Pre-exposure option for reducing HIV in the UK: an open-label randomisation to immediate or deferred daily Truvada for HIV-negative gay men

ISRCTN ISRCTN94465371
DOI https://doi.org/10.1186/ISRCTN94465371
EudraCT/CTIS number 2012-002373-56
ClinicalTrials.gov number NCT02065986
Secondary identifying numbers 13131
Submission date
28/02/2013
Registration date
28/02/2013
Last edited
13/12/2019
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Background and study aims
Human immunodeficiency virus (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. The aim of this study is to assess what happens when a new approach, known as pre-exposure prophylaxis (PrEP), is added to the existing methods available to gay men in the UK to reduce their risk of catching HIV. Prophylaxis is taking a drug to prevent, or at least reduce the risk of, catching an infection. In this study a drug called Truvada is used, which is commonly used to treat HIV. It is a combination of tenofovir and emtricitabine in a single pill, to be taken once a day. A major concern about HIV-negative individuals taking PrEP is that they will decrease their use of other methods such as condoms, thereby increasing their risk of HIV and other sexually transmitted infections. This can only be assessed when people know they are taking an active drug. This study therefore offers people PrEP on an 'open label' basis, meaning that everyone who takes it knows they are taking the drug; no-one takes an inactive placebo pill.

Who can participate?
HIV-negative gay men aged 18 or over

What does the study involve?
In order to assess what happens when PrEP is used, one group of participants needs to be followed for a period before using PrEP, at a time when they are accessing the best available methods for reducing risk. To do this, participants are randomly allocated to be offered PrEP either immediately or after 12 months. All participants are offered other interventions to reduce their risk. They are followed up in clinic every 3 months for 2 years, and tested for HIV. A test for sexually transmitted infections is carried out every 6 months or more frequently if indicated. In between visits, participants are asked to complete a diary and monthly questionnaire reporting anal intercourse and their pill taking when they are on Truvada.

What are the possible benefits and risks of participating?
Not provided at time of registration

Where is the study run from?
Medical Research Council Clinical Trials Unit (MRC CTU) (UK)

When is the study starting and how long is it expected to run for?
November 2012 to October 2016

Who is funding the study?
1. Gilead Sciences (USA)
2. Health Protection Agency (HPA) (UK)
3. Medical Research Council (MRC) (UK)

Who is the main contact?
Dr Sheena McCormack
smc@ctu.mrc.ac.uk

Study website

Contact information

Dr Sheena McCormack
Scientific

MRC CTU
Aviation House
125 Kingsway
London
WC2B 6NH
United Kingdom

Email smc@ctu.mrc.ac.uk

Study information

Study designRandomised interventional study
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Other
Study typePrevention
Participant information sheet Not available in web format, please use the contact details to request a patient information sheet
Scientific titlePRe-exposure Option for reducing HIV in the UK: an open-label randomisation to immediate or Deferred daily Truvada for HIV-negative gay men
Study acronymPROUD
Study objectivesThe aim of this study is to assess what happens when a new approach, known as pre-exposure prophylaxis (PrEP), is added to the existing methods available to gay men in the UK to reduce their risk of catching human immunodeficiency virus (HIV) infection.
Ethics approval(s)First MREC approval date 02/10/2012, ref: 12/LO/1289
Health condition(s) or problem(s) studiedTopic: Infection; Subtopic: Infection (all Subtopics); Disease: Infectious diseases and microbiology
InterventionA major concern about HIV-negative individuals taking PrEP is that they will decrease their use of other methods such as condoms, thereby increasing their risk of HIV and other sexually transmitted infections. This can only be assessed when people know they are taking an active drug. This study will therefore offer people PrEP on an 'open label' basis, meaning that everyone who takes it will know they are taking the drug; no-one will take an inactive placebo pill. In order to assess what happens when PrEP is added, one group will need to be followed for a period before the PrEP is included, at a time when they are accessing the best available methods for reducing risk. To do this, the volunteers will be randomised to either be offered PrEP immediately or after 12 months. This study will use a drug called Truvada, which is commonly used to treat HIV. It is a combination of tenofovir and emtricitabine in a single pill, to be taken once a day. All participants will be offered other interventions to reduce their risk. They will be followed in clinic every 3 months for 2 years, and tested for HIV. A screen for sexually transmitted infections will be done every 6 months or more frequently if indicated. In between visits, participants will be asked to complete a diary and monthly questionnaire reporting anal intercourse and their pill taking when they are on Truvada.
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Applicable
Drug / device / biological / vaccine name(s)Truvada
Primary outcome measureTime to accrual; Timepoint(s): time to accrual of 500 participants
Secondary outcome measuresNo secondary outcome measures
Overall study start date29/11/2012
Completion date01/10/2016

Eligibility

Participant type(s)Healthy volunteer
Age groupAdult
Lower age limit18 Years
SexMale
Target number of participantsUK Sample Size: 500
Key inclusion criteria1. Born to male gender, age 18 years or more
2. Previously attended the enrolling clinic on at least one occasion
3. Completed a screen for HIV and sexually transmitted infections (STIs)
4. HIV negative by a routinely used assay within 4 weeks prior to or on the day of randomisation
5. Reported unprotected anal intercourse (UAI) on more than one occasion within the 90 days prior to randomisation
6. Likely, in the opinion of the volunteer, to have UAI in the next 90 days
7. Willing and able to comply with the visit schedule throughout the follow-up period
8. Willing and able to provide written informed consent
Key exclusion criteria1. An acute viral illness that could be due to HIV seroconversion
2. Any contraindications to Truvada according to the current package insert
3. Treatment for hepatitis B infection indicated or ongoing
4. Unlikely, in the opinion of the clinician, to comply with the randomised allocation
Date of first enrolment29/11/2012
Date of final enrolment28/11/2013

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

MRC CTU
London
WC2B 6NH
United Kingdom

Sponsor information

Medical Research Council Clinical Trials Unit (MRC CTU) (UK)
Research council

Aviation House
125 Kingsway
London
WC2B 6NH
United Kingdom

Website http://www.ctu.mrc.ac.uk/
ROR logo "ROR" https://ror.org/001mm6w73

Funders

Funder type

Industry

Gilead Sciences
Government organisation / For-profit companies (industry)
Alternative name(s)
Gilead, Gilead Sciences, Inc.
Location
United States of America
Health Protection Agency (HPA) (UK)
Government organisation / National government
Alternative name(s)
HPA
Location
United Kingdom
Medical Research Council (MRC) (UK)
Government organisation / National government
Alternative name(s)
Medical Research Council (United Kingdom), UK Medical Research Council, MRC
Location
United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 02/01/2016 Yes No
Results article results 24/03/2016 Yes No
Results article results 10/12/2019 13/12/2019 Yes No
HRA research summary 28/06/2023 No No

Editorial Notes

13/12/2019: Publication reference added.
05/01/2017: The overall trial end date was changed from 28/11/2013 to 01/10/2016.
29/03/2016: Publication reference added.