CD013679. doi: 10.1002/14651858.CD013679.

MeSH Terms

Conditions

Infections

Study Officials

  • Aamir Khan

    Interactive Research and Development (IRD)

    PRINCIPAL INVESTIGATOR
  • Subhash Chandir

    Interactive Research and Development (IRD)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
The participant allocation sequence will be concealed from the study staff responsible for screening and enrolling participants through the use of real time phone based randomization sequence.
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: This is an individually randomized, twelve-arm parallel group design randomized control trial. The study has a cross-cutting design where one experiment (1) will investigate (1a) sharply increasing versus slowly increasing payouts; (1b) high incentive versus low incentive and (1c) simple SMS reminder vs no reminder. A second experiment (2), orthogonal to the first, will also test lottery payouts vs non-lottery payouts and we will cross-cut (1a), (1b) and (1c) with (2). The first experiment would enrol 1600 participants with the second distributing these participants to 900 participants each in the lottery vs non lottery payout. There will also be an SMS only arm and a control arm each enrolling 1600 participants.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Primary Investigator

Study Record Dates

First Submitted

November 22, 2017

First Posted

November 29, 2017

Study Start

November 6, 2017

Primary Completion

April 4, 2020

Study Completion

April 4, 2020

Last Updated

July 29, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations