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

Not Applicable

Completed

• Conditions: Cervical Cancer

• Registration Number: NCT02509702
• Lead Sponsor: Marianne Andersen

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 Timeline

• Study First Submitted: 2015-06-15
• Study First Submitted QC: 2015-07-25
• Study First Posted: 2015-07-28
• Study Start: 2015-08-17
• Primary Completion: 2019-10-06
• Study Completion: 2019-10-06
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-28
• Last Update Posted: 2021-12-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 705

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Effect of SMS intervention on attendance rate to follow-up screening appointment	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

Name	Time	Method
Acceptability of text message intervention	2 years	Qualitative interviews. Open-ended

Trial Locations

Locations (3)

Mawenzi Regional Referral Hospital; 🇹🇿 Moshi, Kilimanjaro, Tanzania

Ocean Road Cancer Institute (ORCI); 🇹🇿 Dar es Salaam, Tanzania

Kilimanjaro Christian Medical Centre (KCMC); 🇹🇿 Moshi, Tanzania