‘The waiting game’: are current chlamydia and gonorrhoea near-patient/point-of-care tests acceptable to service users and will they impact on treatment?

Abstract

The objective of this study was to assess the length of time service users were prepared to wait for chlamydia and gonorrhoea (CT/GC) near-patient/point-of-care test (NP-POCT) results and to determine the possible effect on management. Individuals attending two UK clinics from November 2013 to February 2014 were surveyed asking the maximum length of time they would wait for CT/GC NP-POCT results after consultation. Linked CT/GC prevalence and treatment rates were analysed. A total of 1817 participants were surveyed, and 1356 provided CT/GC NAAT samples, in which it was found that 115 (8.5%) could wait over 90 minutes in clinic for their result. 115 received treatment at consultation, of which 50 were CT/GC negative and 12 were treated for urethritis or cervicitis; 38 attended as CT/GC contacts. Six of this population would have waited over 90 minutes were NP-POCTs available. A total of 129 tested CT/GC positive, of whom 65 were treated at their consultation, 61 at a later date, and three were untreated. Twelve of these 129 patients would also have waited over 90 minutes for a NP-POCT result. We conclude that 90-minute NP-POCTs are not acceptable to most clinic attendees and would not have impacted on treatment rates or inappropriate prescribing, and 20-minute NP-POCTs show a marginal benefit in treating CT/GC. While NP-POCTs for CT/GC are promising, they must meet client expectations and enhance disease management in order to be accepted by patients and clinicians.

Keywords

Sexually trasnmitted infection diagnosis testing point-of-care test chlamydia gonorrhoea waiting time time to result

Introduction

Nucleic acid amplification tests (NAATs) are used widely across the UK in the detection of chlamydia and gonorrhoea (CT/GC), with the majority of results being available to clinicians within five working days.¹ Rapid near-patient diagnostic tests have come to market which may feature more prominently in sexual health clinics, particularly if they provide cost-effective diagnostics whilst improving patient pathways to ensure treatment.

One commercially available pathogen assay provides CT/GC results in 90 minutes and has been shown to have equivalent sensitivities and specificities compared to existing laboratory-based NAATs.^2,3 A proposed pathway for its use involves clients having samples taken prior to consultation and waiting in STI clinics to receive their CT/GC results and treatment. A number of studies using mathematical modelling methods have concluded that the use of such a near-patient point-of-care test (NP-POCT) in place of pre-existing NAATs would reduce costs to the health service, by providing early treatment, reducing avoidable complications of untreated genital CT/GC and removing the need for professionals to handle positive results and recalling untreated patients for antibiotics.^3–5 Such pathways are being established in high prevalence remote rural settings.⁶

Conclusions from modelling data should be interpreted with caution since many do not assess the cost of patients' waiting time or adequately allow for increased staffing and extra facilities required in clinics. In addition, some benefits are difficult to cost: for instance NP-POCTs have the potential of limiting the overtreatment of patients who present as reported contacts of CT/GC who subsequently receive negative results. Such antibiotic stewardship can not only reduce the likelihood of GC resistance but also limit resistance among the human bacterial milieu.

For NP-POCTs to have a maximal impact on care, patients with CT/GC must be willing to wait for results. There are some limited data establishing willingness of patients to wait for their results.⁷ However, there is no work correlating willingness to wait to overall impact on patient outcomes. This study assesses patients’ willingness to wait in clinic for a NP-POCT result and determines the impact NP-POCTs would have on immediate and delayed CT/GC treatment, total antibiotic prescribing and Health Care Professional (HCP) contact efforts.

Methods

We conducted a prospective cohort study by surveying clients accessing level 3 integrated sexual health services at St. Mary’s Hospital, Portsmouth and Royal South Hants Hospital, Southampton between November 2013 and February 2014. Clients aged 16 and over were included. HIV-positive patients were excluded from analysis as these individuals often follow a different care pathway. Those requiring interpretation services were also excluded.

Participants were chosen for the study following registration for walk-in and contraception and pre-booked sexual health (CaSH) clinics. Service users were requested to complete a paper survey asking, ‘What is the maximum time you would be willing to wait in clinic after your consultation for your chlamydia and gonorrhoea result?’ Participants were required to tick one of the following options; 0–20 min, 21–40 min, 41–60 min, 61–90 min, 91–120 min and over 120 min. This question was devised from our knowledge of technologies available and in development for NP-POCT.⁸ Patient records were analysed eight weeks after initial consultation for demographic details, presenting complaint, standard CT/GC NAAT testing outcome (BD Viper system with XTR technology), subsequent time to treatment and number of attempts to contact the patient with their result. The impact of 90-minute NP-POCTs on follow-up was assessed. Chi-Squared and Fisher's Exact test were applied using the SPSS version 21 where appropriate. The questionnaire was provisionally used for an initial one-week period in order to check patient compliance and completeness of data collection. The validity of the questionnaire was not formally assessed. NRES approval was obtained (13/NE/0306).

The maximum cut-off time for willingness to wait for a NP-POCT was assessed to exceed 90 minutes as this was the turnaround time for only rapid commercial assay available at the start of the study. Comparisons were made to a hypothetical turnaround time of 20 minutes as newer assays are being produced with a target processing time of less than 30 minutes.

Results

A total of 1817 clients completing questionnaires met the inclusion criteria. Of these, 1356 had NAAT testing and are included in the subsequent analysis. The 461 excluded from analysis were either attending with a prior result and therefore not offered an additional test at consultation, were attending for contraception only, attending psychosexual health services, declined testing or walked out prior to consultation.

Demographic details are shown in Table 1. 12.1% men waited for a 90-minute test result compared to 6.1% women (p > 0.001). 22.9% of military personnel waited for a NP-POCT compared to 9.4% of civilians (p = 0.018). There was no significant effect of sexuality (8.7% heterosexuals, 5.2% other, p = 0.287) and age (6.1% of 16–20-year-olds, 7.7% aged 21–25, 10.9% aged between 26 and 30, 9.9% of 31–40-year-olds and 10.7% above aged 40, p = 0.217) on willingness to wait.

Table 1.

Participant demographics.

Gender	Men	539 (40%)
Gender	Women	817 (60%)
Age (years)	Median	24
Age (years)	Range	16–72
Sexuality	Heterosexual men	473 (35.9%)
	Heterosexual women	806 (59.4%)
	Men who have sex with men	57 (4.2%)
	Women who have sex with women	7 (0.5%)
	Bisexual men	9 (0.7%)
	Bisexual women	4 (0.3%)
Distance from clinic (miles)	<2	567 (41.8%)
	2.1 < 5	364 (26.8%)
	5.1 < 10	204 (15.0%)
	10.1 < 15	100 (7.4%)
	15.1<	72 (5.3%)
	No address supplied	14 (1.0%)
	Military address supplied	35 (2.6%)

Figure 1 shows the maximum time individuals were prepared to wait for a NP-POCT result. About 91.5% (95% confidence interval, 89.9–92.9%) attendees were unwilling to wait for more than 90 minutes for a NP-POCT result. In contrast, a 20-minute NP-POCT saw 73.8% (95% CI, 71.4% to 76.1%) of participants being tested and receiving their results in clinic. Over a quarter of participants, 26.2%, still could not accept this additional wait after their consultation.

Figure 1.

Maximum time willing to wait for a NP-POCT of the 1356 participants.

Of the 1227 NAAT-negative patients, 50 (4.1%) received treatment although their results for CT/GC were negative. Participants were categorised as symptomatic by the consultation documentation used by HCPs. Service users complaining of dysuria, anogenital discharge and pelvic or testicular pain were included in the symptomatic analysis (CT/GC symptoms). Individuals presenting with genital lumps, ulcers or alternative complaints were classed as symptomatic for other STIs. Thirty-eight were attending as contacts and 12 were symptomatic of possible CT/GC (Table 2). Had clinicians been happy to withhold therapy from contacts or symptomatic patients on the basis of an immediate CT/GC NAAT result then 6 (0.5%) would have been prevented from being treated with a 90-minute NP-POCT, four of whom (0.3%) were attending as contacts. If alternative, faster tests were available, a 20-min NP-POCT would potentially have prevented 39/1227 (3.2%) from being treated, 29 (2.4%) of whom were attending as a contact of CT/GC.

Table 2.

Presenting symptoms and NAAT outcomes.

Presenting complaint	NAAT result	Time to treatment for CT/GC or treatment not received
Asymptomatic N = 782	71 (9.1%) Positive	36 (50.7%) at consultation 35 (49.3%) at a later date
Asymptomatic N = 782	711 (90.9%) Negative	34 (4.8%) treated unnecessarily
Symptomatic of CT/GC N = 142	42 (29.6%) Positive	28 (60.7%) at consultation 12 (28.6%) at a later date 2 (4.8%)not treated
Symptomatic of CT/GC N = 142	100 (70.4%) Negative	13 (13%) treated unnecessarily
Symptomatic of other STI N = 417	13 (3.1%) Positive	1 (7.7%) at consultation 11 (84.6%) at a later date 1 (7.7%) not treated
Symptomatic of other STI N = 417	404 (96.9%) Negative	3 (0.7%) treated unnecessarily
Symptomatic of CT/GC and other N = 16	3 (18.8%) Positive	3 (100%) at a later date
Symptomatic of CT/GC and other N = 16	13 (81.3%) Negative	0 (0%) treated

Of the 129 NAAT-positive patients, 65 were treated at consultation, 61 at a later date and three were lost to follow-up. A 90-minute NP-POCT would have prevented four (3.1%) of the NAAT-positive population from having to return for treatment. Of the NAAT-positive patients who were not treated on the day of attendance, 3/64 (4.9%) remained untreated at review six weeks later; however, these patients would not have waited for a 90-minute NP-POCT result. A 20-minute NP-POCT would have prevented 46/64 (71.9%) individuals from returning for treatment and the three defaulting participants would also have been treated. These data are summarised in Table 3.

Table 3.

Positive individuals’ willingness to wait.

NAAT-positive individuals (N = 129)	Would wait for follow-up at 90 minutes	Would wait for follow-up at 20 minutes
Treated at consultation (N = 65)	8 (12.3%)	54 (83.1%)
Not treated at initial consultation (N = 64)	4 (6.3%)	Returned for treatment	46 (71.9%)
Not treated at initial consultation (N = 64)	4 (6.3%)	Untreated at 6 weeks	3 (4.9%)

Of the NAAT-positive individuals, 17 patients were symptomatic for CT/GC and not treated at consultation. Only one of these 17 (5.9%) patients would have waited for a 90-minute NP-POCT. A 20-minute NP-POCT would have ensured that 14 of these 17 (82.4%) would have received treatment in clinic and prevented them from having to return to the department.

HCPs made a total of 85 attempts (via short messaging service [SMS] and telephone calls) to contact untreated individuals with their positive results. A 90-minute NP-POCT would only have prevented five (5.9%) attempts. A 20-minute NP-POCT would have prevented 66 (77.6%) contact attempts.

Eighty-five patients attended at contacts of CT/GC or reported a positive NAAT diagnosis elsewhere. Of this population, 11 (12.9%) were willing to wait long enough for a 90-minute NP-POCT result, compared to the 115/1356 (8.5%) average for all study participants. Even for this relatively high risk group, 17 of the 85 (20.0%) participants were unwilling to wait for a 20-minute result.

Conclusion

Only 8.5% (CI 95%, 7.1–10.1%) of all tested participants would be willing to wait after consultation for a 90-minute NP-POCT result, 73.8% (CI 95%, 71.4–76.1%) were willing to wait for 20 minutes and interestingly, 20 minutes was deemed too long to wait for 26.2% of clients. This suggests that UK patients have a high expectation of NP-POCTs in terms of turnaround time.

It was found that 50 of the 1227 of participants who had a subsequent negative CT/GC NAAT result received first-line treatment for CT/GC. Currently, UK clinicians are recommended to treat individuals who have been in contact of CT/GC at consultation and not to wait for CT/GC NAATs results. If clinicians were willing to limit treatment to this group on the basis of an immediate NP-POCT result, then potentially a 90-minute NP-POCT would have prevented four of 38 contacts of CT/GC whilst a 20-minute NP-POCT would have prevented 29 of 38 patients from being treated.^9,10

NP-POCTs also have the potential to refine the treatment for CT/GC-negative urethritis and cervicitis allowing for tailored antibiotic use at initial consultation. Twelve study patients were treated for urethritis/cervicitis at initial consultation with an antichlamydial agent who subsequently were found to be CT/GC negative.¹¹ Two out of 12 of these patients were willing to wait 90 minutes and the remainder would have waited 20 minutes.

Whilst professionals working in STI clinics want NP-POCTs to be easy to use and accurate,⁷ the turnaround time for results appears to be the principal characteristic that would determine impact on client pathways. A variety of factors may impact on patient’s willingness to wait including discussion with peers about symptoms, research on the Internet or having been notified as a potential contact of CT/GC. Also, individuals attending walk-in services may have been more inclined to wait due to the structure and management of the clinic, whereas those attending for scheduled appointments may be more reluctant to wait an additional period of time. Furthermore, previous experience of attending sexual health services may have educated patients on expected waiting times for results and individuals may be satisfied with the current 48-h turnaround time. Service users may also have also been aware of results time associated with the routine concomitant screening of HIV and syphilis, which, historically, were not assessed by point of care, thus influencing their maximum waiting time.

Such concerns, as well as the possibility of patients expressing opinions differing to that of their actual behaviours, may well limit the extrapolation of our results.¹² Within this study, almost half of patients with a positive CT/GC result required subsequent attendances for treatment. The importance of NP-POCT in reducing a combined workload of contact tracing and additional consultations only becomes relevant if a result is available within 20 minutes. The population most difficult to reach and most likely to default can only be managed with a test which reaches this 20-minute standard.

In terms of cost reduction, we have shown that a practical benefit would be reducing the number of contact attempts clinicians perform to inform patients of their positive CT/GC results and further clinic episodes where treatment is provided. Although the proposed pathways using NP-POCTs suit low-risk individuals and those without symptoms, the proportion of such patients making up sexual health clinic attendees is highly variable. Risk assessment, examination and clinician-taken samples are often required before patients provide a urine sample and could limit the application of streamlined pathways. The practicalities of also testing patients for blood-borne viruses and syphilis need to be considered.

A benefit of NP-POCTs not assessed in this study was the potential impact on the prevention of spread of disease by early treatment following a positive result. By diagnosing infections at consultation, contact tracing could commence instantaneously which would facilitate the timely treatment to a higher proportion of individuals and reduce the possibility of ongoing transmission through sexual activity while waiting for a result. The use of a well-structured triage system to take a detailed and accurate sexual history, particularly in the week prior to consultation, is an area for consideration. The full benefits of NP-POCTs are unlikely to be realised without effective triage systems.

Whatever the future of STI diagnostics may be, service users’ needs must be considered at all times and further studies assessing the real-time implications of NP-POCTs are necessary before being widely implemented.

Footnotes

Declaration of conflicting interests

The authors declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Funding

The authors received no financial support for the research, authorship, and/or publication of this article.

NHS REC approval

NRES Committee North East – Newcastle and East Tyneside 1 Reference Number 13/NE/0306.

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