NCT02509702

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
705

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 15, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 28, 2015

Completed
20 days until next milestone

Study Start

First participant enrolled

August 17, 2015

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 6, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 6, 2019

Completed
Last Updated

December 29, 2021

Status Verified

December 1, 2021

Enrollment Period

4.1 years

First QC Date

June 15, 2015

Last Update Submit

December 28, 2021

Conditions

Keywords

Mobile healthScreeningEarly detection of cancerHPVSMS interventionRCTTanzania

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Acceptability of text message intervention

    Baseline + 2 years Follow-up (likert scale)

  • Acceptability of text message intervention

    2 years

Other Outcomes (2)

  • Cost-effectiveness of intervention

    Baseline + 14 months

  • Knowledge of cervical cancer and screening

    Baselie + 14 months

Study Arms (2)

Connected to Care

EXPERIMENTAL

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

Control

NO INTERVENTION

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

Interventions

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

Connected to Care

Eligibility Criteria

Age25 Years - 60 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Informed consent
  • HPV positive
  • Age 25 - 60 years
  • Private mobile phone

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Mawenzi Regional Referral Hospital

Moshi, Kilimanjaro, Tanzania

Location

Ocean Road Cancer Institute (ORCI)

Dar es Salaam, 3592, Tanzania

Location

Kilimanjaro Christian Medical Centre (KCMC)

Moshi, 3010, Tanzania

Location

Related Publications (5)

  • 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.

    PMID: 29162148BACKGROUND
  • 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.

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Vibeke Rasch, MD

    University of Southern Denmark

    STUDY CHAIR
  • Julius Mwaiselage, MD

    Ocean Road Cancer Institute

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Clinical professor

Study Record Dates

First Submitted

June 15, 2015

First Posted

July 28, 2015

Study Start

August 17, 2015

Primary Completion

October 6, 2019

Study Completion

October 6, 2019

Last Updated

December 29, 2021

Record last verified: 2021-12

Locations