Abstract
BackgroundGenital Chlamydia trachomatis infection is a major public health problem worldwide affecting mostly youth. Sweden introduced an opportunistic screening approach in 1982 accompanied by treatment, partner notification and case reporting. After an initial decline in infection rate till the mid-90s, the number of reported cases has increased over the last two decades and has now stabilized at a high level of 37,000 reported cases in Sweden per year (85% of cases in youth). Sexual risk-taking among youth is also reported to have significantly increased over the last 20 years. Mobile health (mHealth) interventions could be particularly suitable for youth and sexual health promotion as the intervention is delivered in a familiar and discrete way to a tech savvy at-risk population. This paper presents a protocol for a randomized trial to study the effect of an interactive mHealth application (app) on condom use among the youth of Stockholm.Methods446 youth resident in Stockholm, will be recruited in this two arm parallel group individually randomized trial. Recruitment will be from Youth Health Clinics or via the trial website. Participants will be randomized to receive either the intervention (which comprises an interactive app on safe sexual health that will be installed on their smart phones) or a control group (standard of care). Youth will be followed up for 6 months, with questionnaire responses submitted periodically via the app. Self-reported condom use over 6 months will be the primary outcome. Secondary outcomes will include presence of an infection, Chlamydia tests during the study period and proxy markers of safe sex. Analysis is by intention to treat.DiscussionThis trial exploits the high mobile phone usage among youth to provide a phone app intervention in the area of sexual health. If successful, the results will have implications for health service delivery and health promotion among the youth. From a methodological perspective, this trial is expected to provide information on the strength and challenges of implementing a partially app (internet) based trial in this context.Trial registrationISRCTN 13212899, date of registration June 22, 2017.
Highlights
Genital Chlamydia trachomatis infection is a major public health problem worldwide affecting mostly youth
MHealth interventions to promote safe sexual practices Mobile health – mHealth is an increasingly popular way to deliver health promotive information to large parts of the public at low cost and serve as a complement to ongoing activities within the health care system. mHealth interventions could be suitable for youth and sexual health promotion as the intervention is delivered in a familiar and discrete way to a tech savvy at-risk population [26]. mHealth offers the possibility of a range of different interventions for example reminder, and motivational messages, peer feedback – each of which allows differing levels of engagement [27]
This could reduce costs for the healthcare system; testing and treatment are costly, more so, there are some indications of antibiotic use lead to resistance among C.trachomatis [29]. Such an intervention could be potentially delivered to youth across wide geographic areas at low cost. The aim of this pragmatic randomized trial is to compare the effectiveness of a mobile phone application to improve sexual health among youth of Stockholm County to routine care
Summary
This study is a multicentre (8 recruiting clinics), parallel group randomised controlled trial. At time of the recruitment a member of the research team or the midwife will provide information to youth who show interest in participating in the trial. Description of the control The participants in the control arm will receive an app, which will be a dummy application that will be downloaded onto their phones This app will not provide an information or have any interactive modules but will only contain only the study baseline and follow-up questionnaires. Sample size Sample size has been estimated on the assumption that the smart phone intervention to promote safe sexual practices is expected to increase the self-reported condom use among sexually active youth in Stockholm County by 20% i.e. from 50% to 70%. We plan to do individual interviews with a sample of youth from the intervention arm and hold focus-group discussions with 6–10 participants in each group
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