Ellie Ricketts

Increasing chlamydia screening tests in general practice: a modified Zelen prospective Cluster Randomised Controlled Trial evaluating a complex intervention based on the Theory of Planned Behaviour

Objective To determine if a structured complex intervention increases opportunistic chlamydia screening testing of patients aged 15–24 years attending English general practitioner (GP) practices. Methods A prospective, Cluster Randomised Controlled Trial with a modified Zelen design involving 160 practices in South West England in 2010. The intervention was based on the Theory of Planned Behaviour (TPB). It comprised of practice-based education with up to two additional contacts to increase the importance of screening to GP staff and their confidence to offer tests through skill development (including videos). Practical resources (targets, posters, invitation cards, computer reminders, newsletters including feedback) aimed to actively influence social cognitions of staff, increasing their testing intention. Results Data from 76 intervention and 81 control practices were analysed. In intervention practices, chlamydia screening test rates were 2.43/100 15–24-year-olds registered preintervention, 4.34 during intervention and 3.46 postintervention; controls testing rates were 2.61/100 registered patients prior intervention, 3.0 during intervention and 2.82 postintervention. During the intervention period, testing in intervention practices was 1.76 times as great (CI 1.24 to 2.48) as controls; this persisted for 9 months postintervention (1.57 times as great, CI 1.27 to 2.30). Chlamydia infections detected increased in intervention practices from 2.1/1000 registered 15–24-year-olds prior intervention to 2.5 during the intervention compared with 2.0 and 2.3/1000 in controls (Estimated Rate Ratio intervention versus controls 1.4 (CI 1.01 to 1.93). Conclusions This complex intervention doubled chlamydia screening tests in fully engaged practices. The modified Zelen design gave realistic measures of practice full engagement (63%) and efficacy of this educational intervention in general practice; it should be used more often. Trial registration The trial was registered on the UK Clinical Research Network Study Portfolio database. UKCRN number 9722.

Chlamydia and HIV testing, contraception advice, and free condoms offered in general practice: a qualitative interview study of young adults’ perceptions of this initiative

Background Opportunistic chlamydia screening is actively encouraged in English general practices. Based on recent policy changes, Public Health England piloted 3Cs and HIV in 2013–2014, integrating the offer of chlamydia testing with providing condoms, contraceptive information, and HIV testing (referred to as 3Cs and HIV) according to national guidelines. Aim To determine young adults’ opinions of receiving a broader sexual health offer of 3Cs and HIV at their GP practice. Design and setting Qualitative interviews were conducted in a general practice setting in England between March and June 2013. Method Thirty interviews were conducted with nine male and 21 female patients aged 16–24 years, immediately before or after a routine practice attendance. Data were transcribed verbatim and analysed using a thematic framework. Results Participants indicated that the method of testing, timing, and the way the staff member approached the topic were important aspects to patients being offered 3Cs and HIV. Participants displayed a clear preference for 3Cs and HIV to be offered at the GP practice over other sexual health service providers. Participants highlighted convenience of the practice, assurance of confidentiality, and that the sexual health discussion was appropriate and routine. Barriers identified for patients were embarrassment, unease, lack of time, religion, and patients believing that certain patients could take offence. Suggested facilitators include raising awareness, reassuring confidentiality, and ensuring the offer is made in a professional and non-judgemental way at the end of the consultation. Conclusion General practice staff should facilitate patients’ preferences by ensuring that 3Cs and HIV testing services are made available at their surgery and offered to appropriate patients in a non-judgemental way.

Provision of chlamydia testing, and training of primary health care staff about chlamydia testing, across four European countries

BackgroundThe objectives of this study were to describe and compare chlamydia testing provided by general practitioners (GPs) in four selected European countries with well-developed primary health care systems and high reported chlamydia rates; we aimed to compare contrasting countries where chlamydia testing is provided by GPs (England, Sweden) with countries where primary care chlamydia testing is absent or very limited (France, Estonia).MethodsFor data generation a structured questionnaire was developed and secondary data sources were searched. The questionnaire developed by the research team allowed a systematic approach to analysing chlamydia care (including testing in general practice) and the gathering of relevant data.ResultsThere were no significant differences in the burden of the disease or the type of general practice care provision in the study countries. In all four countries, testing for chlamydia (with nucleic acid amplification test, NAAT) is available in the public sector, a substantial proportion (>60%) of young people aged 16–25 years visit their general practitioner (GP) annually, and reimbursement for chlamydia testing costs to the relevant parties (GPs in England, Sweden and Estonia; and patients in France) by the national health insurance system or its equivalent.In countries where chlamydia testing is provided by GPs (England, Sweden) a national strategy or plan on STI control that specifically mentions chlamydia was in force, chlamydia care guidelines for GPs were in place and STI management was more firmly established in the GP residency training curriculum, either formally (England) or informally (Sweden), than in the other countries.ConclusionFuture research on the effectiveness of chlamydia screening (also in the context of general practice care) and program provision should reflect national needs and the prevention of complications.

A qualitative study exploring the acceptability of the McNulty-Zelen design for randomised controlled trials evaluating educational interventions

BackgroundTraditional randomised controlled trials evaluating the effect of educational interventions in general practice may produce biased results as participants know they are being evaluated. We aimed to explore the acceptability of a McNulty-Zelen Cluster Randomised Control Trial (CRT) design which conceals from educational participants that they are in a RCT. Consent is obtained from a trusted third party considered appropriate to give consent on participants’ behalf, intervention practice staff then choose whether to attend the offered education as would occur with normal continuing professional development.MethodsWe undertook semi structured telephone interviews in England with 16 general practice (GP) staff involved in a RCT evaluating an educational intervention aimed at increasing chlamydia screening tests in general practice using the McNulty-Zelen design, 4 Primary Care (PC) Research Network officers, 5 Primary Care Trust leads in Public or sexual health, and one Research Ethics committee Chair. Interviews were undertaken by members of the original intervention evaluation McNulty-Zelen design RCT study team. These experienced qualitative interviewers used an agreed semi-structured interview schedule and were careful not to lead the participants. To further mitigate against bias, the data analysis was undertaken by a researcher (CR) not involved in the original RCT.ResultsWe reached data saturation and found five main themes; Support for the design: All found the McNulty-Zelen design acceptable because they considered that it generated more reliable evidence of the value of new educational interventions in real life GP settings. Lack of familiarity with study design: The design was novel to all. GP staff likened the evaluation using the McNulty–Zelen design to audit of their activities with feedback, which were to them a daily experience and therefore acceptable. Ethical considerations: Research stakeholders considered the consent procedure should be very clear and that these trial designs should go through at least a proportionate ethical review. GP staff were happy for the PCT leads to give consent on their behalf. GP research capacity and trial participation: GP staff considered the design increased generalisability, as staff who would not normally volunteer to participate in research due to perceived time constraints and paperwork might do so. Design ‘worth it’: All interviewees agreed that the advantages of the “more accurate” or “truer” results and information gained about uptake of workshops within Primary Care Trusts (PCTs) outweighed any disadvantages of the consent procedure.DiscussionOur RCT was evaluating the effect of an educational intervention to increase chlamydia screening tests in general practices where there was routine monitoring of testing rates; our participants may have been less enthusiastic about the design if it had been evaluating a more controversial educational area, or if data monitoring was not routine.ImplicationsThe McNulty-Zelen design should be considered for the evaluation of educational interventions, but these designs should have clear consent protocols and proportionate ethical review.Trial registrationThe trial was registered on the UK Clinical Research Network Study Portfolio database. UKCRN9722.

P100 Exploring why a complex intervention piloted in general practices did not result in an increase in chlamydia screening and diagnosis: a qualitative evaluation using the fidelity of implementation model

Background To facilitate opportunistic chlamydia screening in general practices, a complex intervention (3Cs and HIV), based on the previously successful CIRT trial, was implemented across England. The intervention, to encourage practice staff to routinely offer chlamydia testing, only increased chlamydia screening in larger practices or in those offered incentives. Aims a) Explore why the modified intervention did not increase screening across all general practices. b) Suggest recommendations for future intervention implementation. Methods Phone interviews were carried out with 26 GP staff exploring their opinions on the workshops and intervention implementation in practice. Interview transcripts were thematically analysed and further examined using the fidelity of implementation model. Results Participants were positive about the workshops but attendee numbers were low. Often, the intervention content was not adhered to: practice staff were unaware of any on-going trainer support; computer prompts were only added to the female contraception template; patients were not encouraged to complete the test immediately; and videos and posters were not utilised, as suggested. Staff reported that financial incentives, themselves, were not a motivator; competing priorities and time were identified as major barriers. Conclusions Not adhering to the exact intervention model may explain the lack of significant increases in chlamydia screening. To increase fidelity of implementation and consequently improve likelihood of increased screening, the intervention needs to have: more specific action planning; computer prompts added to systems and used; all staff attend the workshop; and on-going practice staff support.

P111 Perceptions of Chlamydia screening, contraception and HIV testing among 16–24 year old patients visiting a GP surgery

Background A complex intervention based on the Theory of Planned Behaviour significantly increased chlamydia screening in general practice (McNulty et al 2014). It may be more beneficial to extend this intervention to a broader sexual health offer including chlamydia testing, contraception advice and when appropriate, HIV testing (3Cs and HIV). Aim To determine young adults’ opinions of having a broader sexual health offer (3Cs and HIV) at their GP practice. Methods Thirty interviews were conducted with 9 male and 21 female patients, 16–24 years in English GP practices. Participants were interviewed immediately before or after a routine practice attendance of any type. Data was analysed using a thematic framework and using QSR Nvivo 10. Results Participants indicated that method of testing, timing and staff member approach were important aspects to chlamydia screening and contraception discussions. Participants displayed a clear preference for the GP practice over other sexual health service locations. Items most important to participants were convenience, reassurance, and that the sexual health discussion is appropriate and routine. Barriers identified were embarrassment, unease, lack of time, religion and concern of causing offence. Suggested facilitators include raising awareness, reassuring confidentiality, ensuring the discussion is facilitated by trust and professionalism at the end of the consultation. Conclusion The majority of participants are happy to be offered 3Cs and HIV at their GP surgery. Therefore, it is important for GP staff to recognise these preferences and ensure that the full 3Cs and HIV services are made available and offered to appropriate patients.

Service evaluation of a pilot to improve primary care sexual health services in England implemented using a stepped wedge design

Abstract Background Sexual health service provision in primary care is an essential component to universal provision of sexual and reproductive health services. However the offer of these services is not consistent. The 3Cs & HIV was a national pilot that combined educational workshops with posters, testing performance feedback, and continuous support from a specialist trainer. The aim was to improve awareness and skills of staff to increase rates of chlamydia screening in the population at highest risk (men and women aged 15–24 years) and to provide condoms with contraceptive information plus HIV testing according to national guidelines. Methods The pilot used a stepped wedge design over three phases from Aug 1, 2013, to Sept 30, 2014. Chlamydia testing and diagnosis rates in the control (pretraining) and intervention (post-training) periods were compared by use of a multivariable negative binomial regression model with general practice fitted as a random effect. Owing to the stepped wedge design, the number of months contributing to the control and intervention periods differed depending on which phase the general practice was allocated to and when the practice received training. Characteristics of general practices participating were included in the model. Practices were not paid for the intervention. The Research Governance Coordinator for Public Health England confirmed that no ethics approvals were needed for this study. Findings The 460 participating practices conducted 26 021 tests in the control period and 18 797 tests during the intervention period. Intention-to-treat analysis showed decreased median number of tests and diagnoses per month per practice after receiving training (2·68 tests before training [IQR 1·00–4·77] vs 2·67 after training [1·10–4·90]; 0·14 diagnoses before training [0–0·30] vs 0·13 after training [0–0·27]). Adjusted multivariable regression analysis showed no significant change in overall testing or diagnoses (incidence rate ratio [IRR] 1·01, 95% CI 0·96–1·07 and 0·98, 0·84–1·15, respectively). Testing increased significantly in 148 practices where payment was already in place before the intervention (IRR 2·12, 95% CI 1·41–3·18). Interpretation This large national pilot found that educational support sessions to increase chlamydia screening in primary care were only effective in practices that already receive payment for chlamydia screening. 3Cs & HIV training might be a useful way to make better use of the resources already available. However this intervention will not increase national testing rates substantially. Although increases found in subgroups were statistically significant, they were still relatively small in magnitude. Funding The 3Cs & HIV pilot was funded by Public Health England and was part of the Chlamydia Testing Training in Europe (CATTE) project. CATTE is part funded by a Leonardo Transfer of Innovation grant as part of European Union Lifelong Learning Programme.