Sexually transmitted infections Infections and Infestations
Conditions
Interventions
On submission of baseline questionnaire data, participants are randomised by way of a computer algorithm within each recruitment setting, with stratification by ethnicity and sexual orientation. Parti
Sponsors
University of Southampton
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 21/07/2023: Young men in the UK who are ‘at-risk’ of STIs, defined as: 1. Men and people with attributes of a biological male (i.e. penis) 2. Aged 16-25 years 3. Self-reported residency in England 4. 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 3 months 5.. Willingness to commit to the trial duration 6. Capable of giving informed consent _____ Previous inclusion criteria: Young men in the UK who are ‘at-risk’ of STIs, defined as: 1. Men and people with attributes of a biological male (i.e. penis) 2. Aged 16-25 years 3. Current resident of England 4. At risk of STIs through reporting of condomless penile-vaginal or penile-anal intercourse with casual/non-regular or new sexual partners during the previous three months 5. Able to commit to the 12-month duration of the study. 6. Capable of giving informed consent
Exclusion criteria
Exclusion criteria: 1. People without attributes of a biological male (i.e. a penis) 2. A recognised latex allergy 3. No access to the internet 4. Limited written and spoken English proficiency
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Chlamydia test positivity rate, measured through biomarker testing and treatment at baseline, 6 and 12 months, and through self-reporting at other times. The primary health endpoint will be test positivity rate at 6 months. To examine longevity of intervention effect, test positivity will be assessed up until 12 months post randomisation | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the effectiveness of HIS-UK to improve correct and consistent condom use as compared to usual condom distribution care, the following validated online questionnaires obtained at baseline (T0), and at monthly intervals to 12 months (T1-T12) will be used: 1. Condom Barriers Scale 2. Condom Use Errors and Problems Survey 3. Condom Use Self-Efficacy Scale 4. Multidimensional Condom Attitude Scale 5. Sexual behaviour and contraceptive use survey (sexual partner history, relationship status/type, frequency of intercourse, use of contraception/condoms) 6. Health-related quality of life indicators (SF-12 and EQ5D-5L) | — |
Countries
England, United Kingdom
Outcome results
None listed