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Use of SMSs to Improve Attendance to Cervical Cancer Follow-up Screening

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ClinicalTrials.gov Identifier: NCT02509702
Recruitment Status : Active, not recruiting
First Posted : July 28, 2015
Last Update Posted : November 22, 2017
Sponsor:
Information provided by (Responsible Party):
Marianne Andersen, Odense University Hospital

Tracking Information
First Submitted Date  ICMJE June 15, 2015
First Posted Date  ICMJE July 28, 2015
Last Update Posted Date November 22, 2017
Study Start Date  ICMJE August 2015
Estimated Primary Completion Date July 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 21, 2017)
Effect of SMS intervention on attendance rate to follow-up screening appointment [ Time Frame: 14 months ]
The effect measure of the intervention is the 14-month follow-up attendance rate for HPV positive women. The number of women in the intervention group that attend follow-up screening will be compared to the the number of women that attend follow-up screening in the control group.
Original Primary Outcome Measures  ICMJE
 (submitted: July 25, 2015)
Effect of mHealth messages on attendance rate to check-up appointment [ Time Frame: 12 months ]
To assess the effect of mHealth messages, mHealth quizzes, and sms-reminders on HPV-positive women's attendance to check-up appointments at 12 months compared to standard of care.
Change History Complete list of historical versions of study NCT02509702 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 21, 2017)
  • Cost-effectiveness of SMS intervention [ Time Frame: 14 months ]
    The cost-effectiveness of the intervention is estimated through a conventional Cost-Effectiveness Analysis based on the RCT. Two Incremental Cost-Effectiveness Ratios will be calculated; one with and one without the costs of HPV testing.
  • Effect of SMS intervention on knowledge of cervical cancer and screening [ Time Frame: 14 months ]
    A 16-item true/false questionnaire regarding cervical cancer and screening will be used to measure the effect of the intervention on HPV positive women's level of knowledge. The questionnaire will be answered by all participants at baseline and by the intervention group at follow-up.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Use of SMSs to Improve Attendance to Cervical Cancer Follow-up Screening
Official Title  ICMJE Text Messages to Increase Attendance to Follow-up Cervical Cancer Screening Appointments Among HPV Positive Tanzanian Women (Connected2Care)
Brief Summary This study evaluates the effect of the SMS intervention 'Connected2Care' on the attendance rate to cervical cancer screening follow-up appointments.
Detailed Description Connected2Care is a non-blinded, multicentre, parallel-group, randomised controlled trial. Tanzanian Women testing positive to HR HPV at inclusion are randomly assigned in an allocation ratio of 1:1 to the SMS intervention or the control group (standard care). In a period of 10 months, the intervention group will receive 15 one-directional health educative text messages and SMS-reminders for their appointment. The total sample size will be 700 with 350 women in each study arm. Primary outcome is attendance rate for follow-up. Secondary objectives are cost-effectiveness measured through incremental ratios and knowledge of cervical cancer by a 16-item true/false scale questionnaire at baseline and follow-up.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Condition  ICMJE Cervical Cancer
Intervention  ICMJE Behavioral: Connected to Care
10 health educative SMSs' sent once a month 5 SMS-reminders for follow-up appointment sent on days -14, -7, -1 pre- follow-up appointment, and +1, +7 post follow-up appointment
Study Arms  ICMJE
  • Experimental: Connected to Care
    The SMS intervention will consist of 15 text messages that will be sent to the intervention group over a period of 10 months. There will be two types of text messages: (1) educational text messages; and (2) SMS reminders for the follow-up appointment.
    Intervention: Behavioral: Connected to Care
  • No Intervention: Control
    The control group will receive standard care, which is a follow-up appointment at 14 months written on an appointment card.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: November 21, 2017)
702
Original Estimated Enrollment  ICMJE
 (submitted: July 25, 2015)
950
Estimated Study Completion Date  ICMJE July 2018
Estimated Primary Completion Date July 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Informed consent
  • HPV positive
  • Age 25 - 60 years
  • Private mobile phone

Exclusion Criteria:

  • Pregnant on day of enrolment
  • Menstruating on day of enrolment
  • Hysterectomy
  • Diagnosed with cervical pre-cancer within past 12 months
  • Diagnosed with cervical cancer
  • Invalid mobile phone number
  • Unreachable when trying to convey HPV positive result
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 25 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Tanzania
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02509702
Other Study ID Numbers  ICMJE Connected2Care
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Marianne Andersen, Odense University Hospital
Study Sponsor  ICMJE Marianne Andersen
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Vibeke Rasch, MD University of Southern Denmark
Study Chair: Julius Mwaiselage, MD Ocean Road Cancer Institute
PRS Account Odense University Hospital
Verification Date November 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP