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      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

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          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.

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          Most cited references17

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          Efficacy of risk-reduction counseling to prevent human immunodeficiency virus and sexually transmitted diseases: a randomized controlled trial. Project RESPECT Study Group.

          The efficacy of counseling to prevent infection with the human immunodeficiency virus (HIV) and other sexually transmitted diseases (STDs) has not been definitively shown. To compare the effects of 2 interactive HIV/STD counseling interventions with didactic prevention messages typical of current practice. Multicenter randomized controlled trial (Project RESPECT), with participants assigned to 1 of 3 individual face-to-face interventions. Five public STD clinics (Baltimore, Md; Denver, Colo; Long Beach, Calif; Newark, NJ; and San Francisco, Calif) between July 1993 and September 1996. A total of 5758 heterosexual, HIV-negative patients aged 14 years or older who came for STD examinations. Arm 1 received enhanced counseling, 4 interactive theory-based sessions. Arm 2 received brief counseling, 2 interactive risk-reduction sessions. Arms 3 and 4 each received 2 brief didactic messages typical of current care. Arms 1, 2, and 3 were actively followed up after enrollment with questionnaires at 3, 6, 9, and 12 months and STD tests at 6 and 12 months. An intent-to-treat analysis was used to compare interventions. Self-reported condom use and new diagnoses of STDs (gonorrhea, chlamydia, syphilis, HIV) defined by laboratory tests. At the 3- and 6-month follow-up visits, self-reported 100% condom use was higher (P<.05) in both the enhanced counseling and brief counseling arms compared with participants in the didactic messages arm. Through the 6-month interval, 30% fewer participants had new STDs in both the enhanced counseling (7.2%; P= .002) and brief counseling (7.3%; P= .005) arms compared with those in the didactic messages arm (10.4%). Through the 12-month study, 20% fewer participants in each counseling intervention had new STDs compared with those in the didactic messages arm (P = .008). Consistently at each of the 5 study sites, STD incidence was lower in the counseling intervention arms than in the didactic messages intervention arm. Reduction of STD was similar for men and women and greater for adolescents and persons with an STD diagnosed at enrollment. Short counseling interventions using personalized risk reduction plans can increase condom use and prevent new STDs. Effective counseling can be conducted even in busy public clinics.
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            Establishing the National Chlamydia Screening Programme in England: results from the first full year of screening.

            The phased implementation of the National Chlamydia Screening Programme (NCSP) began in September 2002. The NCSP offers opportunistic screening for chlamydia to women and men under 25 years of age attending clinical and non-clinical screening venues using non-invasive urine or vulvo-vaginal swab samples tested via nucleic acid amplification. This review describes the implementation of the NCSP, reports positivity rates for the first year, and explores risk factors for genital chlamydial infection. Cross sectional study of the first year's screening data from the NCSP. A standardised core dataset for each screening test was collected from 302 screening venues, excluding genitourinary medicine (GUM) clinics, across 10 phase 1 programme areas. We estimated chlamydia positivity by demographic and behavioural characteristics, and investigated factors associated with infection through univariate and multivariate analyses. Chlamydia positivity among people under 25 years of age screened in non-GUM settings was 10.1% (1538/15 241) in women and 13.3% (156/1172) in men. Risk factors varied by sex: for women-age 16-19, non-white ethnicity, and sexual behaviours were associated with infection; for men-only age 20-24 and non-white ethnicity were associated with infection. In the first phase of the NCSP, 16 413 opportunistic screens among young adults under 25 years of age were performed at non-GUM settings and testing volume increased over time. Rates of disease were similar to those found during the English screening pilot and were comparable to the first year of widespread screening in Sweden and the United States. The screening programme in England will continue to expand as further phases are included, with national coverage anticipated by 2008.
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              Innate immunity and inflammatory response to Trichomonas vaginalis and bacterial vaginosis: relationship to HIV acquisition.

              Most women contract HIV-1 through sexual intercourse with an infected partner. Highly prevalent, unreported and often asymptomatic lower genital tract infections, including bacterial vaginosis (BV) and trichomoniasis (Trichomonas vaginalis- TV), increase a woman's susceptibility to HIV-1 genital infection, given an exposure. A review of the literature from 1989 to the present was conducted. This article will review potential mechanisms by which BV and TV serve as HIV-1-enhancing cofactors including (i) initiation of a clinical or subclinical mucosal inflammatory response, (ii) alteration of innate mucosal immunity, (iii) alteration of normal vaginal microflora and pH, and (iv) weakening or breach of intact cervico-vaginal mucosa. The transmission of HIV-1, in the absence of cofactors, is poorly efficient. Understanding the mechanisms by which these infections enhance HIV-1 acquisition is important to designing effective, safe and evidence-based prevention modalities. © 2010 John Wiley & Sons A/S.
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                Author and article information

                Contributors
                anna.nielsen.1@ki.se
                ayesha.de.costa@ki.se
                sia.bagenholm@ki.se
                kristina.gemzell@ki.se
                gaetano.marrone@ki.se
                jens.boman@umu.se
                mariano.salazar@ki.se
                vinod.diwan@ki.se
                Journal
                BMC Public Health
                BMC Public Health
                BMC Public Health
                BioMed Central (London )
                1471-2458
                5 February 2018
                5 February 2018
                2018
                : 18
                : 216
                Affiliations
                [1 ]ISNI 0000 0000 9241 5705, GRID grid.24381.3c, Stockholm County Council. Department of Women’s and Childrens Health K6, , Karolinska University Hospital Solna, ; 17176 Stockholm, Sweden
                [2 ]ISNI 0000 0004 1937 0626, GRID grid.4714.6, Department of Public Health Sciences, , Karolinska Institutet, ; Tomtebodavägen 18 A, 171 77 Stockholm, Sweden
                [3 ]ISNI 0000 0000 9241 5705, GRID grid.24381.3c, Department of Women’s and Children’s Health K6’, , Karolinska University Hospital Solna, ; 17176 Stockholm, Sweden
                [4 ]ISNI 0000 0001 1034 3451, GRID grid.12650.30, Department of Clinical Microbiology, , Umeå Universitet, ; SE-90185 Umeå, Sweden
                Author information
                http://orcid.org/0000-0002-5189-6949
                Article
                5110
                10.1186/s12889-018-5110-9
                5799911
                29402241
                8f0d7f5e-05e2-4e3d-a8b6-3b0d306cb97d
                © The Author(s). 2018

                Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License ( http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

                History
                : 13 October 2017
                : 22 January 2018
                Funding
                Funded by: FORTE
                Categories
                Study Protocol
                Custom metadata
                © The Author(s) 2018

                Public health
                pragmatic randomized controlled trial,youth,chlamydia trachomatis,mhealth,smart-phone application

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