Cervical CancerKCCPASNCT02680613
Pilot Study of a Mobile Health Approach to Reduce Barriers to Cervical Cancer Screening in Tanzania
A study testing Motivational SMS and Travel Voucher in people with Cervical Cancer, run by Queen's University at 1 site in Tanzania.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cervical Cancer
- What is being tested?
- Motivational SMS and Travel Voucher
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 851 participants
- Where
- 1 siteTanzania
- Study dates
- Feb 2016to Sep 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 49 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Own a mobile phone or have access to husband's/friend's mobile phone who is not eligible to participate in the research
Who cannot join
- Previous history of cervical cancer or hysterectomy
- Having been screened for cervical cancer in the past year
Trial locations and contacts
1 site in 1 country.
Tanzania1 site
Pamoja Tunaweza Women's Center
Moshi, Kilimanjaro, PO Box 8434
About this study
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.
Read the 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:
- To determine attitudes, barriers and enablers towards smartphone cervicography to ensure an accessible, culturally relevant smartphone cervicography screening program
- To evaluate the impact of a voucher for return transportation towards increasing cervical cancer screening attendance
- 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.
- Conditions
- Cervical Cancer
- Being tested
- Motivational SMS, Travel Voucher
- Keywords
- Behaviour Change, Secondary Prevention, mHealth
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational SMSBehavioural
Behaviour change messages delivered via SMS developed with the theoretical guidance of the Health Belief Model.
Travel VoucherBehavioural
A code for return public transportation to closest cervical cancer screening clinic included in the research.
| Study group | Role | What they receive |
|---|---|---|
| Motivational SMS | Experimental | This arm will receive 15 motivational SMS about cervical cancer and screening. Receives: Behavioral: Motivational SMS |
| 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. Receives: Behavioral: Motivational SMS; Behavioral: Travel Voucher |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: within 60 days from recruitment into study
Secondary outcomes (1)
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.
Measured: Completed if a client attended cervical cancer screening within the follow-up period (within 2 months of randomization)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2016 (estimated)
- Study startFeb 2016
- Primary completion12 May 2016
- Study completionSep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 851 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen's University
- Sponsor type
- University, hospital or other
- Collaborators
- Terry Fox Foundation
- Responsible party
- Principal investigator, Dr. Karen Yeates, Queen's University
- Investigators
- Karen Yeates, MD, Principal investigator, Queen's University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02680613
- Sponsor's protocol ID
- Q-6015511
- Acronym
- KCCPAS
- Status last verified
- Jan 2018
- First submitted
- 9 Feb 2016
- Last updated
- 29 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 25757944Kahesa 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.
PubMed 23253445World 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
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.
PubMed 17261102Yeates 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.
PubMed 28717721Palmer 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.
PubMed 32779730Erwin 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.
PubMed 31645991
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of a Mobile Health Approach to Reduce Barriers to Cervical Cancer Screening in Tanzania
- ClinicalTrials.gov ID
- NCT02680613
- Acronym / sponsor ID
- KCCPAS / Q-6015511
- Conditions
- Cervical Cancer
- Keywords
- Behaviour Change, Secondary Prevention, mHealth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 851 participants (actual)
- Lead sponsor
- Queen's UniversityUniversity, hospital or other
- Collaborators
- Terry Fox Foundation
- Study start
- Feb 2016
- Primary completion
- 12 May 2016 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 11 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To determine attitudes, barriers and enablers towards smartphone cervicography to ensure an accessible, culturally relevant smartphone cervicography screening program
- To evaluate the impact of a voucher for return transportation towards increasing cervical cancer screening attendance
- 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 design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Motivational SMS | Experimental | Behavioral: Motivational SMSThis arm will receive 15 motivational SMS about cervical cancer and screening. |
| Travel Voucher | Experimental | Behavioral: Motivational SMS, Behavioral: Travel VoucherThis 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. |
| 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. |
Who may qualify
- Ages
- 25 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Own a mobile phone or have access to husband's/friend's mobile phone who is not eligible to participate in the research
Key exclusion criteria (2 listed)
- Previous history of cervical cancer or hysterectomy
- Having been screened for cervical cancer in the past year
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Motivational SMSBehaviour change messages delivered via SMS developed with the theoretical guidance of the Health Belief Model. | Behavioural | Motivational SMS, Travel Voucher |
| Travel VoucherA code for return public transportation to closest cervical cancer screening clinic included in the research. | Behavioural | Travel Voucher |
Primary outcome
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.
1 secondary outcome
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2018.
- Background: PubMed 25757944Cunningham 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.
- Background: PubMed 23253445Kahesa 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.
- BackgroundWorld 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
- Background: PubMed 17261102Palanuwong 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.
- Background: PubMed 28717721Yeates 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.
- Derived from this study: PubMed 32779730Palmer 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.
- Derived from this study: PubMed 31645991Erwin 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karen Yeates, MD principal investigator
Queen's University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motivational SMS and Travel Voucher in people with Cervical Cancer, run by Queen's University at 1 site in Tanzania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Tanzania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Attendance at Cervical Cancer Screening at clinics included in Trial (time frame: within 60 days from recruitment into study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02680613, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2018.