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Reducing sexually transmitted infections amongst those at highest risk

Reducing sexually transmitted infections amongst those at highest risk: The Halo randomised controlled trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN51957984
Enrollment
3576
Registered
2025-10-15
Start date
2026-01-07
Completion date
Unknown
Last updated
2026-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infections with a predominantly sexual mode of transmission Infections and Infestations

Interventions

Intervention (Halo plus usual care): Multi-component digital intervention to increase correct and consistent condom use. Control arm (usual care): Usual care in this instance is 1) the usual testing
3576 participants in total). During the feasibilit

Sponsors

University of Hertfordshire
Lead Sponsor

Eligibility

Sex/Gender
All
Age
16 Years to 24 Years

Inclusion criteria

Inclusion criteria: 1. Young people aged 16-24 years old at baseline 2. Living in one of the local authority areas participating in the trial 3. Ordered an STI self-sampling kit that includes tests for chlamydia and gonorrhoea from SH.UK, FreeTest.me or SHL.UK websites 4. Access to a personal mobile phone and the internet 5. Able to read/understand the English language

Exclusion criteria

Exclusion criteria: 1. Unlikely to have penetrative sex (penis in either vagina or anus) over the trial period 2. Do not feel able to commit to the trial over the next 12 months

Design outcomes

Primary

MeasureTime frame
Chlamydia positivity at 12 months, measured using biological STI tests (Nucleic acid amplification; NAA) for chlamydia (baseline, M3, M12)

Secondary

MeasureTime frame
1. Gonorrhoea positivity at 12 months, measured using biological STI tests (Nucleic acid amplification; NAA) for gonorrhoea (baseline, M3, M12) 2. Incidence of repeat infections of chlamydia and gonorrhoea in 12 months post-randomisation, measured using biological STI tests (Nucleic acid amplification; NAA) for chlamydia and gonorrhoea (baseline, M3, M12) and self-report (baseline, M3, M6, M12) 3. Cumulative incidence of chlamydia and gonorrhoea, measured using biological STI tests (Nucleic acid amplification; NAA) for chlamydia and gonorrhoea (baseline, M3, M12) and online survey (baseline, M3, M6, M12) 4. Condom use behaviour (condom use during vaginal and/or anal sexual intercourse: last sex, frequency, and number of protected sex acts; and correct use: using the adapted Condom Use Errors Scale), measured using an online survey (baseline, M3, M6, M12) 5. Behavioural determinants (condom intention, condom use social norms, condom attitude, condom competence, condom accessibility, condom use self-efficacy), measured using an online survey (baseline, M3, M6, M12) 6. Difference in STI and behavioural outcomes by subgroup (ethnicity, sexual orientation and deprivation; demographic characteristics measured using online survey at baseline) 7. Effect of changes in target behaviour and behavioural determinants on STI outcomes 8. Resource use and personal costs, measured using an online survey (baseline, M3, M6, M12) 9. Health-related quality of life (HRQL), measured using the EQ5D-5L via online survey (baseline, M3, M6, M12) 10. Engagement with Halo, measured using within-website analytics during the entire data collection period 11. Difference in engagement with Halo by subgroup (ethnicity, sexual orientation and deprivation), measured using within-website analytics during the entire data collection period

Countries

England, United Kingdom

Contacts

Public ContactPublic Contact
halo@herts.ac.uk-

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Jun 29, 2026