HIVPhase 4PROUDNCT02065986
Pre-exposure Option for Reducing HIV in the UK.(PROUD)
A Phase 4 study testing Truvada (once daily tablet containing 300mg tenofovir disoproxil (TDF) and 200mg of emtricitabine (FTC) in people with HIV, run by MRC [ycm] at 1 site in United Kingdom.
Trial summary
This study is looking at a new way to reduce the risk of catching HIV - Truvada-PrEP. To find out whether a daily tablet, Truvada, can safely reduce the risk of gay men catching HIV, we need to do a large trial in which half the men do not receive Truvada for one year. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- HIV
- What is being tested?
- Truvada (once daily tablet containing 300mg tenofovir disoproxil (TDF) and 200mg of emtricitabine (FTC)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 544 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Oct 2012to Oct 2016
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Born to male gender, age 18 years or more
- Previously attended the enrolling clinic on at least one occasion
- Completed a screen for HIV and STIs
- HIV negative by a routinely used assay within 4 weeks prior to or on the day of randomisation
- Reported unprotected anal intercourse (UAI) on more than one occasion within the 90 days prior to randomisation
- Likely, in the opinion of the volunteer, to have UAI in the next 90 days
- Willing and able to comply with the visit schedule throughout the follow-up period
- Willing and able to provide written informed consent
Who cannot join
- An acute viral illness that could be due to HIV seroconversion
- Any contraindications to Truvada according to the current package insert
- Treatment for hepatitis B infection indicated or ongoing
- Unlikely, in the opinion of the clinician, to comply with the randomised allocation
Trial locations and contacts
1 site in 1 country.
About this study
Official 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.(PROUD)
This study is looking at a new way to reduce the risk of catching HIV - Truvada-PrEP.
To find out whether a daily tablet, Truvada, can safely reduce the risk of gay men catching HIV, we need to do a large trial in which half the men do not receive Truvada for one year. We do not know if gay men at risk of HIV are interested in taking Truvada, and if they are, whether they would be willing to wait a year before they can take it. The reason it may not be safe, is that taking Truvada-PrEP may lead to an increase in risk behaviour. This could mean there was more chance of catching HIV and other infections.
Read more
As well as finding out if a large trial would be possible, this study will looks at other factors including:
- Whether people using PrEP change the number of partners they have sex with
- Whether people using PrEP change how often they use condoms
- Whether PrEP leads to higher rates of other sexually transmitted infections (STIs).
This information on changes in sexual activity over time is one of the most important aspects of the study, because we have never collected this before in the UK. This means we don't know what happens to people's sexual activity without PrEP! In October 2014 an interim analysis of the PROUD study data showed that pre-exposure prophylaxis (PrEP) was highly protective against HIV for gay men and other men who have sex with men (MSM) at high risk of infection. The PROUD Trial Steering Committee announced that participants on the deferred arm of the study, who had not yet started PrEP, should be offered the opportunity to begin PrEP ahead of schedule. As a result, we changed the study design and offered all enrolled participants the opportunity to access PrEP. All study participants will be followed up until study closure in October 2016
Read the detailed description
Intervention and control groups:
Arm A: Immediate offer of Truvada-PrEP Arm B: Deferred (12m) offer of Truvada-PrEP
Method of randomisation:
Randomisation will be performed centrally using a computer algorithm based on random permuted blocks stratified by site.
- Conditions
- HIV
- Being tested
- Truvada (once daily tablet containing 300mg tenofovir disoproxil (TDF) and 200mg of emtricitabine (FTC)
- Keywords
- HIV, Prevention, Truvada
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Truvada (once daily tablet containing 300mg tenofovir disoproxil (TDF) and 200mg of emtricitabine (FTC)Drug
| Study group | Role | What they receive |
|---|---|---|
| Arm A: Immediate offer of Truvada-PrEP | Experimental | Immediate offer of Truvada (once daily tablet containing 300mg tenofovir disoproxil (TDF) and 200mg of emtricitabine (FTC) Receives: Drug: Truvada (once daily tablet containing 300mg tenofovir disoproxil (TDF) and 200mg of emtricitabine (FTC) |
| Arm B: Deferred (12m) offer of Truvada-PrEP | Other | Access to Truvada from 12 months after enrolment Receives: Drug: Truvada (once daily tablet containing 300mg tenofovir disoproxil (TDF) and 200mg of emtricitabine (FTC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to accrual of 500 participants and Retention at 12 and 24 months from randomisation
Measured: 2 years
Secondary outcomes (1)
HIV infections acquired between trial entry and 12 months, and between 12 and 24 months
Measured: 24months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2014 (estimated)
- Study startOct 2012
- Primary completionNov 2014
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 544 participants (actual)
Sponsor and investigators
- Lead sponsor
- MRC [ycm]
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, MRC [ycm], Medical Research Council
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02065986
- Sponsor's protocol ID
- 2012-002373-56
- Acronym
- PROUD
- Status last verified
- Jan 2017
- First submitted
- 16 Feb 2014
- Last updated
- 5 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Miltz A, Lampe F, McCormack S, Dunn D, White E, Rodger A, Phillips A, Sherr L, Sullivan AK, Reeves I, Clarke A, Gafos M. Prevalence and correlates of depressive symptoms among gay, bisexual and other men who have sex with men in the PROUD randomised clinical trial of HIV pre-exposure prophylaxis. BMJ Open. 2019 Dec 10;9(12):e031085. doi: 10.1136/bmjopen-2019-031085.
PubMed 31826890Miltz AR, Lampe FC, Bacchus LJ, McCormack S, Dunn D, White E, Rodger A, Phillips AN, Sherr L, Clarke A, McOwan A, Sullivan A, Gafos M. Intimate partner violence, depression, and sexual behaviour among gay, bisexual and other men who have sex with men in the PROUD trial. BMC Public Health. 2019 Apr 25;19(1):431. doi: 10.1186/s12889-019-6757-6.
PubMed 31023281McCormack S, Dunn DT, Desai M, Dolling DI, Gafos M, Gilson R, Sullivan AK, Clarke A, Reeves I, Schembri G, Mackie N, Bowman C, Lacey CJ, Apea V, Brady M, Fox J, Taylor S, Antonucci S, Khoo SH, Rooney J, Nardone A, Fisher M, McOwan A, Phillips AN, Johnson AM, Gazzard B, Gill ON. Pre-exposure prophylaxis to prevent the acquisition of HIV-1 infection (PROUD): effectiveness results from the pilot phase of a pragmatic open-label randomised trial. Lancet. 2016 Jan 2;387(10013):53-60. doi: 10.1016/S0140-6736(15)00056-2. Epub 2015 Sep 9.
PubMed 26364263
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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.(PROUD)
- ClinicalTrials.gov ID
- NCT02065986
- Acronym / sponsor ID
- PROUD / 2012-002373-56
- Conditions
- HIV
- Keywords
- HIV, Prevention, Truvada
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 544 participants (actual)
- Lead sponsor
- MRC [ycm]Other government
- Study start
- Oct 2012
- Primary completion
- Nov 2014 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 19 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is looking at a new way to reduce the risk of catching HIV - Truvada-PrEP.
To find out whether a daily tablet, Truvada, can safely reduce the risk of gay men catching HIV, we need to do a large trial in which half the men do not receive Truvada for one year. We do not know if gay men at risk of HIV are interested in taking Truvada, and if they are, whether they would be willing to wait a year before they can take it. The reason it may not be safe, is that taking Truvada-PrEP may lead to an increase in risk behaviour. This could mean there was more chance of catching HIV and other infections.
As well as finding out if a large trial would be possible, this study will looks at other factors including:
- Whether people using PrEP change the number of partners they have sex with
- Whether people using PrEP change how often they use condoms
- Whether PrEP leads to higher rates of other sexually transmitted infections (STIs).
This information on changes in sexual activity over time is one of the most important aspects of the study, because we have never collected this before in the UK. This means we don't know what happens to people's sexual activity without PrEP! In October 2014 an interim analysis of the PROUD study data showed that pre-exposure prophylaxis (PrEP) was highly protective against HIV for gay men and other men who have sex with men (MSM) at high risk of infection. The PROUD Trial Steering Committee announced that participants on the deferred arm of the study, who had not yet started PrEP, should be offered the opportunity to begin PrEP ahead of schedule. As a result, we changed the study design and offered all enrolled participants the opportunity to access PrEP. All study participants will be followed up until study closure in October 2016
Detailed description
Intervention and control groups:
Arm A: Immediate offer of Truvada-PrEP Arm B: Deferred (12m) offer of Truvada-PrEP
Method of randomisation:
Randomisation will be performed centrally using a computer algorithm based on random permuted blocks stratified by site.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A: Immediate offer of Truvada-PrEP | Experimental | Drug: Truvada (once daily tablet containing 300mg tenofovir disoproxil (TDF) and 200mg of emtricitabine (FTC)Immediate offer of Truvada (once daily tablet containing 300mg tenofovir disoproxil (TDF) and 200mg of emtricitabine (FTC) |
| Arm B: Deferred (12m) offer of Truvada-PrEP | Other | Drug: Truvada (once daily tablet containing 300mg tenofovir disoproxil (TDF) and 200mg of emtricitabine (FTC)Access to Truvada from 12 months after enrolment |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Born to male gender, age 18 years or more
- Previously attended the enrolling clinic on at least one occasion
- Completed a screen for HIV and STIs
- HIV negative by a routinely used assay within 4 weeks prior to or on the day of randomisation
- Reported unprotected anal intercourse (UAI) on more than one occasion within the 90 days prior to randomisation
Key exclusion criteria (4 listed)
- An acute viral illness that could be due to HIV seroconversion
- Any contraindications to Truvada according to the current package insert
- Treatment for hepatitis B infection indicated or ongoing
- Unlikely, in the opinion of the clinician, to comply with the randomised allocation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Truvada (once daily tablet containing 300mg tenofovir disoproxil (TDF) and 200mg of emtricitabine (FTC) | Drug | Arm A: Immediate offer of Truvada-PrEP, Arm B: Deferred (12m) offer of Truvada-PrEP |
Primary outcome
Time to accrual of 500 participants and Retention at 12 and 24 months from randomisation
Time frame: 2 years
1 secondary outcome
HIV infections acquired between trial entry and 12 months, and between 12 and 24 months
Time frame: 24months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2017.
- Derived from this study: PubMed 31826890Miltz A, Lampe F, McCormack S, Dunn D, White E, Rodger A, Phillips A, Sherr L, Sullivan AK, Reeves I, Clarke A, Gafos M. Prevalence and correlates of depressive symptoms among gay, bisexual and other men who have sex with men in the PROUD randomised clinical trial of HIV pre-exposure prophylaxis. BMJ Open. 2019 Dec 10;9(12):e031085. doi: 10.1136/bmjopen-2019-031085.
- Derived from this study: PubMed 31023281Miltz AR, Lampe FC, Bacchus LJ, McCormack S, Dunn D, White E, Rodger A, Phillips AN, Sherr L, Clarke A, McOwan A, Sullivan A, Gafos M. Intimate partner violence, depression, and sexual behaviour among gay, bisexual and other men who have sex with men in the PROUD trial. BMC Public Health. 2019 Apr 25;19(1):431. doi: 10.1186/s12889-019-6757-6.
- Derived from this study: PubMed 26364263McCormack S, Dunn DT, Desai M, Dolling DI, Gafos M, Gilson R, Sullivan AK, Clarke A, Reeves I, Schembri G, Mackie N, Bowman C, Lacey CJ, Apea V, Brady M, Fox J, Taylor S, Antonucci S, Khoo SH, Rooney J, Nardone A, Fisher M, McOwan A, Phillips AN, Johnson AM, Gazzard B, Gill ON. Pre-exposure prophylaxis to prevent the acquisition of HIV-1 infection (PROUD): effectiveness results from the pilot phase of a pragmatic open-label randomised trial. Lancet. 2016 Jan 2;387(10013):53-60. doi: 10.1016/S0140-6736(15)00056-2. Epub 2015 Sep 9.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Truvada (once daily tablet containing 300mg tenofovir disoproxil (TDF) and 200mg of emtricitabine (FTC) in people with HIV, run by MRC [ycm] at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to accrual of 500 participants and Retention at 12 and 24 months from randomisation (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02065986, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2017.