Plain English Summary
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
Trial website
Contact information
Type
Scientific
Primary contact
Dr Sheena McCormack
ORCID ID
Contact details
MRC CTU
Aviation House
125 Kingsway
London
WC2B 6NH
United Kingdom
-
smc@ctu.mrc.ac.uk
Additional identifiers
EudraCT number
2012-002373-56
ClinicalTrials.gov number
NCT02065986
Protocol/serial number
13131
Study information
Scientific title
PRe-exposure Option for reducing HIV in the UK: an open-label randomisation to immediate or Deferred daily Truvada for HIV-negative gay men
Acronym
PROUD
Study hypothesis
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 human immunodeficiency virus (HIV) infection.
Ethics approval
First MREC approval date 02/10/2012, ref: 12/LO/1289
Study design
Randomised interventional study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Prevention
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Topic: Infection; Subtopic: Infection (all Subtopics); Disease: Infectious diseases and microbiology
Intervention
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 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 type
Drug
Phase
Not Applicable
Drug names
Truvada
Primary outcome measure
Time to accrual; Timepoint(s): time to accrual of 500 participants
Secondary outcome measures
No secondary outcome measures
Overall trial start date
29/11/2012
Overall trial end date
01/10/2016
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. 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
Participant type
Healthy volunteer
Age group
Adult
Gender
Male
Target number of participants
UK Sample Size: 500
Participant exclusion criteria
1. 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
Recruitment start date
29/11/2012
Recruitment end date
28/11/2013
Locations
Countries of recruitment
United Kingdom
Trial participating centre
MRC CTU
London
WC2B 6NH
United Kingdom
Sponsor information
Organisation
Medical Research Council Clinical Trials Unit (MRC CTU) (UK)
Sponsor details
Aviation House
125 Kingsway
London
WC2B 6NH
United Kingdom
Sponsor type
Research council
Website
Funders
Funder type
Industry
Funder name
Gilead Sciences
Alternative name(s)
Gilead, Gilead Sciences, Inc.
Funding Body Type
private sector organisation
Funding Body Subtype
corporate
Location
United States of America
Funder name
Health Protection Agency (HPA) (UK)
Alternative name(s)
HPA
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
United Kingdom
Funder name
Medical Research Council (MRC) (UK)
Alternative name(s)
MRC
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
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26364263
2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/27013513