Feasibility study of the Home-based Exercises for Responsible Sex (HERS) intervention to promote correct and consistent condom use among young women

What is the problem? Rates of sexually transmitted infections (STIs) in England have increased by around 50% over the last 10 years, with about half a million new cases occurring every year. STIs can have serious consequences beyond the immediate impact of the infection itself and the health, social, and economic costs of STIs are huge; the current estimated cost of treatment to the NHS is £620 million per year. The Department of Health has identified the need to reduce STI rates as a priority for improving sexual health and have recognised young heterosexuals as target 'at-risk' groups. Public Health England have launched a campaign to promote condom use.

Why do we need to do something? Male condoms can be protective against STIs when used correctly and consistently; however, there are many issues which stop people using them or using them properly, such as negative attitudes, reduced sexual pleasure, and problems with 'fit and feel'. The protection condoms provide against STIs is also reduced when they are not used from the start to the finish of sex, which is more commonly reported by couples who experience problems whilst using condoms or who express a dislike of them. Many health promotion programmes have tried to increase condom use by focusing on improving men's knowledge and condom use skills, and more recently on promoting pleasure and fun when using condoms and lubricants. However, women also report problems and dissatisfaction with condoms, such as discomfort, vaginal friction, and reduced sensation. Women also often apply condoms to their male partners and report errors and problems when putting them on which can result in erection loss. Educating women as well as men about ways to enhance their pleasurable condom use experience is likely to be an important public health strategy, yet very few interventions to date have focused on this approach.

What are we going to do? We want to develop and test a condom promotion programme for use among young women aged 16-25 in the UK. The programme starts with a training session to build women's confidence and skills related to pleasurable condom and lubricant use. We will then give out "condom kits" (containing different condoms and lubricants) and ask women to try out the contents of the kit at home by themselves and with their sexual partners by completing various homework exercises. As they try out each condom and lubricant they are asked to think about their own pleasure and which they like best. Women then rate the condoms and lubricants they use. The aim of the programme is for women to improve their experiences with condoms and lubricants and their ability to use them as part of pleasurable and safe sexual activity.

To ensure that we develop a programme which is acceptable to young women and which will work we will be interviewing young women and health promotion professionals to find out their views and assist us in developing the components of the new programme. We will then invite local authority commissioned genito-urinary medicine (GUM) and outreach services in Hampshire to take part and help recruit 50 young women aged 16-25, who are at risk of STIs through the non-use of condoms with new and casual partners, to test out the programme.

What we will measure: We want to know if young women like the different components of the programme and if it is possible to recruit for our study from GUM and outreach settings. We are also testing whether it is possible to do a larger trial to see if the programme can change women's attitudes and use of condoms and lubricants, and to estimate the costs, time, resources, sample sizes, outcome measures etc. needed to carry this out. At the end of the programme we will ask women for their views about the study and what we asked them to do.

This work will increase the likelihood of developing an effective condom promotion programme for young women, and will assess whether a larger trial is justified and appropriate.

The DoH has identified the need to reduce rates of sexually transmitted infections (STIs) as a priority for improving sexual health. Although condoms can be highly protective against the transmission of most STIs, there is evidence that they are often not used consistently or correctly. There is a need to develop effective brief interventions designed to promote correct and consistent condom use.

In line with MRC guidance for developing and evaluating complex interventions, the aims of this early phase study are to define, develop, specify, and assess the feasibility of a behaviour change intervention to increase condom use (The Home-based Exercise for Responsible Sex (HERS) Intervention) among young women aged 16-25. HERS-UK is modelled on the HERS-US programme for women and the Kinsey Institute Homework Intervention Strategy (KIHIS/HIS-UK), designed to improve condom skills, enjoyment, and self-efficacy among young men, and which have demonstrated evidence of efficacy. The HERS intervention is novel in that it a) targets the drivers for non-condom use relevant to young women, b) aims to increase condom use by targeting outcome expectancies related to pleasure and enjoyment of sex, which have been identified as important determinants of non-use behaviour; c) will have been adapted with extensive user participation to ensure future successful implementation, and d) will have an accompanying intervention manual specifying targeted outcomes, behaviour, behavioural determinants, behaviour change techniques, methods of delivery, and proposed mechanisms of action, thus ensuring that the future main study can draw conclusions about what has worked and why.

Women at risk of STIs through the non-use of condoms with new and casual partners will be recruited from GUM and outreach services in Hampshire. The study will involve a literature review, development consultation, intervention delivery and feasibility, follow-up, and recommendations for a definitive trial.

The beneficiaries of this research will be young women who are at risk of STIs; young women's male sexual partners; clinicians and health promotion workers who counsel young women on condom use; policy makers and commissioners with responsibility for the provisioning of sexual health services and advice to young people; the academic community; the wider public; and the public purse.

Stakeholders such as the Terence Higgins Trust, Brook, Family Planning Association, the British Association for Sexual Health and HIV (BASSH), the Society of Sexual Health Advisors, the Sex Education Forum, Public Health England (who have recently launched a campaign to protect young people from STIs by using condoms), and NICE (who have recently issued guidance on condom distribution schemes) will also benefit from the research through the development of a theoretically-driven and empirically-based brief condom promotion intervention aimed at young women.

As this is a feasibility study, the impact of the research is likely to be fully realised after the definitive trial of the intervention has been carried out. Nonetheless, this early phase study can have tangible impact at the following levels:

Individual/group level (young women and their sexual partners): More consistent male condom use, enhanced condom use self-efficacy, more positive attitudes toward condom and lubricant use, and a reduction in incident STIs, evidenced using our pre-post intervention measures.

Public: improved public awareness of health risks and the use of male condoms for both pleasure and protection, evidenced through media reports and dissemination activities.

Staff/services: Availability of a brief theoretically derived protocol for condom promotion among young women, evidenced by the provision of the outputs (i.e., intervention manual, best practice guidance and tools).

Strategic (policy makers and commissioners): The engagement of policy makers and commissioners in an advisory capacity will establish important relationships for implementation, dissemination and adoption of the definitive intervention in mainstream practice. This impact will be evidenced through exchanges e.g., email communication, meeting attendance reports, policy recommendations, strategy documentation and campaign materials.

Research/Academic: In line with best practice, our manualised intervention will provide a detailed description of the component-based intervention, including theoretical determinants targeted and BCTs used. This will enable a future full definitive trial to determine which BCTs appear to work best in bringing about change in the outcome measures and, using mediation analyses, the causal pathways by which any positive effects occurred. This impact will be evidenced through conference presentations and publications in high impact factor, open access journals.