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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
Sponsor:
Collaborators:
Public Health England
NHS England
Information provided by (Responsible Party):
St Stephens Aids Trust

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.


Condition or disease Intervention/treatment
HIV Infections Other: This study is non-interventional.

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Study Type : Observational
Estimated Enrollment : 10000 participants
Observational Model: Other
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS


Intervention Details:
  • Other: This study is non-interventional.
    This study is non-interventional.


Primary Outcome Measures :
  1. PrEP Eligibility [ Time Frame: 3 years ]
    The proportion of GUM clinic attendees meeting the eligibility criteria for PrEP

  2. PrEP Eligibility (duration) [ Time Frame: 3 years ]
    The duration for which GUM clinic attendees are eligible for PreP

  3. PrEP Uptake [ Time Frame: 3 years ]
    The proportion of PrEP eligible GUM clinic attendees prescribed PrEP

  4. PrEP Uptake (duration) [ Time Frame: 3 years ]
    The duration for which eligible GUM clinic attendees use PrEP


Secondary Outcome Measures :
  1. HIV [ Time Frame: 3 years ]
    HIV diagnoses reported by sites and identified through the national surveillance dataset

  2. STIs [ Time Frame: 3 years ]
    STI diagnoses (gonorrhoea, chlamydia, syphilis and hepatitis C) reported in the national surveillance dataset

  3. Adverse Events [ Time Frame: 3 years ]
    1. Serious suspected adverse drug reactions reported using the yellow card system
    2. Antiretroviral resistance associated mutations in participants with incident HIV infection



Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

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)-

Information from the National Library of Medicine

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


Contacts
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Contact: Hannah Reaney 07887476175 impact@ststcr.com

Sponsors and Collaborators
St Stephens Aids Trust
Public Health England
NHS England

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Responsible Party: St Stephens Aids Trust
ClinicalTrials.gov Identifier: NCT03253757     History of Changes
Other Study ID Numbers: SSCR104
First Posted: August 18, 2017    Key Record Dates
Last Update Posted: August 18, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: All data used in the study will be pseudo-anonymised and used for the purposes of determining the implementation of PrEP in England.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by St Stephens Aids Trust:
PrEP
HIV

Additional relevant MeSH terms:
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HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases