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临床试验/NCT02680613
NCT02680613已完成不适用

Pilot Study of a Mobile Health Approach to Reduce Barriers to Cervical Cancer Screening in Tanzania

Queen's University2 个研究点 分布在 1 个国家目标入组 851 人开始时间: 2016年2月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
851
试验地点
2
主要终点
Attendance at Cervical Cancer Screening at clinics included in Trial

研究概览

简要总结

The purpose of this study is to determine whether motivational text messages and/or travel vouchers are effective in increasing cervical cancer screening rates in urban and rural regions of Northern Tanzania.

详细描述

Introduction:

Cervical cancer is the leading cause of cancer-related deaths in Tanzania. The age-adjusted incidence rate is estimated to be 54 cases per 100,000 (IARC, 2012) and 80% of Tanzanian women affected by cervical cancer will die due to advanced stage at diagnosis (Kahesa, et al., 2012). Visual Inspection of the cervix under Acetic Acid (VIA) is an effective alternative to the Pap smear, unavailable in most low-resource countries due to weak health systems (Palanuwong, 2007). Nurses typically receive 6 days of training before returning to their communities to provide VIA; however, they often face a total lack of oversight to ensure they are providing quality screening and cryotherapy. This lack of quality control has prevented a decline in cervical cancer morbidity and mortality despite significant investment and implementation of VIA programs.

The Kilimanjaro Cervical Cancer Screening Project (KCCP) is a pilot study of 1000 women that developed and tested a cervicography (taking a digital photo of the cervix) training method using a smartphone camera in the hands of nurses performing cervical cancer screening and receiving 'real time' mentorship through a closed user group of image transfer and guidance by cervicographers located elsewhere in Tanzania. A pilot study completed in February 2015 showed that this method provides safe and high quality screening and the method is moving to implementation and scale up within multiple VIA programs in late 2015 (Yeates et al., Manuscript in preparation). The KCCP continues to screen patients and this provides a significant opportunity to perform further research that will inform the scale-up program.

Measures to encourage increased uptake of cervical cancer screening in the region, and in many low-resource contexts are drastically needed to reduce the burden of cervical cancer in these contexts. The prevalence of screening in the Kilimanjaro is 6%(Cunningham et al, 2015), which is close to the WHO figure of 5% of women in developing countries having been screened in the last five years (World Health Organization, 1986). The largest perceived barriers to cervical cancer screening in the Kilimanjaro region were found to be a lack of knowledge that screening services were available and women anticipated that they would not be able to afford the costs associated with screening, including travel (Cunningham et al, 2015).

Objectives:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Screening
盲法
Double (Participant, Care Provider)

盲法说明

The participants were not aware of which group they were randomized to. The care provider providing the screening service was not aware of the group of the participant.

入排标准

年龄范围
25 Years 至 49 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Own a mobile phone or have access to husband's/friend's mobile phone who is not eligible to participate in the research

排除标准

  • Previous history of cervical cancer or hysterectomy
  • Having been screened for cervical cancer in the past year

研究组 & 干预措施

Motivational SMS

Experimental

This arm will receive 15 motivational SMS about cervical cancer and screening.

干预措施: Motivational SMS (Behavioral)

Travel Voucher

Experimental

This arm will receive a voucher covering return transport from the screening clinic. This arm will also receive identical 15 motivational SMS about cervical cancer and screening as the Motivational SMS arm.

干预措施: Motivational SMS (Behavioral)

Travel Voucher

Experimental

This arm will receive a voucher covering return transport from the screening clinic. This arm will also receive identical 15 motivational SMS about cervical cancer and screening as the Motivational SMS arm.

干预措施: Travel Voucher (Behavioral)

Control

No Intervention

This arm will receive standard sensitization during study period (church announcements, screening promotion by key community leaders and posters in community, as well as sensitization by the research assistants conducting the door-to-door household recruitment) during the study and follow-up period. They will also receive one SMS message with the location of screening services during the study period. At the conclusion of the study, participants in the arm will receive identical motivational SMS as the other two arms.

结局指标

主要结局

Attendance at Cervical Cancer Screening at clinics included in Trial

时间窗: within 60 days from recruitment into study

The primary outcome is binary. It is whether or not participants attend cervical cancer screening at the clinics included in the randomized controlled trial.

次要结局

  • Satisfaction with Smartphone Enhanced Digital Cervicography(Completed if a client attended cervical cancer screening within the follow-up period (within 2 months of randomization))

研究者

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

Dr. Karen Yeates

Principal Investigator

Queen's University

研究点 (2)

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