An observational study in HIV Infections, sponsored by St Stephens Aids Trust. Status unknown. Open to participants aged 16 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-08-18.
Sponsored by St Stephens Aids Trust · Observational
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.
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:
B. HIV negative partners of an HIV positive person when:
C.HIV negative persons who:
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:
B. HIV negative partners of an HIV positive person when:
C.HIV negative persons who:
Participants will therefore be considered eligible for trial enrolment if they fulfil all the following individual eligibility criteria:
Exclusion Criteria:
This study is non-interventional.
PrEP Eligibility
The proportion of GUM clinic attendees meeting the eligibility criteria for PrEP
Time frame: 3 years
PrEP Eligibility (duration)
The duration for which GUM clinic attendees are eligible for PreP
Time frame: 3 years
PrEP Uptake
The proportion of PrEP eligible GUM clinic attendees prescribed PrEP
Time frame: 3 years
PrEP Uptake (duration)
The duration for which eligible GUM clinic attendees use PrEP
Time frame: 3 years
HIV
HIV diagnoses reported by sites and identified through the national surveillance dataset
Time frame: 3 years
STIs
STI diagnoses (gonorrhoea, chlamydia, syphilis and hepatitis C) reported in the national surveillance dataset
Time frame: 3 years
Adverse Events
1. Serious suspected adverse drug reactions reported using the yellow card system 2. Antiretroviral resistance associated mutations in participants with incident HIV infection
Time frame: 3 years
No study locations are listed for this record.
Plan to share: No — All data used in the study will be pseudo-anonymised and used for the purposes of determining the implementation of PrEP in England.
No publications or documents are linked to this record.
This study is status unknown, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.
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St Stephens Aids Trust