跳至主要内容
临床试验/NCT02518178
NCT02518178Unknown不适用

Khushi Baby (KB): Efficacy and Impact Assessment of Novel Mobile Health Solution for Vaccination Record Keeping in Rural Udaipur, Rajasthan, India

Khushi Baby Inc.0 个研究点目标入组 300 人开始时间: 2015年8月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
300
主要终点
20% increase in DTP3 coverage

研究概览

简要总结

This is a three arm cluster randomized controlled trial where the unit of randomization is the immunization camp. Immunization camps are the sole provider of vaccinations in our study area and have catchment areas of several villages. The 96 immunization camps will be randomized evenly to one of three arms:

  1. control arm; where near field communication (NFC) stickers will be placed on existing immunization booklets. These stickers can be scanned using a mobile phone with an installed application whereby information can be entered onto the phone and then scanned onto the sticker
  2. pendant only; where the same NFC technology will be placed into a pendant that is worn by the infant, and
  3. pendant as described above with voice reminders sent 15 days, 1 day prior, and the day of the scheduled immunization camp dates.

详细描述

Routine immunization (RI) is an important tool to achieve the UN Millennium Development Goal (MDG) 4 of reducing child mortality by ensuring childhood protection from infectious disease. Recent 2013 estimates found that of approximately 6.3 million children died before their fifth birthday, with 51.8% (3.3 million) of these deaths attributed to infectious diseases (Liu et al., 2014). In regards to vaccine preventable diseases (VPDs), pneumonia (935,000 deaths) and diarrhea (578,000 deaths) were responsible for the most deaths. Measles, pertussis, tetanus, and meningitis, four other vaccine preventable diseases, were responsible for 362,000 deaths in children under five years old. (Liu et al., 2014)

Vaccination is one of the most cost-effective interventions for increasing childhood survival. (WHO, 2009). Global estimates find that current immunization programs save over 2.5 million lives a year (WHO, 2009). Despite the lifesaving potential of vaccines, in 2012 approximately 17% of children, or about 23 million infants, did not receive all the scheduled vaccines (CDC, 2013) and if they were immunized, they often received the vaccinations late (Clark & Sanderson, 2009).

In 1985, the Government of India launched the Universal Immunization Programme (UIP) to protect all infants (0-12 months) against six preventable diseases: tuberculosis, diphtheria, pertussis, tetanus, poliomyelitis, and measles. The goal of UIP was to ensure 100% coverage of all eligible children with one dose of BCG, three doses of DTP and OPV, and one dose of the measles vaccine. According to the Coverage Evaluation Survey (CES) 2009, a nationwide survey covering all States and Union Territories of India conducted during November 2009 to January 2010 by UNICEF, the national fully immunized coverage (FIC) against the six vaccines included in UIP in the age-group of 12-23 month old children was just 61% (CES, 2009). Coverage with third dose of diphtheria, tetanus and pertussis vaccine (DTP3) is a widely accepted global indicator for RI program performance (Lim SS, et al. 2008). India national estimates found DTP3 coverage was 72% (WHO India 2011), against a global target of 90%. The District Level Health Survey 3 (DLHS 3) findings suggest that the retention rate of childhood immunization was in maximum decline between the second round of DT and polio - 70 % and the third round - 56 % (Shekhar & Yadav, 2013).

The proposed study site, the Udaipur district of Rajasthan, has traditionally had lower immunization estimates than national levels while also performing poorly in other key developmental indicators: infant mortality rate (IMR) is 47 per 1000 live births (SRS Bulletin, 2014, GoI) and maternal mortality rate (MMR) is 244 per 100,000 women of reproductive age (MMR Bulletin, 2013).

To counter the long-standing deficiencies in immunization coverage and other health outcomes, a non-governmental organization (NGO) named Seva Mandir began operations in the area starting in 2004. Seva Mandir, has had a long standing relationship with over 700 villages in Rajasthan, with 105 villages participating in their immunization program. Immunization camps take place at regular, expected intervals throughout the month so caregivers are aware of when the scheduled camps will take place. This study area and its partners have conducted a seminal randomized controlled trial on non-monetary incentives to improve immunization coverage (Banerjee A, et al., 2010).

研究设计

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

入排标准

年龄范围
42 Days 至 6 Months(Child)
性别
All
接受健康志愿者

入选标准

  • Mother/ Primary Caregiver has an infant between the age of 42 days (minimum age for DTP1 administration per WHO guidelines) and 6 months of age; there is no age restriction for inclusion. In the very rare instance that a male is the primary caregiver, they will also be invited to participate in the study. Survey questions are not gender or age specific, but wil require the caregiver to answer questions about his/her children, socioeconomic and health status, and vaccine awareness.
  • Self-identified resident within one of the villages associated with the immunization camp
  • Willing to give informed consent (sign or thumbprint)

排除标准

  • Infant has received at least 1 dose of DTP vaccine
  • Caregiver and infant intends to move before the next 6 camps have been completed (in the next 6-9 months)

结局指标

主要结局

20% increase in DTP3 coverage

时间窗: 6 camps after DTP1 receipt (6 months)

Comparing necklace (with or without voice call reminders) to control arm infants

次要结局

  • Increase in DTP3 coverage for necklace + voice reminder arm compared to other 2 arms(6 camps after DTP1 receipt (6 months))
  • Improved camp attendance rates(Over 6 camp period after DTP1 receipt (6 months))
  • Retention of pendant compared to that of NFC stickered MAMTA card(6 camps after DTP1 receipt (6 months))
  • Increased time efficiency of NFC system (both stickers and pendants) compared to existing paper-based system of recording immunization(Paper log books (status quo control) will be used to establish a baseline for timeliness during first 2 months of the study. In the latter 2 months, the KB app digitization will be timed.)
  • Increased accuracy between NFC system (both stickers and pendants) compared to existing paper-based system of recording immunization(In the first 2 months, the logbook records will be digitized and de-identified for each camp. In the latter 2 months, the digitization of records will take place exclusively through the KB app.)
  • Survey-based outcomes: user satisfaction, socio-demographic profile of infants, vaccine awareness of mothers and the differential effects on vaccination adherence(Intake survey at enrollment + follow-up surveys at each camp (approximately once a month during follow-up period))
  • Failure rate of the Khushi Baby mobile application(Throughout study period of 9 months)

研究者

发起方
Khushi Baby Inc.
申办方类型
Other
责任方
Sponsor

相似试验