Use of SMSs to Improve Attendance to Cervical Cancer Follow-up Screening
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|ClinicalTrials.gov Identifier: NCT02509702|
Recruitment Status : Unknown
Verified November 2017 by Marianne Andersen, Odense University Hospital.
Recruitment status was: Active, not recruiting
First Posted : July 28, 2015
Last Update Posted : November 22, 2017
|Condition or disease||Intervention/treatment||Phase|
|Cervical Cancer||Behavioral: Connected to Care||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||702 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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.
- 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.
- 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.
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
|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|
|Study Chair:||Vibeke Rasch, MD||University of Southern Denmark|
|Study Chair:||Julius Mwaiselage, MD||Ocean Road Cancer Institute|