<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/NCT01681420</url>
  </required_header>
  <id_info>
    <org_study_id>10849</org_study_id>
    <nct_id>NCT01681420</nct_id>
  </id_info>
  <brief_title>Improving Blood Safety and HIV Testing in Brazil</brief_title>
  <official_title>Improving Blood Safety and HIV Testing in Brazil: a Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Vitalant Research Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Vitalant Research Institute</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Conduct a randomized controlled trial (RCT) to test the hypothesis that offering&#xD;
      client-centered HIV counseling and testing (HCT) to blood donor candidates will reduce the&#xD;
      risk of HIV contamination in the blood supply and also increase appropriate referrals to&#xD;
      preventive and care services to persons in need in São Paulo, Brazil.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Although all donated blood is screened for HIV antibodies, a residual risk of contamination&#xD;
      persists due to the immunological window period before antibodies are detectable. Deferral of&#xD;
      donors with behavioral risks for HIV is one means to reduce window period contamination;&#xD;
      recruitment of voluntary donors from the community (versus family replacement donors) is held&#xD;
      to be another. Contrary to expectation, a shift to community donors has not resulted in a&#xD;
      decrease in HIV prevalence in units of blood collected by the investigators transfusion&#xD;
      service. The investigators preliminary research indicates that some persons at elevated risk&#xD;
      use donation as a means of testing for HIV. These test-seeking donors have high trust in the&#xD;
      blood bank, do not know other places to receive testing, have low understanding of the&#xD;
      immunological window period and believe it is acceptable to deny risk in order to be tested&#xD;
      through donation. The test-seeking phenomenon may therefore threaten the safety of the blood&#xD;
      supply. Test seeking at blood banks also ill serves persons who need risk reduction&#xD;
      counseling because they cannot disclose their true behavior during the donation process and&#xD;
      still be tested. Donors also have a low rate of return for test results and therefore do not&#xD;
      receive confirmation or referrals to care.&#xD;
&#xD;
      To assess whether HCT at the time of donation will improve blood safety and address&#xD;
      prevention and care needs, the investigators will randomize donor candidates to be offered&#xD;
      this service on-site. As a biological marker for elevated risk for HIV, the investigators&#xD;
      will compare the prevalence of HSV-2 among donors choosing testing to those choosing to&#xD;
      donate when offered the choice (Aim 1). The impact of the intervention will be measured as an&#xD;
      increase in persons receiving their test results, disclosure counseling and referrals (Aim&#xD;
      2). Secondary outcomes include differences in prevalence of transfusion-transmitted&#xD;
      infections (HIV, HCV, HBV, syphilis, HTLV I/II, Chagas disease), donor motivations (e.g.,&#xD;
      test-seeking vs. altruism), donor deferral rates, use of confidential unit exclusion,&#xD;
      satisfaction with procedures of the blood bank and volume of blood available for use. RCT&#xD;
      results will provide rigorous evidence for or against the provision of on-site HCT as an&#xD;
      effective means to improve blood safety and link individuals to needed health services.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 1, 2012</start_date>
  <completion_date type="Actual">January 31, 2015</completion_date>
  <primary_completion_date type="Actual">May 31, 2013</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Factorial Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>HSV-2 Prevalence in Blood Donors</measure>
    <time_frame>Up to three years.</time_frame>
    <description>As a biological marker for elevated risk for HIV, we will compare the prevalence of HSV-2 among donors choosing testing to those choosing to donate when offered the choice.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Intervention Impact in Blood Donors</measure>
    <time_frame>Up to three years.</time_frame>
    <description>The impact of the intervention will be measured as an increase in persons receiving their test results, disclosure counseling and referrals.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Prevalence of Transfusion-Transmitted Infections in Blood Donors</measure>
    <time_frame>Up to three years.</time_frame>
    <description>Differences in prevalence of transfusion-transmitted infections (HIV, HCV, HBV, syphilis, HTLV I/II, Chagas disease) between arms.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">11900</enrollment>
  <condition>HIV</condition>
  <condition>Herpes Simplex 2</condition>
  <condition>Hepatitis C</condition>
  <condition>Hepatitis B</condition>
  <condition>Chagas Disease</condition>
  <arm_group>
    <arm_group_label>Approved Intervention Counseling</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Approved blood donors randomized to intervention and choosing HIV counseling option with no donation.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Approved Intervention Donation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Approved blood donors randomized to intervention and choosing donation with no HIV counseling.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Deferred Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Deferred blood donors randomized to intervention with HIV counseling.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>HIV Counseling and Testing</intervention_name>
    <description>HIV counseling and testing in lieu of blood donation.</description>
    <arm_group_label>Approved Intervention Counseling</arm_group_label>
    <arm_group_label>Deferred Intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Blood Donation</intervention_name>
    <description>Blood donation without HIV counseling</description>
    <arm_group_label>Approved Intervention Donation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Study subjects will be Portuguese-speaking persons age 18-65 years (determined by&#xD;
             Brazilian law to be the age of donation), who present to donate blood at our center&#xD;
             during the study period and who provide written informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  All those not meeting inclusion criteria.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Thelma T. Goncalez, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Vitalant Research Institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Fundação Pró-sangue Hemocentro de São Paulo</name>
      <address>
        <city>Sao Paulo</city>
        <zip>05403-000</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>January 2018</verification_date>
  <study_first_submitted>February 29, 2012</study_first_submitted>
  <study_first_submitted_qc>September 7, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 10, 2012</study_first_posted>
  <last_update_submitted>January 16, 2018</last_update_submitted>
  <last_update_submitted_qc>January 16, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">January 18, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>HIV counseling</keyword>
  <keyword>Blood donor HIV testing</keyword>
  <keyword>Brazil</keyword>
  <keyword>Blood banks</keyword>
  <keyword>Blood donors</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hepatitis A</mesh_term>
    <mesh_term>Hepatitis C</mesh_term>
    <mesh_term>Hepatitis B</mesh_term>
    <mesh_term>Herpes Simplex</mesh_term>
    <mesh_term>Chagas Disease</mesh_term>
    <mesh_term>Hepatitis</mesh_term>
  </condition_browse>
  <!-- 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/NCT01681420
org study id: 10849
nct id: NCT01681420
lead sponsor: 
has dmc: Yes
Conduct a randomized controlled trial (RCT) to test the hypothesis that offering
      client-centered HIV counseling and testing (HCT) to blood donor candidates will reduce the
      risk of HIV contamination in the blood supply and also increase appropriate referrals to
      preventive and care services to persons in need in São Paulo, Brazil.
Although all donated blood is screened for HIV antibodies, a residual risk of contamination
      persists due to the immunological window period before antibodies are detectable. Deferral of
      donors with behavioral risks for HIV is one means to reduce window period contamination;
      recruitment of voluntary donors from the community (versus family replacement donors) is held
      to be another. Contrary to expectation, a shift to community donors has not resulted in a
      decrease in HIV prevalence in units of blood collected by the investigators transfusion
      service. The investigators preliminary research indicates that some persons at elevated risk
      use donation as a means of testing for HIV. These test-seeking donors have high trust in the
      blood bank, do not know other places to receive testing, have low understanding of the
      immunological window period and believe it is acceptable to deny risk in order to be tested
      through donation. The test-seeking phenomenon may therefore threaten the safety of the blood
      supply. Test seeking at blood banks also ill serves persons who need risk reduction
      counseling because they cannot disclose their true behavior during the donation process and
      still be tested. Donors also have a low rate of return for test results and therefore do not
      receive confirmation or referrals to care.

      To assess whether HCT at the time of donation will improve blood safety and address
      prevention and care needs, the investigators will randomize donor candidates to be offered
      this service on-site. As a biological marker for elevated risk for HIV, the investigators
      will compare the prevalence of HSV-2 among donors choosing testing to those choosing to
      donate when offered the choice (Aim 1). The impact of the intervention will be measured as an
      increase in persons receiving their test results, disclosure counseling and referrals (Aim
      2). Secondary outcomes include differences in prevalence of transfusion-transmitted
      infections (HIV, HCV, HBV, syphilis, HTLV I/II, Chagas disease), donor motivations (e.g.,
      test-seeking vs. altruism), donor deferral rates, use of confidential unit exclusion,
      satisfaction with procedures of the blood bank and volume of blood available for use. RCT
      results will provide rigorous evidence for or against the provision of on-site HCT as an
      effective means to improve blood safety and link individuals to needed health services.
allocation: Randomized
intervention model: Factorial Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: HSV-2 Prevalence in Blood Donors
time frame: Up to three years.
description: As a biological marker for elevated risk for HIV, we will compare the prevalence of HSV-2 among donors choosing testing to those choosing to donate when offered the choice.
measure: Intervention Impact in Blood Donors
time frame: Up to three years.
description: The impact of the intervention will be measured as an increase in persons receiving their test results, disclosure counseling and referrals.
measure: Prevalence of Transfusion-Transmitted Infections in Blood Donors
time frame: Up to three years.
description: Differences in prevalence of transfusion-transmitted infections (HIV, HCV, HBV, syphilis, HTLV I/II, Chagas disease) between arms.
arm group label: Approved Intervention Counseling
arm group type: Experimental
description: Approved blood donors randomized to intervention and choosing HIV counseling option with no donation.
arm group label: Approved Intervention Donation
arm group type: Experimental
description: Approved blood donors randomized to intervention and choosing donation with no HIV counseling.
arm group label: Deferred Intervention
arm group type: Experimental
description: Deferred blood donors randomized to intervention with HIV counseling.
intervention type: Behavioral
intervention name: HIV Counseling and Testing
description: HIV counseling and testing in lieu of blood donation.
arm group label: Approved Intervention Counseling
arm group label: Deferred Intervention
intervention type: Behavioral
intervention name: Blood Donation
description: Blood donation without HIV counseling
arm group label: Approved Intervention Donation
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Thelma T. Goncalez, MD, PhD
role: Principal Investigator
affiliation: Vitalant Research Institute
facility: 
country: Brazil
responsible party type: Sponsor
mesh term: Hepatitis A
mesh term: Hepatitis C
mesh term: Hepatitis B
mesh term: Herpes Simplex
mesh term: Chagas Disease
mesh term: Hepatitis