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临床试验/NCT05151367
NCT05151367已完成不适用

SEARCH: Short Message Service (SMS) Electronic Adolescent Reminders for Completion of HPV Vaccination - Uganda: Pilot

Columbia University2 个研究点 分布在 2 个国家目标入组 154 人开始时间: 2022年2月23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
154
试验地点
2
主要终点
Number of Participants Who Received the Next HPV Vaccine Dose

研究概览

简要总结

This study 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, also in Kampala. While text messages can be used in populations with low literacy, families can opt to receive automated phone call reminders instead. The investigators will pilot assess the impact of vaccine reminders on human papillomavirus (HPV) vaccination. Caregivers of preteens/adolescents will be randomized and stratified by site, language and HPV vaccine dose needed (initiation vs. completion). As this is a feasibility trial, the investigators expect to measure effect size but not necessarily achieve statistical significance.

详细描述

Cervical cancer is the leading female cancer in Uganda. Many women are diagnosed with late-stage disease, and 80% of women die within 5 years of diagnosis, making primary prevention critical. HPV is the principal cause of cervical cancer, making vaccination the single most important primary preventive measure. The national HPV vaccination program in Uganda began in November 2015 and focuses solely on preteen/adolescent girls. Two strategies have been adopted for the multi-dose series: 1) school-based and 2) community-based. However, in Kampala, only 29% of girls receive both needed doses. Reasons for undervaccination include school absenteeism on special vaccination days for those receiving vaccination as part of a school program, failing to remember to come to a health facility for a needed dose for those being vaccinated in the community, and lack of knowledge regarding HPV and the vaccines including vaccine misperceptions. While research regarding the use of text message vaccine reminders is strong in the U.S., their use has not yet been demonstrated in a preteen/adolescent population in Sub-Saharan Africa and other low and middle income countries (LMICs). According to the World Bank, currently 89.9% of urban households in Uganda have a cell phone.

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
Triple (Care Provider, Investigator, 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 pretesting activities

结局指标

主要结局

Number of Participants Who Received the Next HPV Vaccine Dose

时间窗: Up to 6 months from randomization

Timeliness of vaccination will be measured by the number of participants who received the next HPV vaccine dose.

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

Associate Professor of Pediatrics and Population and Family Health

Columbia University

研究点 (2)

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