Trial protocol: a parallel group, individually randomized clinical trial to evaluate the effect of a mobile phone application to improve sexual health among youth in Stockholm County.

BACKGROUND: Genital 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. METHODS: 446 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. DISCUSSION: This 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 REGISTRATION: ISRCTN 13212899, date of registration June 22, 2017.

Development of a Mobile Phone App to Promote Safe Sex Practice Among Youth in Stockholm, Sweden: Qualitative Study.

BACKGROUND: Mobile health (mHealth) has been shown to be effective in increasing knowledge of sexual health among youth. To date, evaluations mostly refer to interventions delivered via computer, email, and text messages. The possibility of downloading apps on mobile devices has opened up opportunities to develop engaging interventions on safe sexual health promotion. To attract young users and have them engage with a sexual health app, it is important to involve youth in intervention development. OBJECTIVE: This study aimed to obtain input from youth on the content of a mobile phone app intended to promote safe sex and increase condom use among youth in Stockholm. METHODS: This study was conducted at the Youth Health Clinics (YHC) in Stockholm County, Sweden. A total of 15 individual in-depth interviews and 2 focus group discussions (with youth aged 18-23 years) were conducted at the YHC in Stockholm. Areas explored were: (1) youth perceptions of condom use (advantages and obstacles), (2) perceptions of mHealth to promote safe sexual practices, and (3) content development for a mobile phone app to promote safe sex. RESULTS: The smartphone app was developed based on the categories that emerged from the data. With regard to content, youth requested sex education, including information on sexually transmitted infections. In addition, condom-specific information, including practical usage technique, advice on how to have the condom talk, and how to decrease shame related to condom use, was requested. Youth suggested different modes to deliver the content, including text messages, movie clips, and push notifications. It was suggested that the tone of the messages delivered should be fun, entertaining, and supportive. The inputs from youth influenced the development of the following sections of the app: Condom Obstacles and Solutions; Quiz; Games; Self-Refection; Challenges; Stories by Peers (stories from peers and information from a doctor); Condom Tips, Pep Talk, and Boosting; and Random Facts. CONCLUSIONS: It is important to use input from youth when developing a smartphone intervention since the success of the intervention largely depends on the level of engagement and usage by youth. Furthermore, if proven efficient in increasing condom use, it is important that the development, including content and mode, is thoroughly described so that the intervention can be replicated. Likewise, if proven inefficient, it is important to learn from mistakes to improve and adjust the intervention. The effect of this smartphone app on safe sexual practices among youth is being evaluated in a pragmatic randomized controlled trial in Stockholm (ISRCTN13212899) and will be reported separately.