Recruitment of young women to a trial of chlamydia screening – as easy as it sounds?

Atherton, Helen; Banks, Debbie; Harbit, Ruth; Long, Linzie; Chadd, Fiona; Hay, Phillip; Kerry, Sally; Simms, Ian; Oakeshott, Pippa

doi:10.1186/1745-6215-8-41

Cited by 12 publications

(18 citation statements)

References 7 publications

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“…The design and recruitment methods of the Prevention of Pelvic Infection (POPI) chlamydia screening trial have been described elsewhere [21,22]. Briefly, 2529 female students were recruited from 20 London universities and further education colleges.…”

Section: Methodsmentioning

confidence: 99%

IsMycoplasma genitaliumin Women the “New Chlamydia?” A Community‐Based Prospective Cohort Study

et al. 2010

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Section: Methodsmentioning

confidence: 99%

IsMycoplasma genitaliumin Women the “New Chlamydia?” A Community‐Based Prospective Cohort Study

et al. 2010

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“…Recent research has focused on strategies of how recruitment can be improved in different settings of clinical research [17-19] and systematic reviews on the topic have identified several interventions, e.g. increasing awareness of the health problem being studied, monetary incentives, using an ‘open label’ rather than placebo design, or making trial materials culturally sensitive [20-22].…”

Section: Introductionmentioning

confidence: 99%

Learning from failure - rationale and design for a study about discontinuation of randomized trials (DISCO study)

Kasenda

Elm

You

et al. 2012

BMC Med Res Methodol

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BackgroundRandomized controlled trials (RCTs) may be discontinued because of apparent harm, benefit, or futility. Other RCTs are discontinued early because of insufficient recruitment. Trial discontinuation has ethical implications, because participants consent on the premise of contributing to new medical knowledge, Research Ethics Committees (RECs) spend considerable effort reviewing study protocols, and limited resources for conducting research are wasted. Currently, little is known regarding the frequency and characteristics of discontinued RCTs.Methods/DesignOur aims are, first, to determine the prevalence of RCT discontinuation for specific reasons; second, to determine whether the risk of RCT discontinuation for specific reasons differs between investigator- and industry-initiated RCTs; third, to identify risk factors for RCT discontinuation due to insufficient recruitment; fourth, to determine at what stage RCTs are discontinued; and fifth, to examine the publication history of discontinued RCTs.We are currently assembling a multicenter cohort of RCTs based on protocols approved between 2000 and 2002/3 by 6 RECs in Switzerland, Germany, and Canada. We are extracting data on RCT characteristics and planned recruitment for all included protocols. Completion and publication status is determined using information from correspondence between investigators and RECs, publications identified through literature searches, or by contacting the investigators. We will use multivariable regression models to identify risk factors for trial discontinuation due to insufficient recruitment. We aim to include over 1000 RCTs of which an anticipated 150 will have been discontinued due to insufficient recruitment.DiscussionOur study will provide insights into the prevalence and characteristics of RCTs that were discontinued. Effective recruitment strategies and the anticipation of problems are key issues in the planning and evaluation of trials by investigators, Clinical Trial Units, RECs and funding agencies. Identification and modification of barriers to successful study completion at an early stage could help to reduce the risk of trial discontinuation, save limited resources, and enable RCTs to better meet their ethical requirements.

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“…2 At baseline, participants completed questionnaires on demographic characteristics, sexual behaviour and history of sexually transmitted infections (STIs). They then provided selftaken vaginal swabs, which were stored in Aptima transport medium (Gen-Probe Inc.,).…”

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Incidence of pelvic inflammatory disease in untreated women infected with Chlamydia trachomatis

Aghaizu

Atherton

Mallinson³

et al. 2008

Int J STD AIDS

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Incidence of pelvic inflammatory disease in untreated women infected with Chlamydia trachomatisSir: Risser and Risser's interesting review shows that the evidence on the incidence of pelvic inflammatory disease (PID) in untreated chlamydia infected women is unclear. 1 They highlight numerous methodological issues concerned with the ability to infer an estimation of the incidence of PID following chlamydia infection, including small sample size, short duration of follow-up period and lack of adequate knowledge of the natural history of chlamydia.The POPI trial (Prevention of Pelvic Infection) is currently collecting data on the development of PID among 2524 female participants (mean age 21, range 16-27 years) recruited from 20 universities and further education colleges in 2004 -2006. 2 At baseline, participants completed questionnaires on demographic characteristics, sexual behaviour and history of sexually transmitted infections (STIs). They then provided selftaken vaginal swabs, which were stored in Aptima transport medium (Gen-Probe Inc.,). All participants were advised to get checked for STIs independently from the study.Within two weeks of recruitment swabs were randomly allocated into two groups. Intervention swabs were tested for chlamydia and infected women referred for treatment. Control group specimens were frozen and tested 12 months later. To see if freezing reduced transcription-mediated amplification test sensitivity, we froze 10 chlamydia-positive specimens at 2808C for a year. All remained positive when retested after 342 to 389 days.To date, an 86% (2161/2524) response rate for 12-month follow-up has been achieved, with questionnaires giving information on sexual behaviour, symptoms of possible PID and history of treatment within the follow-up period. These are verified by review of general practice and hospital records. In addition, 920 participants have returned repeat self-taken vaginal specimens for testing for chlamydia and other organisms 1 -3 years after recruitment.Although a relatively small study in terms of chlamydia positives, the results of our trial and prospective cohort study may contribute to Risser's findings on the incidence of PID. Risser notes that studies including asymptomatic women from settings other than sexual health clinics report a lower incidence of PID. 1 Preliminary results indicate an overall chlamydiapositivity rate of 5.5% (139/2511). Information on the persistence of infection or spontaneous resolution in untreated controls, and on incidence of new infections may further provide insight into the natural history of chlamydia among women recruited outside health-care facilities. 1

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Recruitment of young women to a trial of chlamydia screening – as easy as it sounds?

Cited by 12 publications

References 7 publications

IsMycoplasma genitaliumin Women the “New Chlamydia?” A Community‐Based Prospective Cohort Study

IsMycoplasma genitaliumin Women the “New Chlamydia?” A Community‐Based Prospective Cohort Study

Learning from failure - rationale and design for a study about discontinuation of randomized trials (DISCO study)

Incidence of pelvic inflammatory disease in untreated women infected with Chlamydia trachomatis

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