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

Primary Purpose

Cervical Cancer

Status
Completed
Phase
Not Applicable
Locations
Tanzania
Study Type
Interventional
Intervention
Motivational SMS
Travel Voucher
Sponsored by
Queen's University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Cervical Cancer focused on measuring Behaviour Change, Secondary Prevention, mHealth

Eligibility Criteria

25 Years - 49 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Pamoja Tunaweza Women's Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Motivational SMS

Travel Voucher

Control

Arm Description

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

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.

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.

Outcomes

Primary Outcome Measures

Attendance at Cervical Cancer Screening at clinics included in Trial
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

Satisfaction with Smartphone Enhanced Digital Cervicography
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.

Full Information

First Posted
February 9, 2016
Last Updated
January 25, 2018
Sponsor
Queen's University
Collaborators
Terry Fox Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT02680613
Brief Title
Pilot Study of a Mobile Health Approach to Reduce Barriers to Cervical Cancer Screening in Tanzania
Acronym
KCCPAS
Official Title
Pilot Study of a Mobile Health Approach to Reduce Barriers to Cervical Cancer Screening in Tanzania
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
February 2016 (undefined)
Primary Completion Date
May 12, 2016 (Actual)
Study Completion Date
September 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Queen's University
Collaborators
Terry Fox Foundation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Cancer
Keywords
Behaviour Change, Secondary Prevention, mHealth

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare 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.
Allocation
Randomized
Enrollment
851 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Motivational SMS
Arm Type
Experimental
Arm Description
This arm will receive 15 motivational SMS about cervical cancer and screening.
Arm Title
Travel Voucher
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Motivational SMS
Intervention Description
Behaviour change messages delivered via SMS developed with the theoretical guidance of the Health Belief Model.
Intervention Type
Behavioral
Intervention Name(s)
Travel Voucher
Intervention Description
A code for return public transportation to closest cervical cancer screening clinic included in the research.
Primary Outcome Measure Information:
Title
Attendance at Cervical Cancer Screening at clinics included in Trial
Description
The primary outcome is binary. It is whether or not participants attend cervical cancer screening at the clinics included in the randomized controlled trial.
Time Frame
within 60 days from recruitment into study
Secondary Outcome Measure Information:
Title
Satisfaction with Smartphone Enhanced Digital Cervicography
Description
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.
Time Frame
Completed if a client attended cervical cancer screening within the follow-up period (within 2 months of randomization)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karen Yeates, MD
Organizational Affiliation
Queen's University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pamoja Tunaweza Women's Center
City
Moshi
State/Province
Kilimanjaro
ZIP/Postal Code
PO Box 8434
Country
Tanzania

12. IPD Sharing Statement

Citations:
PubMed Identifier
25757944
Citation
Cunningham MS, Skrastins E, Fitzpatrick R, Jindal P, Oneko O, Yeates K, Booth CM, Carpenter J, Aronson KJ. Cervical cancer screening and HPV vaccine acceptability among rural and urban women in Kilimanjaro Region, Tanzania. BMJ Open. 2015 Mar 10;5(3):e005828. doi: 10.1136/bmjopen-2014-005828.
Results Reference
background
PubMed Identifier
23253445
Citation
Kahesa C, Kjaer S, Mwaiselage J, Ngoma T, Tersbol B, Dartell M, Rasch V. Determinants of acceptance of cervical cancer screening in Dar es Salaam, Tanzania. BMC Public Health. 2012 Dec 19;12:1093. doi: 10.1186/1471-2458-12-1093.
Results Reference
background
Citation
World Health Organization, International Agency for Research on Cancer (IARC) (2012). WHO 2012 estimated cancer incidence, mortality and prevalence in 2012 Available at: http://globocan.iarc.fr/Pages/fact_sheets_population.aspx Accessed February 25, 2015
Results Reference
background
PubMed Identifier
17261102
Citation
Palanuwong B. Alternative cervical cancer prevention in low-resource settings: Experiences of visual inspection by acetic acid with single-visit approach in the first five provinces of Thailand. Aust N Z J Obstet Gynaecol. 2007 Feb;47(1):54-60. doi: 10.1111/j.1479-828X.2006.00680.x.
Results Reference
background
PubMed Identifier
28717721
Citation
Yeates KE, Sleeth J, Hopman W, Ginsburg O, Heus K, Andrews L, Giattas MR, Yuma S, Macheku G, Msuya A, Oneko O. Evaluation of a Smartphone-Based Training Strategy Among Health Care Workers Screening for Cervical Cancer in Northern Tanzania: The Kilimanjaro Method. J Glob Oncol. 2016 May 4;2(6):356-364. doi: 10.1200/JGO.2015.001768. eCollection 2016 Dec.
Results Reference
background
PubMed Identifier
32779730
Citation
Palmer MJ, Henschke N, Villanueva G, Maayan N, Bergman H, Glenton C, Lewin S, Fonhus MS, Tamrat T, Mehl GL, Free C. Targeted client communication via mobile devices for improving sexual and reproductive health. Cochrane Database Syst Rev. 2020 Jul 14;8(8):CD013680. doi: 10.1002/14651858.CD013680.
Results Reference
derived
PubMed Identifier
31645991
Citation
Erwin E, Aronson KJ, Day A, Ginsburg O, Macheku G, Feksi A, Oneko O, Sleeth J, Magoma B, West N, Marandu PD, Yeates K. SMS behaviour change communication and eVoucher interventions to increase uptake of cervical cancer screening in the Kilimanjaro and Arusha regions of Tanzania: a randomised, double-blind, controlled trial of effectiveness. BMJ Innov. 2019 Jan;5(1):28-34. doi: 10.1136/bmjinnov-2018-000276. Epub 2019 Feb 22.
Results Reference
derived

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

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