Plain English Summary

Not provided at time of registration

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

Protocol/serial number

13131

Study information

Scientific title

Acronym

PROUD

Study hypothesis

The aim of this study is to assess what happens when a new approach, known as PrEP, is added to the existing methods available to gay men in the UK to reduce their risk of catching HIV infection.

PrEP is short for pre-exposure prophylaxis. Prophylaxis is taking a drug to prevent, or at least reduce the risk of, catching an infection. In this study we will use a drug called Truvada, which is commonly used to treat Human immunodeficiency virus (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 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, we will need to follow one group 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, half of the volunteers will be offered PrEP immediately, and the other half after 12 months.

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.

More detail can be found at: http://public.ukcrn.org.uk/Search/StudyDetail.aspx?StudyID=13131

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

Not specified

Trial type

Prevention

Patient information sheet

Condition

Topic: Infection; Subtopic: Infection (all Subtopics); Disease: Infectious diseases and microbiology

Intervention

Truvada - immediate or deferred; Follow Up Length: 24 month(s)

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

28/11/2013

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

Patient

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 Inc (USA)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

private sector organisation

Funding Body Subtype

other non-profit

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

Publication citations

Editorial Notes