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临床试验/NCT06161831
NCT06161831进行中(未招募)不适用

SEARCH II: Short Message Service (SMS) Electronic Adolescent Reminders for Completion of HPV Vaccination - Uganda: Randomized Controlled Trial

Columbia University3 个研究点 分布在 2 个国家目标入组 396 人开始时间: 2024年4月22日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
396
试验地点
3
主要终点
Time to Receipt of Second HPV Vaccine Dose

研究概览

简要总结

This RCT will take place at health centres and their affiliated schools and community immunization centers overseen by the Kampala Capital City Authority (KCCA) as well as at the Makerere/Mulago/Columbia Adolescent Health Clinic in Kampala. The investigators will assess the impact of vaccine text message and automated phone reminders on human papillomavirus (HPV) vaccination initiation and completion.

详细描述

Cervical cancer is the leading female cancer in Uganda. HPV is the principal cause of cervical cancer. The national HPV vaccination program in Uganda includes preteen/ adolescent girls. Vaccinations are provided within schools or through community health centers. However, in Kampala, HPV vaccination especially series completion is low. While research regarding the use of text message vaccine reminders is strong in the U.S., their use has not been demonstrated in a preteen/adolescent population in Sub-Saharan Africa and other low and middle income countries (LMICs) in a full RCT. In this study, RCT caregivers of preteens/adolescents will be randomized and stratified by site, language and HPV vaccine dose needed (initiation vs. completion). Intervention families will receive text message or automated phone reminders based on family preference.

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
Double (Care Provider, Outcomes Assessor)

入排标准

年龄范围
10 Years 至 14 Years(Child)
性别
Female
接受健康志愿者

入选标准

  • Be a parenting adult of an adolescent girl aged 10-14 years
  • Reside in Kampala and/or the surrounding districts
  • Speak English or Luganda
  • Have a cell phone with text messaging capability
  • Must have ability to consent

排除标准

  • Parenting adult speaks other language than English or Luganda only
  • Parenting adult already enrolled in the study for another child
  • Participation in previous HPV vaccine reminder study

结局指标

主要结局

Time to Receipt of Second HPV Vaccine Dose

时间窗: 12 months

Timeliness of vaccination (time to event) will be measured

Time to Receipt of First HPV Vaccine Dose

时间窗: 12 months

Timeliness of vaccination (time to event) will be measured

次要结局

未报告次要终点

研究者

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

Melissa Stockwell

Professor of Pediatrics and Population and Family Health

Columbia University

研究点 (3)

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