Linde Ditte S, Andersen Marianne S, Mwaiselage Julius D, Manongi Rachel, Kjaer Susanne K, Rasch Vibeke
Department of Obstetrics and Gynaecology, Odense University Hospital, Odense, Denmark.
Institute of Clinical Research, University of Southern Denmark, Odense, Denmark.
Trials. 2017 Nov 21;18(1):555. doi: 10.1186/s13063-017-2215-x.
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.
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.
ClinicalTrials.gov, ID: NCT02509702 . Registered on 15 June 2015.
宫颈癌是坦桑尼亚一个主要的健康问题，这是由于宫颈癌筛查参与率低以及对高危女性的随访不足所致。移动电话健康干预措施已被证明是在非洲国家改善健康行为的有效工具。到目前为止，对于此类干预措施在低收入环境中与宫颈癌筛查相关的效果尚无了解。本研究旨在评估短信服务（SMS）干预措施能在多大程度上提高宫颈癌筛查中高危（HR）人乳头瘤病毒（HPV）检测呈阳性的女性的预约就诊率。
方法/设计：Connected2Care是一项非盲、多中心、平行组随机对照试验。纳入时HR HPV检测呈阳性的坦桑尼亚女性按1:1的分配比例随机分为短信干预组或对照组（标准护理）。在10个月的时间里，干预组将收到15条单向的健康教育短信以及预约提醒短信。总样本量为700，每个研究组各有350名女性。主要结局是随访就诊率。次要目标是通过增量比衡量的成本效益，以及在基线和随访时通过一份16项正误量表问卷评估的宫颈癌知识。将在一项混合方法的亚人群研究中评估实施干预措施的障碍。
本研究可能会提供有关针对HR HPV检测呈阳性、因此患宫颈癌风险增加的女性群体实施短信干预措施的潜在效果、成本和障碍的信息。这可以指导决策者在低收入环境中有效使用移动技术。试验状态：正在招募。
ClinicalTrials.gov，标识符：NCT02509702。于2015年6月15日注册。
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