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Abstract
Background STIs are a major public health concern. Screening programmes for asymptomatic users are key components of STI control. Traditional limitations of screening programmes include low population coverage and delays in treatments, thus reducing the expected impact on STI control. In our centre, the normal time from test to results was 4 days, and 7 days until treatment was established.
To reduce time to treatment and to increase population coverage, we developed ‘Drassanes Exprés’, a testing service for asymptomatic STIs. The objectives of this study were to provide a guide for the implementation of a service with these characteristics and to evaluate the results of this intervention.
Methods The Drassanes Exprés programme was launched in Spain on 07 November 2016 as a public, confidential and free-of-charge testing service for asymptomatic STIs, with same-day result notification. For this walk-in service, confidentiality was obtained by registering all information into the Laboratory Internal Software instead of the Electronic Patient Records. Samples were processed in a point-of-care laboratory and result notification was provided via mail or short message service.
Information about workflow, screening protocols and result interpretation is detailed. Additionally, demographic characteristics, STI prevalence, and time from patients’ sample collection to notification and treatment are analysed.
Results Between 07 November 2016 and 07 November 2019, 13 993 users attended the Drassanes Exprés screening programme. Of these, 0.5% were transgender people, 29.3% women, 45.2% men who have sex with men and 25.1% men who have sex with women. The median age was 31 years (range: 26–39 years). Overall, 14.6% of users tested positive for at least one STI. The most prevalent infection was Chlamydia trachomatis (8.3%), followed by Neisseria gonorrhoeae (5.7%), syphilis (1.8%), HIV (0.4%) and hepatitis C virus (0.2%). The median time from test to results was 2.4 hours (range: 2–3.1 hours). Of 2049 users diagnosed with an STI, treatment was achieved in 97.0% of cases; the average time to treatment was 2.0 days.
Conclusions Drassanes Exprés is the first public programme for rapid, asymptomatic, STI screening and treatment in Spain. Assessing high-risk practices and providing confidentiality, easy access and rapid results/treatments are key elements in the development of STI screening programmes.
- diagnostic screening programs
- neisseria gonorrhoeae
- serologic tests
- chlamydia infections
Data availability statement
Data are available upon reasonable request. All data relevant to the study are included in the article, however more detailed protocols are available upon request.
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Introduction
STIs are a major public health concern and remain prevalent worldwide despite efforts towards prevention, diagnostics and treatment.1 In Catalonia, the incidence was estimated at 51 per 100 000 inhabitants for gonorrhoea, 71.9 per 100 000 for chlamydia and 22.9 per 100 000 for syphilis. This situation is even more worrisome in high-risk groups like sex workers, drug users or adolescents and young adults (15–25 years old) accounting for 43% of all chlamydia infections, and men who have sex with men (MSM), accounting, respectively, for 44.0% and 69.0% of all gonorrhoea and syphilis infections.2
Traditional measures to reduce STIs include sex counselling, health promotion (ie, condom use), partner notification, vaccination, prophylaxis or screening.3 Screening programmes testing asymptomatic people for prevalent STIs are key components of STI control and prevention that allow prompt treatment of patients and their partners. Some aspects that guarantee the usefulness of these programmes include:
Epidemiological: STIs are frequently asymptomatic favouring ongoing transmission in the community, screening programmes are the only tool to detect carriers in order to treat and prevent transmission.4
Clinical: to diagnose and treat infected persons who otherwise may develop serious complications, including pelvic inflammatory disease, chronic pelvic pain, infertility or pregnancy complications among women and epididymitis and orchitis in men; as well as other long-term sequelae like cardiac and neurological manifestation in syphilis or chronic infection with hepatitis C virus (HCV) and HIV.5
Economical: STIs are a heavy financial burden worldwide. In the USA, approximately $16 billion were allocated for STI management in 2008.6 The vast majority of studies on STI screening costs concluded that screening programmes are cost-effective and sometimes cost saving. 7
Screening recommendations vary by gender, sexual behaviour and even by different health authorities.8–12 However, there is a consensus that some individuals warrant specific screening based on high prevalence of STIs or high morbidity. Despite these recommendations, screening coverage is frequently suboptimal, reducing the expected impact on STI control at the population level.13 14 Commonly reported reasons for not undergoing STI screening included: privacy and confidentiality concerns, coverage or barriers to access preventive services.15
In an ideal scenario, with expected screening rates, we would still have to deal with providing the necessary treatment to curb transmission. Turnaround time (TAT) between screening and treatment varies between health systems and even between local infrastructures, for instance in England’s national chlamydia screening programme, TAT was 4–5 days16 ; while in our centre, TAT for asymptomatic STIs was 7 days. This process easily results in a loss of follow-up of infected patients or at least helps in spreading the infection in groups with a higher prevalence of partnership concurrency, like MSM.17
Low screening coverage and delay in treatments highlight the importance of implementing screening programmes that improve access, preserve confidentiality and provide rapid results to enhance user acceptance. To solve these problems, several services have been implemented worldwide (eg, Dean Street Express in London, UK), yielding public health benefits.18
In Barcelona, there are several settings performing STI screenings; ranging from district hospitals to primary healthcare centres. Many are focused on specific populations; for example, ‘BCN Checkpoint’ and lesbian, gay, bisexual, transgender and intersex non-governmental organisations for MSM and transgender populations, ‘Centro Joven de Atención a la Sexualidad’ for the young population, or ‘atenció a la salut sexual i reproductiva’ mostly for women. Though confidentiality is assured in many, not all fulfil this characteristic. Also, many do not provide rapid results (except for HIV/syphilis testing).
To increase population coverage in our centre and speed up treatment, in November 2016 we launched the ‘Drassanes Exprés’ (DrasExp) programme, a public and confidential screening service with same-day result notification. The main objectives of this study are to provide an implementation guide for this kind of service and to evaluate the results of this intervention. Here we present our 3-year experience with this programme; detailing information about workflow, screening protocols and result interpretation. Additionally, demographic characteristics, STI prevalence, and time from sample collection to notification and treatment are analysed. This report may help to optimise future screening policies.
Material and methods
Manuscript preparation guidelines
Standards for Quality Improvement Reporting Excellence V.2.0 guidelines19 were used in writing this service improvement report.
DrasExp programme
Funded by the European Regional Development Fund, DrasExp programme is a public service for rapid STI screening located at Drassanes Vall d'Hebron Centre for International Health and Infectious Diseases, Barcelona, Spain. In the Drassanes district (a hot spot for infectious disease), this centre is a clinic specialised in infectious diseases, composed of five distinct units: STI; international health and travel medicine; tuberculosis; paediatric care for any of the diseases above and a point-of-care microbiology laboratory. This programme, introduced in November 2016, offers Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), HIV, syphilis and HCV screening (every 3 months) based on a ‘walk-in’ attendance.
DrasExp workflow
On arrival at DrasExp, users are asked to complete an anonymous, short, epidemiological questionnaire (registered in the Laboratory Internal Software (LIS) by a specialised nurse on the patient’s behalf) including: age, gender, gender of sex partners in the last year, sexual practices in the last 3 months (receptive oral, vaginal and/or anal sex), history of STIs (HIV, HCV and syphilis), and phone number or mail address. Based on the reported sexual practices, sex partner gender and history of STIs, the LIS suggests the specimens and tests required for appropriate screening (online supplemental table S1).
Supplemental material
After brief STI prevention counselling, specialised nursing staff provide information and visual documents (online supplemental figure S2) to help users self-sampling correctly for CT and NG testing. Additionally, blood is extracted for HIV, HCV and/or syphilis testing if required. Finally, users are asked to deliver the samples to the in situ laboratory. Once the samples have been processed and as soon as the results are validated by a specialist, an automatic message is sent to users by short message service (SMS)/email (depending on user’s preference). If no STI is detected, the message states this, but if results are relevant, a recommendation to attend the STI Unit Vall d’Hebron-Drassanes is offered, allocating a preferential specific schedule. Only positive results are integrated into the Electronic Patient Records (EPRs) to preserve confidentiality.
Supplemental material
Laboratory screening tests
Serum samples were screened for Ab anti-HIV, Ab anti-HCV (starting November 2018) and/or syphilis treponemal test in a cobas e-411 analyser using the Elecsys HIV combi PT assay,20 ElecsysAnti-HCV assay21 and/or the Elecsys Syphilis assay22 (Roche Diagnostics, Penzberg, Germany), respectively. Additionally, for syphilis diagnostics, a non-treponemal test (Rapid Plasma Reagin test; Biokit, Spain)23 was performed if required. The complete algorithm according to the questionnaire and result interpretation for syphilis can be found in online supplemental figure S3.
Supplemental material
CT/NG detection was performed by nucleic acid amplification tests (NAATs) on the GeneXpert Infinity-48s instrument (Cepheid, Sunnyvale, California, USA).24 All CT-positive rectal samples were further tested for lymphogranuloma venereum (LGV) with the Allplex Genital ulcer Assay (Seegene, South Korea).25
Laboratory confirmatory tests
Confirmatory tests were performed in the microbiology department of Vall d’Hebron University Hospital. Although at the time of the study, swabs for CT, NG or LGV detection were tested using techniques not validated for extragenital samples, systematic reassurance of their diagnostic accuracy was not performed. However, further studies have proven the efficacy of these assays in pharyngeal or rectal specimens,24 25 thus supporting our idea that no further assays were required. Serum reactive results for HIV or HCV, and discrepant results for syphilis (reactive treponemal test and non-reactive non-treponemal test) were confirmed with a new specimen, in a follow-up visit. All repeatedly reactive specimens underwent confirmatory tests (online supplemental table S1).
Data analysis
To evaluate the impact of the DrasExp programme, clinical and epidemiological data were extracted via the questionnaire recorded in the LIS (2016–2019) or via a comprehensive review of the EPR (2015, 1 year before DrasExp).
Of note, no static comparison has been made for these data as we believe this could lead to misinterpretation. Demographics and the number of users seeking STI screening services have evolved during this period, thus the introduction of a new service may not be the only factor to consider.
Additionally, day of clinical attendance following positive results was manually recovered via the EPR system. The time from screening appointment to result notification and clinical attendance for treatment (if indicated) was calculated for each patient.
We described the study population calculating frequencies and percentages for dichotomous and categorical variables and the median for continuous variables (age).
For analysis purposes, users were grouped according to gender and/or sexual behaviour, with exception of transgender people who were grouped together (even though this is a diverse group) because of the small sample size.
All statistical analyses were performed using IBM SPSS Statistics V.22 (IBM Corp). We calculated 95% CIs as appropriate.
Results
Demographic characteristics by population group
During 2015 (before the DrasExp programme), 2941 users were screened at the Drassanes STI unit. Of these, 588 (20.0%; 95% CI 18.6% to 21.5%) were women, 1622 (55.2%; 95% CI 53.3% to 56.9%) MSM and 103 (3.5%; 95% CI 2.9% to 4.2%) men who have sex with women (MSW). Of note, for 628 (21.4%; 95% CI 19.9% to 22.9%) men no information about sexual behaviour could be retrieved.
Between 07 November 2016 and 07 November 2019, 13 993 users attended the DrasExp screening programme. Sixty-three (0.5%; 95% CI 0.4% to 0.6%) were transgender people, 4106 (29.3%; 95% CI 28.6% to 30.1%) women, 6318 (45.2%; 95% CI 44.3% to 46.0%) MSM and 3506 (25.1%; 95% CI 24.3% to 25.8%) MSW. The average number of daily users increased from 9.5 in 2016 to 21.1 in 2019 (online supplemental table S4). The median age was 31 years (range: 26–39 years); young people (under 25 years) accounted for 20.5% (95% CI 19.8% to 21.2%) of users vs 13.9% (95% CI 12.7% to 15.2%) in 2015. Most users referred receptive oral (72.3%; 95% CI 71.5% to 73.0%) or receptive anal intercourse (52.9%; 95% CI 52.1% to 53.7%). Regarding previous infections, 970 (6.9%; 95% CI 6.5% to 7.4%), 2108 (15.1%; 95% CI 14.5% to 15.7%) and 128 users (0.9%; 95% CI 0.8% to 1.1%) reported history of HIV, syphilis and HCV, respectively. More detailed sociodemographic characteristics are shown in table 1.
Supplemental material
Demographic, behavioural and clinical characteristics of the study population
Prevalence of CT, NG, HIV, HCV and syphilis
A total of 13 934 screenings were performed for CT/NG, 13 866 for syphilis (11 758 using a treponemal test and 2108 using a non-treponemal test), 12 888 for HIV and 4489 for HCV. A total of 14.6% (95% CI 14.1% to 15.2%) tested positive for at least one of the STIs tested. Results stratified by population group revealed that MSM and transgender people had the highest prevalence 21.2% (95% CI 20.2% to 22.3%) and 27.0% (95% CI 16.6% to 39.7%), respectively (for specific prevalence per group, see table 2).
Prevalence and time to treatment of Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), syphilis (SY), HIV and hepatitis C virus (HCV) infections by population group
The most prevalent infection was CT 8.3% (95% CI 7.9% to 8.8%) followed by NG 5.7% (95% CI 5.3% to 6.1%), syphilis 1.8% (95% CI 1.6% to 2.1%), HIV 0.4% (95% CI 0.3% to 0.5%) and HCV 0.2% (95% CI 0.1% to 0.3%). This trend was observed regardless of population group except in MSM where the most prevalent infection was NG (n=686 100.9%; 95% CI 10.1% to 11.7%). A total of 1.4% (n=471) tested positive for more than one pathogen, with CT/NG being by far the most frequent coinfection (n=122; 60.7%), followed by NG/syphilis (n=30; 14.9%) and CT/syphilis (n=20; 10%) (figure 1).
STI coinfection patterns among asymptomatic subjects attending the STI screening programme. STI coinfection patterns. (A) Pattern of infections: single infection, coinfections and no infection. (B) Pattern of single infections with one of the five evaluated STIs. (C) Coinfection patterns with concurrent STIs. CT, Chlamydia trachomatis; HCV, hepatitis C virus; NG, Neisseria gonorrhoeae; SY, syphilis.
A total of 25.2% (494) of all diagnosed CT and/or NG infections were only detected in the pharynx, 26.7% (523) in the rectum, 26.7% (523) in genital samples and 21.2% (414) were detected in more than one anatomical location. While the lowest prevalence of NG infection was in the genital tract, for CT the prevalence of genital infections was higher than extragenital infections (online supplemental table S5). Of 509 CT rectal infections, 492 were tested for CT L1, L2, L3. We found an LGV prevalence of 8.9% (95% CI 6.6% to 11.8%) in rectal CT infections.
Supplemental material
After confirmatory tests, 8 (0.1%) discrepant syphilis results, 10 HCV (0.2%) reactive serums and 15 HIV (0.1%) reactive serums were found to be false-positive screening results (online supplemental table S6).
Supplemental material
Laboratory TAT and treatment outcomes
The median time between testing and results was 2.4 hours (range: 2.0–3.1 hours) vs 98.2 hours (range: 57.8–129.5 hours) in the pre-intervention period. The average time to treatment was 2.0 days vs 7.0 days in 2015 (table 3). Of 2049 users diagnosed with an STI, treatment was achieved in 1988 users (97.0%). Treatment could not be administered due to the patient not returning for consultation in 38 CT infections, 14 NG infections, 7 syphilis infections, 2 HIV infections and 1 HCV infection (table 2).
Time between testing, results and treatment before and after introduction of the DrasExp programme
Discussion
Summary
Following DrasExp introduction, we observed an increase in STI testing among subpopulations that are reticent to access the health system (ie, adolescents and young people or sex workers).26 27 Compared with the population screened in 2015 at our centre’s STI unit, DrasExp has attended a larger proportion of women (29.3% vs 20.0%), nearly one-third being under 25 years. Time to results was less than 3 hours and time to treatment was 2 days. In the Drassanes standard sexual health clinic, the median time between testing, results and treatment was 7 days. The number of individuals visited per day has doubled since the implementation of the programme, demonstrating the interest and popularity among sexually active individuals. Confidentiality, easy access to visits, same-day results via mobile message and short-term treatment are probably qualities that influenced the increased demand.
Interpretation
We believe that testing must be offered to the entire population, however screening programmes are usually focused on key populations (ie, MSM, sex workers) because cost-effectiveness improves when the prevalence of disease in the population screened is relatively high.28
In our programme, while STIs were more prevalent in MSM, we found almost the same CT infection rate in women as in MSM (8.7% vs 9.0); whereas prevalence in women for syphilis, HIV and HCV was under 0.5%. These results highlight the need to focus on what test should be offered, according to local prevalence, avoiding a ‘one-size-fits-all’ approach regarding screening recommendations. Several factors like sex working, swinging and drug use have been described as risk factors for STIs.27 29 An effort should be made to identify and incorporate new risk factors to screening algorithms in order to use a ‘risk factors approach’ rather than a ‘key population approach’.
As a same-day results screening service, users expect to receive an SMS, therefore SMS notification cannot wait for confirmatory results from our central microbiology laboratory at the Vall D’Hebron University Hospital. It should be noted that all cases requiring a confirmatory test were contacted before SMS notification to provide a full explanation of the result and to offer a priority slot for the complementary tests. According to mathematical models, shortening time to treatment in STI screening programmes has several benefits, like reducing infectious periods and partner notification; thus improving public health and reducing costs associated with contact tracing (ie, unnecessary treatments or screening test).18 Even so, the number of lost users after result notification can compromise these supposed benefits. In this context, we should highlight that, in this programme, the number of users lost was under 3%. Same-day results and accessibility to treatment are probably factors that avoid missing users.
Ideally, tests and treatments should be offered in the same visit, however, TATs over 45 min imply that users do not wait at the clinic for results.30 In our express service, the median time to result notification was 2.4 hours (90 min attributable to the NAAT technique’s TAT), therefore, time to treatment was 2 days. These data are similar to other rapid services like Dean Street Express (London, UK) proving that once the user leaves the centre, reducing treatment time to under 2 days is difficult.31 Recently, ultra-rapid NAAT techniques have been developed with promising results. Van Der Pol et al evaluated combining PCR amplification with a highly sensitive electrochemical detection technology with results in about 30 min.32 These new techniques would optimise screening programmes by allowing testing and treating in the same visit, dispelling doubts about possible deleterious effects related to loss to follow-up of infected patients.
Limitations
This research has several limitations. As a retrospective descriptive study, differences in population coverage could not be correctly assessed as information about sexual practices was not always available in the pre-intervention period. Also, a selection bias may exist as this programme is based on ‘on-demand’ attendance, hence STI prevalence cannot be generalised to the entire population. Finally, CT/NG site-samples are obtained through an algorithm of sexual practices. This prevents comparing CT/NG prevalence at each site for different populations.
Conclusions
To our knowledge, DrasExp is the first programme for rapid asymptomatic STI screening and treatment in Spain. STI prevalence was higher in MSM and transgender people than in MSW and women. Assessing high-risk practices and providing confidentiality, easy access and rapid results/treatments are key elements in developing successful STI screening programmes. Future improvements including more rapid techniques allowing same-day treatment and the creation of new algorithms based on an enhanced questionnaire of high-risk factors would improve the cost-effectiveness of screening programmes.
Key messages
Low population coverage and delays in treatments are major limitations of screening programmes.
The median time between tests and results was 2.4 hours; average time to treatment was 2.0 days.
By developing a confidential programme for STI testing, we were able to reach subpopulations that are reticent to access the health system.
Abstract translation
This web only file has been produced by the BMJ Publishing Group from an electronic file supplied by the author(s) and has not been edited for content.Data availability statement
Data are available upon reasonable request. All data relevant to the study are included in the article, however more detailed protocols are available upon request.
Ethics statements
Patient consent for publication
Ethics approval
As a service improvement and according to the policy activities that constitute research at our institution, this work met criteria for operational improvement activities exempt from ethics review. The authors declare that there are no conflicts of interest regarding the publication of this report.
Acknowledgments
The authors thank Santiago Pérez Hoyos for statistical analysis support, and the entire DrasExp collaborative group for their involvement in this project.
References
Supplementary materials
Supplementary Data
This web only file has been produced by the BMJ Publishing Group from an electronic file supplied by the author(s) and has not been edited for content.
Footnotes
TP and ME are joint senior authors.
Handling editor Jo Gibbs
Collaborators Statistics and Bioinformatics Unit (Santigo Pérez Hoyos); DrasExp collaborative group (Desideria Martinez Rascon, Encarnación Arellano Muñoz, M Angeles Alvarez Zaragoza, Mercedes Gosch Elcoso, Jose Ignacio Pilarte Villanueva, Edurne Ruiz Marti, Nuria Ortiz, Lourdes Rubio Rubio)
Contributors ME conceived and led the design of this programme. JE, MJB, TP, ML, MV-M and AB contributed to workflow design. ES, JS-P, LL, ML, BA and TP reviewed the initial draft. YH-M, ES, JNG, PS, FZ, MA, VD, LL, MV-M and MJB performed the data collection. YH-M analysed the results and wrote the initial draft with JNG.
Funding DrasExp programme is a public service funded by the Cataluña European Regional Development Fund (ERDF) 2014–2020 operational programme under project number SA51-006646.
Competing interests None declared.
Provenance and peer review Not commissioned; externally peer reviewed.
Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.