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

NCT ID: NCT02509702

Last Updated: 2021-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

705 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-17

Study Completion Date

2019-10-06

Brief Summary

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

Detailed Description

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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.

Conditions

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Cervical Cancer

Keywords

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Mobile health Screening Early detection of cancer HPV SMS intervention RCT Tanzania

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

DOUBLE

Caregivers Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Connected to Care

Intervention Type BEHAVIORAL

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

Control

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

25 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Marianne Andersen

OTHER

Sponsor Role lead

Responsible Party

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Marianne Andersen

Clinical professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Vibeke Rasch, MD

Role: STUDY_CHAIR

University of Southern Denmark

Julius Mwaiselage, MD

Role: STUDY_CHAIR

Ocean Road Cancer Institute

Locations

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Mawenzi Regional Referral Hospital

Moshi, Kilimanjaro, Tanzania

Site Status

Ocean Road Cancer Institute (ORCI)

Dar es Salaam, , Tanzania

Site Status

Kilimanjaro Christian Medical Centre (KCMC)

Moshi, , Tanzania

Site Status

Countries

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Tanzania

References

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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.

Reference Type BACKGROUND
PMID: 29162148 (View on PubMed)

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.

Reference Type DERIVED
PMID: 36123109 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32779730 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32238335 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30819704 (View on PubMed)

Other Identifiers

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Connected2Care

Identifier Type: -

Identifier Source: org_study_id