Clinical trial NCT02509702: 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
Overall status: COMPLETED
Phase: NA
Conditions: Cervical Cancer
Keywords: Mobile health
Screening
Early detection of cancer
HPV
SMS intervention
RCT
Tanzania
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
First posted: 2015-07-28
Enrollment: 705
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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.

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

Primary outcomes:
measure: Effect of SMS intervention on attendance rate to follow-up screening appointment
timeFrame: up to 14 months
Secondary outcomes:
measure: Acceptability of text message intervention
timeFrame: Baseline + 2 years Follow-up (likert scale)
measure: Acceptability of text message intervention
timeFrame: 2 years
Other outcomes:
measure: Cost-effectiveness of intervention
timeFrame: Baseline + 14 months
measure: Knowledge of cervical cancer and screening
timeFrame: Baselie + 14 months
Locations:
city: Moshi
country: Tanzania
facility: Mawenzi Regional Referral Hospital
state: Kilimanjaro
city: Dar es Salaam
country: Tanzania
facility: Ocean Road Cancer Institute (ORCI)
city: Moshi
country: Tanzania
facility: Kilimanjaro Christian Medical Centre (KCMC)
Study officials:
affiliation: University of Southern Denmark
name: Vibeke Rasch, MD
role: STUDY_CHAIR
affiliation: Ocean Road Cancer Institute
name: Julius Mwaiselage, MD
role: STUDY_CHAIR
References:
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.
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.
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.
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.
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.