Adolescent Chlamydia Screening in Pediatric Primary Care: A Quality Improvement Project

Abstract

AIM:

To increase Chlamydia trachomatis screening in adolescents 15–19 years of age from 7.8% to 15% following a 6-week implementation of universal chlamydia screening at three pediatric primary care (PPC) sites.

Methods:

Pre-implementation (1/1/22–10/19/22) and post-implementation (10/20/22–6/1/23) screening rates were tracked through run charts and compared via Chi-square testing. Universal opt-out chlamydia screening with universal urine collection for 15 to 19-year-old was implemented at well visits, along with patient and staff education, and sexually transmitted infection treatment protocols.

Results:

Chlamydia trachomatis screening increased from 7.8% to 34.1% with implementation of universal opt-out chlamydia screening. Proportions of patients screened increased significantly among White individuals, males, and privately insured individuals.

Conclusions:

A universal C. trachomatis screening project can be feasibly implemented in pediatric primary care and successfully increase adolescent chlamydia screening rates.

Implications for the profession:

Implementing a universal opt-out C. trachomatis screening project is feasible in PPC and can help achieve the public health goal of chlamydia identification and treatment.

Impact:

These findings will be impactful for both pediatric primary care and adolescent patients. The universal, opt-out C. trachomatis screening approach facilitated screening increases, improved equity in screening, and led to increased case detection and treatment which has vast significance for those patients.

Reporting Method:

This manuscript is submitted using the SQUIRE 2.0 guidelines for quality improvement reporting.

Patient Contribution:

Patient contribution included de-identified data collection of chlamydia screening rates of eligible adolescents 15–19 years old who attended routine well visits at the three PPC locations. The data were reviewed on a dashboard, then stratified by race, ethnicity, payor and sex assigned at birth.

Background

• Chlamydia trachomatis is the most common sexually transmitted infection (STI) in the United States

• Numerous medical organization guidelines recommend routine C. trachomatis screening

• Our primary objective was to implement a universal opt-out C. trachomatis screening Quality Improvement project across three pediatric primary care sites

Chlamydia trachomatis, the most common sexually transmitted infection (STI) in the United States (Centers for Disease Control and Prevention [CDC], 2021), is spread through vaginal, anal, or oral sex. The CDC (2021) estimates that two-thirds of all new infections occur in adolescents and young adults between 15 and 24 years of age. In 2018, incident STIs were responsible for $16 billion in direct lifetime medical costs, with more than $4 billion associated with youth infections (CDC, 2021). Chlamydia trachomatis is often referred to as a “silent” infection as it is asymptomatic in up to 80% of cases (CDC, 2021), emphasizing the need for routine population-level screening. If untreated, C. trachomatis can lead to serious complications including pelvic inflammatory disease (PID), tubal infertility, ectopic pregnancy, and chronic pelvic pain for females; and epididymitis for males (CDC, 2021).

To prevent severe sequelae following untreated C. trachomatis infections and reduce its high economic burden, numerous medical organization guidelines recommend routine C. trachomatis screening (Davidson, et al., 2021; CDC, 2021; Murray et al., 2014). The U.S. Preventative Services Task Force (USPSTF) specifically recommends routine screening for C. trachomatis and Neisseria gonorrhoeae in all sexually active women 24 years or younger (Davidson, et al., 2021). Similarly, screening sexually active women 16–24 years of age is a federal Quality Measures Reporting System measure (Healthcare Effectiveness Data and Information Set (HEDIS), 2024). Yet, despite strong recommendations, C. trachomatis screening rates in adolescents are highly variable and suboptimal across pediatric clinics, despite rising U.S. C. trachomatis prevalence (Wood et al., 2022; CDC, 2023). Additionally, adolescent screening inequities also are a barrier to effective population-level screening, with lower screening rates in those who are younger or have commercial insurance rather than public (e.g. Medicaid) insurance (Shafii & Levine, 2020; Wiehe et al., 2011). There are also racial disparities in adolescent C. trachomatis screening, with significantly higher rates of screening among non-Hispanic Black and Hispanic adolescents than their White peers (Wood et al., 2022; CDC, 2023).

Prior research supports the effectiveness of universal opt-out C. trachomatis screening--where screening is offered to all adolescents regardless of sex or assumed/assessed risk--in high C. trachomatis prevalence regions. The feasibility of implementing opt-out screening programs has been demonstrated in pediatric primary care settings (Allison et al., 2022; DiVasta et al., 2016; Douglas et al., 2021; Elattma et al., 2020; Tomcho et al., 2021; Wood et al., 2019; Wood et al., 2022). Universal opt-out C. trachomatis screening programs have been shown to decrease STI stigma, increase equitable C. trachomatis screening and treatment, and provide a critical opportunity for screening adolescents who may not be comfortable disclosing sexual activity (DiVasta et al., 2016; Douglas et al., 2021, Tomcho et al., 2021, Wood et al., 2022).

Therefore, based on evidence and expert recommendations, our primary objective was to establish a universal opt-out C. trachomatis screening quality improvement (QI) project across three pediatric primary care (PPC) sites.

Methods

• Three primary care sites from the Children’s Hospital of Philadelphia primary care network were chosen for the project locations

• Lewin’s Change Theory and Plan-Do-Study-Act Model for Improvement were utilized as our project frameworks

• Our SMART Aim was to increase the three-PPC-site C. trachomatis screening rate in all adolescents 15–19 years of age from 5.7% to 15% following a 6-week period

Context and Setting

We conducted our project at three clinics within the Children’s Hospital of Philadelphia (CHOP) primary care network, which includes more than 30 suburban PPC sites in the northeastern United States. The 3 PPC sites were situated in Delaware County, which had a C. trachomatis prevalence rate (in 2017–2019) of 535.9 cases per 100,000 people (Pennsylvania County Health Profile, 2022), higher than the Pennsylvania state-wide rate of 462.1 cases per 100,000 people (Pennsylvania County Health Profile, 2022). Combined, the sites employed 17 physicians and nurse practitioners providing care for more than 22,000 pediatric patients, including ~4,800 adolescents between 15 and 19 years of age. Clinic patients were majority (56.6%) commercially, 31.5% Black or African American, and 5.6% is Hispanic or Latino.

Prior to the project, there was not a standardized STI screening protocol at the PPC sites. During 2021, 2,509 routine adolescent (15–19 years) well visits were conducted across the PPC sites, with a C. trachomatis test positivity rate of 13.7% and a screening rate of 3.9% among females aged 15 to 19 years. This baseline screening rate was substantially lower than the CDC’s published national estimate of 37.4% of U.S. female adolescents 15 to 19 years of age (between 2015–2019) self-report themselves as sexually active (Abma & Martinez, 2023). At the time of the project, a physician-based financial incentive for STI screening of sexually active females had been in place for that fiscal year to improve network-wide screening rates. In addition, participating physicians received MOC credit-- which is the American Board of Pediatrics (ABP) physician continuing education credit required for maintaining board certification status (ABP, 2023). To motivate and encourage PPC provider participation, Type 4 ABP MOC credit was given to physician providers actively participating in the project.

Theoretical Framework

We applied Lewin’s Change Theory as our theoretical framework. This behavioral change theory focuses on three stages of change: unfreezing, moving, and refreezing (Utley, Henry & Smith, 2018). During unfreezing, individuals prepare for change through education, problem identification, and undoing current practices. During moving, individuals accept and implement change through brainstorming, coaching, decreasing negative forces, and identifying benefits of change. During refreezing, the change becomes the new standard and further change is resisted (Utley, Henry & Smith, 2018; Wojciechowski et al., 2016). A Plan-Do-Study-Act (PDSA) Model for Improvement was applied as a guiding Quality Improvement (QI) framework with continuous review by interdisciplinary project team members to ensure a collaborative approach and reinforce PDSA change process implementation.

SMART Aim

Our SMART aim—an improvement goal guiding Specific (S), Measurable (M), Achievable (A), Relevant (R) and Timely (T) change (Jones et al., 2019)—was to increase the three-PPC-site C. trachomatis screening rate in all adolescents 15–19 years of age from 5.7% to 15% following a 6-week period of universal opt-out C. trachomatis screening implementation. The SMART aim 5.7% baseline rate was evaluated pre-implementation based on available data which included only assigned female sex at birth individuals. The data for both male and female adolescents later demonstrated a baseline screening rate of 7.8% for all adolescents (Table 1).

Table 1.

Pre and post-implementation Chlamydia trachomatis screening rates and patient demographics

	Pre-Implementationa (n/% screenedc) N=173	Post-Implementation (n/% screened) N=492	p valueb
Chlamydia trachomatis screening rate c	7.8% (173/2,225)	34.1% (492/1,441)	p <0.001
Chlamydia trachomatis positivity rate d	9.1% (18/198)	6.5% (32/492)	p =0.24
Patient Demographics e
Race
Black	77 (12.38%)	201 (48.91%)	p <0.001
White	76 (6.02%)	217 (27.86%)	p <0.001
Asian	2 (1.89%)	18 (23.38%)	p <0.001
Other	20 (5.99%)	73 (29.55%)	P <0.001
Ethnicity
Hispanic/Latino	14 (13.73%)	20 (40.82%)	p <0.001
Not Hispanic/Latino	159 (7.51%)	471 (33.96%)	p <0.001
Payor
Private	96 (6.69%)	285 (32.13%)	p <0.001
Not Private	71 (9.62%)	197 (37.60%)	p <0.001
Sex f
Female	115 (10.69%)	253 (35.53%)	p <0.001
Male	58 (5.05%)	239 (32.78%)	p <0.001

Note.

^aPre-implementation time frame is from 1/1/22–10/19/22 and the post-implementation time frame is 10/20/22–6/1/23.

^bChi-square tests were performed to compare screening rates between the pre and post implementation periods.

^cScreening rate calculated as tests ordered at the well visit or in the year prior for male and female adolescents, over total well visit encounters during the time period.

^dDefined as positive tests over tests sent, including test sent at both sick and well visits.

^eComparisons of pre and post-implementation screening rates by patient demographics were analyzed using Chi-squared tests (e.g. comparison of screening rates in Black patients post-implementation were compared to Black patients pre-implementation). Data includes all adolescents 15 to 19 years of age attending well visits.

^fSex is defined as sex assigned at birth and documented as male or female in the patient’s electronic medical record.

Quality Improvement Intervention Components

Universal opt-out offer of C. trachomatis and N. gonorrhoeae screening:

We chose a universal opt-out screening strategy for all adolescents, irrespective of sexual activity, as our primary intervention in order to normalize STI screening, standardize care, and be a more inclusive practice for adolescents.

Team Building:

We established an interprofessional project team with a nurse practitioner (NP)-project lead (responsible for project oversight; development, management, and evaluation of the universal screening implementation plan; and review of data collection and PDSA cycles), two PPC provider leads (one NP and one physician responsible to be change agents and disseminate project goals and activities), and one nurse lead (liaison between the project team and PPC nursing staff). The two provider leads were key in reviewing the project and evidence-based practice recommendations as well as helping to implement the processes within their office structures and organizational culture.

Patient and Family Education:

We created a patient and family educational handout, available in English and Spanish, to explain the newly implemented universal C. trachomatis screening process at all scheduled well visits for 15–19 year old patients at the three PPC sites. The handout provided information and national/county statistics about C. trachomatis infections, recommendations from federal and professional organizations, and testing details.

Workflow Reorganization and Universal Opt-Out Screening Offer:

Process maps detailing universal screening logistics for the PPC sites were developed. The current practice was for providers to order tandem C. trachomatis and N. gonorrhoeae NAAT based on sexual history risk assessment, with a urine sample collection at the well visit end. Based on process map reviews, the new workflow for implementing universal opt-out screening included: 1) after visit check-in, patients and families received the patient/family C. trachomatis screening handout and the patient completed the Adolescent Health Questionnaire (AHQ) (DiFiore et al., 2023) including questions assessing sexual history; 2) after entering the exam room, patients were asked to provide a urine sample for C. trachomatis and N. gonorrhoeae NAAT testing; 3) providers reviewed the AHQ responses; 4) providers entered the exam room and offered the screening for C. trachomatis and N. gonorrhoeae; 5) patients provided or declined consent for C. trachomatis screening; and 6) if consent was received, the PPC staff completed the appropriate order process. Although vaginal sampling is the preferred specimen for C. trachomatis screening (Papp et al., 2014), vaginal swab collection was not a routine practice in our pediatric setting and there were concerns noted by the project team about acceptability barriers in patients and clinicians. Given the need to prioritize feasibility and acceptability in a clinic-wide implementation, the project utilized first catch urine-based nucleic acid amplification testing (NAAT) tandem screening for N. gonorrhoeae and C. trachomatis. Vaginal swab collection remained an option for clinicians to screen female patients per the CHOP Primary Care Clinical Pathway for Evaluation/Treatment of Sexually Transmitted Infections in Adolescents (Mollen et al, 2024). Neisseria gonorrhoeae test positivity rates were also monitored during the project.

Safeguarding Adolescent Confidentiality:

Per Pennsylvania state confidentiality laws, which were reviewed with PPC providers and staff, PPC patients younger than 18 years could consent to test or receive treatment for STIs without parental consent (Browne, 2015). However, due to transparency in electronic health record (EHR) documentation and insurance billing confidentiality risks remained an ongoing barrier. Notably, C. trachomatis tests sent to outside laboratories could create confidentiality breaches, as the privacy protections at commercial labs were outside of the jurisdiction of the implementation team. To prevent confidentiality breaches, we used a multifaceted approach including 1) inclusion of language explaining confidentiality safeguards for C. trachomatis in patient/family handouts, 2) scripting separate conversations with adolescents and families to ensure confidentiality, and 3) making PPC providers solely responsible for informing the adolescent of a positive test result and ensuring that results were not released to parents or guardians without prior consent of the adolescent.

Staff Education and Engagement:

The project team conducted a virtual educational meeting for the 17 PPC providers and nurse leader one day before the implementation launch. Providers received detailed information about the patient/family handout, universal opt-out screening process map, and reviewed the recommendation for universal C. trachomatis screening change. We sent emails to the PPC’s 17 providers at weeks 3 and 6 to encourage engagement with the QI process. A debrief meeting at the project end (after week 6) was conducted with provider leads to evaluate implementation process steps and discuss potential revisions. Participating physicians could apply to receive American Board of Pediatrics (ABP) Type 4 Maintenance of Certification (MOC) credit.

Establishing treatment protocols:

For any positive C. trachomatis and N. gonorrhoeae results, appropriate treatment occurred utilizing the CHOP Primary Care Clinical Pathway for Evaluation/Treatment of Sexually Transmitted Infections in Adolescents (Mollen et al, 2024). The Clinical Pathway is based on the CDC Sexually Transmitted Infections Treatment Guidelines (Workowski et al., 2021), and delineates treatment options, procedures for expedited partner therapy, follow up recommendations, and further testing for other STIs and HIV.

Data auditing:

To monitor the universal screening intervention, post-launch project team meetings were scheduled at week 2, 4 and 6 to evaluate the PDCA cycle success and review screening rates captured via de-identified EHR data.

Measures

Our primary outcome was C. trachomatis screening rates for adolescents 15–19 years old attending routine well visits at the three PPC locations. Screening rates were measured using EHR data displayed in a commercial business intelligence platform (Qlik, Radnor PA). The C. trachomatis screening rate was defined as an order of a C. trachomatis test on the day of the well visit or prior 364 days over the number of well visits for adolescents aged 15 to 19 years at the PPC sites. Well visits were defined using EHR-based International Classification of Disease-10 codes. Data were de-identified and visible as continuously updating screening rate run charts on the dashboard. The pre-implementation period was defined as January 1, 2022 to October 19, 2022. Post-implementation data was gathered from October 20, 2022 to June 1, 2023. The dashboard application also captured the percentage of adolescents who had a positive C. trachomatis nucleic acid amplification assay. Data was further stratified by race, ethnicity, payor, and sex assigned at birth (Table 2).

Table 2.

Evaluation of Positivity of Chlamydia trachomatis and Neisseria gonorrhoeae

	Pre-Implementation (1/1/22–10/19/22)				Post-Implementation (10/20/22–6/1/23)
	CT a (nb=198)		NG c(n=198)		CT (n=492)		NG (n=492)
Positivity, n (%)	18 (9.09%)		3 (1.52%)		32 (6.50%)		4 (0.81%)
Positive Cases by Sex, n (%)	Female	Male	Female	Male	Female	Male	Female	Male
	11 (61.11%)	7 (38.89%)	2 (66.67%)	1 (33.33%)	21 (65.63%)	11 (34.38%)	3 (75%)	1 (25%)
Treated, n (%)	18 (100%)		3 (100%)		31 (96.88%)		4 (100%)
Time to treatment in days d, Mean (SD)	0.39 (1.5)		0 (0)		3.06 (10.72)		1.5 (1.29)

Note.

^aCT= Chlamydia trachomatis,

^bn=number of tests completed as a resulted order,

^cNG= Neisseria gonorrhoeae),

^dTime to treatment includes the mean length of time that a medication order was completed or treatment was administered in the office after a result was received..

As a balancing measure, we collected staff feedback regarding delays in the schedule, especially delays in the provider starting the visit. Distribution of handouts to patients and families was encouraged to be monitored by the nurse lead as utilization and feasibility measures. The impact to nursing staff was monitored by the lead nurse who provided information about staff feedback on feasibility and challenges completing the urine sample including amount of time spent to identify any delays.

Data Analysis

Descriptive statistics summarized characteristics of the patients and clinic sites. We compared proportions of eligible adolescents in the pre and post-intervention periods using chi square tests. We measured the effectiveness by assessing for special cause variation with the review of the run charts. We defined special cause variation as eight points above the mean screening rate pre intervention (Wood et al., 2019).

To assess for differences in proportions of adolescents screened in the pre-implementation and implementation periods by sex, race, ethnicity, and payor, we conducted chi-square tests for each demographic group, using a Bonferroni correction for statistical significance given multiple comparisons, with an alpha of 0.01 denoting statistical significance. Analyses were completed in Stata, version 18.0 (StataCorp LLC).

Ethical Considerations

This project was reviewed prior to initiation by the CHOP Committees for the Protection of Human Subjects (the Institutional Review Board) and determined to not meet criteria for human subjects research.

Results

• Chlamydia trachomatis screening increased from a baseline mean of 7.8% to a mean of 34.1%, demonstrating a statistically significant improvement (p<0.001) in screening.

• The increases in screening, comparing pre and post-implementation, were statistically significant across all race, ethnicity, payor and sex assigned at birth groups.

• There was not a statistically significant difference in test positivity rates comparing pre and post-implementation periods.

We implemented the universal C. trachomatis screening project on October 20, 2022, through December 1, 2022 for 15- to 19-year-old adolescents at routine well visits. An event timeline highlighting the major QI interventions is represented in Figure 1, noting real-time modifications to the original project plan. During the implementation period there was an unprecedented viral illness visit surge resulting in minor delays to timelines and data review.

Figure 1.

Timeline of QI Project and Procedures

The overall C. trachomatis screening rates at the three PPC sites for all eligible adolescents increased from a pre-implementation mean rate of 7.8% to a mean implementation period screening rate of 34.1% (Table 1, Figure 2), demonstrating a statistically significant improvement (p<0.001) in screening. In addition, implementation phase C. trachomatis screening rates met special cause variation by showing a run of eight monthly screening rates above the baseline mean screening rate (Figure 2). We also identified statistically significant differences in screening rates by race, ethnicity, payor and sex post-implementation compared to pre-implementation (Table 1). In the post-implementation maintenance phase, we observed that screening rates decreased, while remaining above the mean baseline rate (Figure 2).

Figure 2.

Adolescent Chlamydia Screening in Pediatric Primary Care

Note. The implementation period of universal chlamydia screening at well visits for adolescents 15 to 19 years of age at the three PPC sites was between 10/20/22 to 12/1/22.

We did not observe a statistically significant difference in test positivity rates post-implementation, likely given the increased number of tests sent which inflated the denominator from pre-implementation test positivity rates (Table 1). There were 32 C. trachomatis cases and 4 N. gonorrhoeae cases identified in the implementation phase (Table 2). Of these cases, 96.88% of C. trachomatis cases and 100% of N. gonorrhoeae cases were successfully confirmed as treated. The one case of C. trachomatis that was not treated during the implementation period was successfully treated at a later date. Given that the increased case detection could lead to missed treatment, it was determined that procedures were necessary to refer untreated patients to the regional Department of Health.

With respect to balancing measures, no data were able to be collected on the number of handouts distributed due to difficulty with feasibility of monitoring distribution across three PPC sites. Staff reported no significant changes with schedule delays or with providers being delayed in starting the visit to the provider leads and nurse lead.

Discussion

• Universal opt-out screening for C. trachomatis was an effective strategy for increasing C. trachomatis screening rates

• Universal opt-out screening for C. trachomatis helped create more inclusive screening practices by race, sex, and payor

• A screening program for C. trachomatis can be feasibly implemented in pediatric primary care settings

We found that universal opt-out screening for C. trachomatis was an effective strategy for increasing C. trachomatis screening rates and case detection. Our C. trachomatis screening project was implemented with a practice change of obtaining a urine screen before the visit and offering C. trachomatis testing to all adolescents, regardless of self-reported sexual activity. In addition, we also identified additional N. gonorrhoeae cases. Finally, during the intervention period, we identified statistically significant increases in screening across race, ethnicity, payor and sex groups which helped create more inclusive screening practices. Notably, the screening rates after implementation decreased each month post-implementation, but still showed positive overall growth. Future interventions are needed to improve the sustainability of universal opt-out screening interventions and include vaginal sampling for females as a routine practice for universal screening.

Our QI intervention contained several elements that could be replicated in other settings. The clinician education and physician MOC credit supported the provider team in project participation and maintaining engagement. The creation of standardized workflows simplified and delineated screening processes for medical assistants, nurses, and clinicians. Patient and family education materials normalized the process of screenings. Finally, well established treatment protocols allowed safe and timely patient treatment, averting the potential harm of PID, infertility, chronic pelvic pain, ectopic pregnancy for females or epididymitis for males.

Our project confirmed the findings published in the current literature that a universal opt-out screening approach can facilitate increased C. trachomatis screening in pediatric primary care settings for adolescents (Allison et al., 2021; DiVasta et al., 2016; Elattma et al., 2020; Tomcho et al., 2021; Wood et al., 2022). Future work is needed to develop methods to mitigate the risk of confidentiality breaches with commercial insurance and lab billing due to explanations of benefits sent to the home. While within-health system interventions such as blocking release of STI results to parents can be efficacious, more advocacy is needed with payor and insurance providers to prevent confidentiality breaches outside the healthcare system.

The limitations of this project included a short implementation timeline. Future studies should improve specimen collection with vaginal swab sampling for females and examine barriers and facilitators of sustainability after intervention implementation. Additionally, staff were unable to monitor the number of universal C. trachomatis screening patient handouts distributed to patients and families, and we were not able to report data on this balancing measure.

In conclusion, this QI intervention identified that a universal opt-out C. trachomatis screening project significantly increased screening for all adolescents. While we saw marked initial gains in screening, we did note attrition after the initial QI intervention. Implementing a universal C. trachomatis screening project can create the groundwork for reducing the stigma of STI screening and normalizing the public health need of treating C. trachomatis. Universal opt-out C. trachomatis screening projects can be feasibly implemented in pediatric settings and improve equitable delivery of adolescent health care.

Wider Global Clinical Community Contribution:

• Chlamydia trachomatis Screening and Treatment

• Equitable screening practice to normalize STI screening and treatment