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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

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 702 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Text Messages to Increase Attendance to Follow-up Cervical Cancer Screening Appointments Among HPV Positive Tanzanian Women (Connected2Care)
Study Start Date : August 2015
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : July 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cervical Cancer

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.



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.



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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

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
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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
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Study Chair: Vibeke Rasch, MD University of Southern Denmark
Study Chair: Julius Mwaiselage, MD Ocean Road Cancer Institute

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Marianne Andersen, Clinical professor, Odense University Hospital
ClinicalTrials.gov Identifier: NCT02509702     History of Changes
Other Study ID Numbers: Connected2Care
First Posted: July 28, 2015    Key Record Dates
Last Update Posted: November 22, 2017
Last Verified: November 2017
Keywords provided by Marianne Andersen, Odense University Hospital:
Mobile health
Screening
Early detection of cancer
HPV
SMS intervention
RCT
Tanzania
Additional relevant MeSH terms:
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Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female