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

• ClinicalTrials.gov Identifier: NCT02509702
• Recruitment Status: Completed
• First Posted: July 28, 2015
• Last Update Posted: December 29, 2021
• Sponsor: Marianne Andersen
• Information provided by (Responsible Party): Marianne Andersen, Odense University Hospital

Tracking Information

• First Submitted Date: June 15, 2015
• First Posted Date: July 28, 2015
• Last Update Posted Date: December 29, 2021
• Actual Study Start Date: August 17, 2015
• Actual Primary Completion Date: October 6, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: December 28, 2021)

Effect of SMS intervention on attendance rate to follow-up screening appointment [ Time Frame: 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.

Original Primary Outcome Measures (submitted: July 25, 2015)

Effect of mHealth messages on attendance rate to check-up appointment [ Time Frame: 12 months ]

To assess the effect of mHealth messages, mHealth quizzes, and sms-reminders on HPV-positive women's attendance to check-up appointments at 12 months compared to standard of care.

Current Secondary Outcome Measures (submitted: December 28, 2021)

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

• Original Secondary Outcome Measures: Not Provided

Current Other Pre-specified Outcome Measures (submitted: December 28, 2021)

• Cost-effectiveness of intervention [ Time Frame: Baseline + 14 months ]
  Incremental cost-effectiveness ratio
• Knowledge of cervical cancer and screening [ Time Frame: Baselie + 14 months ]
  16 item true-false questionaire

• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Use of SMSs to Improve Attendance to Cervical Cancer Follow-up Screening
• Official Title: Text Messages to Increase Attendance to Follow-up Cervical Cancer Screening Appointments Among HPV Positive Tanzanian Women (Connected2Care)
• 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 Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Care Provider, Outcomes Assessor); Primary Purpose: Screening
• Condition: Cervical Cancer

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

Study Arms

• 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.
  Intervention: Behavioral: Connected to Care
• No Intervention: Control
  The control group will receive standard care, which is a follow-up appointment at 14 months written on an appointment card.

Publications *

• 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.
• Lokke KF, Rasch V, Mwaiselage J, Gammeltoft T, Linde DS. Acceptability of text messages and knowledge change for cervical cancer screening: a Tanzanian mixed methods study. BMJ Open. 2022 Sep 19;12(9):e058450. doi: 10.1136/bmjopen-2021-058450.
• Palmer MJ, Henschke N, Villanueva G, Maayan N, Bergman H, Glenton C, Lewin S, Fonhus MS, Tamrat T, Mehl GL, Free C. Targeted client communication via mobile devices for improving sexual and reproductive health. Cochrane Database Syst Rev. 2020 Jul 14;8(8):CD013680. doi: 10.1002/14651858.CD013680.
• Linde DS, Andersen MS, Mwaiselage J, Manongi R, Kjaer SK, Rasch V. Effectiveness of One-Way Text Messaging on Attendance to Follow-Up Cervical Cancer Screening Among Human Papillomavirus-Positive Tanzanian Women (Connected2Care): Parallel-Group Randomized Controlled Trial. J Med Internet Res. 2020 Apr 2;22(4):e15863. doi: 10.2196/15863.
• Linde DS, Rasch V, Mwaiselage JD, Gammeltoft TM. Competing needs: a qualitative study of cervical cancer screening attendance among HPV-positive women in Tanzania. BMJ Open. 2019 Feb 27;9(2):e024011. doi: 10.1136/bmjopen-2018-024011.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: December 28, 2021): 705
• Original Estimated Enrollment (submitted: July 25, 2015): 950
• Actual Study Completion Date: October 6, 2019
• Actual Primary Completion Date: October 6, 2019 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 25 Years to 60 Years (Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Tanzania

Administrative Information

• NCT Number: NCT02509702
• Other Study ID Numbers: Connected2Care
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Marianne Andersen, Odense University Hospital
• Original Responsible Party: Same as current
• Current Study Sponsor: Marianne Andersen
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

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

• PRS Account: Odense University Hospital
• Verification Date: December 2021