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RESEARCH AND PRACTICE |
Kathleen P. Tebb, Samantha C. Pecson, Meaghan Pai-Dhungat, and Mary-Ann B. Shafer are with the Division of Adolescent Medicine, Department of Pediatrics, University of California, San Francisco. Robert H. Pantell is with the Department of Pediatrics, University of California, San Francisco. Charles J. Wibbelsman is with Kaiser Permanente, San Francisco. John M. Neuhaus is with the Department of Epidemiology and Biostatistics, School of Medicine, University of California, San Francisco. Ann C. Tipton and Timothy H. Ko are with Kaiser Permanente, Oakland, Calif.
Correspondence: Requests for reprints should be sent to Kathleen P. Tebb, PhD, University of California, San Francisco, School of Medicine, Department of Pediatrics, Division of Adolescent Medicine, Box 0503, San Francisco, CA 94143-0503 (e-mail: tebb{at}itsa.ucsf.edu).
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ABSTRACT |
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 TOP ABSTRACT INTRODUCTIONMETHODSRESULTSDISCUSSIONReferences |
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Objectives. We sought to determine the effectiveness of a systems-based intervention designed to increase Chlamydia trachomatis (CT) screening among adolescent boys.
Methods. An intervention aimed at increasing CT screening among adolescent girls was extended to adolescent boys (14–18 years). Ten pediatric clinics in a health maintenance organization with an ethnically diverse population were randomized. Experimental clinics participated in a clinical practice improvement intervention; control clinics received traditional information on screening.
Results. The intervention significantly increased CT screening at the experimental sites from 0% (baseline) to 60% (18-month posttest); control sites evidenced a change only from 0% to 5%. The overall prevalence of CT was 4%.
Conclusions. Although routine CT screening is currently recommended only for young sexually active women, the present results show that screening interventions can be successful in the case of adolescent boys, among whom CT is a moderate problem.
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INTRODUCTION |
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TOPABSTRACTINTRODUCTIONMETHODSRESULTSDISCUSSIONReferences |
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Consequently, all major policy groups recommend screening sexually active young women aged 15 to 25 years for CT infection,7–10 but only the American Medical Association guidelines recommend screening sexually active male adolescents for genital CT via urine leukocyte esterase analysis.11 The CT epidemic, especially asymptomatic infection, has been well documented among sexually active female adolescents.12,13 Earlier studies in which prevalence data were gathered from sexually active male adolescents primarily involved high-risk populations of poor urban youths, youths in detention, young military populations, and school-based clinic samples.14–18
Three recent studies focusing on prevalence rates among young adult men at lower risk are more indicative of rates among the overall young male population: the National Longitudinal Study of Adolescent Health documented a rate of 3.7%19; we found a rate of 3.8% in our study of healthy, asymptomatic young adolescent males receiving routine care in the pediatric departments of a large health maintenance organization (HMO)20; and a study conducted among young male army recruits revealed an infection rate of 5.3%.21 This potentially significant but largely undetected pool of CT infection in the general young adult male population can contribute to the overall CT epidemic and merits further attention.
With the advent of urine-based testing technologies, CT testing is more accessible, less invasive, and less expensive. The aim of this study was to increase CT screening among asymptomatic sexually active male adolescents and determine whether implementing a systems-based CT screening intervention was acceptable, feasible, and effective in a large HMO serving a multiethnic population of youths during pediatric health maintenance visits (HMVs).
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METHODS |
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TOPABSTRACTINTRODUCTIONMETHODSRESULTSDISCUSSIONReferences |
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Setting and Participants
The study was conducted in 10 geographically distinct ambulatory pediatric departments within a large HMO that serves one of every 3 adolescents in the ethnically diverse population of northern California. We identified the 15 sites with the largest adolescent enrollments within a 100-mi (160-km) radius of San Francisco. Our screening rate analysis included all sexually active 14- to 18-year-old male adolescents scheduled for routine HMVs between January 2001 and June 2002.
Procedures
All pediatric chiefs of the 15 eligible clinics (see Shafer et al.22 for eligibility criteria) agreed to participate and to have their individual clinic sites randomized, limiting selection bias. We selected the largest 10 clinics, each with 10 to 14 pediatric providers. Participants were unaware of the study conditions and were informed that the goal of the study was to evaluate 2 types of interventions that varied in intensity. The professional staff at the control clinics (e.g., health care providers, medical assistants, and administrators) attended a 1-hour lecture describing CT screening and urine-based testing recommendations.
Each intervention clinic established a quality improvement team that actively participated in a clinical practice improvement intervention involving the use of rapid cycle methodology to increase CT screening rates. In brief, clinic teams (e.g., a health care provider specializing in adolescent medicine, a medical assistant, a clinic manager, and a receptionist) established protocols for gathering confidential sexual histories and collecting urine samples. Each month, the teams reviewed protocols and screening rates and discussed ways to reduce barriers to screening. They made incremental changes to overcome barriers and then reassessed their performance according to monthly screening rates and quarterly chart reviews. The intervention methodology has been described in more detail elsewhere.22
All participants were requested to provide a first void urine specimen before seeing a clinician "in case the clinician needs it." In private, the provider queried participants about their sexual activity, explained the purpose of the urine specimen, and received sexually active adolescents’ verbal consent to be tested as part of a routine standard of care. CT urine specimens were then sent to the central HMO laboratory for processing via the strand displacement amplification technique (Becton Dickinson, Sparks, Md), allowing direct qualitative detection of CT and maintaining the cold chain.23
Because confidential gathering of sexual histories and appropriate STD screening are an integral part of routine pediatric practice,24 because the focus of the intervention was the system rather than the individual patient, and because data were pooled with no patient identifiers, the committees on human research at both participating institutions deemed it unnecessary to obtain written consent from the participants. For example, laboratory test results were routinely entered into the HMO central data system by hospital laboratory personnel, and all patient identifiers were eliminated before transfer to the authors for further data analysis. In addition, a 5-item anonymous survey (for which the response rate was above 70%) was administered confidentially to all adolescents having HMVs over the first 3 months of the study to obtain clinic-level race/ethnicity information, which is not routinely collected by the HMO.
Data Analysis
In our statistical analyses, we assessed differences in changes in urine-based CT screening rates over time between the intervention and control clinic sites using repeated measures analysis of variance25; we used the "Proc Mixed" routine in SAS (version 8; SAS Institute Inc, Cary, NC) to conduct the mixed-effects model analysis. The 18-month post-intervention period was divided into 6 separate 3-month intervals to provide more stable screening estimates and to monitor changes over time. Baseline screening information was also available from a 2-month time period that began with the first availability of the urine-based test and ended with the initiation of the study intervention. Thus, the data consisted of 7 repeated measurements for each of the 10 study sites.
The analysis of variance model, in which screening rate was the response variable, contained interaction terms that assessed differences in changes between treatment groups and provided estimates of the magnitudes of these changes. F tests were used to assess the statistical significance of the Time x Group effect. As a means of illustrating the magnitude of the treatment effects, the analysis of variance results were used in calculating predicted screening rate means (and their associated 95% confidence intervals [CIs]) according to time and treatment group (Table 1
and Figure 1).
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We used data from the exit polls to assess whether characteristics such as age, sexual activity, and ethnicity were balanced between the intervention and control groups. We used each characteristic as the outcome in a generalized linear model that included study group as the single explanatory variable and tested the hypothesis that the regression coefficient associated with study group had a value of zero. This allowed assessment of the hypothesis that mean values for characteristics were the same in the intervention and control groups. Specifically, we used a linear model with age, a logistic model with previous sexual activity, and a multinomial logistic model with ethnicity (Asian, Black, Latino, White, multiethnic, or other). We fit the models using generalized estimating equation routines included in the Stata package (Stata Corp, College Station, Tex) to accommodate within-site clustering of responses.26
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RESULTS |
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TOPABSTRACTINTRODUCTIONMETHODSRESULTSDISCUSSIONReferences |
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The race/ethnicity profile reflected the diversity of the greater San Francisco Bay area: 32% of participants were White, 28% were African American, 18% were Latino, 12% were Asian American, and 10% were categorized as multiethnic or "other." Significantly more Asians (27% vs 8%) and fewer Whites (24% vs 59%) visited the intervention clinics than the control clinics; thus, we accounted for these differences in our mixed-effects analysis of screening rates (see results described subsequently). No other significant ethnic differences were observed.
There were no significant differences in response rates according to study group (intervention group: 70.8%; control group: 71.4%; P= .634). Fewer than 5% of participants were unable or unwilling to provide a urine specimen upon request. At baseline, there were no significant differences between the estimated proportions of sexually active male adolescents screened for CT at control clinics and intervention clinics.
After implementation of the intervention, the percentage of male adolescents screened at intervention clinics was significantly greater than the percentage screened at control clinics. By the end of the study period, 48% (n = 58) of the estimated number of sexually active participants (n=121) had been screened for CT. In contrast, only 9% (n = 11) of the estimated number of sexually active participants (n = 128) at the control clinics had been screened.
As noted, because there were significant ethnic differences between the 2 study groups, we adjusted for the imbalance in ethnicity between groups by including site-specific baseline percentage of non-White participants as a covariate in the linear mixed-effects models. Adjustment for this covariate at each site had very little effect on the mixed-effects analysis. The predicted proportions of participants screened at each time point and the significance values for the Time Period x Study Group interaction from the ethnicity-adjusted analyses were nearly identical to those of the unadjusted analyses. Table 1
presents estimated percentages of participants screened according to time period and study group. The F test of the Time x Group interaction effect was highly significant (F6,60 = 4.54, P= .0007). The infection rate for the sample as a whole was 3.8% (95% CI = 2.5%, 5.5%).
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DISCUSSION |
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TOPABSTRACTINTRODUCTIONMETHODSRESULTSDISCUSSIONReferences |
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While considerable efforts are still needed to improve screening among young women, the question to screen or not to screen young males has been virtually ignored, despite a 1984 study suggesting the value of such screening.28 More recently, prevalence rates among relatively low-risk, younger adolescents are beginning to converge with the male rates of 3.7% to 5.3%.19–21 Establishing a better understanding of CT prevalence rates in otherwise healthy populations as well as the cost effectiveness of various strategies for screening young men as a means of preventing adverse outcomes of CT is still necessary to determine whether universal male screening should be recommended.
In our study, we used an intervention primarily designed to increase screening among female adolescents to learn more about the issues associated with male screening. Our findings show that the intervention developed for female adolescents translated effectively to male CT screening, resulting in a marked increase in male screening rates at the intervention clinics when screening took place in conjunction with an intervention in which young women were screened. By the end of the study, intervention clinic screening rates were 5-fold higher than control clinic rates, indicating the success of the intervention. We expect that these high rates were in part because of the fact that the male and female interventions occurred simultaneously.
At present, most professional organizations do not recommend male screening, and such screening is not a HEDIS performance measure. Therefore, it should not be surprising that, at the end of the study, half of the estimated number of sexually active male adolescents were not being screened. However, the male screening rate in our intervention clinics exceeded the female rate in our control clinics (21%)22 as well as reported national screening rates among young women (16 to 20 years) in commercial (27%) and Medicaid (41%) plans.27 As a preventive effort, screening of sexually active male adolescents was an initiative valued and actively supported by all of the pediatric site chiefs and clinic staff involved in this study, despite the lack of guidelines or requirements. These sites are continuing to screen male adolescents (along with female adolescents), even though this phase of the research has been completed.
This study involved a number of limitations. As discussed in the Methods section, we gathered data on sexual activity rates for a 3-month period to estimate rates during the study period. Given the magnitude of the change from baseline to study completion at the intervention sites and the magnitude of the difference between the intervention and control sites, it is unlikely that estimation errors would alter our findings. Also, this study of male screening occurred in parallel with an intervention focusing on female screening. Undoubtedly, there was some benefit to this pairing, and it is unclear what change would have occurred if the male intervention had been conducted in isolation; however, given the pressing need to screen sexually active female adolescents, we chose to conduct our interventions simultaneously rather than at the exclusion of screening young women.
An additional limitation is that we did not have individual provider information at baseline or at the subsequent follow-up periods. However, this was a system-level intervention, and it was not specifically targeted at individual pediatric providers. Furthermore, the study took place at an HMO where adolescents were assured confidentiality and there were no financial barriers to screening (i.e., laboratory fees were waived to maintain confidentiality). Finally, this study was conducted during routine HMVs, in which gathering of confidential sexual histories (from both male and female adolescents) is considered to be the standard of care. Thus, the generalizability of our results to other types of visits (e.g., urgent care) is not yet known but is currently being investigated by our research team. In addition, while generalizability to other types of clinics remains to be tested, we were able to demonstrate the feasibility of the intervention during HMVs taking place in busy community clinical settings.
CT infections appear to be common and largely asymptomatic among sexually active male adolescents. Such undetected infections have the potential for transmission to young women who then are at risk for developing major, often irreversible reproductive morbidity, especially infertility. CT also acts as a marker for a number of high-risk behaviors, including unprotected sexual intercourse with the potential for transmission of other sexually transmitted infections and pregnancy.
Our CT male screening program was effective in identifying a treatable condition with a moderate level of prevalence and morbidity via an accurate, acceptable, and feasible screening mechanism in a busy community clinic setting, and our results provide information about the potential translation of such screening to other office practice models beyond HMOs. Given emerging data on the prevalence of CT in healthy, asymptomatic male adolescents and the ease of obtaining urine-based specimens, it is time to reassess the need for screening sexually active young men to complement ongoing screening efforts among young women; it is even conceivable that these efforts would be synergistic.
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Acknowledgments |
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We wish to thank all of the Kaiser Permanente Northern California providers, staff, and administrators, especially the site "champions," who helped make this project possible. We also wish to acknowledge the support we received from all of the chiefs of pediatrics.
Human Participant Protection
This study was approved by the committee on human research of the University of California, San Francisco, and by the Kaiser Research Foundation Institute. Participants provided verbal consent for their urine samples to be tested.
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Footnotes |
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Contributors
K. P. Tebb, R. H. Pantell, C. J. Wibbelsman, A. C. Tipton, and M.B. Shafer helped conceive the study, conceptualize ideas, interpret findings, and review drafts of the article. K. P. Tebb led the writing and supervised all aspects of its implementation. J. M. Neuhaus assisted with the study methodology and completed and helped synthesize data analyses. S. C. Pecson and M. Pai-Dhungat assisted with study implementation, conceptualized ideas, and reviewed drafts of the article. T. H. Ko assisted with the study methodology and helped compile and synthesize data analyses.
Accepted for publication January 26, 2005.
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References |
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TOPABSTRACTINTRODUCTIONMETHODSRESULTSDISCUSSIONReferences |
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This article has been cited by other articles:
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  J. C. Frye, L. Wallace, R. S. Chavez, and D. A. Luce Screening and Treatment Guidelines for Chlamydia trachomatis in Incarcerated Adolescents: A Review Journal of Correctional Health Care, April 1, 2008; 14(2): 89 - 98. [Abstract] [PDF]
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 M. J. Park and D. Breland Starting on a Healthy Path: Promotion of Young Men's Sexual Health American Journal of Men's Health, June 1, 2007; 1(2): 148 - 153. [Abstract] [PDF]
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| HOME | HELP | FEEDBACK | SUBSCRIPTIONS | ARCHIVE | SEARCH | TABLE OF CONTENTS |
