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
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
Contact information
Scientific
MRC CTU
Aviation House
125 Kingsway
London
WC2B 6NH
United Kingdom
| smc@ctu.mrc.ac.uk |
Study information
| Study design | Randomised interventional study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| 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 |
| Study acronym | PROUD |
| Study objectives | 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(s) | First MREC approval date 02/10/2012, ref: 12/LO/1289 |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Truvada |
| Primary outcome measure | Time to accrual; Timepoint(s): time to accrual of 500 participants |
| Secondary outcome measures | No secondary outcome measures |
| Overall study start date | 29/11/2012 |
| Completion date | 01/10/2016 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Male |
| Target number of participants | UK Sample Size: 500 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 29/11/2012 |
| Date of final enrolment | 28/11/2013 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
WC2B 6NH
United Kingdom
Sponsor information
Research council
Aviation House
125 Kingsway
London
WC2B 6NH
United Kingdom
| Website | http://www.ctu.mrc.ac.uk/ |
|---|---|
"ROR" |
https://ror.org/001mm6w73 |
Funders
Funder type
Industry
Government organisation / For-profit companies (industry)
- Alternative name(s)
- Gilead, Gilead Sciences, Inc.
- Location
- United States of America
Government organisation / National government
- Alternative name(s)
- HPA
- Location
- United Kingdom
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 share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not 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.
