BACKGROUND: Cervical cancer is a major health concern in Tanzania, caused by poor attendance for cervical cancer screening and follow-up of women at risk. Mobile telephone health interventions are proven effective tools to improve health behaviour in African countries. So far, no knowledge exists on how such interventions may perform in relation to cervical cancer screening in low-income settings. This study aims to assess the degree to which a Short Message Service (SMS) intervention can increase attendance at appointments among women who have tested positive for high-risk (HR) Human Papillomavirus (HPV) during cervical cancer screening. METHODS/DESIGN: 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. Barriers against implementing the intervention will be assessed in a mixed-methods sub-population study. DISCUSSION: This study may provide information on the potential effects, costs, and barriers in implementing an SMS intervention targeting a group of women who are followed up after testing positive for HR HPV and are, therefore, at increased risk of developing cervical cancer. This can guide decision-makers on the effective use of mobile technology in a low-income setting. Trial status: recruiting. TRIAL REGISTRATION: ClinicalTrials.gov, ID: NCT02509702 . Registered on 15 June 2015.
Background: Rapid human papillomavirus (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. Objective: This study aimed to determine if one-way text messages improved attendance to a 14-month follow-up cervical cancer screening among HPV-positive women. Methods: This multicenter, parallel-group randomized controlled trial was conducted at 3 hospitals in Tanzania. Eligible participants were aged between 25 and 60 years, had tested positive to a rapid HPV test during a patient-initiated screening, had been informed of their HPV result, and had a private mobile phone with a valid number. Participants were randomly assigned in a 1:1 ratio to 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 at a 14-month health provider-initiated follow-up screening. Participants were not blinded, but outcome assessors were. The analysis was based on intention to treat. Results: Between August 2015 and July 2017, 4080 women were screened for cervical cancer, of which 705 were included in this trial—358 women were allocated to the intervention group, and 347 women were allocated to the control group. Moreover, 16 women were excluded before the analysis because they developed cervical cancer or died (8 from each group). In the intervention group, 24.0% (84/350) women attended their follow-up screening, and in the control group, 23.8% (80/335) women attended their follow-up screening (risk ratio 1.02, 95% CI 0.79-1.33). Conclusions: 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 as a primary screening method at the clinic level entails the challenge of ensuring a proper follow-up of women. Trial Registration: ClinicalTrials.gov NCT02509702; https://clinicaltrials.gov/ct2/show/NCT02509702.