An HIV self-testing public health interventio

Not Applicable

Completed

• Conditions: HIV; Infections and Infestations; Human immunodeficiency virus [HIV] disease

• Registration Number: ISRCTN20312003
• Lead Sponsor: niversity College London (UCL)

Brief Summary

2018 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/30352556 protocol 2019 Interim results article in https://www.ncbi.nlm.nih.gov/pubmed/31391003 feasibility and acceptability results (added 04/11/2019) 2022 Interim results article in https://pubmed.ncbi.nlm.nih.gov/35459233/ Experiences and attitudes of participants of colour (added 25/04/2022) 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/36460023/ (added 05/12/2022) 2023 Other publications in https://pubmed.ncbi.nlm.nih.gov/37607814/ (added 25/08/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-10-24
• Study Completion: 2020-01-31
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Completed
• Sex: Male
• Target Recruitment: 10111

Inclusion Criteria

For first randomisation (A):
1. Male (including trans men)
2. Has ever had anal sex with a man
3. Is not known to be HIV positive
4. Aged =18 years old
5. Resident in England or Wales
6. Willing to provide name, date of birth, and a valid email address
7. Consent for linkage of survey responses to surveillance and clinic databases held by PHE
8. Willing to complete online surveys
9. Has not been previously randomised to the study

For second randomisation (B):
1. Allocated to baseline self-test (BT) in randomisation A
2. Has completed the 3-month survey and:
2.1. Reports using self-test sent at baseline
2.2. Remains HIV negative
2.3. Expresses interest in using HIV self-test kits in the future
2.4. Is considers to be at high-risk for HIV infection. Defined as reporting condomless anal sex with =1 male partners (in previous 3 months)

Exclusion Criteria

None (all criteria are based on inclusion)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Confirmed HIV diagnosis, identified through the Public Health England Diagnoses Database, supplemented with data from Genitourinary Medicine Clinic Activity Database (GUMCADv3) and participant self-report. For the first randomisation, the outcome will be a confirmed HIV diagnosis within 3 months of enrolment. For the second randomisation it will be time, from time of randomisation when participants are HIV negative, to a confirmed diagnosed HIV diagnosis.

Secondary Outcome Measures

Name	Time	Method
1. The overall frequency of HIV testing irrespective of testing modality i.e. where and how individuals test<br>2. Frequency of STI screening<br>3. Markers of the recency of infection at the time of HIV diagnosis, where available e.g. CD4 count, antibody avidity assays<br>4. Frequency of condomless sex, either self-reported or as reflected in new STI diagnosis <br><br>Outcomes will mainly be measured in surveys, which are 3-monthly after the first randomisation. Additional information will come from data linkage with Public Health England – in particular this will give us data on CD4 counts and other biological information. The exactl timelines for this linkage are not yet decided, but we will have linked data for all trial participants by the time of final analysis.