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临床试验/NCT03355989
NCT03355989已完成不适用

Testing the Effect of Mobile Conditional Cash Transfers (mCCTs) of Different Schedules and Amounts on Routine Childhood Immunization Coverage and Timeliness in Pakistan: A Randomized Control Trial.

Interactive Research and Development1 个研究点 分布在 1 个国家目标入组 11,197 人开始时间: 2017年11月6日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
11,197
试验地点
1
主要终点
Proportion of fully immunized children

研究概览

简要总结

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.

详细描述

The study is a three - year randomized controlled trial that will experimentally evaluate the impact of CCTs and SMS reminders on immunization rates of children under 2 years of age. The study will investigate the influence of different amounts, schedules and design of CCTs on immunization rates to (1) determine the impact of small incentives on immunization coverage and timeliness in 0-23 months old Pakistani children, (2) measure the relative effectiveness and cost of effectiveness of different types of incentives structures (including the amount, progressivity and certainty of payment) on immunization coverage rates and timeliness in 0-23 months old Pakistani children and (3)determine the impact of SMS reminder (both with and without incentives) on immunization coverage rates and timeliness in 0-23 months old Pakistani children.

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 will cross-cut (1a), (1b) and (1c) with (2). Moreover two different incentive disbursement methods will be utilised namely mobile phone credit (air time) and mobile money (hard cash) through a mobile money provider-EasyPaisa.

The study will have a total twelve arms. The first ten arms will be the incentive arms with eight using mobile phone credit and two utilising mobile money. Additionally arm eleven will only provide SMS reminders while control arm twelve will neither receive CCT nor SMS.

The study will enroll a total of 11,200 participants. Additionally to evaluate the proportion of immunized children, the study will also (4) examine 15% of the enrolled children for sero-survey biomarkers - the gold standard for establishing immunity, among different intervention and control arms

Study Site

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

盲法说明

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.

入排标准

年龄范围
— 至 23 Months(Child)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Proportion of fully immunized children

时间窗: When the participants reach 2 years of age

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.

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Subhash Chandir

Primary Investigator

Interactive Research and Development

研究点 (1)

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