Evaluating HIS-UK, a condom promotion intervention to reduce chlamydia infection among young me

Not Applicable

• Conditions: Sexually transmitted infections; Infections and Infestations

• Registration Number: ISRCTN11400820
• Lead Sponsor: niversity of Southampton

Brief Summary

2022 Protocol article in https://pubmed.ncbi.nlm.nih.gov/35947422/ (added 12/08/2022)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-10-23
• Last Update Posted: 7 August 2023
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: Male
• Target Recruitment: 725

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

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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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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:<br>1. Condom Barriers Scale<br>2. Condom Use Errors and Problems Survey<br>3. Condom Use Self-Efficacy Scale<br>4. Multidimensional Condom Attitude Scale<br>5. Sexual behaviour and contraceptive use survey (sexual partner history, relationship status/type, frequency of intercourse, use of contraception/condoms)<br>6. Health-related quality of life indicators (SF-12 and EQ5D-5L)