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Completed

NCT Number: NCT02509702

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

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

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Key information

Conditions

Cervical Cancer Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Neoplasms Neoplasms by Site Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms

Age range

25 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Mawenzi Regional Referral Hospital, Moshi, Kilimanjaro, Tanzania

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Connected to Care

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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)

  2. Acceptability of text message intervention

    Time frame: 2 years

    Qualitative interviews. Open-ended

Other outcomes

  1. Cost-effectiveness of intervention

    Time frame: Baseline + 14 months

    Incremental cost-effectiveness ratio

  2. Knowledge of cervical cancer and screening

    Time frame: Baselie + 14 months

    16 item true-false questionaire

Sponsors and collaborators

Lead sponsor

Marianne Andersen

Other

Registry information

Official study title

Text Messages to Increase Attendance to Follow-up Cervical Cancer Screening Appointments Among HPV Positive Tanzanian Women (Connected2Care)

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Jul 28, 2015
Registry last updated
Dec 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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