PrEP Impact Trial: A Pragmatic Health Technology Assessment of PrEP and Implementation
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|ClinicalTrials.gov Identifier: NCT03253757|
Recruitment Status : Not yet recruiting
First Posted : August 18, 2017
Last Update Posted : August 18, 2017
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.
|Condition or disease||Intervention/treatment|
|HIV Infections||Other: This study is non-interventional.|
|Study Type :||Observational|
|Estimated Enrollment :||10000 participants|
|Official Title:||PrEP Impact Trial: A Pragmatic Health Technology Assessment of PrEP and Implementation|
|Estimated Study Start Date :||September 1, 2017|
|Estimated Primary Completion Date :||September 1, 2020|
|Estimated Study Completion Date :||September 1, 2020|
- Other: This study is non-interventional.
This study is non-interventional.
- PrEP Eligibility [ Time Frame: 3 years ]The proportion of GUM clinic attendees meeting the eligibility criteria for PrEP
- PrEP Eligibility (duration) [ Time Frame: 3 years ]The duration for which GUM clinic attendees are eligible for PreP
- PrEP Uptake [ Time Frame: 3 years ]The proportion of PrEP eligible GUM clinic attendees prescribed PrEP
- PrEP Uptake (duration) [ Time Frame: 3 years ]The duration for which eligible GUM clinic attendees use PrEP
- HIV [ Time Frame: 3 years ]HIV diagnoses reported by sites and identified through the national surveillance dataset
- STIs [ Time Frame: 3 years ]STI diagnoses (gonorrhoea, chlamydia, syphilis and hepatitis C) reported in the national surveillance dataset
- Adverse Events [ Time Frame: 3 years ]
- Serious suspected adverse drug reactions reported using the yellow card system
- Antiretroviral resistance associated mutations in participants with incident HIV infection
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03253757
|Contact: Hannah Reaneyemail@example.com|