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

Study Overview
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Brief Summary
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This study evaluates the effect of the SMS intervention 'Connected2Care' on the attendance rate to cervical cancer screening follow-up appointments.

Detailed Description
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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.

Official Title
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Text Messages to Increase Attendance to Follow-up Cervical Cancer Screening Appointments Among HPV Positive Tanzanian Women (Connected2Care)

Conditions
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Cervical Cancer

Intervention / Treatment
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* Behavioral: Connected to Care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Connected to Care<br>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<br>* 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<br>|
| No Intervention: Control<br>The control group will receive standard care, which is a follow-up appointment at 14 months written on an appointment card. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of SMS intervention on attendance rate to follow-up screening appointment | 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. | up to 14 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acceptability of text message intervention | 6-point Likert scale (1: I do not like it at all - 6: I like it very much) | Baseline + 2 years Follow-up (likert scale) | 
| Acceptability of text message intervention | Qualitative interviews. Open-ended | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mobile health, Screening, Early detection of cancer, HPV, SMS intervention, RCT, Tanzania