Audit report
The impact of the 2011 UK post-exposure prophylaxis for HIV following sexual exposure guidelines: a regional retrospective audit
International Journal of STD & AIDS 2015, Vol. 26(10) 746–748 ! The Author(s) 2014 Reprints and permissions: sagepub.co.uk/journalsPermissions.nav DOI: 10.1177/0956462414556329 std.sagepub.com
A Bennett1, E Wainwright2, E Lord2, M Oduru3, F Chen3, N Desmond1, J Sherrard2 and S Duncan4
Abstract A re-audit of prescribing of post-exposure prophylaxis for HIV following sexual exposure in the Thames Valley demonstrated that an updated proforma has led to significant improvements in clinician-led outcomes, but had no impact on completion or follow-up rates.
Keywords HIV, AIDS, antiretroviral therapy, post-exposure prophylaxis, PEP, prevention, sexual intercourse, high-risk behaviour, audit Date received: 19 June 2014; accepted: 23 September 2014
Introduction The use of post-exposure prophylaxis for the prevention of HIV infection following sexual exposure (PEPSE) is well established.1 Since 2011, The British Association for Sexual Health and HIV (BASHH) no longer recommend the use of PEPSE for sexual exposure to an HIV positive partner who has an undetectable viral load (VL), except in unprotected receptive anal intercourse (RAI).2 A regional audit of PEPSE prescribing during 2011, in anticipation of the new guideline, showed that onethird of patients requesting PEPSE in our region had had sex with a known HIV-positive partner. However only 4% of cases had clear documentation of a partner’s undetectable VL. We recognised that documenting partners’ HIV treatment status and viraemia is key to guideline adherence.3 This study aims to firstly re-audit the documentation of partners’ HIV treatment status and VL following the introduction of a new proforma and secondly compare PEPSE prescribing to BASHH recommendations.2 Our region has a cohort of 1400 HIV patients and all involved centres have a diagnosed prevalence of >2 per 1000 population.4
Methods A re-audit of PEPSE prescribing at three sexual health clinics in the Thames Valley was completed by a
retrospective case note and pathology database review of all cases from 1st May 2012 to 1st May 2013. Electronic records databases identified patients prescribed PEPSE. Results were compared with our 2011 data and descriptive statistics were calculated in STATA version 11.0 (StataCorp., College Station, TX).
Results One hundred and twenty-five patient episodes were identified and all notes reviewed. A total of 105/125 PEPSE recipients were men (84%) of whom 84/105 (80%) were men who have sex with men (MSM). A total of 58/125 were men reporting RAI (46%) compared with 36/91 (40%) in 2011 (p ¼ 0.316). Frequency of unprotected sex was unchanged (84/125 [68%] versus 52/91 [57%], p ¼ 0.09), the remainder being condom 1
The Garden Clinic, Upton Hospital, Slough, Berkshire, UK The Churchill Hospital, Old Road, Headington, Oxford, UK 3 The Florey Unit, Royal Berkshire Hospital, Reading, UK 4 Darlington Memorial Hospital, Hundens Lane, Darlington, UK 2
Corresponding author: A Bennett, Department of Genitourinary Medicine, Upton Hospital, Berkshire Healthcare NHS Foundation Trust, Albert Street, Slough, SL1 2BJ, UK. Email: [email protected]
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Bennett et al.
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Table 1. Auditable outcomes from UK Guideline for the use of PEP for HIV following sexual exposure, BASHH.2 Auditable outcome measure
Target (%)
2013 (%) (n ¼ 125)
2011 (%) (n ¼ 91)
P value
Patients having a baseline HIV test within 72 h of presenting for PEPSE PEPSE prescriptions that fit within recommended indications PEPSE prescriptions administered within 72 h of risk exposure Individuals completing 4-week course of PEPSE Individuals seeking PEPSE undergoing testing for STIs Individuals completing 12-week post-PEPSE HIV antigen/antibody testing
100
91.2
81%
0.032
90 90 75 90 60
65.6 99.2 54.4 90.4 30.4
51 96 46 71 32
0.02 0.11 0.223 0.0002 0.8
Table 2. Parameters of patients’ HIV-positive partners. Partner’s parameters
Frequency 2013 (%)
Frequency 2011 (%)
P value
Partner Partner Partner Partner Partner Partner
30/125 5/30 11/30 12/30 2/30 4/30
32/91 10/32 4/32 3/32 15/32 4/32
0.0774 0.1815 0.026 0.0049 0.0004 0.9221
HIV positive HIVþ on ART HIVþ not on ART HIVþ unknown if on ART HIVþ not documented if on ART HIVþ and HIV-1 serum VL < 20 cp/ml
failures or uncertain of condom use. Baseline HIV testing was performed in 114 patients (114/125, 91%) and were all negative – of those untested, four started PEPSE elsewhere without a documented check that baseline testing had been performed, one had a test 3 weeks prior, one restarted a PEPSE pack at home, and the remainder had no clear reason for omission. Comparison of our PEPSE prescribing to BASHH recommendations is summarised in Table 1. In 2013, 82/125 (65.6%) patients were prescribed PEPSE as per BASHH recommended indications. This included those in the ‘consider’ category with relevant contributing factors, e.g. sexual assault. Of the remainder, 29/125 fell within the ‘consider’ indications (for sex other than RAI, with a source from high prevalence group/ area) and 14/125 (11.2%) were ‘not recommended’ indications (predominantly for low risk sexual assault, sex workers, MSM fellatio, or HIVþ partner with VL < 20). One hundred and twenty-three (98%) patients were prescribed a recommended drug combination. Thirty per cent attended 12-week HIV testing; of these 58% were high risk exposures. Subsequently, no patients tested positive for HIV.
Documentation of partner’s HIV treatment status In 2013 the number of patients reporting an HIV-positive partner was unchanged (30/125 [24%] versus 32/91 in 2011 [35%] p ¼ 0.07). Importantly, documentation of patients’ partners’ treatment statuses was more
(24) (16.5) (36.5) (40) (7) (17)
(35) (31) (12.5) (9) (47) (12.5)
comprehensive (Table 2). In 2011, 15/32 (47%) HIVpositive partners did not have a documented treatment status, compared to 2/30 (7%) in 2013 (p ¼ 0.0004). For the four patients with an HIV-positive partner where the HIV VL was undetectable, one reported unprotected RAI. The remaining three reported unprotected insertive anal intercourse: PEPSE was discontinued in one case once the partner’s VL was confirmed (counted as a ‘recommended’ prescription at baseline), but continued in two cases due to bleeding after sex and patient anxiety. Of the 12 patients documented to have an HIVpositive partner of unknown treatment status, 50% had RAI, hence PEPSE was recommended regardless.
Discussion The benefit of using a proforma to facilitate adherence with clinical standards has been recently highlighted in the context of managing young people in the UK.5 Our experience shows a marked improvement in cliniciandependent auditable outcomes, such as baseline HIV testing and STI screening, which could be reproducible in other PEPSE prescribing settings such as AþE and primary care. Approximately two-thirds of prescriptions were guideline recommended. Prescribing outside these recommendations may reflect a lack of clinician awareness of the new guidelines, over-cautious prescribing, or patient pressure. Re-education of staff is currently ongoing at all centres to address this. In addition, each clinic proforma now contains a table with the BASHH
Downloaded from std.sagepub.com at UNIV OF OTTAWA LIBRARY on August 4, 2015
748
International Journal of STD & AIDS 26(10)
PEPSE recommendations to facilitate more appropriate prescribing.2 Further work is required to assess the effectiveness of these interventions. Patient-led outcomes such as completion rates and 12-week testing rates remain unchanged and are consistent with other published UK PEPSE data.6 Further strategies such as enhanced or innovative follow-up methods need exploring within regional settings like ours where the frequency of prescriptions do not warrant a dedicated PEPSE clinic. One-third (41/125, 33%) of all prescriptions were amongst MSM, for unprotected RAI with partners of unknown HIV status – a risk group unaffected by current guidelines. A lack of local codes identifying consultations where PEPSE was discussed but not prescribed meant we were unable to collate data on appropriate, guideline-driven episodes of non-prescribing, e.g. exposure to positive partners with undetectable viraemia. 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.
References 1. BHIVA Standards of care for people living with HIV. www.bhiva.org (2013, accessed 16 June 2014). 2. Benn P, Fisher M and Kulasegaram R. UK guideline for the use of post-exposure prophylaxis for HIV following sexual exposure (2011). Int J STD AIDS 2011; 22: 695–708. 3. Duncan S, Pease E, Morgan E, et al. Abstracts of the Eleventh International Congress on drug therapy in HIV infection. J Int AIDS Soc 2012; 15(Suppl 4): 18168. 4. http://www.hpa.org.uk/webc/HPAwebFile/HPAweb_C/ 1317139920150 (accessed 16 June 2014). 5. Bailey HR, Lazaro N, Sashidharan PN, et al. A national audit of the management of young people in genitourinary medicine clinics (level 3 services) in the United Kingdom. Int J STD AIDS 2014; 25: 363–365. 6. McCarty EJ, Quah S, Maw R, et al. Post-exposure prophylaxis following sexual exposure to HIV: a sevenyear retrospective analysis in a regional centre. Int J STD AIDS 2011; 22: 407–408.
Downloaded from std.sagepub.com at UNIV OF OTTAWA LIBRARY on August 4, 2015
The impact of the 2011 UK post-exposure prophylaxis for HIV following sexual exposure guidelines: a regional retrospective audit
International Journal of STD & AIDS 2015, Vol. 26(10) 746–748 ! The Author(s) 2014 Reprints and permissions: sagepub.co.uk/journalsPermissions.nav DOI: 10.1177/0956462414556329 std.sagepub.com
A Bennett1, E Wainwright2, E Lord2, M Oduru3, F Chen3, N Desmond1, J Sherrard2 and S Duncan4
Abstract A re-audit of prescribing of post-exposure prophylaxis for HIV following sexual exposure in the Thames Valley demonstrated that an updated proforma has led to significant improvements in clinician-led outcomes, but had no impact on completion or follow-up rates.
Keywords HIV, AIDS, antiretroviral therapy, post-exposure prophylaxis, PEP, prevention, sexual intercourse, high-risk behaviour, audit Date received: 19 June 2014; accepted: 23 September 2014
Introduction The use of post-exposure prophylaxis for the prevention of HIV infection following sexual exposure (PEPSE) is well established.1 Since 2011, The British Association for Sexual Health and HIV (BASHH) no longer recommend the use of PEPSE for sexual exposure to an HIV positive partner who has an undetectable viral load (VL), except in unprotected receptive anal intercourse (RAI).2 A regional audit of PEPSE prescribing during 2011, in anticipation of the new guideline, showed that onethird of patients requesting PEPSE in our region had had sex with a known HIV-positive partner. However only 4% of cases had clear documentation of a partner’s undetectable VL. We recognised that documenting partners’ HIV treatment status and viraemia is key to guideline adherence.3 This study aims to firstly re-audit the documentation of partners’ HIV treatment status and VL following the introduction of a new proforma and secondly compare PEPSE prescribing to BASHH recommendations.2 Our region has a cohort of 1400 HIV patients and all involved centres have a diagnosed prevalence of >2 per 1000 population.4
Methods A re-audit of PEPSE prescribing at three sexual health clinics in the Thames Valley was completed by a
retrospective case note and pathology database review of all cases from 1st May 2012 to 1st May 2013. Electronic records databases identified patients prescribed PEPSE. Results were compared with our 2011 data and descriptive statistics were calculated in STATA version 11.0 (StataCorp., College Station, TX).
Results One hundred and twenty-five patient episodes were identified and all notes reviewed. A total of 105/125 PEPSE recipients were men (84%) of whom 84/105 (80%) were men who have sex with men (MSM). A total of 58/125 were men reporting RAI (46%) compared with 36/91 (40%) in 2011 (p ¼ 0.316). Frequency of unprotected sex was unchanged (84/125 [68%] versus 52/91 [57%], p ¼ 0.09), the remainder being condom 1
The Garden Clinic, Upton Hospital, Slough, Berkshire, UK The Churchill Hospital, Old Road, Headington, Oxford, UK 3 The Florey Unit, Royal Berkshire Hospital, Reading, UK 4 Darlington Memorial Hospital, Hundens Lane, Darlington, UK 2
Corresponding author: A Bennett, Department of Genitourinary Medicine, Upton Hospital, Berkshire Healthcare NHS Foundation Trust, Albert Street, Slough, SL1 2BJ, UK. Email: [email protected]
Downloaded from std.sagepub.com at UNIV OF OTTAWA LIBRARY on August 4, 2015
Bennett et al.
747
Table 1. Auditable outcomes from UK Guideline for the use of PEP for HIV following sexual exposure, BASHH.2 Auditable outcome measure
Target (%)
2013 (%) (n ¼ 125)
2011 (%) (n ¼ 91)
P value
Patients having a baseline HIV test within 72 h of presenting for PEPSE PEPSE prescriptions that fit within recommended indications PEPSE prescriptions administered within 72 h of risk exposure Individuals completing 4-week course of PEPSE Individuals seeking PEPSE undergoing testing for STIs Individuals completing 12-week post-PEPSE HIV antigen/antibody testing
100
91.2
81%
0.032
90 90 75 90 60
65.6 99.2 54.4 90.4 30.4
51 96 46 71 32
0.02 0.11 0.223 0.0002 0.8
Table 2. Parameters of patients’ HIV-positive partners. Partner’s parameters
Frequency 2013 (%)
Frequency 2011 (%)
P value
Partner Partner Partner Partner Partner Partner
30/125 5/30 11/30 12/30 2/30 4/30
32/91 10/32 4/32 3/32 15/32 4/32
0.0774 0.1815 0.026 0.0049 0.0004 0.9221
HIV positive HIVþ on ART HIVþ not on ART HIVþ unknown if on ART HIVþ not documented if on ART HIVþ and HIV-1 serum VL < 20 cp/ml
failures or uncertain of condom use. Baseline HIV testing was performed in 114 patients (114/125, 91%) and were all negative – of those untested, four started PEPSE elsewhere without a documented check that baseline testing had been performed, one had a test 3 weeks prior, one restarted a PEPSE pack at home, and the remainder had no clear reason for omission. Comparison of our PEPSE prescribing to BASHH recommendations is summarised in Table 1. In 2013, 82/125 (65.6%) patients were prescribed PEPSE as per BASHH recommended indications. This included those in the ‘consider’ category with relevant contributing factors, e.g. sexual assault. Of the remainder, 29/125 fell within the ‘consider’ indications (for sex other than RAI, with a source from high prevalence group/ area) and 14/125 (11.2%) were ‘not recommended’ indications (predominantly for low risk sexual assault, sex workers, MSM fellatio, or HIVþ partner with VL < 20). One hundred and twenty-three (98%) patients were prescribed a recommended drug combination. Thirty per cent attended 12-week HIV testing; of these 58% were high risk exposures. Subsequently, no patients tested positive for HIV.
Documentation of partner’s HIV treatment status In 2013 the number of patients reporting an HIV-positive partner was unchanged (30/125 [24%] versus 32/91 in 2011 [35%] p ¼ 0.07). Importantly, documentation of patients’ partners’ treatment statuses was more
(24) (16.5) (36.5) (40) (7) (17)
(35) (31) (12.5) (9) (47) (12.5)
comprehensive (Table 2). In 2011, 15/32 (47%) HIVpositive partners did not have a documented treatment status, compared to 2/30 (7%) in 2013 (p ¼ 0.0004). For the four patients with an HIV-positive partner where the HIV VL was undetectable, one reported unprotected RAI. The remaining three reported unprotected insertive anal intercourse: PEPSE was discontinued in one case once the partner’s VL was confirmed (counted as a ‘recommended’ prescription at baseline), but continued in two cases due to bleeding after sex and patient anxiety. Of the 12 patients documented to have an HIVpositive partner of unknown treatment status, 50% had RAI, hence PEPSE was recommended regardless.
Discussion The benefit of using a proforma to facilitate adherence with clinical standards has been recently highlighted in the context of managing young people in the UK.5 Our experience shows a marked improvement in cliniciandependent auditable outcomes, such as baseline HIV testing and STI screening, which could be reproducible in other PEPSE prescribing settings such as AþE and primary care. Approximately two-thirds of prescriptions were guideline recommended. Prescribing outside these recommendations may reflect a lack of clinician awareness of the new guidelines, over-cautious prescribing, or patient pressure. Re-education of staff is currently ongoing at all centres to address this. In addition, each clinic proforma now contains a table with the BASHH
Downloaded from std.sagepub.com at UNIV OF OTTAWA LIBRARY on August 4, 2015
748
International Journal of STD & AIDS 26(10)
PEPSE recommendations to facilitate more appropriate prescribing.2 Further work is required to assess the effectiveness of these interventions. Patient-led outcomes such as completion rates and 12-week testing rates remain unchanged and are consistent with other published UK PEPSE data.6 Further strategies such as enhanced or innovative follow-up methods need exploring within regional settings like ours where the frequency of prescriptions do not warrant a dedicated PEPSE clinic. One-third (41/125, 33%) of all prescriptions were amongst MSM, for unprotected RAI with partners of unknown HIV status – a risk group unaffected by current guidelines. A lack of local codes identifying consultations where PEPSE was discussed but not prescribed meant we were unable to collate data on appropriate, guideline-driven episodes of non-prescribing, e.g. exposure to positive partners with undetectable viraemia. 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.
References 1. BHIVA Standards of care for people living with HIV. www.bhiva.org (2013, accessed 16 June 2014). 2. Benn P, Fisher M and Kulasegaram R. UK guideline for the use of post-exposure prophylaxis for HIV following sexual exposure (2011). Int J STD AIDS 2011; 22: 695–708. 3. Duncan S, Pease E, Morgan E, et al. Abstracts of the Eleventh International Congress on drug therapy in HIV infection. J Int AIDS Soc 2012; 15(Suppl 4): 18168. 4. http://www.hpa.org.uk/webc/HPAwebFile/HPAweb_C/ 1317139920150 (accessed 16 June 2014). 5. Bailey HR, Lazaro N, Sashidharan PN, et al. A national audit of the management of young people in genitourinary medicine clinics (level 3 services) in the United Kingdom. Int J STD AIDS 2014; 25: 363–365. 6. McCarty EJ, Quah S, Maw R, et al. Post-exposure prophylaxis following sexual exposure to HIV: a sevenyear retrospective analysis in a regional centre. Int J STD AIDS 2011; 22: 407–408.
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