Condition category
Infections and Infestations
Date applied
28/02/2013
Date assigned
28/02/2013
Last edited
05/01/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

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

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 measures

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

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

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

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

Results - basic reporting

Publication summary

2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26364263
2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/27013513

Publication citations

Additional files

Editorial Notes

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