NCT02680613

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
851

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2016

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

February 9, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 11, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 12, 2016

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

January 29, 2018

Status Verified

January 1, 2018

Enrollment Period

3 months

First QC Date

February 9, 2016

Last Update Submit

January 25, 2018

Conditions

Cervical Cancer

Keywords

Behaviour ChangeSecondary PreventionmHealth

Outcome Measures

Primary Outcomes (1)

  • 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.

    within 60 days from recruitment into study

Secondary Outcomes (1)

  • Satisfaction with Smartphone Enhanced Digital Cervicography

    Completed if a client attended cervical cancer screening within the follow-up period (within 2 months of randomization)

Study Arms (3)

Motivational SMS

EXPERIMENTAL

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

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.

Behavioral: Motivational SMSBehavioral: 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.

Interventions

Motivational SMSBEHAVIORAL

Behaviour change messages delivered via SMS developed with the theoretical guidance of the Health Belief Model.

Motivational SMSTravel Voucher
Travel VoucherBEHAVIORAL

A code for return public transportation to closest cervical cancer screening clinic included in the research.

Travel Voucher

Eligibility Criteria

Age25 Years - 49 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pamoja Tunaweza Women's Center

Moshi, Kilimanjaro, PO Box 8434, Tanzania

Location

Related Publications (7)

  • 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.

    PMID: 25757944BACKGROUND

  • 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.

    PMID: 23253445BACKGROUND

  • 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

    BACKGROUND

  • 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.

    PMID: 17261102BACKGROUND

  • 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.

    PMID: 28717721BACKGROUND

  • 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.

    PMID: 32779730DERIVED

  • 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.

    PMID: 31645991DERIVED

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Karen Yeates, MD

    Queen's University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Masking Details
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.
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 9, 2016

First Posted

February 11, 2016

Study Start

February 1, 2016

Primary Completion

May 12, 2016

Study Completion

September 1, 2017

Last Updated

January 29, 2018

Record last verified: 2018-01

Locations

TA(1)