Condition category
Infections and Infestations
Date applied
10/08/2016
Date assigned
24/10/2016
Last edited
01/11/2017
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
HIV is a virus that attacks the immune system and weakens the body's ability to fight infections and disease. It is most commonly caught by having sex without a condom. This study is looking at whether the offer of free HIV self-tests could help reduce the spread of HIV in men who have sex with men (MSM). The annual rate of HIV diagnosis in MSM is increasing in the UK, but many MSM do not regularly test for HIV and as many as 1 in 4 may never have been tested. Currently, most HIV tests are conducted in genito-urinary medicine (GUM) clinics. HIV self-testing is where a person carries out the test themselves. They take a sample of blood or saliva and process it themselves using a self-testing kit. Some people may be more likely to test for HIV using this method than others because it is more private, quick and convenient than visiting a clinic. This study aims to investigate the potential impact of self-testing in the UK, how MSM feel about using self-testing, whether free self-testing could increase HIV diagnosis and lead to more people receiving treatment for HIV, and whether the NHS should provide free HIV self-testing.

Who can participate?
Men (including trans men), aged 18 or over, who have had anal sex with a man, and have not been diagnosed HIV positive

What does the study involve?
Participants are recruited via social media, other internet advertisements, and publicity in the gay press. Participants do not need to attend clinics or other healthcare settings in order to take part. Participants are randomly allocated to receive either a free HIV self-test or no free self-test. For those who receive one, the free self-test is delivered directly by the kit provider. All participants in this part of the study are asked to complete a survey at 3 months. These include questions about their experience with the self-test and the test results (if they received a test), their sexual behaviour and their HIV and STI testing since the start of the study. After 3 months, some of the people who received a test before are able to receive additional tests at regular intervals until the end of the study. This is only for people who used the test they received, found that they were HIV negative, and tell us they would be interested in receiving more tests. Whether or not they do receive more is decided by random allocation. All of the people who could have received additional tests – whether they do or not – are asked to complete regular surveys until the end of the study. The study is looking to compare the numbers of HIV diagnoses in the different groups (that is, those who receive tests and those who don’t). This information is collected in two ways: when people tell us in survey responses that they have been diagnosed HIV positive, and using the Public Health England database that records all new HIV diagnoses in the UK.

What are the possible benefits and risks of participating?
Most participants in the study receive at least one free HIV self-test kit. This would otherwise cost £30. Some people might prefer the experience of testing on their own or with someone they trust, instead of having to go to a clinic. Being diagnosed as HIV positive, while distressing, has important benefits for long-term health compared to being undiagnosed. It is possible that participants may find the process of taking the self-test, or more likely the results, difficult. This may lead to other potential problems, such as with mental health or self-harm, or negative reactions towards partners.

Where is the study run from?
The study is run by researchers at the Royal Free Hospital, Sigma Research at London School of Hygiene and Tropical Medicine, University College London (UCL), the Medical Research Council Clinical Trials Unit at UCL and Public Health England. We have also had input from HIV iBase and a community advisory group.

When is study starting and how long is it expected to run for?
March 2014 to October 2019

Who is funding the study?
National Institute for Health Research (NIHR) (UK)

Who is the main contact?
1. SELPHI study team (mrcctu.selphi@ucl.ac.uk)
2. Chief Investigator: Dr Alison Rodger

Trial website

http://www.selphi.org/

Contact information

Type

Public

Primary contact

Dr Alison Rodger

ORCID ID

Contact details

Royal Free Hospital
Pond Street
London
NW3 2QG
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

9233/001

Study information

Scientific title

An HIV SELf-testing Public Health Intervention (SELPHI): a randomised controlled trial

Acronym

SELPHI

Study hypothesis

1. Is the online promotion and postal delivery of free HIV self-test kits (with testing reminders) feasible and acceptable?
2. Will the offer of a single free HIV self-test at enrolment lead to the confirmed diagnosis of prevalent HIV infections and entry to standard HIV clinical care?
3. Among seronegative men at high risk of acquiring HIV Infection, will the offer of regular free self-tests with testing reminders result in more rapid confirmed diagnosis of an incident HIV infection and entry into standard HIV clinical care?
4. Generate data to inform key parameters for cost-effectiveness models

Ethics approval

University College London Research Ethics Committee – submission pending

Study design

Internet-based randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Internet

Trial type

Diagnostic

Patient information sheet

Condition

HIV

Intervention

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 ongoing risk who have expressed an interest in receiving more kits randomised to either a regular (3-monthly) offer of additional self-tests vs none in a 1:1 ratio.

Intervention type

Other

Phase

Drug names

Primary outcome measures

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

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.

Overall trial start date

31/03/2014

Overall trial end date

31/10/2019

Reason abandoned

Eligibility

Participant 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)

Participant type

Other

Age group

Adult

Gender

Male

Target number of participants

10000

Participant exclusion criteria

None (all criteria are based on inclusion)

Recruitment start date

01/11/2016

Recruitment end date

31/10/2017

Locations

Countries of recruitment

United Kingdom

Trial participating centre

No centres in this trial as it is internet-based
-

Sponsor information

Organisation

University College London (UCL)

Sponsor details

MRC Clinical Trials Unit at UCL
Aviation House
125 Kingsway
London
WC2B 6NH
United Kingdom

Sponsor type

University/education

Website

http://www.ctu.mrc.ac.uk

Funders

Funder type

Government

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

31/10/2020

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

01/11/2017: Internal review.