<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03253757</url>
  </required_header>
  <id_info>
    <org_study_id>SSCR104</org_study_id>
    <nct_id>NCT03253757</nct_id>
  </id_info>
  <brief_title>PrEP Impact Trial: A Pragmatic Health Technology Assessment of PrEP and Implementation</brief_title>
  <official_title>PrEP Impact Trial: A Pragmatic Health Technology Assessment of PrEP and Implementation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>St Stephens Aids Trust</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Public Health England</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>NHS England</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>St Stephens Aids Trust</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      HIV pre-exposure prophylaxis (PrEP) is the use of anti-HIV medicines by HIV negative people&#xD;
      in order to prevent them from becoming HIV positive if exposed to HIV.&#xD;
&#xD;
      Currently, the combination drug containing tenofovir and emtricitabine is licensed in Europe&#xD;
      for use as HIV PrEP. We know from previous studies worldwide that this combination drug is&#xD;
      very good at reducing the risk of HIV infection and several countries have implemented PrEP&#xD;
      programmes to provide PrEP to individuals at high risk of HIV.&#xD;
&#xD;
      However, it is difficult to effectively plan for a national PrEP programme in England without&#xD;
      knowing how many people will need PrEP, how many will want to take PrEP, and how long they&#xD;
      will stay on PrEP.&#xD;
&#xD;
      In order to find this out, the PrEP Impact Trial will make PrEP available to at least 10,000&#xD;
      people over three years. HIV negative men and women attending sexual health clinics in&#xD;
      England will have their risk of HIV assessed by their care team and be offered PrEP if they&#xD;
      meet the eligibility criteria. Through the trial we will be able to measure how many&#xD;
      attendees at sexual health clinics meet eligibility criteria for PrEP, how many of these take&#xD;
      up the offer of PrEP and how long they remain on PrEP for.&#xD;
&#xD;
      There will not be any additional tests other than those recommended for the safe delivery of&#xD;
      PrEP. These include tests for sexually transmitted infections (STIs) and HIV as well as urine&#xD;
      and blood tests to monitor kidney function. Information about attendances and test results&#xD;
      will be anonymously collected through the existing data reporting system that sexual health&#xD;
      clinics currently use to report to Public Health England.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">September 1, 2017</start_date>
  <completion_date type="Anticipated">September 1, 2020</completion_date>
  <primary_completion_date type="Anticipated">September 1, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>PrEP Eligibility</measure>
    <time_frame>3 years</time_frame>
    <description>The proportion of GUM clinic attendees meeting the eligibility criteria for PrEP</description>
  </primary_outcome>
  <primary_outcome>
    <measure>PrEP Eligibility (duration)</measure>
    <time_frame>3 years</time_frame>
    <description>The duration for which GUM clinic attendees are eligible for PreP</description>
  </primary_outcome>
  <primary_outcome>
    <measure>PrEP Uptake</measure>
    <time_frame>3 years</time_frame>
    <description>The proportion of PrEP eligible GUM clinic attendees prescribed PrEP</description>
  </primary_outcome>
  <primary_outcome>
    <measure>PrEP Uptake (duration)</measure>
    <time_frame>3 years</time_frame>
    <description>The duration for which eligible GUM clinic attendees use PrEP</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>HIV</measure>
    <time_frame>3 years</time_frame>
    <description>HIV diagnoses reported by sites and identified through the national surveillance dataset</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>STIs</measure>
    <time_frame>3 years</time_frame>
    <description>STI diagnoses (gonorrhoea, chlamydia, syphilis and hepatitis C) reported in the national surveillance dataset</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse Events</measure>
    <time_frame>3 years</time_frame>
    <description>Serious suspected adverse drug reactions reported using the yellow card system&#xD;
Antiretroviral resistance associated mutations in participants with incident HIV infection</description>
  </secondary_outcome>
  <enrollment type="Anticipated">10000</enrollment>
  <condition>HIV Infections</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>This study is non-interventional.</intervention_name>
    <description>This study is non-interventional.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The participant populations for this trial will be men and women attending GUM clinics who&#xD;
        belong to one of three populations recognised to be at high risk for HIV, namely:&#xD;
&#xD;
        A. Men (cisgender and transgender) and transgender women who:&#xD;
&#xD;
          1. Have sex with men&#xD;
&#xD;
          2. Have had an HIV negative test during an earlier episode of care in the preceding year&#xD;
&#xD;
          3. Report condomless intercourse in the previous 3 months&#xD;
&#xD;
          4. Affirm their likelihood of having condomless intercourse in the next 3 months&#xD;
&#xD;
        B. HIV negative partners of an HIV positive person when:&#xD;
&#xD;
          1. The HIV positive partner is not known to be virally suppressed (&lt;200 copies/ml for 6&#xD;
             months or more)&#xD;
&#xD;
          2. Condomless intercourse is anticipated before treatment of the HIV positive partner&#xD;
             takes effect&#xD;
&#xD;
        C.HIV negative persons who:&#xD;
&#xD;
        1. Are clinically assessed and considered to be at similar high risk of HIV acquisition as&#xD;
        those with a serodiscordant partner who is not known to be virally suppressed&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        The participant populations for this trial will be men and women attending GUM clinics who&#xD;
        belong to one of three populations recognised to be at high risk for HIV, namely:&#xD;
&#xD;
        A. Men (cisgender and transgender) and transgender women who:&#xD;
&#xD;
          1. Have sex with men&#xD;
&#xD;
          2. Have had an HIV negative test during an earlier episode of care in the preceding year&#xD;
&#xD;
          3. Report condomless intercourse in the previous 3 months&#xD;
&#xD;
          4. Affirm their likelihood of having condomless intercourse in the next 3 months&#xD;
&#xD;
        B. HIV negative partners of an HIV positive person when:&#xD;
&#xD;
          1. The HIV positive partner is not known to be virally suppressed (&lt;200 copies/ml for 6&#xD;
             months or more)&#xD;
&#xD;
          2. Condomless intercourse is anticipated before treatment of the HIV positive partner&#xD;
             takes effect&#xD;
&#xD;
        C.HIV negative persons who:&#xD;
&#xD;
        1. Are clinically assessed and considered to be at similar high risk of HIV acquisition as&#xD;
        those with a serodiscordant partner who is not known to be virally suppressed&#xD;
&#xD;
        Participants will therefore be considered eligible for trial enrolment if they fulfil all&#xD;
        the following individual eligibility criteria:&#xD;
&#xD;
          1. Belongs to one of the three at high HIV risk populations described above&#xD;
&#xD;
          2. Aged 16 years or over (no upper limit)&#xD;
&#xD;
          3. Considered to be HIV negative on the day of enrolment&#xD;
&#xD;
          4. Willing and able to provide informed consent&#xD;
&#xD;
          5. Willing to adhere to the recommended PrEP regimen&#xD;
&#xD;
          6. Willing to re-attend the trial clinic at appropriate intervals for risk assessment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. An acute viral illness that could be due to HIV seroconversion&#xD;
&#xD;
          2. Any contraindication to Tenofovir Disoproxil (TD)/ Emtricitabine (FTC)-&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Hannah Reaney</last_name>
    <phone>07887476175</phone>
    <email>impact@ststcr.com</email>
  </overall_contact>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>June 16, 2017</study_first_submitted>
  <study_first_submitted_qc>August 15, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 18, 2017</study_first_posted>
  <last_update_submitted>August 15, 2017</last_update_submitted>
  <last_update_submitted_qc>August 15, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 18, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>PrEP</keyword>
  <keyword>HIV</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>HIV Infections</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>All data used in the study will be pseudo-anonymised and used for the purposes of determining the implementation of PrEP in England.</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03253757
org study id: SSCR104
nct id: NCT03253757
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
observational model: Other
time perspective: Prospective
measure: PrEP Eligibility
time frame: 3 years
description: The proportion of GUM clinic attendees meeting the eligibility criteria for PrEP
measure: PrEP Eligibility (duration)
time frame: 3 years
description: The duration for which GUM clinic attendees are eligible for PreP
measure: PrEP Uptake
time frame: 3 years
description: The proportion of PrEP eligible GUM clinic attendees prescribed PrEP
measure: PrEP Uptake (duration)
time frame: 3 years
description: The duration for which eligible GUM clinic attendees use PrEP
measure: HIV
time frame: 3 years
description: HIV diagnoses reported by sites and identified through the national surveillance dataset
measure: STIs
time frame: 3 years
description: STI diagnoses (gonorrhoea, chlamydia, syphilis and hepatitis C) reported in the national surveillance dataset
measure: Adverse Events
time frame: 3 years
description: Serious suspected adverse drug reactions reported using the yellow card system
Antiretroviral resistance associated mutations in participants with incident HIV infection
intervention type: Other
intervention name: This study is non-interventional.
description: This study is non-interventional.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 16 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Hannah Reaney
phone: 07887476175
email: impact@ststcr.com
responsible party type: Sponsor
mesh term: HIV Infections
sharing ipd: No
ipd description: All data used in the study will be pseudo-anonymised and used for the purposes of determining the implementation of PrEP in England.