Expedited partner therapy for Chlamydia trachomatis at the community pharmacy

Transcription

1 DOI: /j x Genitourinary medicine Expedited partner therapy for Chlamydia trachomatis at the community pharmacy ST Cameron, a,b A Glasier, a,b A Muir, c G Scott, d A Johnstone, a,b H Quarrell, a C Oroz, a,e M McIntyre, f D Miranda, a G Todd g a Dean Terrace Centre, NHS Lothian, Edinburgh, UK b Department of Reproductive and Developmental Sciences, University of Edinburgh, Royal Infirmary of Edinburgh, Edinburgh, UK c Department of Public Health, NHS Lothian, Edinburgh, UK d Department of Genitourinary Medicine, Royal Infirmary of Edinburgh, Edinburgh, UK e Genitourinary Medicine Clinic, Howden Health Centre, Livingston, West Lothian, UK f Richard Verney Health Centre, Edinburgh, UK g Pharmacy Department, Roodlands Hospital, NHS Lothian, Haddington, East Lothian, UK Correspondence: Dr ST Cameron, Consultant Gynaecologist, 18 Dean Terrace, Edinburgh EH4 1NL, UK. Sharon.Cameron@ed.ac.uk Accepted 16 March Published Online 25 May Objective Expedited partner treatment (EPT) for uncomplicated Chlamydia trachomatis at the pharmacy is an alternative approach to partner notification that has not yet been evaluated within the UK. The aim of this study was to evaluate EPT for partners using pharmacies in Lothian. Design A pilot study over 18 months. Setting Selected healthcare settings and community pharmacies in Lothian, Scotland, UK. Population Sexual partners of index cases with uncomplicated C. trachomatis. Methods Index cases with uncomplicated C. trachomatis were given a pharmacy voucher to pass onto sexual partners. Partners could redeem vouchers for free treatment (azithromycin) at one of 90 pharmacies in the area. Main outcome measures The main outcome measure was the proportion of vouchers redeemed. Secondary outcomes included patient satisfaction, as determined at a telephone follow-up of a subgroup of female index cases from one study site, 1 month later. Results In total 577 vouchers were issued to chlamydia-positive index patients of mean age 22.9 years (range years). A total of 231 vouchers were redeemed (40%), at a median of 2 days after issue. Only 4% of partners attended a clinic for treatment. Most index patients surveyed reported that partners were satisfied with this method of treatment (48 out of 55; 87%). Conclusions Expedited partner treatment for uncomplicated chlamydia at a pharmacy is a popular choice, and increases options on where, when and how partners are treated. Keywords Chlamydia trachomatis, expedited partner therapy, partner notification, pharmacy. Please cite this paper as: Cameron S, Glasier A, Muir A, Scott G, Johnstone A, Quarrell H, Oroz C, McIntyre M, Miranda D, Todd G. Expedited partner therapy for Chlamydia trachomatis at the community pharmacy. BJOG 2010;117: Introduction In the past decade, advances have been made for the detection and treatment of uncomplicated chlamydia infection, with more sensitive tests and single-dose antibiotic treatment regimes. However, strategies to ensure sexual contacts are treated remain largely unchanged. Partner notification is the traditional means for arranging partner treatment. This usually involves partner attendance at a genitourinary medicine (GUM) clinic, where specialised staff offer testing and may give empirical epidemiological treatment at the same time. 1 However, partners may be deterred from attending a GUM clinic because of the stigma associated with having a sexually transmitted infection (STI). 2 Delay in seeking treatment may be further compounded by the difficulty of access to general practice (GP) surgeries and GUM clinics, especially at weekends and evenings. Timely treatment of sex partners is important to prevent index patients from reinfection as a consequence of the resumption of sex with an untreated partner. Reinfection in women is believed to increase the likelihood of complications such as tubal infertility. 3 One strategy to expedite partner treatment is patient-delivered partner therapy (PDPT). 4 This involves the index patient delivering a dose of anti-chlamydial therapy to each sexual partner. Large randomised controlled trials (RCTs) in the USA and UK 1074 ª 2010 The Authors Journal compilation ª RCOG 2010 BJOG An International Journal of Obstetrics and Gynaecology

2 Pharmacy treatment for chlamydia have shown that it is as least as effective as patient referral, both in terms of reinfection rates in index patients and in the proportion of sexual contacts treated. 5 7 Although permitted in 20 states within the USA, 4 adopting the PDPT approach in the UK would require legislative change to permit clinicians to administer antibiotics for an individual they have not met and been able to evaluate. At present, therefore, use of PDPT within the UK is not recommended outwith the confines of a tightly controlled research study. 7 An alternative approach is that of expedited partner treatment (EPT) at a pharmacy. Increasing numbers of pharmacies have private interview rooms, and pharmacists are well placed to interview a patient about their medical history and any contraindications to antibiotic therapy, and to identify possible drug interactions with other medicines that the individual may be taking. Furthermore, attending the pharmacist for treatment could arguably be less stigmatising than attending a clinic or GP. In a recent survey in Lothian, community pharmacists were overwhelmingly positive towards providing a treatment service for individuals or sexual contacts with uncomplicated chlamydia. 8 We therefore decided to undertake a pilot study within NHS Lothian (Edinburgh and surrounding area), designed to evaluate partner treatment at community pharmacies as an additional choice to treatment at family planning clinics, GUM clinics or at the GP. As part of this project, entitled NHS Pharmacy Direct, index patients who had been treated for Chlamydia trachomatis (uncomplicated) at selected health service sites in Lothian were given a pharmacy treatment voucher to pass on to their sexual partner(s). These partners could redeem the voucher for free treatment (single 1-g dose of azithromycin) at participating pharmacies, if they wished to do so, unless they preferred to attend a clinic or their GP for treatment. The main outcome of the study was the proportion of pharmacy vouchers that were redeemed. Secondary outcomes were satisfaction with the voucher scheme and voucher use by different clinical populations. Methods A total of 90 pharmacies across Lothian agreed to participate (out of a total of the 179 pharmacies invited to take part) in NHS Pharmacy Direct, and to provide free treatment to individuals upon receipt of a study voucher. Five selected health service sites throughout Lothian took part between December 2007 and May Four of the sites were city centre sites in Edinburgh: a family planning clinic (FPC), a hospital termination of pregnancy clinic (TOP), a university student health service (GP) and a GUM clinic. The fifth site was a GUM clinic in West Lothian. At all five sites index cases (men and women with uncomplicated C. trachomatis only, i.e. no other STIs) were treated, and received both written and verbal information about chlamydia and the importance of partner treatment (sexual partners from within the past 6 months). Index cases were then given a pharmacy treatment voucher for each sexual partner (within the last 6 months) that partners could take to a participating pharmacy and redeem for free treatment. The voucher stated that the bearer was a partner of an individual with chlamydia infection who should be treated immediately with 1 g of azithromycin orally (as per Lothian Formulary guidelines). The reverse of the voucher listed the names, addresses and phone numbers of all the pharmacies that had agreed to participate. Vouchers were only given to those individuals with at least one contactable partner who had not already been treated, and who was resident in Lothian. All vouchers had a unique number that was recorded and matched with the index case identifying number in order to provide data on partner notification rates. At all sites except TOP and GUM clinics in West Lothian, the reasons for not issuing vouchers to chlamydia-positive individuals were recorded. At GUM clinics, both male and female index cases were given vouchers, but all other sites treated only female index cases. Vouchers were not given to men who have sex with men (MSM), as they were felt to constitute a high-risk group for co-morbidities that should be managed at a specialist GUM clinic. At all sites vouchers could be issued by all medical and nursing staff responsible for managing patients with chlamydia infection. Index cases were also given a leaflet for sexual partners that provided contact details for clinics that offered testing and treatment should they prefer to be treated at a clinic. The leaflet also advised that anyone with pelvic pain, vaginal or penile discharge or dysuria, or who was currently pregnant should attend a doctor instead of a pharmacy. On presentation of the voucher, pharmacists would check that the individual had no contraindications to azithromycin before dispensing this via a patient group direction (PGD). The voucher was later returned to the coordinating study nurse. Pharmacists also gave individuals a chlamydia information leaflet that contained details of GUM and FPC clinics where STI testing could be performed. All participating pharmacists were familiar with the requirements of PGDs, and all had received written information about the study and chlamydia, together with information leaflets about chlamydia for patients, in advance of the study commencing. In addition, information on chlamydia for pharmacists was available via NHS Education Scotland. 9 For further information or advice, pharmacists could contact the study investigators. As part of this project, pharmacies received a 5 fee for treating each sexual partner, plus the corresponding British National Formulary cost for azithromycin. ª 2010 The Authors Journal compilation ª RCOG 2010 BJOG An International Journal of Obstetrics and Gynaecology 1075

3 Cameron et al. Data was thus available on the proportion of vouchers that were issued from each study site, the number of vouchers redeemed and the date of redemption, the pharmacies used and the proportion of index patients whose partners opted for treatment in this way. In addition, at the FPC and both GUM clinics, an audit of case records was conducted to determine the proportion of partners who attended the FPC or GUM clinics for treatment rather than using the Pharmacy Direct voucher. At the FPC, a survey of patient satisfaction with the voucher scheme was conducted by telephone 1 month after treatment among women issued with a voucher between May 2008 and June Women were asked if they had given the vouchers to their partners, if their partners had used the voucher for treatment, and if so, how acceptable their partners found this method of treatment. Women that did not respond were deemed lost to follow-up after three unsuccessful telephone calls. The study protocol was reviewed by the chair of one of the Lothian research ethics committees, who confirmed that ethical committee Table 1. Reasons why clinical staff did not issue vouchers to 235 out of 1047 (22%) chlamydia-positive index cases (family planning clinic, student GP clinic and genitourinary medicine clinic in the city centre) n = 235 n (%) Partner not contactable/refuses contact 81 (34) Partner already treated 63 (27) Partner not in Lothian 43 (18) Index case declined voucher 27 (11) Provider referral 18 (8) Other 3 (1) Patient-delivered partner therapy 2 Partner pregnant 1 approval was not required for this health services research project. Statistical analysis Comparison of voucher use between groups was performed using chi-square tests, using spss. Results Voucher issue During the 18 months of the study, a total of 577 vouchers were issued to chlamydia-positive index patients. This represented 63% of all eligible patients at the non-gum sites (304 vouchers issued out of 482 patients who tested positive), compared with 20% at the GUM sites (273 vouchers issued out of 1340 patients who tested positive); P < Reasons for not issuing vouchers were recorded for 235 of the 1047 (22%) index cases. The commonest reasons recorded for non-issue are shown in Table 1. Index patients who were issued with vouchers were of mean age 22.9 years (range years) (Table 2). Most vouchers were given to female index patients (n = 392 vouchers; 68%). At GUM sites 23% (n = 133) of the total number of vouchers issued were given to male index patients. The sex of the index patient was not recorded in the remaining 52 patients (9%). Data on the total number of vouchers issued per index patient were recorded in 73% of cases (423 out of 577). The median number of vouchers issued was one per index case (range 1 4 vouchers), with 12% of index patients receiving more than one voucher. Voucher redemption In total 231 vouchers (40%) were redeemed at pharmacies. The highest voucher redemption rates were observed for vouchers issued from the FPC, but this difference did not reach statistical significance (Table 2) (P = 0.059). Voucher Table 2. Number of vouchers issued at each site, proportion of vouchers redeemed and proportion of partners choosing to be treated at a clinic Site Sex of index patient Mean age in years (range) of index patients No. of vouchers issued Vouchers redeemed n (%) Partners treated at clinic n (%) Family planning clinic Female 24.9 (15 47) (52) 1 (1) Genitourinary medicine clinic (city centre) Male and female 23.3 (16 46) (38) 10 (4) Genitourinary medicine clinic (West Lothian) Male and female 23.2 (16 43) (40) 4 (13) Termination of pregnancy clinic Female 21.2 (15 41) (34) NK Student general practice clinic Female 21.8 (19 28) (45) NK Total 22.9 (15 47) (40) 15 (4) NK, not known. There was no statistically significant difference in voucher redemption rates between sites (P = 0.059) ª 2010 The Authors Journal compilation ª RCOG 2010 BJOG An International Journal of Obstetrics and Gynaecology

4 Pharmacy treatment for chlamydia redemption by partners of male index cases (presumed to be female) was 41% (55 redeemed out of 133 vouchers issued), and did not differ significantly from that of partners of female index cases (presumed male), which was 45% (176 redeemed out of 392 issued); P = The time to redemption of the voucher was a median of 2 days after issue (range days). The majority of participating pharmacies (57 out of 90; 63%) were used by partners. Partners choosing to attend a clinic rather than use voucher Only 15 partners out of a total of 375 at the sites audited (4%) chose to be treated at a GUM or FPC clinic (Table 2). Index patient and partner satisfaction The patient satisfaction survey was conducted over 13 months among 67 consecutive index patients, who received a total of 79 vouchers (corresponding to 60% of the total vouchers issued at the FPC). A total of 60 of these 67 women responded to telephone contact (90%). Most women (n = 55; 92%) stated that they had given a voucher to at least one partner. In the five cases where women stated that they did not pass on vouchers, this was because the partner attended a clinic for treatment (n = 2), the partner refused the voucher (n = 1), the index case had not yet made contact with the partner (n = 1) or the index case had lost the voucher (n = 1). Most of the 55 index cases (n = 48; 87%) reported that partners were either very satisfied (n = 27; 49%) or quite satisfied (n = 21; 38%) with treatment in this way. Two women reported that partners were neutral about treatment in this way (4%), and the remaining five women stated that they did not know how satisfied their partners were (9%). Of these 55 women who delivered vouchers to partners, the vouchers were actually redeemed in 34 cases (62%), in a median of 3 days (range 0 78 days). The voucher that was reported as lost by the index patient at the 1-month telephone contact was redeemed 78 days after issue. Index patients were asked how satisfied they were themselves with having a voucher to pass onto partners in this way. Out of the 60 respondents, most (46; 77%) stated that they were either very satisfied (n = 24; 40%) or quite satisfied (n = 22; 37%). Five women were neutral (8%) about satisfaction, and eight women did not know how satisfied they were (13%). The one woman who lost the voucher was very dissatisfied (2%) with this type of treatment. Discussion This pilot study demonstrated that, when given the option, a high proportion (40%) of partners of patients with uncomplicated chlamydia chose to be treated at a pharmacy rather than attend a clinic. This figure is likely to be an underestimate of the actual proportion of contacts that would choose to be treated in this way, as index patients did not always pass on vouchers to their partners. Vouchers were redeemed a median of 2 days after index patients received them, which compares favourably with waiting times for an appointment at a specialist clinic or with a GP. In our recent RCT of different strategies for treating male partners of women with chlamydia, namely standard patient referral to a GUM clinic, the use of a postal testing kit or PDPT, we demonstrated that 19%, 23% and 32% of partners were actually treated by these interventions, respectively. 7 So the 40% voucher redemption rate in this current study shows that treatment of partners at a pharmacy results in a favourable treatment rate. In the current study only 4% of partners from patients attending a GUM or FPC clinic, chose to be treated at a clinic rather than use the vouchers, compared with 18% of partners who were known to have chosen to attend a clinic rather than use PDPT in our earlier RCT. 7 The pharmacy voucher treatment scheme overcomes any safety concerns of PDPT, as recipients are questioned by the pharmacists to ensure that those with known allergies or contraindications to azithromycin do not receive the medication. Furthermore, pharmacy treatment would appear to overcome the legislative and regulatory difficulties that currently impede the clinical use of PDPT in the UK. 7,11 In this pilot study, partners were treated without testing for chlamydia. One criticism of this approach to managing partners is that it removes the opportunity to test partners for chlamydia and other STIs. Partner testing is thought to be important, as failure to confirm chlamydia positivity is thought to reduce the likelihood that other sexual contacts the partner may have had will be notified and treated. 10 However, in a previous study we showed that detection of secondary contacts was inefficient in this population. 7 Clearly, however, partner testing for chlamydia at the pharmacy has been shown to be feasible, 12 and could easily be incorporated into a voucher treatment scheme, although this would add significantly to the cost. Alternatively, as nucleic acid amplification tests for C. trachomatis may remain positive for up to 6 weeks after treatment, partners can still choose to be treated at the pharmacy and subsequently attend a clinic for testing if they wished to do so. With regards to testing partners for other STIs, a previous study in Lothian showed that there were no cases of gonorrhoea, syphilis or HIV detected, out of 488 partners of women with C. trachomatis attending a GUM clinic. 13 Thus, the value of testing partners for other STIs may depend upon the prevalence within the community. It was interesting in this study that 45% of partners (presumed male) of female index cases chose to use the ª 2010 The Authors Journal compilation ª RCOG 2010 BJOG An International Journal of Obstetrics and Gynaecology 1077

5 Cameron et al. pharmacy voucher. This is in contrast to the findings of a previous questionnaire survey of men in Lothian who seemed to prefer (at least in theory) to attend a clinic for testing. 14 Women who were surveyed in our telephone interviews at the FPC site reported high levels of satisfaction with the voucher scheme. Chlamydia-positive women have previously reported overwhelming enthusiasm towards the theoretical possibility of delivering antibiotics directly to partners. 14 Whereas the small group of respondents in our current survey may, or may not, reflect the views of the larger population, nevertheless this does give some indication that expedited partner treatment via a pharmacy may also be acceptable to women. This study was a pragmatic study, and all staff (medical and nursing) who were responsible for managing chlamydia-positive patients issued vouchers. We believe therefore that the findings of this study are likely to reflect what would happen if this pharmacy voucher scheme or expedited partner therapy at the pharmacy were to be adopted into everyday clinical practice. The lower voucher issue rate at GUM clinics is interesting. This may represent more complex cases attending specialist GUM settings, and/or differences in staff skills or acceptability towards this form of treatment. These findings suggest that this partner treatment strategy may be particularly useful outside GUM settings, where the majority of C. trachomatis infection in women in Scotland is now being diagnosed. 15 Given the increasing workload that has been recorded at GUM clinics throughout Scotland, pharmacy treatment of uncomplicated C. trachomatis may also help to ease the burden that management of this condition places upon specialist services. 15 Clearly, not all partners chose to use the voucher, and not all index patients were issued with vouchers, highlighting that pharmacy voucher treatment cannot replace traditional partner notification and patient referral to specialist clinics. It does, however, add choice for patients on where, when and how they are treated. Furthermore, it may improve access to timely treatment, which is important in preventing reinfection through the resumption of sex with untreated partners. Further larger studies of expedited partner therapy at the pharmacy that include the determination of repeat infection rates and a cost economic analysis are therefore warranted. Disclosure of interests None to declare. Contribution to authorship STC, AG, AM and GS designed the study and contributed to the writing of the paper. AJ, HQ, CO, MM and DM conducted the study and audits. GT and AM designed the PGD used in the study. All authors approved the final version. Details of ethics approval The study protocol was reviewed by the chair of one of the Lothian research ethics committees, who confirmed that ethical committee approval was not required for this health services research project. Funding This project was funded by the Scottish Government and the Edinburgh Community Health Partnership of NHS Lothian. Acknowledgements We would like to acknowledge Tara Duthie (GUM) for help with data collection, Anne Lorimer (Pharmacy) and Laura Fleetham (Dean Terrace) for disseminating information to pharmacists, and Eilidh Fletcher (Public Health) for statistical assistance. j References 1 UK national guideline for the management of genital infection with Chlamydia trachomatis2006. [ 61/61.pdf]. Accessed 3 December Mercer CH, Sutcliffe L, Johnson AM, White PJ, Brook G, Ross JD, et al. How much do delayed health care seeking, delayed care provision and diversion from primary care contribute to the transmission of STI s? Sex Transm Infect 2007;83: Patton DL, Wolner Hanssen P, Cosgrove SJ, Holmes KK. The effects of Chlamydia trachomatis on the female reproductive tract of the macara memestrina after a single tubal challenge following repeated inoculations. Obstet Gynecol 1990;76: Centers for Disease Control and Prevention. [ legal/default.htm] Accessed 4 December Kissinger P, Mohammed H, Richardson-Alston G, Leichliter JS, Taylor SN, Martin DH. Patient-delivered partner treatment for male urethritis: a randomized controlled trial. Clin Infect Dis 2005;41: Golden MR, Whittington WLH, Handsfield HH, Hughes TP, Stamm WE, Hogben M, et al. Effect of expedited treatment of sex partners on recurrent or persistent gonorrhea or chlamydial infection. N Engl J Med 2005;352: Cameron ST, Glasier A, Scott G, Young H, Melvin L, Johnstone A, et al. Novel interventions to reduce re-infection in women with chlamydia: a randomised controlled trial. Hum Reprod 2009;24: Cameron ST, Melvin L, Glasier A, Scott G, Johnstone A, Young H. Willingness of gynaecologists, doctors in family planning, gp s, practice nurses and pharmacists to adopt novel interventions for treating sexual partners of women with Chlamydia. BJOG 2007;114: Sexual health and hormonal contraception, module 5. NHS Education for Scotland. [ public_health/]. Accessed 1 March SIGN guideline no.109. Management of genital Chlamydia trachomatis infection. Scottish Intercollegiate Guideline network. March 2009 [ Accessed 1 March Cameron ST. Patient delivered partner therapy for Chlamydia- a realistic public health measure in the UK. BJOG 2009;116: ª 2010 The Authors Journal compilation ª RCOG 2010 BJOG An International Journal of Obstetrics and Gynaecology

6 Pharmacy treatment for chlamydia 12 Baraitser P, Pearce V, Holmes J, Horne N, Boynton PM. Chlamydia testing in community pharmacies: evaluation of a feasibility pilot in south east London. Qual Saf Health Care 2007;16: Manavi K, McMillan A, Young H. Genital infection in male partners of women with chlamydial infection. Int J STD AIDS 2006; 17: Melvin L, Cameron ST, Glasier A, Scott G, Johnstone A, Elton R. Preferred strategies of men and women for managing chlamydial infection. BJOG 2009;116: Health Protection Scotland Scotlands sexual health information. NHS Scotland. [ publications/sshi pdf]. Accessed 3 December Journal club Discussion points 1. Background: Describe the prevalence of genital infection with Chlamydia in your area as well as worldwide, and the implications for public health. Critically appraise the available evidence with regards to patient-delivered treatment versus partner notification versus selective screening for sexually transmitted infections, with reference to compliance, cost-effectiveness and patient satisfaction. Debate the differences between developing and developed countries, paying particular attention to cultural and practical issues. 2. Methodological considerations: In this study, the researchers relied on the reports of service users to assess the satisfaction of their partners: discuss. Debate the possible effect of spousal versus casual partners on the outcome measures. 3. Results and implications: Discuss possible serious adverse effects of patient-delivered treatment, both in general and comparing patient-delivered antibiotics with vouchers. The results of this study show fair compliance with the intervention, a process measure. Evaluate the use of process versus outcome measures to judge the effectiveness of healthcare interventions, using this study as an example for more general discussions. Brainstorm possible ways to improve the effectiveness, acceptability, equality and safety of patient-delivered treatment for the partners of people with sexually transmitted infections. j D Siassakos Southmead Hospital, Bristol, UK jsiasakos@gmail.com ª 2010 The Authors Journal compilation ª RCOG 2010 BJOG An International Journal of Obstetrics and Gynaecology 1079