Feasibility study of the Kinsey Institute Homework Intervention (KIHISUK) to promote correct and consistent condom use
Lead Research Organisation:
University of Southampton
Department Name: Sch of Psychology
Abstract
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. The health, social, and economic costs of STIs are huge. Untreated chlamydia, for example, can lead to pelvic inflammatory disease and infertility. 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.
Why do we need to do something? Although condoms can be protective against STIs when used correctly and consistently, there are many barriers to their use such as negative attitudes, reduced sexual pleasure, "fit-and-feel " problems, and erection difficulties. The effectiveness of condoms is also reduced by incomplete use of condoms (i.e. not using condoms from start to the finish of sex), which is more commonly reported by men who experience problems whilst using condoms. Many health promotion interventions try to improve knowledge and skills to increase condom use; results, however, have been mixed. Although there is some evidence that these interventions can be effective, in practice health promotion staff may not have the time or the money to use these. There is therefore an urgent need to develop quick but effective interventions to improve condom use experiences, increase consistent and correct condom use, and reduce sexual risk among young people.
What are we going to do? We want to adapt a condom promotion programme which has been developed and tested in the US for use among young men in the UK. The US programme gives out "condom kits" (containing different condoms and lubricants) asks men to try out the condoms at home by themselves by completing various homework exercises. As they test each condom they are asked to think about their own pleasure and which condoms they like best. Men then score/rate the condoms they use. The aim of the programme is for men to improve their condom skills by 1) finding the "right/best" types of condoms and lubricants, 2) testing techniques of applying them, and 3) by practicing with them in no pressure situations (on their own).
In this study we want to see if the idea can be adapted for use with men in the UK to improve their skills in applying condoms and their pleasure in using them. To do this we will be speaking to young men and health promotion professionals to find out their views and help us modify and develop the components of the new programme. We will then invite young people's information and advice services in community and educational establishments in Hampshire and the West Midlands to take part and help recruit 50 young men aged 16-25 to test out the programme.
What we will measure: We want to know if young men like the different elements of the programme and if it is possible to run our study in the different settings. We are also testing whether it is possible to do a larger trial to see if the programme can change men's views and use of condoms, 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 participants 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 intervention, and to assess whether a larger trial is justified and appropriate.
Why do we need to do something? Although condoms can be protective against STIs when used correctly and consistently, there are many barriers to their use such as negative attitudes, reduced sexual pleasure, "fit-and-feel " problems, and erection difficulties. The effectiveness of condoms is also reduced by incomplete use of condoms (i.e. not using condoms from start to the finish of sex), which is more commonly reported by men who experience problems whilst using condoms. Many health promotion interventions try to improve knowledge and skills to increase condom use; results, however, have been mixed. Although there is some evidence that these interventions can be effective, in practice health promotion staff may not have the time or the money to use these. There is therefore an urgent need to develop quick but effective interventions to improve condom use experiences, increase consistent and correct condom use, and reduce sexual risk among young people.
What are we going to do? We want to adapt a condom promotion programme which has been developed and tested in the US for use among young men in the UK. The US programme gives out "condom kits" (containing different condoms and lubricants) asks men to try out the condoms at home by themselves by completing various homework exercises. As they test each condom they are asked to think about their own pleasure and which condoms they like best. Men then score/rate the condoms they use. The aim of the programme is for men to improve their condom skills by 1) finding the "right/best" types of condoms and lubricants, 2) testing techniques of applying them, and 3) by practicing with them in no pressure situations (on their own).
In this study we want to see if the idea can be adapted for use with men in the UK to improve their skills in applying condoms and their pleasure in using them. To do this we will be speaking to young men and health promotion professionals to find out their views and help us modify and develop the components of the new programme. We will then invite young people's information and advice services in community and educational establishments in Hampshire and the West Midlands to take part and help recruit 50 young men aged 16-25 to test out the programme.
What we will measure: We want to know if young men like the different elements of the programme and if it is possible to run our study in the different settings. We are also testing whether it is possible to do a larger trial to see if the programme can change men's views and use of condoms, 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 participants 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 intervention, and to assess whether a larger trial is justified and appropriate.
Technical Summary
The DoH has identified the need to reduce rates of HIV, sexually transmitted infections (STIs), and unintended pregnancies as priorities for improving sexual health. Although male condoms can be highly protective against pregnancy and 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 adapt, specify, and assess the feasibility of a behaviour change intervention to increase condom use (The Kinsey Institute Homework Intervention Strategy; KIHIS) for use in the UK. The KIHIS, designed to improve condom skills, enjoyment, and self-efficacy, has demonstrated early evidence of efficacy in two studies. The proposed KIHIS-UK intervention is novel in that it a) aims to increase condom use by targeting outcome expectancies related to enjoyment of sex, which have been identified in previous research as important determinants of behaviour amongst non-users; b) will have been adapted with extensive user participation to ensure future successful implementation, and c) 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 or, indeed, what does not work.
The target population will be young men aged 16-25, recruited from young people's information, advice, counselling and support services located in community settings and educational establishments in Hampshire and the West Midlands. The early phase study will involve a literature review, development/design consultation, intervention delivery and feasibility, follow-up, and recommendations for a definitive trial.
In line with MRC guidance for developing and evaluating complex interventions, the aims of this early phase study are to adapt, specify, and assess the feasibility of a behaviour change intervention to increase condom use (The Kinsey Institute Homework Intervention Strategy; KIHIS) for use in the UK. The KIHIS, designed to improve condom skills, enjoyment, and self-efficacy, has demonstrated early evidence of efficacy in two studies. The proposed KIHIS-UK intervention is novel in that it a) aims to increase condom use by targeting outcome expectancies related to enjoyment of sex, which have been identified in previous research as important determinants of behaviour amongst non-users; b) will have been adapted with extensive user participation to ensure future successful implementation, and c) 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 or, indeed, what does not work.
The target population will be young men aged 16-25, recruited from young people's information, advice, counselling and support services located in community settings and educational establishments in Hampshire and the West Midlands. The early phase study will involve a literature review, development/design consultation, intervention delivery and feasibility, follow-up, and recommendations for a definitive trial.
Publications
Graham C
(2016)
P029 HIS-UK Condom Study: An intervention development study working with young men to improve condom use skills and enhance condom use experiences
in Sexually Transmitted Infections
Stone N
(2018)
Enhancing condom use experiences among young men to improve correct and consistent condom use: feasibility of a home-based intervention strategy (HIS-UK).
in Pilot and feasibility studies
Anstee S
(2019)
Evidence for behavioural interventions addressing condom use fit and feel issues to improve condom use: a systematic review.
in Sexual health
Title | Condom Instructions Leaflet |
Description | Having searched widely for, and failed to find, an existing product for use in this study we have developed a comprehensive leaflet for this study. This includes essential condom home practice, general guidance for condom application and use, and advice and where to access free condoms and sexual health services |
Type Of Art | Artefact (including digital) |
Year Produced | 2016 |
Impact | Most other condom application resources were found to be lacking in certain essential aspects. The leaflet we have developed could be used as a general resource after the study by all providers of sexual health services. |
Description | British Association for Sexual Health and HIV (BASHH) Member of committee to update BASHH Safer Sex Guidance |
Geographic Reach | National |
Policy Influence Type | Membership of a guideline committee |
Description | Condom provision and awareness of fit & feel issues |
Geographic Reach | Local/Municipal/Regional |
Policy Influence Type | Influenced training of practitioners or researchers |
Description | Evaluating the Home-based Intervention Strategy (HIS-UK) to reduce new chlamydia infection among young men aged 16-25 years by promoting correct and consistent condom use: What is the cost effectiveness of two different delivery models (face-to-face and d |
Amount | £1,300,000 (GBP) |
Funding ID | 17/54/06 |
Organisation | NIHR Evaluation, Trials and Studies Coordinating Centre (NETSCC) |
Sector | Public |
Country | United Kingdom |
Start | 02/2019 |
End | 01/2023 |
Description | Feasibility study of the Home-based Exercises for Responsible Sex (HERS) intervention to promote correct and consistent condom use among young women |
Amount | £151,065 (GBP) |
Funding ID | MR/S002200/1 |
Organisation | Medical Research Council (MRC) |
Sector | Public |
Country | United Kingdom |
Start | 11/2018 |
End | 04/2020 |
Title | Behaviour Change Techniques Taxonomy - use in intervention development |
Description | BCTs were used to identify active components of an intervention requiring adaption and development. In combination with Rapid Review Methods we identified further interventions in the same field (condom use) tested for effectiveness and identified active components for addition to the existing intervention. The resulting intervention then has all it's active components identified allowing later analysis of the effective elements of the behavioural intervention. |
Type Of Material | Improvements to research infrastructure |
Provided To Others? | No |
Impact | It will aid Intervention Descriptions, improving reproducibility and translation to practice |
Description | No Limits, Southampton |
Organisation | No Limits |
Country | United Kingdom |
Sector | Charity/Non Profit |
PI Contribution | This Southampton-based youth organisation was very involved in helping with recruitment for our HIS-UK study and continues to be involved in our current HERS-UK project and NIHR-PHR funded RCT of HIS-UK. |
Collaborator Contribution | Assistance with recruitment and involvement in advisory group and PPI activities. |
Impact | No outputs but one outcome that has been reported to us by No Limits staff is that our research and the findings from the HIS-UK feasibility have led to changes in their staff's clinical practice e.g., how they respond to young people who report errors or problems using condoms. |
Start Year | 2015 |
Description | Solent NHS Trust Sexual Health Services |
Organisation | Solent NHS Trust |
Country | United Kingdom |
Sector | Public |
PI Contribution | An awareness of condom 'fit and feel' issues that relate to condom errors and problems and resultant consistent use. This may lead to further working partnerships in the future. |
Collaborator Contribution | Assistance with raising awareness of the study activities, which in turn will aid recruitment in the community |
Impact | Aid in raising awareness and participation |
Start Year | 2015 |
Title | Development of HIS-UK intervention |
Description | The HIS-UK intervention to improve condom use experience among young was developed and refined as part of our MRC-PHIND feasibility study and formed the basis for our NIHR PHR -funded study to evaluate the intervention. |
Type | Preventative Intervention - Behavioural risk modification |
Current Stage Of Development | Refinement. Non-clinical |
Year Development Stage Completed | 2018 |
Development Status | Under active development/distribution |
Impact | The intervention was the basis for our successful application to NIHR-PHR for funding an RCT. |
Description | An intervention development study working with young men to improve condom use skills and enhance condom use experiences |
Form Of Engagement Activity | A talk or presentation |
Part Of Official Scheme? | No |
Geographic Reach | National |
Primary Audience | Professional Practitioners |
Results and Impact | Presentation on development of our HIS intervention study to National Annual Conference for the Society of Sexual Health Advisors, London, September 2016. |
Year(s) Of Engagement Activity | 2016 |
URL | http://ssha.info/ |
Description | BBC 3 - Have we fallen out of love with safe sex? |
Form Of Engagement Activity | A press release, press conference or response to a media enquiry/interview |
Part Of Official Scheme? | No |
Geographic Reach | International |
Primary Audience | Media (as a channel to the public) |
Results and Impact | I was interviewed by Natasha Preskey for a BBC 3 feature on safer sex and I was quoted talking about the barriers to condom use and about our HIS-UK intervention to increase condom use. |
Year(s) Of Engagement Activity | 2019 |
URL | https://www.bbc.co.uk/bbcthree/article/e59064b9-549e-4dd8-9be7-2c2b0599b77f |
Description | BBC3 article "Have we fallen out of love with safe sex?" |
Form Of Engagement Activity | A press release, press conference or response to a media enquiry/interview |
Part Of Official Scheme? | No |
Geographic Reach | International |
Primary Audience | Media (as a channel to the public) |
Results and Impact | Interviewed by Natasha Preskey for a feature article on problems/challenges using condoms. I talked about our research findings on condom errors and problems. |
Year(s) Of Engagement Activity | 2019 |
URL | https://www.bbc.co.uk/bbcthree/article/e59064b9-549e-4dd8-9be7-2c2b0599b77f |
Description | Condoms and pleasure |
Form Of Engagement Activity | A talk or presentation |
Part Of Official Scheme? | No |
Geographic Reach | National |
Primary Audience | Professional Practitioners |
Results and Impact | This was an invited talk by the British Association of Sexual Health and HIV (BASHH) Sexual Dysfunction Special Interest Group. I spoke about the findings from the HIS-UK feasibility project and also about our planned HERS study, also funded by the MRC PHIND scheme. |
Year(s) Of Engagement Activity | 2019 |
URL | https://www.youtube.com/watch?v=ckrrexqrG9k&feature=youtu.be |
Description | Interview with BBC journalist on innovations in condoms |
Form Of Engagement Activity | A press release, press conference or response to a media enquiry/interview |
Part Of Official Scheme? | No |
Geographic Reach | International |
Primary Audience | Media (as a channel to the public) |
Results and Impact | I was invited to do a media phone interview by Chermaine Lee for BBC Futures on my own research on condoms and condom applicators and on future innovations in condom development |
Year(s) Of Engagement Activity | 2020,2021 |
Description | Invited keynote talk to the BASHH-SSSTDI 2017 Annual Conference in Belfast (18-20th June 2017) |
Form Of Engagement Activity | A talk or presentation |
Part Of Official Scheme? | No |
Geographic Reach | National |
Primary Audience | Professional Practitioners |
Results and Impact | I was invited as a Keynote speaker to give a talk entitled "Improving condom use skills and experiences in young men" at the British Association of Sexual Health and HIV (BASHH-SSSTDI) 2017 Annual Conference in Belfast (18-20th June 2017) as part of the health advisers/Nurses symposium.. I made good contacts with researchers and clinicians working in sexual health clinics around the UK, and in other organisations such as the Terence Higgins Trust. |
Year(s) Of Engagement Activity | 2017 |
Description | Invited podcast for Science of Sex series with Dr Zhana Vrangalova, New York City |
Form Of Engagement Activity | A press release, press conference or response to a media enquiry/interview |
Part Of Official Scheme? | No |
Geographic Reach | International |
Primary Audience | Public/other audiences |
Results and Impact | I was invited to be interviewed on this podcast series which is available to access for free both in iTunes and in Soundcloud. The topic was condom errors and problems and our HIS intervention to improve condom use. |
Year(s) Of Engagement Activity | 2018 |
URL | https://soundcloud.com/user-252312803 |
Description | Presentation to the International Centre for Reproductive Health at the University of Ghent, Belgium |
Form Of Engagement Activity | A talk or presentation |
Part Of Official Scheme? | No |
Geographic Reach | International |
Primary Audience | Professional Practitioners |
Results and Impact | The talk involved explaining the importance of embedding evidence from behavioural science in interventions aiming to change health outcomes by changing behaviour. The medics and researchers present were interested in the evidence-based approaches we typically use and this sparked discussion and debate and we are looking at future collaborative opportunities that link our work with theirs and that make use of this centres links with Africa, South America and China. |
Year(s) Of Engagement Activity | 2016 |
Description | Sexual Health Promotion Professionals Workshops |
Form Of Engagement Activity | Participation in an activity, workshop or similar |
Part Of Official Scheme? | No |
Geographic Reach | Regional |
Primary Audience | Professional Practitioners |
Results and Impact | We held 2 workshops for Health Promotion Professionals and Public Patient Involvement representatives: 1 in Coventry also covering staff from Warwickshire/West Midlands and one in Southampton also covering Hampshire. Members included anyone engaging the public in sexual health advise and condom provision e.g. Justice service, homeless hostels, etc. The workshop covered: current sexual behaviours, condom practice and interventions being currently used, followed by development of the intervention this study will be using. The workshops were educational for everyone involved and had the additional value of allowing networking relationships that most said would continue beyond the workshops |
Year(s) Of Engagement Activity | 2015 |
Description | Stakeholder Advisory Group |
Form Of Engagement Activity | A formal working group, expert panel or dialogue |
Part Of Official Scheme? | No |
Geographic Reach | Regional |
Primary Audience | Professional Practitioners |
Results and Impact | Four stakeholder advisory group meetings were held during the study (groups in both Southampton and Coventry). These culminated in a stakeholder dissemination workshop held at the study. Each group involved key professionals such as commissioners, lead health promotion specialists, clinical consultants, researchers, and consultants working with young people. |
Year(s) Of Engagement Activity | 2015,2016 |
Description | Study Advisory Groups |
Form Of Engagement Activity | A formal working group, expert panel or dialogue |
Part Of Official Scheme? | No |
Geographic Reach | Regional |
Primary Audience | Policymakers/politicians |
Results and Impact | We held 2 Advisory Groups including Commissioner, Researchers, Senior Consultants, Health Promotion Professionals and Public Patient Involvement representatives: 1 in Coventry also covering staff from Warwickshire/West Midlands and one in Southampton also covering Hampshire. The Advisory Groups discussed issues covered in the workshops (current sexual behaviours, condom practice and interventions being currently used, followed by development of the intervention this study will be using) AND, overarching policies, funding, research governance, future research and implementation. |
Year(s) Of Engagement Activity | 2015 |
Description | Website |
Form Of Engagement Activity | Engagement focused website, blog or social media channel |
Part Of Official Scheme? | No |
Geographic Reach | National |
Primary Audience | Study participants or study members |
Results and Impact | Development of a study website. The purpose of the website was to raise awareness, recruit young men to the study, and disseminate findings |
Year(s) Of Engagement Activity | 2015,2016,2017 |
URL | https://www.his-uk.net/ |