Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2018 Feb 5;18(1):216.
doi: 10.1186/s12889-018-5110-9.

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

Anna Nielsen  1 , Ayesha De Costa  2 , Aspasia Bågenholm  2 , Kristina Gemzell Danielsson  3 , Gaetano Marrone  2 , Jens Boman  4 , Mariano Salazar  2 , Vinod Diwan  2
Affiliations
Randomized Controlled Trial

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

Anna Nielsen et al. BMC Public Health. .

Abstract

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.

Keywords: Chlamydia trachomatis; Pragmatic randomized controlled trial; Youth; mHealth; smart-phone application.

PubMed Disclaimer

Conflict of interest statement

Ethics approval and consent to participate

Written informed consent will be obtained from each participant. Participation is voluntary, confidentiality is assured and each participant will be informed that they can withdraw from the study at any time. The research protocol was approved by the Stockholm Regional Ethical board (reference number: 2017/651–31/4).

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Flow diagram
See this image and copyright information in PMC

Similar articles

See all similar articles

Cited by

References

    1. World Health Organization: Global Health Sector Strategy on Sexually Transmitted Infections 2016–2021 In. Retrieved 10.10.16 from: http://apps.who.int/iris/bitstream/10665/246296/1/WHO-RHR-16.09-eng.pdf?...; 2016. - PubMed
    1. Nigro G, Mazzocco M, Mattia E, Di Renzo GC, Carta G, Anceschi MM. Role of the infections in recurrent spontaneous abortion. J Matern Fetal Neonatal Med. 2011;24(8):983–9. - PubMed
    1. Thurman AR, Doncel GF. Innate immunity and inflammatory response to Trichomonas vaginalis and bacterial vaginosis: relationship to HIV acquisition. Am J Reprod Immunol. 2011;65(2):89–98. doi: 10.1111/j.1600-0897.2010.00902.x. - DOI - PubMed
    1. ECDC: European Centre for Disease prevention and Control; Chlamydia Control in Eurpoe - a survey of Member States. In. Retrieved 21.03.16 from: http://ecdc.europa.eu/en/publications/Publications/chlamydia-control-sur...; 2012.
    1. DS LM, Fenton KA, Randall S, Anderson S, Carter P. Establishing the National Chlamydia Screening Programme in England: results from the first full year of screening. Sex Transm Infect. 2004;80(5):335–341. doi: 10.1136/sti.2004.012856. - DOI - PMC - PubMed

Publication types

Associated data