<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/NCT04440813</url>
  </required_header>
  <id_info>
    <org_study_id>R21AI150302</org_study_id>
    <secondary_id>R21AI150302-01</secondary_id>
    <nct_id>NCT04440813</nct_id>
  </id_info>
  <brief_title>The Risk of HIV Acquisition Among Traditional Healers in South Africa</brief_title>
  <official_title>The Risk of HIV Acquisition Among Traditional Healers in South Africa: Implementing Novel Strategies to Improve Protective Behaviors</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Vanderbilt University Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of Allergy and Infectious Diseases (NIAID)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Witwatersrand, South Africa</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Vanderbilt University Medical Center</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>
      Traditional healers, community-based partners with the national health system of South&#xD;
      Africa, are exposed to patient blood an average of 1,500 times during their careers due to&#xD;
      the practice of delivering herbal remedies via herbs rubbed into dozens of sub-cutaneous&#xD;
      cuts. The purpose of this proposal is to compare two implementation strategies to increase&#xD;
      consistent use of Personal Protective Equipment (PPE): (1) a health care worker provided&#xD;
      training program followed by 3 educational outreach and coaching visits at the healer's place&#xD;
      of practice vs. (2) a training and educational outreach initiative led by a team of health&#xD;
      care workers and healers who adopted and use PPE on their own (early adopters) to assess&#xD;
      their effects on exposure to patient blood. With an HIV prevalence among healers well above&#xD;
      that in the baseline population (30% vs. 19%) and HIV prevalence of 59% among those exposed&#xD;
      to patient blood, this study will allow the investigators to test a novel implementation&#xD;
      strategy for delivering PPE training to prevent new HIV infections among a newly identified&#xD;
      high-risk population in a region with the world's highest HIV prevalence.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In South Africa there are an estimated 200,000 traditional healers providing health services.&#xD;
      Like allopathic health care workers (HCW), traditional healers are exposed to bloodborne&#xD;
      pathogens through the widespread practice of traditional &quot;injections&quot;, where healers perform&#xD;
      dozens of subcutaneous incisions to rub herbs directly into the bloodied skin. 98 percent of&#xD;
      healers perform these treatments; they experience an average of 1,500 blood exposures over&#xD;
      the course of their lifetime. This high frequency of blood exposure, coupled with treating&#xD;
      high-risk patients, can result in an increased risk of patient-to-healer disease transmission&#xD;
      if personal protective equipment (PPE) are not used. Healers in South Africa who reported&#xD;
      patient blood touched their skin had 2.59 times higher risk of being HIV-positive than those&#xD;
      with no exposure (59% vs. 25%); overall healers have a substantially higher HIV prevalence&#xD;
      (30%) than the general population (19%).&#xD;
&#xD;
      Free PPE are made available at local health facilities, but most healers have low levels of&#xD;
      literacy, limited ability to assess blood exposure risk, and have no PPE training. Given&#xD;
      these limitations, use of PPE during treatments is inconsistent. A small proportion of&#xD;
      healers employ PPE appropriately during each treatment; these &quot;early adopter&quot; healers suggest&#xD;
      PPE use is sustainable in rural sub-Saharan Africa if a healer has the necessary skills, risk&#xD;
      assessment training, and encouragement. This proposal compares two implementation strategies&#xD;
      to increase PPE use during procedures and decrease the number of injections performed: (1)&#xD;
      HCW led education on risk of blood exposure and development of PPE donning, use and doffing&#xD;
      skills through a week-long training followed by 3 educational outreach visits at the healer's&#xD;
      place of practice vs. (2) &quot;Early adopter&quot; healer and HCW co-led week-long training followed&#xD;
      by 3 educational outreach visits. The investigators hypothesize that the strategy of engaging&#xD;
      &quot;early adopter&quot; healers as trainers will lead to more accurate participant risk assessments,&#xD;
      increase participant self-efficacy, and lead to more consistent use of PPE during treatments.&#xD;
&#xD;
      The Specific Aims of this study are to:&#xD;
&#xD;
        1. Adapt PPE training using the &quot;ADAPT-ITT&quot; model;&#xD;
&#xD;
        2. Compare fidelity of PPE training between the HCW-only team versus the healer + HCW team;&#xD;
&#xD;
        3. Compare the effects of two implementation strategies on healer exposure to patient&#xD;
           blood.&#xD;
&#xD;
      This potentially high-impact intervention is well-suited to the R21 mechanism. While some&#xD;
      allopathic providers may recommend an outright ban on the procedure, patients and healers&#xD;
      have strongly believed in the efficacy of these treatments for hundreds of years- they are&#xD;
      not likely to stop because of a Department of Health recommendation. It is up healthcare&#xD;
      workers and governments to overcome their own biases to develop an effective strategy to&#xD;
      prevent HIV seroconversion. The team of South African and U.S. investigators has a proven&#xD;
      record of HIV research success and specific experience successfully engaging traditional&#xD;
      healers, HIV prevention studies, as well as, dissemination and implementation research.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 23, 2021</start_date>
  <completion_date type="Actual">January 25, 2023</completion_date>
  <primary_completion_date type="Actual">January 25, 2023</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>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Blood Exposure</measure>
    <time_frame>7 months</time_frame>
    <description>Number of Glove Pairs Used Per Razor Blade Used</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">136</enrollment>
  <condition>HIV Infections</condition>
  <arm_group>
    <arm_group_label>Clinician Training</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Traditional healers randomized to the control arm will receive PPE education and training, general HIV prevention education and skill building (including condom use, positive prevention, and pre-/post-exposure prophylaxis services), and three educational outreach and coaching visits at the healer's place of practice to provide on-the-ground advice and support for PPE use. All training will be provided by trained medical personnel.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Healer + Clinician Training</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Traditional healers randomized to the intervention arm will receive PPE education and training, general HIV prevention education and skill building (including condom use, positive prevention, and pre-/post-exposure prophylaxis services), and three educational outreach and coaching visits at the healer's place of practice to provide on-the-ground advice and support for PPE use. All training will be provided by both healers who already use PPE regularly and trained medical personnel.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Education and Training by Clinicians</intervention_name>
    <description>Training in the use of PPE and education about the risks of blood exposure.</description>
    <arm_group_label>Clinician Training</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Training and Education from Traditional Healers and Clinicians</intervention_name>
    <description>Training in the use of PPE and education about the risks of blood exposure.</description>
    <arm_group_label>Healer + Clinician Training</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Traditional healers &gt; 18 years of age, who are registered as traditional healers with&#xD;
             the government of South Africa, are currently practicing in the Bushbuckridge area,&#xD;
             and conduct traditional vaccinations.&#xD;
&#xD;
          2. Biomedical practitioners &gt; 18 years of age, who are currently providing health care&#xD;
             services to patients at government or private health facilities in Bushbuckridge. '&#xD;
&#xD;
          3. Community members &gt; 18 years of age, who currently live in Bushbuckridge and sought&#xD;
             health care services from a traditional healer in the past year.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Traditional healers &lt;18 years of age, who are not registered as traditional healers&#xD;
             with the government of South Africa, are not currently practicing, or do not conduct&#xD;
             traditional vaccinations on their patients.&#xD;
&#xD;
          2. Biomedical practitioners &lt; 18 years of age or who are not currently providing health&#xD;
             services in the Bushbuckridge area.&#xD;
&#xD;
          3. Community members &lt; 18 years of age or who do not seek health care services from&#xD;
             traditional healers.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Carolyn M Audet, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Vanderbilt University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Ludlow</name>
      <address>
        <city>Ludlow</city>
        <state>MPM</state>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>South Africa</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>June 17, 2020</study_first_submitted>
  <study_first_submitted_qc>June 17, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 22, 2020</study_first_posted>
  <results_first_submitted>February 1, 2023</results_first_submitted>
  <results_first_submitted_qc>February 27, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">March 22, 2023</results_first_posted>
  <last_update_submitted>February 27, 2023</last_update_submitted>
  <last_update_submitted_qc>February 27, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 22, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Vanderbilt University Medical Center</investigator_affiliation>
    <investigator_full_name>Carolyn Audet</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <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>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>May 28, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/13/NCT04440813/Prot_SAP_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>February 7, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/13/NCT04440813/ICF_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Clinician Training</title>
          <description>Traditional healers randomized to the control arm will receive PPE education and training, general HIV prevention education and skill building (including condom use, positive prevention, and pre-/post-exposure prophylaxis services), and three educational outreach and coaching visits at the healer's place of practice to provide on-the-ground advice and support for PPE use. All training will be provided by trained medical personnel.&#xD;
Education and Training by Clinicians: Training in the use of PPE and education about the risks of blood exposure.</description>
        </group>
        <group group_id="P2">
          <title>Healer + Clinician Training</title>
          <description>Traditional healers randomized to the intervention arm will receive PPE education and training, general HIV prevention education and skill building (including condom use, positive prevention, and pre-/post-exposure prophylaxis services), and three educational outreach and coaching visits at the healer's place of practice to provide on-the-ground advice and support for PPE use. All training will be provided by both healers who already use PPE regularly and trained medical personnel.&#xD;
Training and Education from Traditional Healers and Clinicians: Training in the use of PPE and education about the risks of blood exposure.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="69"/>
                <participants group_id="P2" count="67"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="64"/>
                <participants group_id="P2" count="62"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="5"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="5"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Clinician Training</title>
          <description>Traditional healers randomized to the control arm will receive PPE education and training, general HIV prevention education and skill building (including condom use, positive prevention, and pre-/post-exposure prophylaxis services), and three educational outreach and coaching visits at the healer's place of practice to provide on-the-ground advice and support for PPE use. All training will be provided by trained medical personnel.&#xD;
Education and Training by Clinicians: Training in the use of PPE and education about the risks of blood exposure.</description>
        </group>
        <group group_id="B2">
          <title>Healer + Clinician Training</title>
          <description>Traditional healers randomized to the intervention arm will receive PPE education and training, general HIV prevention education and skill building (including condom use, positive prevention, and pre-/post-exposure prophylaxis services), and three educational outreach and coaching visits at the healer's place of practice to provide on-the-ground advice and support for PPE use. All training will be provided by both healers who already use PPE regularly and trained medical personnel.&#xD;
Training and Education from Traditional Healers and Clinicians: Training in the use of PPE and education about the risks of blood exposure.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="69"/>
            <count group_id="B2" value="67"/>
            <count group_id="B3" value="136"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="49.1" spread="12.64"/>
                    <measurement group_id="B2" value="53" spread="14.18"/>
                    <measurement group_id="B3" value="51.0" spread="13.51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="57"/>
                    <measurement group_id="B2" value="53"/>
                    <measurement group_id="B3" value="110"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="69"/>
                    <measurement group_id="B2" value="67"/>
                    <measurement group_id="B3" value="136"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>South Africa</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="69"/>
                    <measurement group_id="B2" value="67"/>
                    <measurement group_id="B3" value="136"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>HIV knowledge- HIV is caused by curse</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Answered correctly</title>
                  <measurement_list>
                    <measurement group_id="B1" value="42"/>
                    <measurement group_id="B2" value="38"/>
                    <measurement group_id="B3" value="80"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Answered incorrectly</title>
                  <measurement_list>
                    <measurement group_id="B1" value="27"/>
                    <measurement group_id="B2" value="29"/>
                    <measurement group_id="B3" value="56"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Blood Exposure</title>
        <description>Number of Glove Pairs Used Per Razor Blade Used</description>
        <time_frame>7 months</time_frame>
        <population>Some of the traditional healers did not conduct any traditional vaccinations during the study period, thus our numbers are smaller than the total number of participants</population>
        <group_list>
          <group group_id="O1">
            <title>Clinician Training</title>
            <description>Traditional healers randomized to the control arm will receive PPE education and training, general HIV prevention education and skill building (including condom use, positive prevention, and pre-/post-exposure prophylaxis services), and three educational outreach and coaching visits at the healer's place of practice to provide on-the-ground advice and support for PPE use. All training will be provided by trained medical personnel.&#xD;
Education and Training by Clinicians: Training in the use of PPE and education about the risks of blood exposure.</description>
          </group>
          <group group_id="O2">
            <title>Healer + Clinician Training</title>
            <description>Traditional healers randomized to the intervention arm will receive PPE education and training, general HIV prevention education and skill building (including condom use, positive prevention, and pre-/post-exposure prophylaxis services), and three educational outreach and coaching visits at the healer's place of practice to provide on-the-ground advice and support for PPE use. All training will be provided by both healers who already use PPE regularly and trained medical personnel.&#xD;
Training and Education from Traditional Healers and Clinicians: Training in the use of PPE and education about the risks of blood exposure.</description>
          </group>
        </group_list>
        <measure>
          <title>Blood Exposure</title>
          <description>Number of Glove Pairs Used Per Razor Blade Used</description>
          <population>Some of the traditional healers did not conduct any traditional vaccinations during the study period, thus our numbers are smaller than the total number of participants</population>
          <units>Number of Glove Pairs Used Per Razor Bla</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="53"/>
                <count group_id="O2" value="60"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.9" spread="0.79"/>
                    <measurement group_id="O2" value="1.9" spread="0.73"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>7 months</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Clinician Training</title>
          <description>Traditional healers randomized to the control arm will receive PPE education and training, general HIV prevention education and skill building (including condom use, positive prevention, and pre-/post-exposure prophylaxis services), and three educational outreach and coaching visits at the healer's place of practice to provide on-the-ground advice and support for PPE use. All training will be provided by trained medical personnel.&#xD;
Education and Training by Clinicians: Training in the use of PPE and education about the risks of blood exposure.</description>
        </group>
        <group group_id="E2">
          <title>Healer + Clinician Training</title>
          <description>Traditional healers randomized to the intervention arm will receive PPE education and training, general HIV prevention education and skill building (including condom use, positive prevention, and pre-/post-exposure prophylaxis services), and three educational outreach and coaching visits at the healer's place of practice to provide on-the-ground advice and support for PPE use. All training will be provided by both healers who already use PPE regularly and trained medical personnel.&#xD;
Training and Education from Traditional Healers and Clinicians: Training in the use of PPE and education about the risks of blood exposure.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="67"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="67"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="67"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Carolyn Audet</name_or_title>
      <organization>Vanderbilt University Medical Center</organization>
      <phone>615-343-2418</phone>
      <email>carolyn.m.audet@vumc.org</email>
    </point_of_contact>
  </clinical_results>
</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/NCT04440813
org study id: R21AI150302
secondary id: R21AI150302-01
nct id: NCT04440813
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Traditional healers, community-based partners with the national health system of South
      Africa, are exposed to patient blood an average of 1,500 times during their careers due to
      the practice of delivering herbal remedies via herbs rubbed into dozens of sub-cutaneous
      cuts. The purpose of this proposal is to compare two implementation strategies to increase
      consistent use of Personal Protective Equipment (PPE): (1) a health care worker provided
      training program followed by 3 educational outreach and coaching visits at the healer's place
      of practice vs. (2) a training and educational outreach initiative led by a team of health
      care workers and healers who adopted and use PPE on their own (early adopters) to assess
      their effects on exposure to patient blood. With an HIV prevalence among healers well above
      that in the baseline population (30% vs. 19%) and HIV prevalence of 59% among those exposed
      to patient blood, this study will allow the investigators to test a novel implementation
      strategy for delivering PPE training to prevent new HIV infections among a newly identified
      high-risk population in a region with the world's highest HIV prevalence.
In South Africa there are an estimated 200,000 traditional healers providing health services.
      Like allopathic health care workers (HCW), traditional healers are exposed to bloodborne
      pathogens through the widespread practice of traditional "injections", where healers perform
      dozens of subcutaneous incisions to rub herbs directly into the bloodied skin. 98 percent of
      healers perform these treatments; they experience an average of 1,500 blood exposures over
      the course of their lifetime. This high frequency of blood exposure, coupled with treating
      high-risk patients, can result in an increased risk of patient-to-healer disease transmission
      if personal protective equipment (PPE) are not used. Healers in South Africa who reported
      patient blood touched their skin had 2.59 times higher risk of being HIV-positive than those
      with no exposure (59% vs. 25%); overall healers have a substantially higher HIV prevalence
      (30%) than the general population (19%).

      Free PPE are made available at local health facilities, but most healers have low levels of
      literacy, limited ability to assess blood exposure risk, and have no PPE training. Given
      these limitations, use of PPE during treatments is inconsistent. A small proportion of
      healers employ PPE appropriately during each treatment; these "early adopter" healers suggest
      PPE use is sustainable in rural sub-Saharan Africa if a healer has the necessary skills, risk
      assessment training, and encouragement. This proposal compares two implementation strategies
      to increase PPE use during procedures and decrease the number of injections performed: (1)
      HCW led education on risk of blood exposure and development of PPE donning, use and doffing
      skills through a week-long training followed by 3 educational outreach visits at the healer's
      place of practice vs. (2) "Early adopter" healer and HCW co-led week-long training followed
      by 3 educational outreach visits. The investigators hypothesize that the strategy of engaging
      "early adopter" healers as trainers will lead to more accurate participant risk assessments,
      increase participant self-efficacy, and lead to more consistent use of PPE during treatments.

      The Specific Aims of this study are to:

        1. Adapt PPE training using the "ADAPT-ITT" model;

        2. Compare fidelity of PPE training between the HCW-only team versus the healer + HCW team;

        3. Compare the effects of two implementation strategies on healer exposure to patient
           blood.

      This potentially high-impact intervention is well-suited to the R21 mechanism. While some
      allopathic providers may recommend an outright ban on the procedure, patients and healers
      have strongly believed in the efficacy of these treatments for hundreds of years- they are
      not likely to stop because of a Department of Health recommendation. It is up healthcare
      workers and governments to overcome their own biases to develop an effective strategy to
      prevent HIV seroconversion. The team of South African and U.S. investigators has a proven
      record of HIV research success and specific experience successfully engaging traditional
      healers, HIV prevention studies, as well as, dissemination and implementation research.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Blood Exposure
time frame: 7 months
description: Number of Glove Pairs Used Per Razor Blade Used
arm group label: Clinician Training
arm group type: Active Comparator
description: Traditional healers randomized to the control arm will receive PPE education and training, general HIV prevention education and skill building (including condom use, positive prevention, and pre-/post-exposure prophylaxis services), and three educational outreach and coaching visits at the healer's place of practice to provide on-the-ground advice and support for PPE use. All training will be provided by trained medical personnel.
arm group label: Healer + Clinician Training
arm group type: Experimental
description: Traditional healers randomized to the intervention arm will receive PPE education and training, general HIV prevention education and skill building (including condom use, positive prevention, and pre-/post-exposure prophylaxis services), and three educational outreach and coaching visits at the healer's place of practice to provide on-the-ground advice and support for PPE use. All training will be provided by both healers who already use PPE regularly and trained medical personnel.
intervention type: Behavioral
intervention name: Education and Training by Clinicians
description: Training in the use of PPE and education about the risks of blood exposure.
arm group label: Clinician Training
intervention type: Behavioral
intervention name: Training and Education from Traditional Healers and Clinicians
description: Training in the use of PPE and education about the risks of blood exposure.
arm group label: Healer + Clinician Training
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Carolyn M Audet, PhD
role: Principal Investigator
affiliation: Vanderbilt University
facility: 
country: South Africa
responsible party type: Principal Investigator
investigator affiliation: Vanderbilt University Medical Center
investigator full name: Carolyn Audet
investigator title: Assistant Professor
mesh term: HIV Infections
sharing ipd: No
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 