An interventional study of Connected to Care in Cervical Cancer, sponsored by Marianne Andersen. Completed at 3 sites in Tanzania. Open to female participants aged 25 Years to 60 Years. Per ClinicalTrials.gov, last updated 2021-12-29.
Sponsored by Marianne Andersen · Not applicable, Interventional, and Screening
This study evaluates the effect of the SMS intervention 'Connected2Care' on the attendance rate to cervical cancer screening follow-up appointments.
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.
1,881 studies on the registry are indexed under Uterine Cervical Neoplasms; 567 are open to participants now.
This study's enrollment of 705 is above the median of 100 across 1,377 interventional studies indexed under Uterine Cervical Neoplasms.
Browse Uterine Cervical Neoplasms studies →Marianne Andersen is the lead sponsor of 5 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
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
The control group will receive standard care, which is a follow-up appointment at 14 months written on an appointment card.
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
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.
Time frame: up to 14 months
Acceptability of text message intervention
6-point Likert scale (1: I do not like it at all - 6: I like it very much)
Time frame: Baseline + 2 years Follow-up (likert scale)
Acceptability of text message intervention
Qualitative interviews. Open-ended
Time frame: 2 years
Cost-effectiveness of intervention
Incremental cost-effectiveness ratio
Time frame: Baseline + 14 months
Knowledge of cervical cancer and screening
16 item true-false questionaire
Time frame: Baselie + 14 months
This study is completed, as verified in Dec 2021. You cannot join it, but the record below documents what was studied.
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Marianne Andersen