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

Cervical Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02509702
• Other study ID #: Connected2Care
• Status: Completed
• Phase: N/A
• Start date: August 17, 2015
• Est. completion date: October 6, 2019

Study information

• Verified date: December 2021
• Source: Odense University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 705
• Est. completion date: October 6, 2019
• Est. primary completion date: October 6, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 25 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Cervical Cancer
• Uterine Cervical Neoplasms

Intervention

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

Locations

Country	Name	City	State
Tanzania	Ocean Road Cancer Institute (ORCI)	Dar es Salaam
Tanzania	Kilimanjaro Christian Medical Centre (KCMC)	Moshi
Tanzania	Mawenzi Regional Referral Hospital	Moshi	Kilimanjaro

Sponsors (1)

Lead Sponsor	Collaborator
Marianne Andersen

Country where clinical trial is conducted

Tanzania, 

References & Publications (1)

Linde DS, Andersen MS, Mwaiselage JD, Manongi R, Kjaer SK, Rasch V. Text messages to increase attendance to follow-up cervical cancer screening appointments among HPV-positive Tanzanian women (Connected2Care): study protocol for a randomised controlled trial. Trials. 2017 Nov 21;18(1):555. doi: 10.1186/s13063-017-2215-x. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Cost-effectiveness of intervention	Incremental cost-effectiveness ratio	Baseline + 14 months
Other	Knowledge of cervical cancer and screening	16 item true-false questionaire	Baselie + 14 months
Primary	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	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)
Secondary	Acceptability of text message intervention	Qualitative interviews. Open-ended	2 years