The committee's discussion

Evidence statement numbers are given in square brackets. For an explanation of the evidence statement numbering, see the evidence reviews section.

Background

This guideline supplements existing NICE guidance on contraceptive services. The committee agreed that although the focus of the guideline is on sexually transmitted infections (STIs), condom distribution schemes may lead to wider benefits, such as preventing unplanned pregnancies or getting young people involved with health services. It agreed that people should be advised to use condoms to reduce the risk of STIs in addition to their chosen method of birth control.

The committee noted that there is often a substantial overlap between condom schemes that just provide or sell condoms and multicomponent schemes that provide additional training, advice, information or support. For example, a multicomponent scheme for young people may also sell cost-price condoms to other groups.

The committee did not examine evidence about condom schemes in prisons or other detention centres because these were excluded from the scope. The committee noted that NICE's guideline on the physical health of people in prison addresses this.

Overview of the effectiveness evidence

The committee expressed its concern about the quality of the evidence on condom schemes in the UK. Much evidence dated from the 1990s and most was from the US (little was identified from the UK). In many cases, key statistics and intervention details are missing from the papers. Limited evidence was available on how the components of schemes influenced effectiveness or cost effectiveness. No evidence was identified on the effectiveness and cost effectiveness of the C‑Card scheme, which is commonly used with young people in the UK.

Most of the evidence that was available focused on condom schemes for HIV prevention, whereas current UK schemes focus on preventing a broad range of STIs and unwanted pregnancies [ES1, ES2, ES3, ES4, ES5, ES6, ES7, ES8].

The committee did not make any recommendation based on ES8, which compared sexual risk taking after different types of condom provision, because there were no statistically significant differences that could inform or enhance a recommendation.

The committee discussed a paper submitted during the consultation process. It had not been published in a peer-reviewed publication and did not meet the inclusion criteria for the review. It claimed that some condom schemes increased teenage pregnancy rates in the US during the 1990s (The incidental fertility effects of school condom distribution programs Buckles and Hungerman 2016). The committee noted that, because there were extensive methodological issues with the paper, no clear conclusions could be drawn.

Outcomes

Most included studies reported intermediate outcomes, such as intention to use condoms, condom use at last intercourse or attitudinal measures. Few reported STI outcomes – those that did were poor quality studies.

The committee was aware that the focus of this guideline was condom provision to prevent STIs and that avoiding pregnancy was outside the scope. But it was also clear that increasing condom use would help avoid some pregnancies. Indeed, many of the proxy measures mentioned are as relevant to preventing pregnancy as to STI prevention.

The costs of these avoided pregnancies were included in the economic analysis. In addition, the review database was checked to ensure that no studies with pregnancy outcomes alone had been overlooked and the committee was confident that a body of evidence had not been missed.

The committee was aware of a recently published meta-analysis indicating that: 'interventions increasing the availability of, or accessibility to, condoms were shown to be efficacious in increasing condom use behaviours and that condom schemes provide an efficacious means of HIV/STI prevention'. Although most papers in the meta-analysis did not meet the inclusion criteria for this guideline (for example, two-thirds were in Africa or Asia) the committee was reassured that this review supported its conclusions[1].

Unintended consequences

The included studies clearly showed that condom schemes do not increase levels of sexual activity among young people, nor do they reduce the age at which young people become sexually active [ES1, ES5].

Key gaps in the evidence

The committee was clear that an understanding of behaviour change must underpin condom schemes, but there was no specific evidence on the techniques used to deliver any of the evaluated schemes. The committee agreed that schemes should be delivered in line with NICE's guidelines on behaviour change: general approaches, behaviour change: individual approaches and patient experience in adult NHS services: improving the experience of care for people using adult NHS services.

The committee discussed the importance of collecting data from UK-based condom schemes. An expert told the committee that one of the largest sources of evidence could be existing C‑Card schemes. Many of these undertake regular, extensive monitoring and evaluation of their programmes, as recommended in the C‑Card guidance [EP1].

The committee agreed that a standardised approach to assessing the effectiveness of local schemes would be extremely beneficial and enable a national evidence synthesis to explore the effectiveness of C‑Card schemes in STI prevention. It agreed this should be strongly reflected in the research recommendations.

The committee discussed the possibility that online services could address some equity issues for people in rural areas. But the evidence was poor so the committee made a research recommendation on this.

Some GP surgeries provide condoms as part of their reproductive health role, but the committee questioned whether they would want to get involved in condom schemes aimed specifically at preventing STIs. Stakeholder comments reassured them that GPs might be interested in delivering such schemes. The committee agreed that this approach could be particularly useful for GP practices used by those most at risk, for example, in universities. But because there was little evidence, the committee made a research recommendation on this.

Targeting services

The discussion below explains how we made recommendations 1.1.1 to 1.1.4.

The committee agreed that people are most at risk of STIs if they are involved in higher rates of risky sex (for example, they may have multiple partners or frequently change partners). There may be more people involved in such activities in some groups than others, but this does not mean that everyone in the group is necessarily at high risk. For example, men who have sex with men are the highest risk group for STIs and HIV, but this does not mean that every person in that group is at high risk.

The committee agreed that a person's behaviour was the key determinant of their risk, so recommendation 1.1.1 refers to 'those most at risk'.

The committee discussed the importance of integrating condom schemes with broader services, not just sexual and reproductive health services but, for example, general practice, young people's services, education, school nursing and pharmacies. It recognised that areas needed to plan their own mix of the different types of condom scheme recommended in the guideline based on local need.

The committee discussed evidence that a small media campaign had been effective in raising awareness of syphilis and condom use. Members agreed that advertising and publicity were a key component of effective condom schemes [ES6, EP1, EP2].

Cost effectiveness

The committee heard expert testimony on the cost effectiveness of condom schemes. This showed that they are most cost effective and sustainable if they target people at most risk of STIs and are embedded into existing services. It was also told that: "Commissioning is currently taking place within the context of a challenging economic climate. Local authority budgets, in particular, are reducing, which results in less funding available for prevention work … [such as] for condom and lube schemes."

The expert noted that commissioners need to work collaboratively and commission services for communities of people who share a common interest, belief or other characteristic, not just communities linked by geographical area. Another expert told the committee that in recent years some schemes have been commissioned to cover multiple local authority areas. Examples include the Come Correct scheme in London, which is funded by more than 20 local authorities. This enables local areas to buy into a pre-designed scheme and potentially benefit from economies of scale [ES10, EA, EP1, EP2].

Inequalities

The committee recognised that targeting schemes at different population groups or geographical areas could lead to inequalities (for example, people living outside cities may not have access to city-based services). It also noted the lack of evidence of effectiveness for some groups, for example, people with learning disabilities. For this reason, the committee kept its recommendations as broad as possible.

It also agreed that, although the evidence for selling condoms at cost price was lacking, it could help offset some of the potential inequalities generated by targeted schemes. It agreed that web-based postal systems, in particular, might help to overcome inequalities related to geographical isolation or stigma [ES7]. But, based on the economic modelling, these schemes would need to be very low cost.

Multicomponent schemes for young people in education, youth and outreach settings

The discussion below explains how we made recommendations 1.2.1 to 1.2.11.

The committee was aware that young people under 16 need to be assessed as competent to consent to sexual intercourse before providing them with condoms. Either they should have parental permission or they should demonstrate that they can understand and appraise the nature and implications of condom use. This includes understanding the risks of not using them, and alternative courses of action. As a result, the committee agreed that if there are concerns about a young person's competency to consent, multicomponent schemes are more appropriate than single component schemes, even though they are much more costly.

The committee was aware that multicomponent schemes also provide information and training (both in terms of education and hands-on training or demonstration) so 'condom naive' young people can take responsibility for using them effectively. But it was unclear from the evidence exactly what mix of components made multicomponent schemes more or less effective, so the committee was unable to make firm recommendations about their exact content [ES1, ES2, ES3].

No evidence of effectiveness was identified for the C‑Card scheme, the most common multicomponent scheme in the UK. The committee agreed this is a key gap because most of these schemes provide condoms to young people up to the age of 25 – and because young people aged 16 to 25 have one of the highest rates of STIs. It also agreed that, in lieu of this evidence, the C‑Card best practice guidance is helpful.

On balance, members agreed that multicomponent condom schemes should consider providing their service to young people up to the age of 25 [EP1].

Cost effectiveness

The economic analysis used a model scheme that provided education, condoms (using a credit card type C‑Card) and telephone counselling, because these are common elements. Effectiveness data came from a multicomponent scheme for school students (aged 17) who were 1.23 times more likely to use a condom than students in a school without a scheme. It cost £0.48 per person per year, calculated from cost data from 4 UK C‑Card schemes. This included costs for: condoms and lubricants, staff time for training and administration, website, advertising and the C‑Card.

STIs included in the model were chlamydia, gonorrhoea, HIV and syphilis. STI diagnosis rates were used to judge the initial prevalence of these STIs. STI incidence in the model was influenced by initial prevalence, transmission rates, sexual activity levels and condom failure rates, as well as condom use. The incidence of each STI was associated with a quality-adjusted life year (QALY) loss and a cost.

For a target population aged 13 to 18, the model showed a condom distribution scheme prevented 1,373 STIs. This led to savings on STI-related costs of £758,947. Each person gained 17 QALYs. The scheme cost £1,538,499 and the incremental cost effectiveness ratio (ICER) of using condom schemes to prevent STIs only was £45,856.

The committee was clear that increasing condom use would also help avoid some pregnancies, so an economic analysis was conducted on preventing pregnancies for a population aged 14 to 18. This used an economic model from NICE's guideline on contraceptive services for under 25s. The model assumed that all pregnancies in this age group were unintended and that increased condom use would either delay or prevent pregnancy, as well as preventing STIs.

The committee noted that for a population of 100,000 people aged 14 to 18, increasing condom use by 22% would lead to pregnancy-related savings of over £11 million. This would make condom schemes highly cost saving.

Analysis conducted for a target population aged 13 to 25, considering the effect of condom schemes on STIs only, resulted in an ICER of £17,411. Condom schemes were more cost effective for this broader age group because the rates of both sexual activity and STI prevalence were higher. In this age group, an analysis of the effect of increasing HIV prevalence to 0.19% (the UK average) showed that this would make the condom scheme cost saving. So it would be more effective and cost less than not providing a scheme. A scenario analysis considered that training provided by multicomponent schemes may reduce condom breakage. This reduced the ICER to £14,469, potentially demonstrating the importance of including training in condom schemes.

The committee noted a threshold analysis in which effectiveness (relative risk of condom use) and cost per person in the target population were varied. This suggested that schemes can be cost effective even without considering pregnancy effects, as long as costs and condom use effects can be balanced. If a scheme did not achieve any change in condom use it would not be cost effective because it would accrue the cost for no health benefits.

Additionally, the committee heard that the use of static models and short time horizons are likely to have underestimated the cost effectiveness of schemes.

Single component schemes

The discussion below explains how we made recommendations 1.3.1 to 1.3.5.

The committee discussed the challenges of making sure condoms are available to the widest possible audience, while ensuring schemes are cost effective by targeting populations most at risk of an STI. It also discussed the transition for young people from multicomponent to single component schemes.

The committee was aware that young people under 16 might also use single component schemes. It agreed that there was no way to prevent this. But it was clear that multicomponent schemes are the best option for them and for anyone over 16 for whom there is a duty of care (for example, if they have special educational needs or disabilities).

It agreed that providing condoms freely to people most at risk of STIs is important, although it is better if this takes place in the context of broader information provision or education, especially for young people. One expert told the committee that:

"…free condoms and lube within locations (including gay bars, clubs and saunas) should be maintained. It is appropriate to provide free condoms and lubricant targeted at gay, bisexual and other men who have sex with men, due to them shouldering a disproportionate burden of HIV and other STIs.

"Furthermore, condoms and lube available within bars, clubs, saunas and other settings provide important visibility, helping to increase social norms of condom and lube usage.

"Ensuring that they are free reduces one of the barriers for people accessing condoms and lube, [that is] cost. This is particularly important given the fact that addressing social determinants is an important aspect of HIV prevention." [ES6, EP2]

The committee noted the lack of published evidence about the effectiveness of single component condom schemes, but it also noted the range and flexibility of these schemes. In addition, it noted that the cost effectiveness evidence for them was compelling. As a result, the committee did recommend these schemes but, because of the lack of published evidence, could only make this a 'consider' recommendation.

Cost effectiveness

The committee noted that specific cost and effectiveness data were not available for condom schemes aimed at adults most at risk of STIs. Cost effectiveness analysis was conducted for 2 groups that include people most at risk of HIV: men who have sex with men, and black Africans. This showed that distributing free condoms to people at most risk is highly cost effective or cost saving, even with high scheme costs and relatively small effects. That is because, among people most at risk of an STI, a small increase in condom usage can avert numerous HIV cases, saving £100,000 and 4.5 QALYs per case [EA].

Men who have sex with men

For groups of men who have sex with men, in populations with a low HIV prevalence (using diagnosis rates, average 0.05%), the committee noted schemes would be cost effective or cost saving with a cost per person per year up to:

  • £5 if they increased condom use by 4%

  • £10 if they increased it by 6%

  • £15 if they increased it by 8%.

For populations with a medium to high HIV prevalence (average 5 to 9%), schemes costing up to £15 per person per year would be cost effective or cost saving if condom use increased by 2% [EA]. If a scheme did not achieve any change in condom use it would not be cost effective because it would accrue the cost for no health benefits.

Black Africans

The committee noted economic evidence supporting large-scale condom distribution among black Africans. It noted that for black African populations with a low HIV prevalence (average 1.46% for men and 3.84% for women), schemes that increased condom use by at least 8% would be cost effective or cost saving if the cost per person per year was less than £15. With medium HIV prevalence (average 1.79% for men and 4.55% for women), schemes would be cost effective or cost saving at up to:

  • £5 per person per year if they increased condom use by 2%

  • £10 if they increased it by 4%

  • £15 if they increased it by 6% [ES9; EA].

If a scheme did not achieve any change in condom use it would not be cost effective because it would accrue the cost for no health benefits.

Cost-price sales schemes

The committee noted that cost-price sales schemes may encourage more of the general population to use condoms, and it may be possible to deliver these at a low cost. This could help people who might not be regarded as most at risk to get low price condoms and so help offset any potential differential impact resulting from this guideline.

Cost effectiveness

The committee agreed that programmes selling condoms at cost or reduced price, particularly large-scale programmes such as a national web-based scheme, could be cost effective. They would have the added advantage of diminishing some of the potential inequalities in service provision as a result of specific targeting of condom schemes – possibly reaching people who would not otherwise be able to access schemes. This was particularly felt to be the case for web-based postal schemes [ES7].

The committee considered the cost effectiveness of condom schemes for the general population. It noted that when using diagnosis rates for HIV prevalence, condom schemes would have to increase condom use by 20% and cost less than £0.20 per person per year. It noted that any reduction in unplanned pregnancies would increase the cost effectiveness of schemes.

In an analysis that increased HIV prevalence to an average of 0.19%, schemes that cost £5 per person would be cost effective if they increased condom use by more than 50%.

The committee discussed the fact that ICERs are higher for the general population because of the relatively low prevalence of STIs, and that schemes targeting those most at risk would be more cost effective.

In an analysis that increased HIV prevalence to 0.4%, condom schemes costing up to £2 per person per year would be cost effective if they increased condom use by 10%. Those costing £5 would be cost effective if they increased use by 24%. If a scheme did not achieve any change in condom use it would not be cost effective because it would accrue the cost for no health benefits.

If cost-price sales schemes can recover any administrative costs, through charging for condoms and postage and packaging, they could be cost‑neutral.

Evidence reviews

Details of the evidence discussed are in evidence reviews, reports and papers from experts in the area.

The evidence statements are short summaries of evidence. Each statement has a short code indicating which document the evidence has come from.

Evidence statement (ES) number 1 indicates that the linked statement is numbered 1 in the evidence review. EP1 indicates that expert paper 'C card distribution scheme' is linked to a recommendation. EP2 indicates that expert paper 'LGBT Foundation condom & lube distribution scheme' is linked to a recommendation. EA indicates that the recommendation is supported by the economic analysis 'A model to evaluate the cost effectiveness of condom distribution (CD) schemes'.

If a recommendation is not directly taken from the evidence statements, but is inferred from the evidence, this is indicated by IDE (inference derived from the evidence).

Recommendation 1.1.1: EA; EP1; IDE

Recommendation 1.1.2: EA; EP1; IDE

Recommendation 1.1.3: ES6; EP1

Recommendation 1.1.4: ES6; EP1, EP2

Recommendation 1.2.1: ES1, ES2, ES3, ES4

Recommendation 1.2.2: EA; IDE

Recommendation 1.2.3: EA; IDE

Recommendation 1.2.4: IDE

Recommendation 1.2.5: ES1, ES2, ES3, ES4; EP1; IDE

Recommendation 1.2.6: ES1, ES2, ES3, ES4; EP1; IDE

Recommendation 1.2.7: EP1, EP2; IDE

Recommendation 1.2.8: ES1, ES2, ES3, ES4; EP1; IDE

Recommendation 1.2.9: IDE

Recommendation 1.2.10: ES2, ES3, ES10; IDE

Recommendation 1.2.11: IDE

Recommendation 1.3.1: EA; EP2; IDE

Recommendation 1.3.2: EA; EP2; IDE

Recommendation 1.3.3: EP2; IDE

Recommendation 1.3.4: EA; ES7; IDE

Recommendation 1.3.5: EP2; IDE



[1] Charania MR, Crepaz N, Guenther-Gray C et al. (2011) Efficacy of structural-level condom distribution interventions: a meta-analysis of U.S. and international studies, 1998-2007. AIDS and behavior 15: 1283–97.

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