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

Primary Purpose

Cervical Cancer

Status
Completed
Phase
Not Applicable
Locations
Tanzania
Study Type
Interventional
Intervention
Connected to Care
Sponsored by
Marianne Andersen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Cervical Cancer focused on measuring Mobile health, Screening, Early detection of cancer, HPV, SMS intervention, RCT, Tanzania

Eligibility Criteria

25 Years - 60 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Mawenzi Regional Referral Hospital
  • Ocean Road Cancer Institute (ORCI)
  • Kilimanjaro Christian Medical Centre (KCMC)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Connected to Care

Control

Arm Description

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.

The control group will receive standard care, which is a follow-up appointment at 14 months written on an appointment card.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Acceptability of text message intervention
6-point Likert scale (1: I do not like it at all - 6: I like it very much)
Acceptability of text message intervention
Qualitative interviews. Open-ended

Full Information

First Posted
June 15, 2015
Last Updated
December 28, 2021
Sponsor
Marianne Andersen
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1. Study Identification

Unique Protocol Identification Number
NCT02509702
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)
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
August 17, 2015 (Actual)
Primary Completion Date
October 6, 2019 (Actual)
Study Completion Date
October 6, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Marianne Andersen

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Cancer
Keywords
Mobile health, Screening, Early detection of cancer, HPV, SMS intervention, RCT, Tanzania

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
705 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Connected to Care
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
The control group will receive standard care, which is a follow-up appointment at 14 months written on an appointment card.
Intervention Type
Behavioral
Intervention Name(s)
Connected to Care
Intervention Description
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
Primary Outcome Measure Information:
Title
Effect of SMS intervention on attendance rate to follow-up screening appointment
Description
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.
Time Frame
up to 14 months
Secondary Outcome Measure Information:
Title
Acceptability of text message intervention
Description
6-point Likert scale (1: I do not like it at all - 6: I like it very much)
Time Frame
Baseline + 2 years Follow-up (likert scale)
Title
Acceptability of text message intervention
Description
Qualitative interviews. Open-ended
Time Frame
2 years
Other Pre-specified Outcome Measures:
Title
Cost-effectiveness of intervention
Description
Incremental cost-effectiveness ratio
Time Frame
Baseline + 14 months
Title
Knowledge of cervical cancer and screening
Description
16 item true-false questionaire
Time Frame
Baselie + 14 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vibeke Rasch, MD
Organizational Affiliation
University of Southern Denmark
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Julius Mwaiselage, MD
Organizational Affiliation
Ocean Road Cancer Institute
Official's Role
Study Chair
Facility Information:
Facility Name
Mawenzi Regional Referral Hospital
City
Moshi
State/Province
Kilimanjaro
Country
Tanzania
Facility Name
Ocean Road Cancer Institute (ORCI)
City
Dar es Salaam
ZIP/Postal Code
3592
Country
Tanzania
Facility Name
Kilimanjaro Christian Medical Centre (KCMC)
City
Moshi
ZIP/Postal Code
3010
Country
Tanzania

12. IPD Sharing Statement

Citations:
PubMed Identifier
29162148
Citation
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.
Results Reference
background
PubMed Identifier
36123109
Citation
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.
Results Reference
derived
PubMed Identifier
32779730
Citation
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.
Results Reference
derived
PubMed Identifier
32238335
Citation
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.
Results Reference
derived
PubMed Identifier
30819704
Citation
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.
Results Reference
derived

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

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