Introduction
From our experience in phase 1 (see Chapter 1), it was evident that the major challenge we faced was to identify and implement effective means of increasing the number of STI cases diagnosed in each practice, in order to recruit an adequate number of patients into the trial.
Phase 2 of the pilot ran from March 2011 to June 2011. Our overall aim was to identify solutions to our recruitment challenges. We also addressed challenges in operationalising different approaches to PN, which are separately reported in Chapter 9.
The objectives for phase 2 were:
to undertake a review of literature relevant to improving uptake of chlamydia testing within general practice
to explore in detail existing chlamydia testing rates in general practice, with a view to optimising recruitment of additional practices
to explore the potential for use of incentives to boost recruitment
to interview primary care practice staff involved in phase 1 to identify barriers to recruitment, potential facilitators and challenges in managing the trial
to maintain and enhance recruitment in existing practices.
Literature review
Methods
Since our application for funding, the NCSP had moved on in its policy and practice. Given the degree of local variation in its implementation, we were keen to identify novel and effective approaches to increasing testing rates. We therefore undertook a literature review, aimed at identifying alternative approaches to increasing STI testing in general practice and generally optimising our approach to recruitment.
Based on our experiences in phase 1, the review focused particularly on interventions that could improve chlamydia testing/screening rates for young people up to 24 years old in general practice or similar settings; the use of incentives (for patients or health-care staff) to improve testing rates and/or recruitment in the field of sexual health; clinical pathways used to organise the testing of young people for STIs in general practice or similar settings; general practice staff experiences, behaviour and attitudes to STI testing; and the use of general practice by young people.
Three broad sources of evidence were reviewed, of which the findings are presented in . The review was targeted, but did not take the form of a formal systematic review.
Chlamydia testing in general practice: research summary
First, we studied a review published in 2006, which summarised evidence for various elements of chlamydia screening and testing programmes relevant to the UK health system.5 Second, we searched PubMed for peer-reviewed publications since 2005 on chlamydia testing and screening, using relevant search terms derived from the review in order to identify recently published settings. We reviewed full-text versions of original research relating to the UK and settings where general practice has a broadly similar role (e.g. Australia). Third, we reviewed policy documents, newsletters and conference abstracts focused on England, which described the implementation of chlamydia screening and testing in the general practice setting and included evaluation of effectiveness. The studies we identified are summarised in Table 6.
Findings
Potential for testing young people through postal and in-practice approaches
In a study of consultations by young adults in general practice, Salisbury et al.42 compared opportunistic and systematic postal chlamydia screening methods using 27 general practice surgeries around Bristol and Birmingham, reporting on patients aged 16 to 24 years. They estimated that, on their own, each method (face-to-face through the general practice surgery when attending at least once over a 12-month period, or being sent a test kit via post) would fail to contact a substantial minority of the target group. Of nearly 13,000 eligible patients, an estimated 21% of patients would not attend their practice during the 12-month period but would be reached by postal screening, 9% would not receive a postal invitation (e.g. because the wrong address was held by their general practice surgery) but would attend their general practice surgery, and 11% would be missed by both methods.
Andersen et al.43 compared in-home screening with usual care practices for chlamydial infection with nearly 30,500 21- to 23-year-olds in Aarhus County, Denmark, between October 1997 and February 1998. The authors had previously shown this age group to have the highest infection rates, of 23.7% (men aged 21 years) and 8.7% (women aged 22 years). Patients were randomly assigned to one of three groups. Group 1 (n = 4500) were sent a home sampling kit to their centrally registered home address; group 2 (n = 4500) were sent a reply card (pre-stamped and addressed to the study centre) to their home address with which a home sampling kit could be ordered; and group 3 (n = 21,439), as well as groups 1 and 2, had access to their usual care of swab sampling at their general practice surgery. The invitation contained a letter describing the outreach programme and a leaflet about the infection. The test was a urine capture for men, and a saline pipette vaginal flush for women, which were posted directly back to the test lab at Aarhus hospital (pre-paid postal packaging was included in the kit). Results could be sent to any address or their doctor. Although only 1.4% of men and 19.4% of women in the usual care-only control group received any test during the year, this was substantially increased by the two mailing options. For males, options 1 and 2 were equal, with overall coverage around 17%. In females, 39% in group 1 and 33% in group 2 received a test. Although in women an equal number of infections was detected in groups 1 and 2, among men more infections were detected when the kit was posted to them than when they were invited to request a test kit.43 In all three arms, about 9% of women and only 0.5–1.4% of males received a conventional test in the practice.
Recruitment and retention of young people in sexual health intervention studies
A longitudinal investigation was conducted in Australia (CIRIS – Chlamydia Incidence and Reinfection Rates Study) by Walker et al.40 to investigate retention in a chlamydia screening study in women between 16 and 25 years old recruited to primary health-care clinics. Follow-up was by post at 3-monthly intervals plus the return of questionnaires and self-collected vaginal swabs. To maximise retention, the team used recruiting staff who were independent of clinic staff, patients were recruited in private, patients regularly communicated with study staff and follow-up was made as easy as possible including incentives and small gifts to patients (of gift vouchers – AUS$10 voucher at 3 months, AUS$25 at 6 and 9 months, and AUS$50 at 12 months plus small gifts with each follow-up test kit, e.g. tampons, cosmetics, confectionery, as agreed by the local ethics committee) to maintain good will. At the start, information on the study was presented with STI information, some condoms and lubricant. Female research assistants were placed in each clinic for up to 6 months and approached every 16- to 25-year-old woman presenting for a consultation. They recruited 66% of eligible women, 79% of whom were retained to the end of the 12-month study. Sixty-six per cent of the total were recruited from general practice clinics.
Walker et al.40 reported that loss to follow-up was associated with lower education level, recruitment from a sexual health centre rather than a general practice and previously testing positive for chlamydia. Other factors, including age and number of sexual partners, were not associated with loss to follow-up. They believe face-to-face recruitment was a strong factor in its success. Intensive communication strategies with patients through a variety of means and prompting for contact detail updates before sending out the next follow-up pack were associated with good retention in this and other studies (Atherton et al., 2010, cited by Walker et al.40).
The experiences, attitudes and behaviours of general practice staff
In a recent study, McNulty et al.39 interviewed practice staff to explore attitudes and testing behaviours within the NCSP. The focus was on the opportunistic screening habits of practice staff with 16- to 24-year-olds who attended their practice for any reason. Twenty-five focus groups were held from late 2005 to early 2007, comprising 72 GPs, 46 nurses, 23 administrators and receptionists, eight practice managers and seven other staff. Interviews with two low-screening practices were conducted later.
The range of practice chlamydia screening rates was 0% to > 30%, and in all screening programme areas the majority of practices had screened fewer than 5% of their 16- to 24-year-old patients.
McNulty and colleagues found stark differences between staff attitudes to opportunistic screening for chlamydia in low- and high-screening practices. Low-screeners tended to have low belief in the success of screening in this way, and tended to only have a single champion within the practice. In contrast, high-screening practices’ staff held strong beliefs in the utility of opportunistic screening of the target group. All practices reported low numbers of offers to men and felt motivation would be increased with regular reminders at practice meetings, screening training and feedback to practices on successful detection rates from NCSP. In all practices, clinicians’ (GPs, nurses and health-care assistants) self-belief in raising the screening regardless of the patient’s reason for attending was a key factor to their frequency of approach. A whole-team positive view on the value of chlamydia screening was identified as being crucial to the practice’s screening rates. There was no Quality and Outcomes Framework measure associated with chlamydia screening, which also had the effect of decreasing the perceived priority of the NCSP’s campaign. Auditing of offers and acceptance rates is problematic whilst there is no Read code to record this information. The authors conclude that their results are likely to be generalisable across England, but raise the issue of a lack of short- and long-term intervention studies to assess whether or not the methods used by high-screening practices can transform attitudes about opportunistic screening and offers within the teams of low-screening practices.
The authors noted that high screening practices had:
a screening champion (not necessarily the GP)
normalised screening, so all at-risk patients were offered opportunistic screening whenever they attended
facilitated screening using a variety of time-saving methods including computer prompts, test kits in the reception area, youth clinics and receptionist involvement
sustained screening through frequent reminders to practices via newsletters from the CSO with feedback on their performance and those of their neighbours
advertised screening to the ‘at-risk’ population
undertaken training prior to registration as a screening site.
44
The guidance, during the time of our phase 1 pilot, on chlamydia screening to providers and commissioners from NCSP was:
that PCTs build their programmes around the existing core services of Reproductive and Sexual Health (RSH) Services, community pharmacy, general practice, and termination of pregnancy services – and then consider other measures to increase access and target specific ‘at risk’ groups such as websites, outreach etc.45
Incentives for practices to test young people for chlamydia
In England’s pilot chlamydia screening studies, where general practice surgeries were paid to test, they achieved a 33% screening rate for women in the 16–24 years age group who were invited while attending their general practice surgery for any reason. An average of 80% of women in the 16–24 years age group accepted screening at their general practice surgery when asked, with acceptance lower in younger women.25 In this first large-scale opportunistic chlamydia screening study in England, the research covered settings including general practice, family planning, GUM clinics, adolescent sexual health clinics, termination of pregnancy clinics and women’s services in hospitals (antenatal, colposcopy, gynaecology and infertility clinics) in two health authorities (Wirral, and Portsmouth and South East Hampshire). Pimenta et al.25 also reported in this study that major factors influencing women’s decision to accept screening were the non-invasive nature of the urine test method and treatment, desire to protect future fertility and the experimental nature of the screening programme.
Investigators on the Australian Chlamydia Control Effectiveness Pilot (ACCEPt) research study, currently ongoing, explored in a pilot stage the use of incentives to GPs for opportunistic chlamydia testing of young women between 16 and 24 years.41 Of 145 general practices approached, 12 practices were recruited and assigned to receive either a small payment (AUS$5) or no payment for testing a patient for chlamydia. Forty-five GPs participated between May 2008 and January 2009. GPs were advised to use first-pass urine, self-collected vaginal swabs or endocervical swabs. Practices were provided with screening posters and leaflets for waiting rooms, and a DVD of the education session for GPs unable to attend their training session. Chlamydia testing increased from 6.2% to 8.8% in the control group and from 11.5% to 13.4% in the intervention group, a non-significant increase. The GPs reported that the major barriers to increased chlamydia testing included lack of time, difficulty in remembering to offer a test and lack of patient awareness around testing. The authors believe the lack of test-rate feedback and payment made at the end of the 6-month period to the intervention group GPs were both limiting factors, as many GPs appeared to forget they were in a trial. They also believe the control group’s testing increase was partly due to the educational components of the study. They note there is insufficient research on the use of reminders and incentives to determine what an appropriate level is to raise screening rates by GPs (Professor J Hocking, Melbourne School of Population and Global Health, 2011, personal communication).
We also reviewed a recent example from a chlamydia screening programme which was local to one of the pilot practices (Jason May and Suzy Dion, Northamptonshire Healthcare NHS Foundation Trust, 2011, personal communication and unpublished report). This district had used incentives for GPs to encourage each practice to meet a 10% screening target, as recommended by the NCSP. For every month that a practice opportunistically screened 10% of their 16- to 24-year-old cohort, a £50 gift voucher was paid. We were advised that this had resulted in an increase in screening rates, although only 27% reached their 10% target at least once over the period, but we were not able to identify a formal evaluation.
Incentives
Expert advice from a marketing specialist
As a result of the literature review and poor uptake of testing in phase 1 of the trial, we felt we should explore the possibility of using incentives for the trial. In addition to the literature review summarised above, we spoke to a marketing specialist with substantial experience in running national campaigns, marketing and public relation projects. He suggested that we consider incentives for both the patients and practice staff as described in the sections following (Harvey Atkinson, University of Brighton Students’ Union, 2011, personal communication).
Patient incentives
We were advised that it was felt that for our target age group (16–24 years) we would need to have incentives and that those incentives would need to have an immediate gain for the individual. It was suggested that this could be an inexpensive incentive which could be reinforced by a substantial deferred reward, such as a raffle for an iPod. The marketing specialist also speculated that this age group might be more likely to engage if approached by someone of their own age group, by using volunteers to approach individuals.
Practice incentives
For the practice, incentives could be given to the group and/or the individual. For individual incentives, the team would need to ascertain how each individual could be motivated. The motivations of the reception staff, for example, might be different from the motivation of nurses. It was suggested that there needed to be a practice champion who would act as the change agent and have ownership of the study. The team would need to consider by whom the different staff types are influenced, and whoever this is would need to deliver the message of why screening is important. The marketing specialist also emphasised that screening needed to be embedded into practice behaviour, making it normal practice, and that all parties needed to be engaged.
For group incentives at practice level, a deferred reward must be attractive to all involved (there should be a consensus amongst the group). It was suggested that it could be beneficial for the team to attend a practice meeting, along with the contraception and sexual health nurse and local chlamydia screening officers. This meeting would include explaining why screening is so important, clearly stating how much money can be earned by improving screening numbers and what the incentives are for individuals at the practice.
It was recommended that an outline for a poster could be provided to the practice for the practice manager to tailor to practice requirements. Furthermore, weekly and/or monthly updates should be sent to the practice on screening rates and highlighting numbers screened. It was proposed that competitions could be set up between practices (e.g. practice of the month), encouraging increased testing.
The marketing specialist suggested we discover what works best for the practice and give them various options for running the screening, allowing them to tailor the screening process to fit in with their own procedures (e.g. manual or electronic check-in system).
Survey of young people
We also conducted a short survey over a 2-week period by snowball recruitment using a social networking site, members of a youth group, and members of a sexual health-oriented group (Sexpression) to explore incentives for young people. A short questionnaire, consisting of nine questions, was posted online for young people aged 16–24 years to access and respond to anonymously (a hard copy was also made available).
One hundred and seventy-three young people took part, the majority of whom were in full-time education (74%, n = 128). Twenty per cent were not in any form of education or training (n = 34) and 6% were in part-time education (n = 11).
A large majority of respondents (83%, n = 144) said that they would take a chlamydia test if a doctor or nurse asked them to during a routine appointment. This was more than those who said they would if the receptionist asked them to test (61%, n = 105) or if self-test kits were available in the reception (66%, n = 115). Of the 17% (n = 29) who would not take a test, 38% (n = 11) said they would change their mind if offered an incentive. One participant who would not take the test or take part in the study was concerned that sexual health issues would appear on their medical record and they also expressed concern that ‘you don’t get paid to see a doctor so why get paid for this?’ This response demonstrated potential barriers to using incentives.
We asked all participants which incentives would make them more likely to take a test and participate in the study. One hundred and seventy-one participants replied to this question, of whom 42% (n = 72) said that incentives would not make a difference. Of the remaining 99 participants, 88 (89%) said that a cash incentive would make them more likely to take a chlamydia test and be part of a study, 64 (65%) said that shopping vouchers would, and only 13 (13%) said that mobile phone credits would make a difference to their participation (respondents were able to select more than one option).
When asked the lowest value of incentive that would make them more likely to participate, 39% (n = 58) of 172 participants still responded that no amount would make a difference, although this was less than for the previous question. A £5 incentive was the most popular option among those who said that an incentive would make them more likely to participate, with 34% of participants choosing this response (n = 58). Seventeen per cent of participants replied that £10 would be the minimum they would accept (n = 29), 6% (n = 11) chose £2, and 4% chose £1 (n = 7). The majority of respondents (76% of 167, n = 127) stated that they would prefer all participants to receive the same incentive, rather than a small incentive to take part and the chance to win a much larger prize (lottery incentives).
In conclusion, over 40% of the sample stated that incentives would not make a difference to their decision whether or not to participate in the study, and more than 80% of respondents would participate if asked by their doctor or nurse. This suggests that incentives for patients may not be an effective way to boost testing and recruitment. It should be noted, however, that this group included a high percentage of students still in full-time education, which may have biased the results, as they may not be representative of all 16- to 24-year-olds.
Maintaining and enhancing ongoing recruitment
Recruitment report
This study had been funded on the assumption that a large number of chlamydia tests would be taken within general practice, in accordance with national data showing a large and growing proportion of all chlamydia tests taking place in this setting. However, the low number of tests we were experiencing was surprising. We therefore collaborated with the Health Protection Agency (HPA) to explore the distribution of chlamydia testing within practices in more detail, since these data were not publicly available.
The Chlamydia Vital Signs Indicator 2010/11 measures the proportion of the 15- to 24-year-old total population tested for chlamydia outside GUM clinics. The target set by the Department of Health was 35% for testing undertaken during the period 1 April 2010 to 31 March 2011. Data for monitoring the vital signs indicator are based on NCSP data returns and testing outside GUM not reported to the NCSP. In 2010–11, 25.2% of the population aged 15–24 years were tested for chlamydia (1,733,220 tests) based on data reported to the NCSP.46
Data received from the NCSP reported 6319 participating NCSP practices across England, of which around one-third (n = 2895) registered no positive chlamydia test results between April and December 2010. The range of tests performed by these practices over this period was 1–176, with a mean of nine tests per practice. Only eight practices performed between 332 and 2336 tests, averaging 797, and obtained over 30 positive results.
This indicates that there were very few NCSP practices testing for chlamydia at the rate the trial required to conduct the planned study (). Positivity varied little by practice, and stood at 6% at the time of the study.
National Chlamydia Screening Programme data (April 2010–December 2010) (n = 6319)
What are the general practice consultation rates of young people?
reports data from a QRESEARCH® (University of Nottingham, Nottingham, UK) report showing the patient consultation rates with GPs and nurses of 15- to 19-year-olds and 20- to 24-year-olds over the period 1998–2009 in England.47
Consultation in general practice 2008/9
Although measures of dispersion are not given in this report, the data indicate that a substantial majority of people within the 15–24 years age group are visiting their registered practice for a GP or nurse appointment at least once per year.
Summary of findings relevant to improving testing rates and recruitment through modification of our processes
Despite a wide range of innovative approaches in the NCSP, including incentives both for young people and for staff, we had identified little robust evaluation that could reliably inform our strategies to improve recruitment.
However, recently emerging peer-reviewed literature suggested that addressing practice organisation and culture could be useful. A team approach to recruitment, along with an identified ‘champion’ within a practice, appeared to be important, and a good understanding across all staff of the benefits of chlamydia testing appeared to be key. Newsletters and feedback on practice-level performance were also seen to be helpful and relevant to our study.
Embarrassment of practice staff about offering a chlamydia test in an unrelated consultation was consistently reported to be a challenge, and emerged in our practice interviews as a barrier. The peer-reviewed literature emphasised the need to normalise the offer of testing, an approach which was likely to be best addressed through training and a whole-practice approach. Published research reported that widespread advertising of chlamydia testing as a standard offer within the practice through posters and leaflets was widely used in practices with high testing rates. It also suggested that a highly organised and strategic approach using computer prompts and similar aides-memoires was necessary to identify young people. We concluded that it would be helpful to support practices in developing focused plans aimed at approaching, offering tests to and recruiting young people to the study (the latter particularly in ‘consent at test’ practices). We also planned to use newsletters and feedback on testing rates more proactively as a way of improving engagement.
The peer-reviewed literature (notably from the CLaSS study) suggested that mailed offers of chlamydia testing kits could yield uptake of up to a third of young people. However, in studies using this approach, the patient’s first encounter with the general practice was at the time of treatment. Our approach of inviting young people by letter, and additionally asking the practice to undertake opportunistic testing, had not yielded useful numbers of people attending the practice in order to have a test. Moreover, it seemed to have encouraged practices to ‘take their eye off the ball’ in taking advantage of young people’s attendance as an opportunity to test. Our commission was to evaluate different approaches to PN within primary care (taken to mean general practice for the purposes of this study), and we also noted that the current direction of Department of Health policy was to encourage chlamydia testing within general practice, as the major complement to sexual health settings. We therefore concluded that in order to focus the intervention on primary care we needed to focus wholly on the opportunistic approach which had been successful in the initial English pilots of chlamydia testing.25,48
Our practice interviews were consonant with the peer-reviewed literature on barriers to testing. However, we identified three myths which emerged in many interviews and which were discouraging primary care staff from enthusiastic or strategic approaches to opportunistic testing. First, there was a widespread belief that very few young people attended the practice; second, it was generally thought that, even if common nationally, chlamydia was not common in their area; and, finally, many staff believed that young people would be unwilling to test in a practice setting. These findings suggested that we could use high-quality data from a number of domains to address these beliefs. The high-quality data on attendance rates in general practice that we consulted suggest that attendance – particularly of young men – is much higher than generally thought, while epidemiological data show that variation in chlamydia prevalence by geography is much lower than in many other STIs. Previous studies show high levels of acceptability for testing despite the initial concerns of staff. We concluded that active information campaigns could be used to counter these myths within participating practices.
The question of incentivisation was complex and challenging. Our opportunities for personal incentivisation of practice staff were limited by the internal structures of each practice, regulations on use of our research funding, and NHS research ethics approvals (including their likely view of any proposal to incentivise staff either for testing or for recruitment). This is likely to explain the paucity of evaluations of staff incentivisation. We did identify one NCSP location where vouchers had been offered to staff, but the evaluation was not sufficiently robust to ascribe effect to cause. On balance, we felt we were not in a position to offer direct staff recruitment. Nevertheless, we were able to pay NHS service support costs that fully covered research-related staff costs (including initial testing), and it was not clear to us how or whether the information on this practice-level incentive was being used. This had potential for improving practice engagement, through a ‘top-down’ approach, and we concluded that information on potential income ‘lost’ should be reported to practices in order to encourage effective planning for chlamydia testing.
The question of whether or not young people should be incentivised was very interesting. At this time, many NCSP locations were using incentives ranging from key rings and boxer shorts to prize draws for (for example) iPads. However, there was little evidence of evaluation and no evidence on which to choose between the range of incentives on offer. The marketing expert we consulted was insistent that monetary or voucher incentives would be necessary for recruitment of young people. However, we remained concerned as a research group to maintain the distinction between retention in research (really required only after a positive diagnosis) and the testing situation in which an intervention was being offered in a situation of relative trust for the benefit of the young person’s own health. Interestingly, our survey of young people suggested that such interventions offered by a health-care professional were not much more likely to be taken up if an incentive were offered. This may not apply where an offer is made in non-health-care settings (e.g. peer-led sessions in schools or universities), where no relationship of trust is in play. Based on this, and the finding above that practice staff themselves had a number of beliefs and attitudes that made them reluctant to offer tests, we concluded that incentivisation of young people was unlikely to produce any important increase in testing rates.
Finally, there was clearly great variability in the processes of treatment and testing. The NCSP had, by and large, set up systems in which local chlamydia co-ordinators, generally employed by the PCT, undertook to inform young people of their results, treat positives and organise PN. This was different from other tests for infection undertaken by the practice, and also from the proportion of chlamydia tests which were taken from people who were not eligible for the NCSP on grounds of age or for whom the ‘wrong’ (i.e. non-NCSP) form was used. We concluded that it would be necessary to have a customised pathway to address this within each practice.
Phase 2 recruitment rates
During the second phase of the pilot (March 2011 to June 2011) testing increased by 100% (from 31 to 62 tests). However, this accounted for only 11% of the 16- to 24-year-olds attending the practices over that period ().
Summary of recruitment data for phase 2 (including phase 1 for comparison)
