Cervical Cancer
Conditions
Keywords
Mobile health, Screening, Early detection of cancer, HPV, SMS intervention, RCT, Tanzania
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.
Interventions
BEHAVIORALConnected 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
Sponsors
Marianne Andersen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
DOUBLE (Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
25 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effect of SMS intervention on attendance rate to follow-up screening appointment | 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
| Measure | Time frame | Description |
|---|---|---|
| Acceptability of text message intervention | 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) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Cost-effectiveness of intervention | Baseline + 14 months | Incremental cost-effectiveness ratio |
| Knowledge of cervical cancer and screening | Baselie + 14 months | 16 item true-false questionaire |
Countries
Tanzania
Outcome results
None listed