Challenges in implementing the 2015 BASHH guidelines for the appropriate use of post-exposure prophylaxis for HIV following sexual exposure

The use of post exposure prophylaxis for human immunodeficiency virus (HIV) following sexual exposure (PEPSE) was retrospectively audited in an inner city genitourinary clinic against the 2015 national guidelines by the British Association for Sexual Health and HIV (BASHH). One-hundred out of a total of 101 patients (99%) had a baseline HIV test done. 82.1% (n=83) of patients were given PEPSE prescriptions fitting within recommended indications lower than the 90% target set by BASHH. 84.2% (n=85) of patients had PEPSE administered within 72 hours lower than the 90%. 61.4% (n=62) of patients were known to have completed four weeks of PEPSE lower than the 75% target. 61.4% (n=62) of patients were screened for sexually transmitted infections (STIs) lower than the 90% target. 59.4% (n=60%) of patients had post-PEPSE HIV bloods slightly lower than the 60% target.


Introduction
Post-exposure prophylaxis for HIV involves taking antiretrovirals by human immunodeficiency virus (HIV)-negative individuals for four weeks, after a suspected or known exposure to HIV to reduce the risk of transmission 1,2 . In 2015 the British Association for Sexual Health and HIV updated national guidelines on the appropriate use of post exposure prophylaxis after sexual exposure to HIV (PEPSE) 3 . --The guidelines provide indications for when PEPSE use; is recommended; can be considered; or is not appropriate. It also recommends PEPSE use within 72 hours; baseline HIV testing, appropriate sexually transmitted infection (STI) testing, and completion of four weeks of PEPSE with follow up HIV bloods after completion of PEPSE. BASHH have specified auditable targets for these recommendations, and this retrospective audit compares the use of PEPSE in our genitourinary clinic against these recommendations.

Method
A retrospective case note review was carried out at Walsall Centre of Sexual Health. One-hundred one patients who were coded as having received PEPSE between June 2013 and September 2015 were identified on the computer system. No permission was required to conduct the study and publish these results. Notes of these patients were reviewed and data regarding; the indication of PEPSE administration; time since exposure; investigations carried out; completion of four weeks of PEPSE and whether the patient had follow up investigation were uploaded onto a Microsoft Excel database.

Results
The results of 101 patients who received PEPSE were analysed (Table 1) 59.4% (n=60%) of patients had post-PEPSE HIV bloods slightly lower than the 60% target. All 100 patients that had baseline HIV bloods taken had appropriate investigations into hepatitis B and syphilis. However 61.4% (n=62) of patients were screened for chlamydia and gonorrhoea lower than the 90% target. None of the patients who had come for PEPSE after needle stick injury had testing for gonorrhoea and chlamydia, and not taking into account these patients 73% of patients had screening for chlamydia and gonorrhoea.

Discussion
The majority of patients prescribed PEPSE where given so under indications that were deemed compliant with BASHH guidelines and within 72 hours of the suspected exposure. All but one of these patients had baselines HIV bloods taken, and appropriate testing for syphilis and hepatitis B, with post-PEPSE follow-up testing levels being near the BASHH target.
Documentation regarding whether patients were taking or discontinuing PEPSE was lacking. There was also difficulty determining whether patients who did not attend after their initial visit had completed their PEPSE course.
One particular guideline that we found difficulty in reaching was screening for chlamydia and gonorrhoea, especially in patients coming in after needlestick injuries. Often times it is either not considered suitable or the patient declines the screening as they do not feel they are at risk. Screening should always be encouraged and there should be documentation that the screening tests have been declined if that is case.
Another issue is patients not visiting for follow-ups. Often screening for chlamydia and gonorrhoea is delayed until after the window period for investigations to identify these organisms. Follow-ups are also important for identifying whether the patient is compliant with the antiretrovirals, and for post-PEPSE HIV blood tests.
Carrying out an audit against the BASHH guidelines have highlighted areas in our clinical practice which need improvement.
In response to this audit we have created clear proformas for prescribing PEPSE which include; whether the indication the patient is coming in with fits with BASHH guidelines; whether the exposure was less than 72 hours ago, and a list of the relevant investigations that should be considered. Proformas for follow-up have also been made to assess whether the patient is completing the course of PEPSE and having follow-up bloods after completion of therapy. Training has been given to educate all staff on the indications for PEPSE prescribing, the need to identify HIV status and viral load of source, the need to have accurate documentation, to offer rapid-HIV testing, and fourth generation HIV testing for post-PEPSE follow-up. We have also decided to get patients to book their follow-up appointment during their initial visit to the clinic. We will then send SMS reminders the day before the follow-up appointment to remind patients to attend. We plan to carry out a re-audit in one year.

Data availability
All raw data are provided in the tables above.

Competing interests
The authors declare no conflict of interest.

Grant information
The author declared that no grants were involved in supporting this work. This is an interesting report of a clinical audit conducted to assess the implementation of UK BASHH guidelines on Post Exposure Prophylaxis following sexual exposure. The paper provides a clear summary of the methods and results compared to national guidelines. The recommendations and subsequent actions taken following the results are of interest to the audience. Further clarification in some sections could enhance the key message of the paper. In places the grammar and language could be improved.

Open Peer Review
Comments and considerations for the authors:

Method
Please provide further geographical detail (region, country) to allow the audience to understand the context of the setting. Consider rewording the sentence regarding permission. As secondary data has been used no patient consent was needed but how was confidentiality maintained, was the data anonymised? Did you seek any ethical approval or institutional approval? Note Excel is not a classic database, please revise to spreadsheet, unless alternative database was used for analysis.

Results
Consider using 'performed' or 'conducted' in place of 'done'.

If applicable, is the statistical analysis and its interpretation appropriate? Yes
Are all the source data underlying the results available to ensure full reproducibility? Yes

Are the conclusions drawn adequately supported by the results? Yes
No competing interests were disclosed.

Competing Interests:
I have read this submission. I believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard, however I have significant reservations, as outlined above. Another question raised is how many of those receiving PEP in this study may have also been appropriate candidates for PeEP given our current knowledge of the effectiveness of that prevention approach.

If applicable, is the statistical analysis and its interpretation appropriate? Yes
Are all the source data underlying the results available to ensure full reproducibility?

Are the conclusions drawn adequately supported by the results? Yes
No competing interests were disclosed.

Competing Interests:
I have read this submission. I believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard. There are some language and grammatical errors that need attention.
The link provided to the BASHH guidelines is for the draft document and not the final version.
More detail about the context is need e.g. where is the Walsall Centre of Sexual Health located? Reference 1: I could unfortunately not access the full article, but the reference to this 1997 article in support of post-exposure prophylaxis does not seem to be the best choice since it deals with "Immune response to human immunodeficiency virus (HIV) in health care workers occupationally exposed to HIV-contaminated blood" and does not seem to deal with post-exposure prophylaxis.
The second reference in support of PEP is also not the most relevant reference since it is an animal study and the final conclusion of this article is that "limited antiviral drug diffusion in secondary lymphoid tissues may allow persistent viral replication in these tissues and could represent an obstacle to HIV prevention and eradication".
It would be interesting to know how many of the patients were repeat users of PEPSE. A possible recommendation could be monitoring for repeat users of PEPSE and referring them for PrEP.
It would also be interesting to know what antiretroviral medication had been prescribed for PEPSE and whether this complied with the guidelines.
It is preferable not to refer to "bi-sexual/homosexual" but rather to men who have sex with men and/or women.  This seems to be very high and since the guideline only covers needle stick injuries in the community, the circumstances surrounding the injuries should be explained. I recommend that all exposure categories be listed in order to improve understanding. It seems that Tables 1 and 2 could be merged. Table 2: The recommended VL above which PEPSE should be given is 200 copies/ml and not 40 copies/ml -the unit of measure is not given in the table. In addition, the meaning of the category "Men who have sex with men (MSM) High prevalence/unknown" is unclear.
The proportion of PEPSE prescriptions administered within 24 hours (and not 72 hours) of risk exposure is the auditable outcome and should also be shown.
The author states that "There was also difficulty determining whether patients who did not attend after their initial visit had completed their PEPSE course". What measures were taken to determine this?
What steps had been taken to assess the VL of HIV-infected partners?
"No permission was required to conduct the study and publish these results." I presume the author means that informed consent was not considered relevant since the data used were anonymous, but surely institutional permission was needed?
Article should make reference to other related work, e.g.