Plain English Summary
Background and study aims
Chlamydia trachomatis (C.trachomatis) is the most commonly reported sexually transmitted infection (STI) worldwide. It is considered a major public health problem as it could lead to reproductive health issues such as infertility. It also increases the chances of getting the HIV infection. Secondary preventive strategies such as testing and treatment are important as they enable new cases to be detected and treated, interrupting the transmission chain. Many screening programs focus on secondary preventive strategies, alongside a varying element of prevention. Despite the recent focus on diagnosis and treatment, there has been a steady rise in infection rates among youth in Stockholm over the last two decades. However, primary preventive strategies such as condom campaigns, sexual education, and increased knowledge regarding STIs are equally, if not more, important in order to avoid new infections in the first place. A recent large population survey showed that a large number of youth reported not using a condom and did not use a condom with a new partner during their last intercourse. Staff in the Youth Health Clinics are stretched and therefore sometimes constrained with the preventive work they can do. Previous work from our research group has indicated that youth have varying level of knowledge and motivations to adopt safe sexual practices. C.trachomatis infection is highest in the youth, a group indeed familiar with and high consumers of mobile phone technology. The aim of this study is to evaluate the effects of a smart phone application to increase condom use and reduce risky sexual behaviour to see if it can be delivered to large groups of youth in Sweden and elsewhere at a low cost and support the preventive work of the screening programs.
Who can participate?
Youth aged 18 to 23 who own a smart phone and are sexually active.
What does the study involve?
Participants are randomly allocated to one of two groups. Those in the first group receive the mobile application called “"Skyddslaget”. This application provides information about sexual health and tips on a daily bases and send reminders to the users. Participants can use the application to complete challenges, quizzes, self-reflection and gain information about STIs and condom use. The application will include new activities for users. Participants in the second group receive a “dummy” or fake application. All participants are assessed before the study and again at three and six months with questionnaires to assess their sexual health habits and to compare the results between the groups.
What are the possible benefits and risks of participating?
Participants may benefit from the opportunity to reflect on their sexual behavior and this may help them engage in safe sexual practices. As sexual health is a sensitive topic, there is a risk that participants may feel uncomfortable.
Where is the study run from?
This study is being run by the Karolinska Institute (Karolinska Institutet) (Sweden) and takes place in eight youth health clinics in Sweden.
When is the study starting and how long is it expected to run for?
January 2017 to September 2018
Who is funding the study?
FORTE Swedish Research Council for Health, Working life and Welfare (Sweden)
Who is the main contact?
Mrs Anna Nielsen
anna.nielsen.1@ki.se
Trial website
Contact information
Type
Scientific
Primary contact
Mrs Anna Nielsen
ORCID ID
http://orcid.org/0000-0002-5189-6949
Contact details
Karolinska Institute (Karolinska Institutet)
Department of Women's and Children's Health (KBH)
K6
Division of Obstetrics and Gynecology
Karolinska Universitetssjukhuset
Kvinnokliniken
Stockholm
17176
Sweden
+46 70 4078496
anna.nielsen.1@ki.se
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
Protocol Version 1.9
Study information
Scientific title
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
Acronym
MOSEXY - TRIAL
Study hypothesis
The smart phone intervention designed to promote safe sexual practices will increase condom use and therefore reduce the rate of new infections, among sexually active youth in Stockholm County.
Ethics approval
The study was approved by the Regional Ethical Board in Stockholm (EPN Regionala Etikprövningsnämnden i Stockholm), 26/08/2017, ref: 2017/651-31/4
Study design
Multicentre interventional pragmatic randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Prevention
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Sexually Transmitted Infection / Condom Use
Intervention
Participants are individually randomly allocated to one of two groups. The randomisation allocation sequence is generated using a central computer-generated random numbers and is stratified by sex.
Intervention group: Participants receive the intervention in the form of a smart phone application called "Skyddslaget". The application delivers information and activities on a daily bases and users are reminded of the application by push-notices. The application includes things like condom-tips, self-reflections exercises, challenges, and information about sexually transmitted infections. The application will have one permanent part containing facts about STI and condoms and a second dynamic more interactive part. These include challenges and quiz, personal stories from peers, and self-rapport (elucidating ones behaviour in relation to sexual practices). Activities/information within each of these functions will be dynamic, i.e. change periodically over time such as activities. New information will be added in the application in a daily basis for 180 days. Participants are assessed at baseline and at follow up at three and six months to assess their sexual health.
Control group: Participants download a dummy application that only contains the baseline and follow-up questionnaires at three and six months.
Intervention type
Behavioural
Phase
Drug names
Primary outcome measure
Self-reported condom use during the past six months is measured using the assessment questionnaires at baseline, at three and six months.
Secondary outcome measures
1. Number of partners during the study period is measured using assessment questionnaires, at three and six months
2. Number of tests during the study period is measured using assessment questionnaires at six months
3. Occurrence of STI during the study period measured using assessment questionnaires at six months
4. Occurrence of pregnancy during study period is measured using assessment questionnaires at six months
Overall trial start date
23/01/2017
Overall trial end date
30/06/2019
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Youth aged 18-23
2. Youth who own a smart phone
3. Youth who are sexually active (had at least two partners during the past six months). Added 16/10/2017: This criteria is to ensure youth included in the trial have recently had sex outside a stable relationship
Participant type
Healthy volunteer
Age group
Adult
Gender
Both
Target number of participants
446
Participant exclusion criteria
Current exclusion criteria as of 20/11/2017:
1. Youth who do fulfil inclusion criteria
2. Youth who do not wish to participate
3. Women who only have sex with women will be excluded from the study as the interventions mainly focuses on safe sexual practices related to condom use
4. Close friend/sibling recruited into the trial
Exclusion criteria as of 05/09/2017:
1. Youth who do fulfil inclusion criteria
2. Youth who do not wish to participate
3. Women who only have sex with women will be excluded from the study as the interventions mainly focuses on safe sexual practices related to condom use
Previous exclusion criteria:
1. Youth who do fulfil inclusion criteria
2. Youth who do not wish to participate
Recruitment start date
01/09/2017
Recruitment end date
18/04/2018
Locations
Countries of recruitment
Sweden
Trial participating centre
Södermalm ungdomsmottagning (Youth Centre)
118 46
Sweden
Trial participating centre
Nacka ungdomsmottagning (Youth Centre)
131 53
Sweden
Trial participating centre
Farsta ungdomsmottagning (Youth Centre)
123 47
Sweden
Trial participating centre
Tyresö ungdomsmottagning (Youth Centre)
135 40
Sweden
Trial participating centre
Skärholmen ungdomsmottagning (Youth Centre)
127 48
Sweden
Trial participating centre
Midsommarkransen ungdomsmottagning (Youth Centre)
126 32
Sweden
Trial participating centre
Järva ungdomsmottagning (Youth Centre)
164 40
Sweden
Trial participating centre
Västerort ungdomsmottagning (Youth Centre)
162 61
Sweden
Sponsor information
Organisation
FORTE Swedish Research Council for Health, Working life and Welfare
Sponsor details
Östra Järnvägsgatan 27
Stockholm
101 37
Sweden
+46 8 775 40 70
forte@forte.se
Sponsor type
Research council
Website
Funders
Funder type
Research council
Funder name
Forskningsrådet om Hälsa, Arbetsliv och Välfärd
Alternative name(s)
Swedish Research Council for Health, Working Life and Welfare, FORTE
Funding Body Type
government organisation
Funding Body Subtype
Local government
Location
Sweden
Results and Publications
Publication and dissemination plan
The results of the trial will be published in a peer-reviewed journal. It will be of a doctoral thesis describing testing habits; sexual risk-taking and preventive strategies among youth in Stockholm County. All participants in the trial will, if they so wish, be notified about the findings after the trial period is over. Findings will also be communicated to stakeholders and policymakers in Stockholm County as well as to The Public Agency of Public Health. Finding will also be communicated to the public via media.
IPD sharing statement:
The datasets generated during and/or analysed during the current study are/will be available upon request from [anna.nielsen.1@ki.se]
Intention to publish date
30/09/2019
Participant level data
Available on request
Basic results (scientific)
Publication list
2018 protocol in https://www.ncbi.nlm.nih.gov/pubmed/29402241