Status:
UNKNOWN
PrEP Impact Trial: A Pragmatic Health Technology Assessment of PrEP and Implementation
Lead Sponsor:
St Stephens Aids Trust
Collaborating Sponsors:
Public Health England
NHS England
Conditions:
HIV Infections
Eligibility:
All Genders
16+ years
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 cont...
Eligibility Criteria
Inclusion
- 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:
- Have sex with men
- Have had an HIV negative test during an earlier episode of care in the preceding year
- Report condomless intercourse in the previous 3 months
- Affirm their likelihood of having condomless intercourse in the next 3 months
- B. HIV negative partners of an HIV positive person when:
- The HIV positive partner is not known to be virally suppressed (\<200 copies/ml for 6 months or more)
- 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:
- Belongs to one of the three at high HIV risk populations described above
- Aged 16 years or over (no upper limit)
- Considered to be HIV negative on the day of enrolment
- Willing and able to provide informed consent
- Willing to adhere to the recommended PrEP regimen
- Willing to re-attend the trial clinic at appropriate intervals for risk assessment
Exclusion
- An acute viral illness that could be due to HIV seroconversion
- Any contraindication to Tenofovir Disoproxil (TD)/ Emtricitabine (FTC)-
Key Trial Info
Start Date :
September 1 2017
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 1 2020
Estimated Enrollment :
10000 Patients enrolled
Trial Details
Trial ID
NCT03253757
Start Date
September 1 2017
End Date
September 1 2020
Last Update
August 18 2017
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