Background The health, social, and economic costs of sexually transmitted infections (STIs) represent a major public health concern. Young people are considered one of the groups most at risk for acquiring and transmitting STIs. Correct and consistent condom use has been shown to be the most effective method for reducing STIs; however, condoms are often not used properly. Evidence shows that brief behavior change interventions that focus on skills, communication, and motivation to acquire safe sex practices should be adopted into routine care to reduce STIs. Funding for sexual health services in England has declined dramatically, so novel ways of reducing clinic attendance are being sought. The home-based intervention strategy (HIS-UK) to promote condom use among young men has shown promise in feasibility and pilot studies by demonstrating high acceptability of the intervention in participant and health professional feedback, including aiding men to find condoms they like and feel more confident when using condoms. Objective The aim of this study is to determine the effectiveness and cost-effectiveness of HIS-UK when compared to usual condom distribution care among young men. Methods The 3 trial arms consisting of “e-HIS” (HIS-UK delivered digitally), “ProHIS” (HIS-UK delivered face-to-face), and control condition (usual National Health Service [NHS] care) will be compared against the following 3 primary outcomes: the extent to which correct and consistent condom use is increased; improvement of condom use experiences (pleasure as well as fit and feel); and decrease in chlamydia test positivity. Eligibility criteria include men aged 16-25 years at risk of STIs through reporting of condom use errors (ie, breakage or slippage) or condomless penile-vaginal or penile-anal intercourse with casual or new sexual partners during the previous 3 months. Prospective participants will be recruited through targeted advertisements and an opportunistic direct approach at selected sexual health and genitourinary medicine services and university-associated health centers and general practitioner practices. Community and educational establishments will be used to further advertise the study and signpost men to recruitment sites. Participants will be randomly allocated to 1 of 3 trial arms. A repeated measures design will assess the parallel arms with baseline and 12 monthly follow-up questionnaires after intervention and 3 chlamydia screening points (baseline, 6, and 12 months). Results Recruitment commenced in March 2020. Due to the COVID-19 pandemic, the study was halted and has since reopened for recruitment in Summer 2021. A 30-month recruitment period is planned. Conclusions If effective and cost-effective, HIS-UK can be scaled up into routine NHS usual care to reduce both STI transmission in young people and pressure on NHS resources. This intervention may further encourage sexual health services to adopt digital technologies, allowing for them to become more widely available to young people while decreasing health inequalities and fear of stigmatization. Trial Registration ISRCTN Registry ISRCTN11400820; https://www.isrctn.com/ISRCTN11400820
Objectives: The female condom (FC) is an effective strategy against sexually transmitted infections (STIs) in susceptible women and men who have sex with men. FCs are the only female-initiated dual protection method that protects against both STIs and unintended pregnancy. As healthcare professionals (HCPs) are a key element in the promotion of contraceptive use, it is important to examine attitudes toward FCs among this group. Study participants: 15 male and female HCPs aged between 22-57 years recruited from sexual and reproductive health settings located in Brighton, London, and Glasgow. Sampling method: purposive sampling with targeted advertisements (newsletters and bulletins). Study design: face-to-face and telephone interviews with sexual health HCPs. Main outcome measure: potential barriers and facilitators to FCs in the UK. Data were analysed thematically to identify common views and perspectives. Results: FCs were thought to be unacceptable to most women due to stigma, design, negative visual appeal, insertion difficulties and lack of familiarity. The perceived unavailability and higher cost of FCs, in comparison to male condoms, are major barriers to their use. Conclusions: HCPs are reluctant to promote FCs, often due to the perceived social stigma surrounding FCs. Further education and promotion are needed to increase acceptability and correct usage. Future research needs to explore strategies to increase the acceptability of FCs among women, men who have sex with men and HCPs.
BACKGROUND The health, social, and economic costs of sexually transmitted infections (STIs) represent a major public health concern. Young people are considered one of the groups most at risk for acquiring and transmitting STIs. Correct and consistent condom use has been shown to be the most effective method for reducing STIs; however, condoms are often not used properly. Evidence has shown that brief behavioural change interventions that focus on skills, communication, and motivation to acquire safe sex practices, should be adopted into routine care to reduce STIs. Funding for sexual health services (SHS) in England has declined dramatically, so novel ways of reducing clinic attendance are being sought. The Home-based Intervention Strategy (HIS-UK) to promote condom use among young men has shown promise in feasibility and pilot studies by demonstrating high acceptability of the intervention in participant and health professional feedback, including aiding men to find condoms that they like and to feel more confident when using condoms. OBJECTIVE To determine the effectiveness and cost-effectiveness of HIS-UK when compared to usual condom distribution care in young men. The three trial arms consisting of ‘eHIS’ (HIS-UK delivered digitally), ‘proHIS’ (HIS-UK delivered face-to-face) and control condition (usual NHS care) will be compared against three primary outcomes: the extent to which they increase correct and consistent condom use, improve condom use experiences (pleasure, fit-and-feel), and reduce chlamydia test positivity. METHODS The study aims to address skills acquisition and motivation to use condoms. Eligibility criteria include men aged 16-25 years at risk of STIs through reporting of condom use errors (i.e. breakage/slippage) or condomless penile-vaginal or penile-anal intercourse with casual/non-regular or new sexual partners during the previous three months. Prospective participants will be recruited through targeted advertisements and an opportunistic direct approach at selected sexual health and genitourinary medicine services and University-associated health centres and GP practices. Community and educational establishments will be used to further advertise the study and signpost men to recruitment sites. Participants will be randomly allocated to one of three trial arms. A repeated measures design will assess the three parallel arms with baseline and 12 monthly follow-up questionnaires post intervention and three chlamydia screening points (baseline, 6 and 12 months). RESULTS Recruitment commenced in March 2020. Due to the COVID-19 pandemic the study was halted and has since reopened for recruitment in Summer 2021. CONCLUSIONS If effective and cost-effective, HIS-UK can be scaled up into routine NHS usual care to reduce both STI transmission in young people and pressure on NHS resources. This intervention may further encourage SHSs to adopt further digital technologies, allowing for such services to become more widely available to young people whilst also decreasing health inequalities and fear of stigmatisation. CLINICALTRIAL ISRCTN: 11400820, October 2019
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