Guidance
Rationale and impact
- Accessing sexual health services
- Meeting the needs of groups with greater sexual health or access needs
- Co-producing interventions to reduce STI transmission
- Delivering and evaluating interventions to reduce STI transmission
- Self-sampling to improve the uptake and increase the frequency of STI testing
- Tailoring interventions to improve the uptake and increase the frequency of STI testing
- Partner notification
- HPV and hepatitis A and B vaccination in gay, bisexual and other men who have sex with men
- Raising awareness of pre-exposure prophylaxis for HIV
- Service design for PrEP services
- Access to PrEP services
- Prescribing PrEP
Rationale and impact
These sections briefly explain why the committee made the recommendations and how they might affect practice or services.
Accessing sexual health services
Recommendations 1.1.1 to 1.1.3
Why the committee made the recommendations
The committee considered who should be offered interventions and when, noting that often, the people who most need support with their sexual health and wellbeing are those least likely to access services. They also noted that people who do access services may be doing so because they have had sex that they perceive to have been unsafe. The committee noted the importance of sexual history taking in this context. They agreed this could help to identify issues such as sexual violence and exploitation, coercion, and drug and alcohol use in the context of sex. They noted the British Association for Sexual Health and HIV (BASHH) 2019 UK National Guideline for consultations requiring sexual history taking as an example of good practice.
The committee recognised the value of collaborative working and the importance of supporting people to access services that already deliver suitable interventions. However, they also acknowledged regional variations in provision and that many tailored interventions for higher risk minority groups do not exist outside London. They agreed that the responsibility should be on services to support people in accessing the service that is right for them rather than just leaving it up to the person. They agreed that a single service was unlikely to meet the needs of every person and highlighted the importance of networks of services and clear pathways into them.
The committee noted that some people did not realise that services were confidential and open access (that is, they are free for anyone to use). Those people might not access services because they thought they were not entitled to do so, that they would have to pay, or that their data might be shared with other organisations. Therefore, the committee agreed it was important to ensure that staff and people who use services know about this.
How the recommendations might affect practice or services
Existing clinic appointments could be used to identify people with greater sexual health or access needs and signpost them to appropriate services. However, additional appointment time would be needed for conversations about sexual wellbeing and risk reduction, particularly if brief motivational interviewing, cognitive behavioural therapy or condom-focused interventions are used.
Changing settings in which services are delivered could have a cost impact because services may need to be moved or started up, but reducing barriers to access those services need not be resource intensive. The committee noted that fairly simple changes can make a large difference to people's ability to access services.
Meeting the needs of groups with greater sexual health or access needs
Recommendations 1.1.4 and 1.1.5
Why the committee made the recommendations
The committee discussed how the wider determinants of health can influence sexual health and wellbeing. These include stigma, discrimination faced by those who are part of a minority group, housing instability, poverty, substance use, mental health and intimate partner violence. They agreed that it is important to consider the social, cultural, emotional and economic aspects of a person's life when seeking to address their sexual risk behaviour. The committee also recognised that sexually transmitted infection (STI) incidence is just 1 aspect of sexual health, and that taking a broad perspective that encompasses wider aspects of sexual wellbeing is important.
The committee agreed that interventions and services should be targeted at people with greater sexual health and access needs because that represents the most effective and cost-effective strategy. They discussed the complexity of reaching individual people with greater sexual health and access needs rather than targeting everyone in higher risk groups because not all people in higher risk groups need sexual health support or interventions. However, by targeting higher risk groups, individuals needing help would benefit. The committee recognised that local areas vary in their cultural and demographic profiles and agreed that data from various sources (including the Joint Strategic Needs Assessment [JSNA] and relevant health equity audits) should be used to commission and provide services to meet local need. They agreed that although it was important to engage with groups with greater sexual health or access needs, in many cases it would be challenging to do so.
The committee discussed the evidence specific to each of the higher risk groups and agreed that interventions should be tailored to the needs of specific groups, such as gay, bisexual and other men who have sex with men, or trans people. However, they noted that the degree of intersectionality and the likely variation in experiences and identities within these groups made group-specific recommendations somewhat problematic. They agreed that there was little evidence about how to tailor outreach services to best meet the needs of specific groups to improve their access to sexual health services and uptake of STI testing, although expert testimony provided some promising examples. Therefore, they made a recommendation for research on tailoring outreach services. The committee also considered the evidence for culturally relevant interventions and agreed that interventions should be culturally competent.
The committee discussed the expert testimony about the inclusion health agenda and their own expertise and experience of reducing barriers to services for people from underserved groups (those who existing services are not accessible to). They noted that a key part of service accessibility was about avoiding assumptions about things like gender or sexuality, or being judgemental about people's relationships or sexual practices. The committee noted that staff may need additional training to do this.
How the recommendations might affect services
Targeting interventions at groups in which greater sexual health needs have been identified locally will make the use of resources more efficient by ensuring that they are used where they are most needed. Identifying groups will make use of existing data, for example from the JSNA or from STI diagnosis data, and will not have a large resource impact. However, the committee agreed that this could be challenging because the data may be limited or not as robust. Engaging with groups with greater needs is already good practice in sexual health and should not have an impact on resources.
Co-producing interventions to reduce STI transmission
Recommendations 1.1.6 to 1.1.10
Why the committee made the recommendations
Committee members suggested that the most effective way to ensure that interventions and services meet the needs of specific groups, communities or cultures is to plan, design and implement them in consultation with the people who will be using them (co-production). This was supported by the broader evidence and expert testimony. It helps to ensure that they are culturally sensitive and appropriate to the group they are for. They noted that further research was needed to understand and reduce the stigma associated with accessing sexual health services, and therefore made a recommendation for research on the most effective and cost-effective methods of reducing stigma.
The committee considered evidence for a range of interventions designed to reduce sexual risk and prevent STIs. The evidence was mixed, with some studies showing no effect on sexual health outcomes and other studies showing a positive impact on condom use, STI incidence and sexual health knowledge. No single intervention type emerged as consistently or substantially effective. Motivation-based approaches, cognitive behavioural therapy and cognitive approaches, condom-focused approaches and culturally relevant interventions all performed comparatively well compared with no intervention. Based on this evidence and their experience, the committee agreed that interventions should aim to adopt a multi-model approach by incorporating components from some or all of these approaches, and that people designing interventions should look at NICE's guidance on behaviour change. The committee also agreed that all interventions should be sex and identity positive – that is, they should recognise the broad range of people's sex lives and their identities without being judgemental.
The committee noted the evidence for condom-focused approaches and agreed that condom use is a fundamental method of preventing STIs. Therefore, supporting people to use condoms correctly and consistently is important. They agreed that condom-positive approaches would be most effective, with a focus on pleasure, the wide variety of condoms available, the importance of fit and feel, barriers to use and strategies for negotiating use. They also noted the importance of both internal and external condoms. They agreed that demonstrations of condom use were also valuable, particularly if people were given the opportunity to practise.
The committee agreed that motivation-based approaches such as motivational interviewing were useful for risk-reduction interventions but recognised that the evidence for their effectiveness was mixed. They heard expert testimony from organisations delivering motivation-based interventions, which helped them to better understand how well these approaches work, who they may be most suited to and the best way to deliver them.
The committee agreed that, given the challenging life contexts in which many people with greater sexual health needs live, it is important to offer people support to develop their understanding of the link between emotions and sexual wellbeing, stress management and coping skills, and that these should be incorporated into sexual risk reduction interventions. They discussed that cognitive behavioural approaches were particularly useful for addressing psychological aspects of sexual wellbeing and the evidence to some extent supported this.
How the recommendations might affect services
The committee agreed that co-produced interventions were far more likely to be effective and therefore cost effective because they would be better suited to the people they were serving. They agreed that although co-production does have a resource impact compared with usual planning and commissioning, it need not be significant and it is already widely used in other areas of the public sector.
Delivering and evaluating interventions to reduce STI transmission
Recommendations 1.1.11 to 1.1.15
Why the committee made the recommendations
The setting of interventions is important. The committee discussed current sexual health provision across primary care, sexual health services and third sector organisations and agreed that people should be able to attend the service most suited to them. They also agreed that online services were an integral and important part of this.
The committee also discussed the importance of Making Every Contact Count. They agreed that 1 of the ways that people could be encouraged to use sexual health services was to provide them as part of broader support services, for example drug and alcohol services, HIV care and mental health services. They agreed it was important to take into account that people's sexual health is only 1 aspect of their overall wellbeing. The committee were unaware of research about the most effective ways to deliver sexual health services together with other services and made a recommendation for research on delivering effective sexual health services as part of other services.
The committee agreed that co-producing interventions would help people to decide if interventions were best delivered in one-to-one or group settings (this might also relate to considerations about safety and stigma).
The committee considered the evidence for peer delivery and, in combination with their experience, agreed that interventions were best delivered by peers if possible. The committee clarified their understanding of peers as people with a shared identity with the target group or another person who they could relate to, and that the ability to empathise and understand the person's needs and life context was crucial. Committee members with experience of commissioning and delivering peer-led interventions emphasised the value and effectiveness of this approach.
The committee agreed that it was important for people delivering interventions to do so in ways that respected people's identities and choices, for example by using gender-neutral pronouns until a person expressed a preferred pronoun. They also discussed the importance of using those pronouns in written records – currently most written records have limited options and use a 'tick box' approach to gender and sexual identity.
The committee agreed that because the interventions were not based on strong evidence that it was important to evaluate them regularly and use the results of the evaluation to improve services and pathways. They noted that resources were available that could help with this, such as the UK Health Security Agency's (previously Public Health England) sexual health, reproductive health and HIV services: evaluation resources.
How the recommendations might affect services
Increased awareness of personal risk may lead to more people accessing STI testing services, which may affect service capacity and allocation of resources in clinics that deliver STI testing. However, the committee expect sexual health services in general to be providing cost-effective interventions and care, so even if more people using them increases costs, that is likely to be a cost-effective use of resources.
Evaluating interventions should already be inbuilt into all intervention delivery and therefore will not have a resource impact.
Self-sampling to improve the uptake and increase the frequency of STI testing
Recommendations 1.2.1 to 1.2.6
Why the committee made the recommendations
The committee were satisfied that the evidence supports the use of STI testing outside clinical services using self-sampling kits for people who are asymptomatic. They agreed that it encourages people who have previously never engaged with sexual health services to come forward for testing, so widening access to these kits would be a good thing. They noted that being able to access kits from a variety of locations could increase uptake. Possible locations include community pharmacies, which are already an integral part of test kit provision in some areas. However, these services would need to be commissioned.
The committee agreed that local service websites needed to be kept up to date about available options so that people knew what was available in their area and how to access it. However, they noted that the 'digital divide' could potentially widen health inequalities because not everyone who might want to order a remote self-sampling kit would necessarily have access to online ordering services. They also agreed that knowing who was accessing remote self-sampling would highlight groups where there may be inequalities in uptake. Services could then be tailored to address this.
There is regional variation in whether remote self-sampling is offered and how many kits are available. In locations that do offer it, not everyone who is eligible can have a test kit. This is because the demand for these kits is often greater than the supply and kits are not always returned, so there is some concern about wasting money if the return rate is low. As a result, the committee were aware that some areas were capping the number of kits available, creating a tension between widening access and limiting the number of kits. The committee therefore agreed that services should monitor kit return rates in different populations to ensure they were meeting the populations' needs. They also noted that there can be unintended consequences as a result of not having direct contact with a clinician. For example, a person with a positive test may not go to a service and there might be a missed opportunity to treat an STI and to start partner notification. They agreed remote self-sampling was an important option for testing, but not the only option.
In committee members' experiences, self-sampling is suitable for STIs, but tests that need a blood sample, such as syphilis, are more challenging to complete so are more likely to be returned in an unsuitable state for analysis. Antibodies from previous infections can also result in initially reactive results that need confirmation through a test at a clinic. In spite of this, they agreed that the tests offered through self-sampling should be the same as those offered in clinic so that people using the service would not be at a disadvantage. They concluded that remote self-sampling should be part of a suite of testing options and be aimed primarily at people without symptoms.
Committee members highlighted the self-efficacy needed to access, complete and return tests and to understand the implications of the results. They discussed how some people might have difficulty accessing the right tests for their anatomy or understanding the instructions. Therefore, they agreed on the importance of ensuring that kits meet accessibility and inclusivity standards. They noted the usefulness of resources such as BASHH guidance for the design of self-sampling packs and associated support for self-sampling processes within sexually transmitted infection and blood borne virus testing.
The committee were aware that during the COVID‑19 pandemic, some areas had used remote self-sampling after telephone triage for people who had symptoms. The evidence was unclear about this, so the committee made a recommendation for research to assess the effectiveness and adverse outcomes of self-sampling for people with symptoms. Overall, they agreed that it was better to attend a clinic if symptoms were present, but acknowledged that in extenuating circumstances (for example, during the COVID‑19 pandemic), using self-sampling kits even for some symptomatic people was better than not testing them at all. They were interested to know whether people's attitudes to home-based self-sampling and regular testing for STIs had changed as a result of the self-sampling for COVID‑19 that most people have undertaken, and made a recommendation for research on people's attitudes to remote self-sampling.
The committee agreed that increasing the uptake of testing was only 1 part of the solution and that re-testing and prompt treatment were also important aspects of STI prevention. They noted the BASHH standards for the management of sexually transmitted infections specify that people should be offered an appointment within 2 days of contacting the service.
The committee discussed the lack of evidence for the value of incentives in encouraging uptake of STI testing, but agreed there needed to be further research on this and made a recommendation for research on the value of incentives. They also discussed the lack of evidence for improving the uptake of testing in people from very high-risk groups such as sex workers and men who engage in group sex under the influence of stimulant drugs (such as methamphetamine or mephedrone), typically with multiple partners (so-called chemsex). Although there was a lack of evidence, the committee agreed that the recommendations they had made would be applicable to these groups.
How the recommendations might affect services
The committee agreed that most local areas are already providing some kind of asymptomatic remote self-sampling service, often as part of larger collaboratives. However, they noted that recommendations to widen access to this might have a cost impact. Although remote self-sampling is a cheaper method of testing than in clinic, the extra positive cases detected mean there will be an overall increase in costs. It would be important to monitor things like return rates for kits and positive test result rates to determine whether broader testing was identifying more people with STIs. They were also satisfied that the evidence supported a strategy of offering remote self-sampling as being cost effective compared with clinic only testing, but that this was very sensitive to the return rate of the self-sampling kits.
Tailoring interventions to improve the uptake and increase the frequency of STI testing
Recommendations 1.2.7 to 1.2.9
Why the committee made the recommendations
The committee agreed that it was important to target information to the groups identified in the recommendations on preventing transmission (for example, a website could be tailored towards particular communities that are at higher risk), and that the same considerations about co-producing information materials with the target groups and communities meant that information about testing would be more likely to make an impact. But they were also aware that this should not exclude other groups.
The committee reiterated that people providing services need to look at those using services holistically rather than assuming they are at risk because they are members of a group with a high incidence of STIs.
The evidence showed that individually tailored interventions were effective, whereas motivational interventions without tailoring were not. The committee thought that this was consistent with previous discussions about cultural competence in targeting interventions to specific groups. They decided that detailed and specific tailoring may be too resource intensive in practice, so favoured low-level personalisation such as adding names and demographic-specific information to communications. They noted that 'opt-in' automated recall messages are already widely used, but additional safety concerns may need to be taken into account when personalising those messages.
The committee were interested in the experiences of LGBT+ people in accessing STI testing services, including online services, and made a recommendation for research on delivering effective sexual health services. They believed this could improve services for LGBT+ people in the future.
The committee discussed the lack of evidence for improving the uptake of testing in people from very high-risk groups such as sex workers and men who engage in sex under the influence of stimulant drugs (such as methamphetamine or mephedrone), typically with multiple partners (so-called chemsex). Although there was a lack of evidence, the committee agreed that the recommendations they had made would be applicable to these groups.
How the recommendations might affect services
The committee agreed that low-level tailoring of interventions would mostly involve modifying things that are already being done and need not have a substantial resource impact.
Partner notification
Recommendations 1.3.1 to 1.3.6
Why the committee made the recommendations
The committee acknowledged that any type of partner notification is beneficial. It is 1 of the most important ways of preventing reinfection and reducing the transmission of STIs. It also ensures that partners have the opportunity to be tested and, if necessary, have their STI treated. They noted the importance of discussing these benefits with people newly diagnosed with an STI, including both the personal benefits and benefits to their sexual partners.
The committee noted the importance of making people aware of the different partner notification methods, and providing information about the methods available to them may support their decision making. The quantitative and qualitative evidence supported the committee's view that patient-led referral to sexual health services may be particularly beneficial for both index patients and their partners. They also recognised the benefits of other methods of partner notification, such as provider referral or online partner notification in certain contexts (for example, if the person feels unable to make the referral themselves).
The committee recognised that partner notification could lead to negative responses from partners, including the potential for violence. Although experiences of violence or compromised patient safety were not reported in any of the included qualitative studies, the committee agreed that they remain a potentially adverse consequence that needs to be taken into account. They therefore discussed the need for recommendations about patient safety and patient choice, and acknowledged that there may be situations in which partner notification is not appropriate. The committee also noted that their clinical responsibility was to the index patient and not their sex partners, although the needs and preferences of partners being notified remain important.
The committee considered other potential harms of partner notification, including unintended disclosure of relationship, sexuality or STI status. They recognised the importance of anonymity and confidentiality for all partner notification methods but did not consider it necessary to make specific recommendations about patient confidentiality because this is standard practice for all healthcare professionals. However, the committee agreed that when telling people about the partner notification methods available, it is important to highlight the option to maintain anonymity. They noted that provider referral may be the most appropriate method when the person expresses a desire to remain anonymous.
The committee discussed anonymous sex arranged using geospatial networking apps and websites and how this made partner notification difficult. They noted that there was a potential to use these apps for partner tracing and notification if the person did not know their partner's name or contact details. They agreed that this could be done by the person themselves, and were aware that some services set up profiles on these apps for the purposes of anonymous partner notification.
How the recommendations might affect practice
These recommendations are already within the scope of practice of services that undertake partner notification, so there should be no additional cost. Some services may need to improve their practices in this area, which may have a modest resource impact (for example, increasing the length of appointments).
HPV and hepatitis A and B vaccination in gay, bisexual and other men who have sex with men
Recommendations 1.4.1 to 1.4.5
Why the committee made the recommendations
The committee were aware that a NICE guideline on improving vaccine uptake in the general population was being developed and agreed that it would be important to consider the recommendations in that guideline when thinking about human papilloma virus (HPV) and hepatitis vaccinations. They also noted that the scope of this guideline asked very specifically about vaccinations for gay, bisexual and other men who have sex with men but that the eligibility criteria for these vaccinations were broader than just that group. The committee saw very little evidence about the effectiveness of interventions to increase the initial uptake of HPV and hepatitis vaccinations, and less evidence on whether interventions improved course completion. As a result, they felt unable to recommend specific interventions to increase vaccine uptake, and therefore made a recommendation for research on vaccination course completion.
The committee saw qualitative evidence about the perceived barriers to vaccination among gay, bisexual and other men who have sex with men and agreed that this supported their expertise and experience. On this basis, they agreed on the need to encourage all healthcare professionals to opportunistically discuss vaccination and explain the importance of completing the full course of vaccinations. They also discussed that many gay, bisexual and other men who have sex with men still find it difficult to discuss their sexual health needs with healthcare professionals, so it was important for organisations to consider ways to make services more accessible. They agreed that the Department of Health and Social Care's 'You're welcome' quality criteria, although specifically aimed at young people, modelled good practice that could also be used for other groups (see also recommendation 1.1.3). They noted that in their view and experience, many men did not return for their follow-up vaccines. They agreed that it was important to highlight this, and the need to follow those men up, by making a recommendation.
Although they did not see any evidence to support it, the committee agreed that in their experience, uptake might be increased by providing these vaccines during other routine health appointments for gay, bisexual and other men who have sex with men. However, they acknowledged that this will be limited by the availability of vaccines in alternative settings.
How the recommendations might affect practice
The committee agreed that these recommendations would not have a large impact on resource use. Sexual health services should already be providing information about vaccination to gay, bisexual and other men who have sex with men who are eligible for vaccination, and many primary care providers already offer these vaccines. Providing vaccinations alongside existing services should be a more efficient method of delivery, where this is possible.
The committee also noted that because these vaccines had already been assessed as being cost effective by the Joint Committee on Vaccination and Immunisation, an increase in the number of people being vaccinated should also be cost effective.
Raising awareness of pre-exposure prophylaxis for HIV
Recommendations 1.5.1 to 1.5.6
Why the committee made the recommendations
The committee agreed that increasing uptake of pre-exposure prophylaxis for HIV (PrEP) among eligible populations was the highest priority. The evidence showed differing experiences and beliefs about PrEP for different populations, so they wanted to target populations that had negative experiences or are less engaged. With this in mind, they agreed that local groups with greater sexual health or access needs were an appropriate target for awareness raising, in line with NICE's guideline on community engagement and HIV Prevention England's PrEP health promotion campaign guidance. They agreed that particular attention needed to be paid to groups in which uptake of PrEP is lower, such as cisgender women with a Black African family background. They cautioned that it was also very important to make sure that people knew that PrEP was for HIV prevention specifically and that it did not protect against other STIs. The committee noted that the eligibility criteria for PrEP currently restricted it to people who reported recent condomless sex. They were therefore interested in whether providing PrEP to people who do not report recent condomless sex would also be cost effective, and made a recommendation for research on eligibility for PrEP.
The evidence showed that people are more likely to trust those from their own community or group when it came to information about PrEP. So the committee agreed that engaging with peers was a good way to normalise PrEP use and reduce both stigma and mistrust in services. They noted qualitative findings (from research predating more widespread use of PrEP) that stereotyped people who use PrEP as promiscuous or reckless. They also agreed that co-producing materials with those communities and groups could help to challenge stigma.
The committee noted that trans people in qualitative studies frequently expressed concerns about potential interactions between PrEP and gender-affirming hormones and the possibility of PrEP interfering with their transition. The committee reported information from the University of Liverpool's HIV drug interaction checker, which they agreed was robust based on communication with the University of Liverpool about the methodology underpinning the checker. This showed that there were no interactions expected, and thought that education was needed to raise awareness of the safety of PrEP for those undergoing medical transition. The committee agreed it was important to use this information to reassure potential PrEP users because participants with these concerns expressed that they would prioritise their transition above HIV prevention and may avoid PrEP because of this uncertainty.
The committee noted the importance of the Department of Health and Social Care's Towards zero: the HIV action plan for England (2022 to 2025), which was published after this guideline was drafted. They agreed that the action plan was consistent with this guideline and welcomed it.
How the recommendations might affect practice and services
Additional resources will be needed to train healthcare professionals on the needs of populations eligible for PrEP. If the total time allotted for training does not increase, this training will come at the expense of other training options.
Existing appointments can be used to identify people eligible for PrEP and signpost them to appropriate services, but this might add to the time needed for each appointment to cover the additional conversations about PrEP.
Service design for PrEP services
Recommendations 1.5.7 to 1.5.9
Why the committee made the recommendations
The committee were concerned that access to services is a barrier to PrEP uptake. The evidence suggested that this is because PrEP is only provided at sexual health clinics (in line with current NHS England commissioning policy) and that some groups are less likely to seek healthcare in this setting. Conversely, some committee members thought that PrEP should only be prescribed by healthcare professionals with knowledge of it and training in sexual health, which would generally mean only in a sexual health clinic.
The committee agreed that it is important that healthcare professionals in primary care, community settings and gender identity clinics are aware of who is eligible for PrEP, regardless of whether the setting provides it. This means that they will be better able to refer eligible people to services where PrEP can be provided. They agreed that healthcare professionals needed training about this. They acknowledged that some populations face particular barriers to accessing PrEP services in sexual health clinics.
The qualitative evidence indicated that some groups, particularly LGBT+ people, thought that healthcare professionals did not understand their sexual practices and individual risk factors. This led to them feeling uncomfortable discussing sexual health and being worried about feeling judged, therefore making it harder for them to start conversations about PrEP.
How the recommendations might affect practice and services
Additional resources will be needed to train healthcare professionals on the needs of populations eligible for PrEP. If the total time allotted for training does not increase, this training will come at the expense of other training options.
Increased uptake of PrEP is likely to have an impact on service capacity and allocation of resources in clinics that deliver PrEP and provide monitoring and testing for PrEP users. Clinics may need additional funding or expansion of services to meet increased demand. However, PrEP itself is a highly cost-effective intervention and therefore this should be a cost-effective use of resources.
Access to PrEP services
Recommendations 1.5.10 to 1.5.12
Why the committee made the recommendations
In addition to making existing services more accessible, the committee were interested in the possibility of offering PrEP in other settings. However, they agreed that more evidence was needed on the effectiveness of doing this before they could recommend specific actions, therefore they made a recommendation for research on the availability of PrEP. They thought that, for now, increasing awareness of eligibility and enabling wider services to refer people to PrEP clinics was more important than prescribing PrEP in other settings. They agreed that there needs to be clear pathways for healthcare professionals who cannot or do not provide PrEP to support people in accessing services that prescribe it, and that the responsibility for this should lie with the healthcare professional. The committee agreed that this meant it was important for people to be able to access services outside of their local area or community.
How the recommendations might affect practice and services
Additional resources will be needed to train healthcare professionals on the needs of populations eligible for PrEP. If the total time allotted for training does not increase, this training will come at the expense of other training options.
Existing appointments can be used to identify people eligible for PrEP and signpost them to appropriate services, but this might add to the time needed for each appointment to cover the additional conversations about PrEP.
Prescribing PrEP
Recommendations 1.5.13 to 1.5.19
Why the committee made the recommendations
The committee recognised the evidence for the effectiveness of PrEP and thought that it was important for all groups outlined in the BASHH/BHIVA (British HIV Association) guidelines to be able to access it according to the risk criteria in these guidelines.
The committee agreed that the available economic evidence showed PrEP to be cost effective in a population of gay, bisexual and other men who have sex with men at higher risk of HIV (matching the criteria in the BASHH/BHIVA guidance). They also agreed that the findings should be generalisable to other populations at equivalent risk of HIV, as both the potential benefits and costs in those populations should be similar. The evidence also suggested that PrEP would remain cost effective in these populations regardless of potential unintended consequences (such as changes in condom use). Therefore, they were confident that these potential consequences did not need to result in any restrictions made to people eligible for PrEP.
The committee recognised from the evidence that the effectiveness of PrEP directly corresponded to adherence, so it is vital that people taking it are made aware of this and given support to take it as prescribed (see NICE's guideline on medicines adherence). They recognised that some people might experience barriers to adherence, so promoting knowledge and understanding about PrEP would be important for these people. The committee agreed that anyone taking PrEP needed knowledge of the risks involved (HIV, antiretroviral drug resistance) in not adhering to the treatment.
The committee recognised the importance of adherence to PrEP, the risk of adverse events and the potential relationship between these. So they agreed that clinical follow up of anyone taking PrEP was important and that the BASHH/BHIVA good practice points could be followed. The committee agreed that people who buy their own PrEP should also be able to access clinical follow up and monitoring via NHS services.
The committee were also interested in the potential adherence benefits of offering long-acting PrEP (for example, by injection) and noted that some people may prefer it to taking tablets on a daily or frequent basis (depending on the kind of PrEP they are using). However, they thought there was insufficient evidence to recommend long-acting PrEP and that research was needed to establish whether it is as effective as daily (or frequent) PrEP tablets. Therefore, they made a recommendation for research on mode of PrEP delivery.
The evidence also suggested some adverse effects associated with PrEP use (such as kidney or gastrointestinal symptoms). The committee recognised that people needed to be made aware of these so they could make an informed choice and manage their symptoms (see NICE's guideline on shared decision making). They noted that the evidence for increased risk of kidney problems corresponded to their own knowledge of how PrEP works pharmacologically. They therefore agreed that monitoring the renal health of those taking PrEP was important. Although the committee were aware of evidence showing that bone-mineral density will rebound after stopping PrEP, there was a lack of data on this for young people who have not yet reached their peak bone density (see the recommendation for research on mode of PrEP delivery).
The committee discussed the risk of antiretroviral therapy resistance in prescribing PrEP to people who were HIV positive and strongly supported current guidelines about the importance of regular HIV testing and the requirement for a negative HIV test before prescribing.
The committee noted that ongoing research seemed to be showing an association between people taking PrEP and an increase in STI rates, but they emphasised that it was not clear whether there was any causal link. They discussed several other plausible reasons for the association and agreed that it will be important to see how the evidence develops. They agreed on the value of providing condoms and behavioural support to this high-risk population, and that they should have regular screening for other STIs.
How the recommendations might affect practice and services
Increased uptake of PrEP is likely to have an impact on service capacity and allocation of resources in clinics that deliver PrEP and provide monitoring and testing for PrEP users. Clinics may need additional funding or expansion of services to meet increased demand. However, PrEP itself is a highly cost-effective intervention and therefore this should be a cost-effective use of resources.