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

January 25, 2018 updated by: Dr. Karen Yeates, Queen's University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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:

A) To determine attitudes, barriers and enablers towards smartphone cervicography to ensure an accessible, culturally relevant smartphone cervicography screening program

B) To evaluate the impact of a voucher for return transportation towards increasing cervical cancer screening attendance

C) To evaluate the impact of motivational text messages towards increasing cervical cancer screening attendance

Methodology:

This study will comprise of a descriptive cross-sectional survey and a randomized controlled trial (RCT). Household surveys, capturing baseline characteristics, using stratified systematic random sampling in urban and rural areas will be used to recruit participants for the RCT. Cross-sectional survey participants will be recruited opportunistically at screening clinics associated with the study.

RCT participants will be randomized into one of three arms. The first arm will be a control group and will not receive any correspondence. The second arm will receive a series of motivational text messages, including screening dates and locations. The third group will receive a travel voucher code via SMS and motivational text messages with the same content as the second group.

A post-screening survey will be conducted following cervical cancer screening at clinics participating in the study to evaluate screening attendance and attitudes towards smartphone digital cervicography.

Study Type

Interventional

Enrollment (Actual)

851

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Tanzania
    • Kilimanjaro
      • Moshi, Kilimanjaro, Tanzania, PO Box 8434
        • Pamoja Tunaweza Women's Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 49 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Motivational SMS
This arm will receive 15 motivational SMS about cervical cancer and screening.
Behavioral: Motivational SMS
Behaviour change messages delivered via SMS developed with the theoretical guidance of the Health Belief Model.
Experimental: Travel Voucher
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.
Behavioral: Motivational SMS
Behaviour change messages delivered via SMS developed with the theoretical guidance of the Health Belief Model.
Behavioral: Travel Voucher
A code for return public transportation to closest cervical cancer screening clinic included in the research.
No Intervention: Control
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Attendance at Cervical Cancer Screening at clinics included in Trial
Time Frame: 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.
within 60 days from recruitment into study

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Satisfaction with Smartphone Enhanced Digital Cervicography
Time Frame: Completed if a client attended cervical cancer screening within the follow-up period (within 2 months of randomization)
The secondary outcome is measured by two survey questions that were part of a exit-survey completed women following cervical cancer screening using the Smartphone Enhanced Visual Inspection with Acetic Acid (SEVIA) used at the two screening clinics included in our trial. The client is considered satisfied if they answer "Yes" to the question "Did you feel comfortable with having a photo of your cervix taken at screening?" and "Definitely Agree" or "Agree" to the question "Did reviewing the picture of your cervix at screening and using it to discuss your risks for cancer increase your knowledge of your risk of cancer?". Otherwise the client is considered dissatisfied.
Completed if a client attended cervical cancer screening within the follow-up period (within 2 months of randomization)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Queen's University

Collaborators

Terry Fox Foundation

Investigators

  • Principal Investigator: Karen Yeates, MD, Queen's University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2016

Primary Completion (Actual)

May 12, 2016

Study Completion (Actual)

September 1, 2017

Study Registration Dates

First Submitted

February 9, 2016

First Submitted That Met QC Criteria

February 10, 2016

First Posted (Estimate)

February 11, 2016

Study Record Updates

Last Update Posted (Actual)

January 29, 2018

Last Update Submitted That Met QC Criteria

January 25, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Q-6015511

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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