We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Try the New Site
We're building a modernized ClinicalTrials.gov! Visit Beta.ClinicalTrials.gov to try the new functionality.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02509702
Recruitment Status : Completed
First Posted : July 28, 2015
Last Update Posted : December 29, 2021
Sponsor:
Information provided by (Responsible Party):
Marianne Andersen, Odense University Hospital

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
This study evaluates the effect of the SMS intervention 'Connected2Care' on the attendance rate to cervical cancer screening follow-up appointments.

Condition or disease Intervention/treatment Phase
Cervical Cancer Behavioral: Connected to Care Not Applicable

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 705 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary Purpose: Screening
Official Title: Text Messages to Increase Attendance to Follow-up Cervical Cancer Screening Appointments Among HPV Positive Tanzanian Women (Connected2Care)
Actual Study Start Date : August 17, 2015
Actual Primary Completion Date : October 6, 2019
Actual Study Completion Date : October 6, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cervical Cancer

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
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.
 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
No Intervention: Control
The control group will receive standard care, which is a follow-up appointment at 14 months written on an appointment card.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Effect of SMS intervention on attendance rate to follow-up screening appointment [ Time Frame: up to 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.


Secondary Outcome Measures :
  1. Acceptability of text message intervention [ Time Frame: Baseline + 2 years Follow-up (likert scale) ]
    6-point Likert scale (1: I do not like it at all - 6: I like it very much)

  2. Acceptability of text message intervention [ Time Frame: 2 years ]
    Qualitative interviews. Open-ended


Other Outcome Measures:
  1. Cost-effectiveness of intervention [ Time Frame: Baseline + 14 months ]
    Incremental cost-effectiveness ratio

  2. Knowledge of cervical cancer and screening [ Time Frame: Baselie + 14 months ]
    16 item true-false questionaire


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   25 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT02509702


Locations
Layout table for location information
Tanzania
Mawenzi Regional Referral Hospital
Moshi, Kilimanjaro, Tanzania
Ocean Road Cancer Institute (ORCI)
Dar es Salaam, Tanzania, 3592
Kilimanjaro Christian Medical Centre (KCMC)
Moshi, Tanzania, 3010
Sponsors and Collaborators
Marianne Andersen
Investigators
Layout table for investigator information
Study Chair: Vibeke Rasch, MD University of Southern Denmark
Study Chair: Julius Mwaiselage, MD Ocean Road Cancer Institute
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Marianne Andersen, Clinical professor, Odense University Hospital
ClinicalTrials.gov Identifier: NCT02509702    
Other Study ID Numbers: Connected2Care
First Posted: July 28, 2015    Key Record Dates
Last Update Posted: December 29, 2021
Last Verified: December 2021
Keywords provided by Marianne Andersen, Odense University Hospital:
Mobile health
Screening
Early detection of cancer
HPV
 SMS intervention
RCT
Tanzania
Additional relevant MeSH terms:
Layout table for MeSH terms
Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
 Uterine Diseases
Genital Diseases, Female
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Genital Diseases