One-Way Text Messages versus No Text Messages on Attendance to Follow-Up Cervical Cancer Screening Among HPV-Positive Tanzanian Women (Connected2Care): A Parallel-Group Randomised Controlled Trial

Background: Rapid HPV DNA testing is an emerging cervical cancer screening strategy in resource-limited countries, yet it requires follow-up of women who test HPV-positive. We conducted a randomised controlled trial to determine if one-way text messages improved attendance to a 14-months follow-up cervical cancer screening among HPV-positive women. Methods: This multi-centre, parallel-group randomised controlled trial was conducted at three hospitals in Tanzania. Eligible participants were between 25-60 years, had tested positive to a rapid HPV-test during a patient-initiated screening, been informed of their HPV-result, and had a private mobile phone with a valid number. Participants were randomly assigned 1:1 into the intervention or control group through an incorporated algorithm in the text message system. The intervention group received one-way text messages, and the control group received no text messages. The primary outcome was attendance to a 14-months health provider-initiated follow-up screening. Participants were not blinded but outcome assessors were. The analysis was intention-to-treat. Findings: Between August 2015 and July 2017, 4080 women were screened for cervical cancer of which 705 were included into this trial; 358 were allocated to the intervention group and 347 to the control group. Sixteen women were excluded prior to analysis due to developing cervical cancer or dying (eight from each group). In the intervention group, 84 women (24%) attended their follow-up screening, and in the control group 80 women (24%) attended (RR: 1·02; 95% CI: 0·79-1·33). Interpretation: Attendance to a health provider-initiated follow-up cervical cancer screening among HPV-positive women was strikingly low, and one-way text messages did not improve the attendance rate. Implementation of rapid HPV-testing at clinic level in Tanzania entails a challenge of ensuring a proper follow-up of women. Trial Registration: ClinicalTrials.gov;NCT02509702; active, not recruiting. Funding Statement: The study is funded by the Danish International Development Agency (Danida; 14-P02-Tan/A26775) and the University of Southern Denmark (internal funds). Declaration of Interests: There are no competing interests for any of the authors. Ethics Approval Statement: The study protocol has been published elsewhere, and joined ethical approval for all study sites was obtained from the National Institute for Medical Research in Tanzania.