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

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ClinicalTrials.gov Identifier: NCT02680613
Recruitment Status : Completed
First Posted : February 11, 2016
Last Update Posted : January 29, 2018
Sponsor:
Collaborator:
Terry Fox Foundation
Information provided by (Responsible Party):
Dr. Karen Yeates, Queen's University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Cervical Cancer Behavioral: Motivational SMS Behavioral: Travel Voucher Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 851 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Masking Description: 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.
Primary Purpose: Screening
Official Title: Pilot Study of a Mobile Health Approach to Reduce Barriers to Cervical Cancer Screening in Tanzania
Study Start Date : February 2016
Actual Primary Completion Date : May 12, 2016
Actual Study Completion Date : September 2017

Resource links provided by the National Library of Medicine


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.



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   25 Years to 49 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02680613


Locations
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Tanzania
Pamoja Tunaweza Women's Center
Moshi, Kilimanjaro, Tanzania, PO Box 8434
Sponsors and Collaborators
Queen's University
Terry Fox Foundation
Investigators
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Principal Investigator: Karen Yeates, MD Queen's University

Publications:
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Responsible Party: Dr. Karen Yeates, Principal Investigator, Queen's University
ClinicalTrials.gov Identifier: NCT02680613     History of Changes
Other Study ID Numbers: Q-6015511
First Posted: February 11, 2016    Key Record Dates
Last Update Posted: January 29, 2018
Last Verified: January 2018
Keywords provided by Dr. Karen Yeates, Queen's University:
Behaviour Change
Secondary Prevention
mHealth
Additional relevant MeSH terms:
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Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female