An HIV self-testing public health intervention

Conditions

HIV Infections and Infestations Human immunodeficiency virus [HIV] disease

Janey Sewell, T. Charles Witzel, David Dunn, Fiona Lampe, Fiona Burns et al. (15 authors)

Programme Grants for Applied Research2024-10-01

Understanding experiences of potential harm among MSM (cis and trans) using HIV self-testing in the SELPHI randomised controlled trial in England and Wales: a mixed-methods study

T. Charles Witzel, Emily Jay Nicholls, Leanne McCabe, Peter Weatherburn, Sheena McCormack et al. (17 authors)

Sexually Transmitted Infections2023-08-223 citations

10.1136/sextrans-2023-055840

Free HIV self-test for identification and linkage to care of previously undetected HIV infection in men who have sex with men in England and Wales (SELPHI): an open-label, internet-based, randomised controlled trial.

Rodger AJ, McCabe L, Phillips AN, Lampe FC, Burns F, Ward D, Delpech V, Weatherburn P, Witzel TC, Pebody R, Kirwan P, Gabriel M, Khawam J, Brady M, Fenton KA, Trevelion R, Collaco-Moraes Y, McCormack S, Dunn D.

2022-12-0123 citations

10.1016/s2352-3018(22)00266-1

Protocol, rationale and design of SELPHI: a randomised controlled trial assessing whether offering free HIV self-testing kits via the internet increases the rate of HIV diagnosis

Michelle M. Gabriel, David Dunn, Andrew Speakman, Leanne McCabe, Denise Ward et al. (15 authors)

BMC Infectious Diseases2018-10-2324 citations

10.1186/s12879-018-3433-x

Interventions

Internet-based study with two randomisations: at baseline, 10,000 eligible men randomised to receive either one free HIV self-test vs none in a 60:40 ratio, then at 3 months 3,000 eligible men at ongo

Eligibility

Sex/Gender

Male

Inclusion criteria

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

Exclusion criteria: None (all criteria are based on inclusion)

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Secondary

Measure	Time frame
1. The overall frequency of HIV testing irrespective of testing modality i.e. where and how individuals test 2. Frequency of STI screening 3. Markers of the recency of infection at the time of HIV diagnosis, where available e.g. CD4 count, antibody avidity assays 4. Frequency of condomless sex, either self-reported or as reflected in new STI diagnosis 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.	—

Measure

Time frame

1. The overall frequency of HIV testing irrespective of testing modality i.e. where and how individuals test 2. Frequency of STI screening 3. Markers of the recency of infection at the time of HIV diagnosis, where available e.g. CD4 count, antibody avidity assays 4. Frequency of condomless sex, either self-reported or as reflected in new STI diagnosis 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.

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Countries

United Kingdom

Contacts

Public ContactAlison Rodger

Outcome results

None listed