Clinical trial NCT03253757: PrEP Impact Trial: A Pragmatic Health Technology Assessment of PrEP and Implementation
Official title: PrEP Impact Trial: A Pragmatic Health Technology Assessment of PrEP and Implementation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: HIV Infections
Keywords: PrEP
HIV
Lead sponsor: St Stephens Aids Trust
Sponsor class: OTHER
Collaborators: name: Public Health England
name: NHS England
First posted: 2017-08-18
Enrollment: 10000
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The participant populations for this trial will be men and women attending GUM clinics who belong to one of three populations recognised to be at high risk for HIV, namely:

A. Men (cisgender and transgender) and transgender women who:

1. Have sex with men
2. Have had an HIV negative test during an earlier episode of care in the preceding year
3. Report condomless intercourse in the previous 3 months
4. Affirm their likelihood of having condomless intercourse in the next 3 months

B. HIV negative partners of an HIV positive person when:

1. The HIV positive partner is not known to be virally suppressed (\<200 copies/ml for 6 months or more)
2. Condomless intercourse is anticipated before treatment of the HIV positive partner takes effect

C.HIV negative persons who:

1. Are clinically assessed and considered to be at similar high risk of HIV acquisition as those with a serodiscordant partner who is not known to be virally suppressed

Brief summary: HIV pre-exposure prophylaxis (PrEP) is the use of anti-HIV medicines by HIV negative people in order to prevent them from becoming HIV positive if exposed to HIV.

Currently, the combination drug containing tenofovir and emtricitabine is licensed in Europe for use as HIV PrEP. We know from previous studies worldwide that this combination drug is very good at reducing the risk of HIV infection and several countries have implemented PrEP programmes to provide PrEP to individuals at high risk of HIV.

However, it is difficult to effectively plan for a national PrEP programme in England without knowing how many people will need PrEP, how many will want to take PrEP, and how long they will stay on PrEP.

In order to find this out, the PrEP Impact Trial will make PrEP available to at least 10,000 people over three years. HIV negative men and women attending sexual health clinics in England will have their risk of HIV assessed by their care team and be offered PrEP if they meet the eligibility criteria. Through the trial we will be able to measure how many attendees at sexual health clinics meet eligibility criteria for PrEP, how many of these take up the offer of PrEP and how long they remain on PrEP for.

There will not be any additional tests other than those recommended for the safe delivery of PrEP. These include tests for sexually transmitted infections (STIs) and HIV as well as urine and blood tests to monitor kidney function. Information about attendances and test results will be anonymously collected through the existing data reporting system that sexual health clinics currently use to report to Public Health England.


Eligibility criteria: Inclusion Criteria:

The participant populations for this trial will be men and women attending GUM clinics who belong to one of three populations recognised to be at high risk for HIV, namely:

A. Men (cisgender and transgender) and transgender women who:

1. Have sex with men
2. Have had an HIV negative test during an earlier episode of care in the preceding year
3. Report condomless intercourse in the previous 3 months
4. Affirm their likelihood of having condomless intercourse in the next 3 months

B. HIV negative partners of an HIV positive person when:

1. The HIV positive partner is not known to be virally suppressed (\<200 copies/ml for 6 months or more)
2. Condomless intercourse is anticipated before treatment of the HIV positive partner takes effect

C.HIV negative persons who:

1. Are clinically assessed and considered to be at similar high risk of HIV acquisition as those with a serodiscordant partner who is not known to be virally suppressed

Participants will therefore be considered eligible for trial enrolment if they fulfil all the following individual eligibility criteria:

1. Belongs to one of the three at high HIV risk populations described above
2. Aged 16 years or over (no upper limit)
3. Considered to be HIV negative on the day of enrolment
4. Willing and able to provide informed consent
5. Willing to adhere to the recommended PrEP regimen
6. Willing to re-attend the trial clinic at appropriate intervals for risk assessment

Exclusion Criteria:

1. An acute viral illness that could be due to HIV seroconversion
2. Any contraindication to Tenofovir Disoproxil (TD)/ Emtricitabine (FTC)-

Primary outcomes:
measure: PrEP Eligibility
timeFrame: 3 years
measure: PrEP Eligibility (duration)
timeFrame: 3 years
measure: PrEP Uptake
timeFrame: 3 years
measure: PrEP Uptake (duration)
timeFrame: 3 years
Secondary outcomes:
measure: HIV
timeFrame: 3 years
measure: STIs
timeFrame: 3 years
measure: Adverse Events
timeFrame: 3 years
Other outcomes:
Locations:
Study officials:
References: