PrEP suitability guidance

These recommendations have been assessed using the GRADE system. 

Who should be offered PrEP? 

We recommend that PrEP should be offered to people, regardless of their gender or sexual orientation who would benefit from a reduction in HIV risk* including:  

• people who request PrEP (2B) 

• people with an increased probability of HIV acquisition*(1A/1B depending on group) 

• people who, regardless of gender or sexual orientation, are likely to have condomless anal or vaginal sex with people with an increased probability  of HIV acquisition (2B) 

• people who inject drugs who might share injecting equipment (1A) 

*defined as where the probability of HIV acquisition is likely to be in excess of the background UK population and where benefit outweighs clinical risk of PrEP^1-3

When should PrEP be prescribed? 

We recommend that PrEP should be prescribed for people in whom it is suitable as soon as HIV risk is identified as benefit is immediate and toxicity is uncommon and delayed. (1A)  

PrEP offer: We suggest that PrEP should be considered in people identifying or identified as having increased probability  of HIV acquisition. For example, where HIV testing is performed, or an individual presents for regular or emergency contraception or STI testing.

Reviewing PrEP risk/benefit: We suggest that there is ongoing consideration and review of risk and benefit as this can change over time.  

Assessment of PrEP suitability: We suggest that assessment of HIV and STI risk and suitability for PrEP should be integrated into the broader sexual and reproductive health context. People who could benefit from PrEP will be encountered in community healthcare, general practice, and sexual and reproductive health services. HIV risk may become apparent in the context of care related to contraception, pregnancy or abortion, or in the emergency setting in the context of HIV testing or PEPSE provision. This particularly applies to women and other people who would benefit from a reduction in HIV risk but do not attend sexual health services. It also includes people in whom HIV or STI testing is stigmatised or who had not previously considered HIV risk.  

Risks and benefits of PrEP 

The benefits of PrEP are rapid and substantial. Therefore, with only uncommon exceptions, PrEP should be initiated in people who request it or who identify or are identified as having an increased probability of HIV acquisition, as defined above. PrEP is a key part of transmission elimination strategies in the UK and globally^1,4-6. PrEP is well-tolerated and current evidence suggests that any toxicities are delayed, uncommon, specific and reversible in the context of adequate monitoring as outlined in the UK PrEP Guidelines (Chapters 4,6 & 7)^7,8.  

The move away from trial eligibility criteria 

Focussing on eligibility criteria for clinical trials makes it difficult to fully identify the range of individuals who would benefit from PrEP, particularly those with an increased probability  of HIV acquisition due to their partners’ sexual behaviour, or those who do not initially report risk. Eligibility criteria are often determined by clinical trial design and do not represent an evidence base for the limits of risk-benefit assessments. While defining these limits helps to identify people who would benefit from PrEP, caution should be exercised to ensure that people are not excluded. A wider range of population–level and individual level indicators are appropriate to ensure that PrEP reaches all those who could benefit.

Population groups with the greatest demonstrated clinical benefit of PrEP  

The decision to offer or initiate PrEP is informed by sexual and or drug use history and risks that have occurred in the preceding months or are likely to occur in the following months.  

Evidence of PrEP benefit is greatest for men who have sex with men, trans women who have sex with men who report receptive condomless anal sex and people who report condomless vaginal or anal sex with an HIV positive partner without viral suppression.  

People in one or more of the following groups are also likely to benefit from PrEP: people who have sexualised drug use (chemsex), people who have condomless anal or vaginal sex with a partner of unknown HIV status where their partner or the person themselves is a man who has sex with men and or from a country with a high HIV prevalence, people who inject drugs who share injecting equipment or who have multiple factors including through sex⁹.

When should PrEP be offered?  

PrEP is suitable for most people who request it and, in almost all situations, offering and initiating PrEP to those who request it is appropriate. Exceptions include where the individual probability of HIV acquisition is not higher than that of the background UK population or where clinical risk of PrEP outweighs benefit^7,8. Wherever clinicians or other health workers are reviewing the risk of sexually transmitted infection (STI), including HIV, or discussing contraception with a patient, the suitability for PrEP should be considered. These situations include when an HIV test or other STI tests are offered or the results reviewed, when an STI is diagnosed or treated, when partner notification occurs, when PEPSE is initiated or reviewed and in many contraception and other sexual and reproductive health consultations. In people for whom transmission risk is difficult to ascertain and/or who have an elevated risk of PrEP toxicity, expert advice or MDT discussion may be appropriate to determine the appropriate advice to the individual. 

People with anxiety about HIV transmission that seems greater than their objective probability  of HIV acquisition  may request PrEP. Longitudinal risk may be greater or less than initially reported and PrEP is very safe in the context of regular monitoring, particularly in the short term while longitudinal risk is being assessed. Although people who take PrEP gain significant relief of anxiety and psychological distress, recommendations on PrEP benefit should be based on probability  of HIV acquisition. Referral for ongoing discussion and support or to psychological services, if relevant, should be considered for people whose anxiety is disproportionate to their reported risk of HIV acquisition.   

PrEP is not indicated for people who only have sex with a person/people living with HIV on ART with viral load <200 copies/ml as the risk of HIV transmission is zero. It is important that PrEP information, education and individual discussions do not inadvertently undermine U=U messages and contribute to HIV stigma.  

Note 

*Scottish population-level data showed that any recent bacterial STI (not solely rectal) in GBMSM was a predictor of HIV seroconversion.  

Population level indicators:

• Gay, bisexual and other men who have sex with men (GBMSM) (1A)^7,8

• Black African men and women (1A)^7,8

• Transgender women (1A)^7,8 

• Recent migrants (1D)¹⁰

• People who inject drugs (1A)^7,8

• People who report sex work or transactional sex (1A for MSM & TGW, FSW)^7,8,11

Behavioural and personal indicators (2D):

• Condomless anal or vaginal/frontal sex with one of the groups listed above. 

• Condomless anal or vaginal/frontal sex where a sexual partner may have undiagnosed or untreated HIV infection (1A)^12,13

• Chemsex or group sex (1B for GBMSM) 

• Injecting drug use using shared equipment (1A)^7,8

• Travel to countries with high HIV prevalence where sex with people from those countries is likely** 

Other clinical markers:

• Other sexually transmitted infection (1C)⁹ 

• HCV infection (1C)⁹

• PEPSE use (1C)¹⁴

Injecting drug use (1A):

• Injecting in an unsafe setting, sharing injecting equipment or limited access to needle and syringe programmes (NSP) or opiate substitution treatment (OST). 

• Sexual risk in people who use drugs. 

Reduced sexual health autonomy (2D):

• Drug and alcohol use. 

• Safeguarding, consent and vulnerability issues. 

• Inability to negotiate and/or use condoms (or employ other HIV prevention methods) with sexual partners.  

• Coercive and/or violent power dynamics in relationships (e.g. intimate partner/domestic violence).  

• Precarious housing or homelessness, and/or other factors that may affect material circumstances.  

• Risk of sexual exploitation and trafficking.  

** Factors known to be associated with HIV risk should prompt a consideration of PrEP and include population level indicators, clinical indicators (e.g. previous / current STIs and PEPSE use in GBMSM¹⁴, reported sexual behaviour / likely sexual behaviour and drug use and vulnerability factors affecting sexual autonomy.