<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/NCT02223390</url>
  </required_header>
  <id_info>
    <org_study_id>C147</org_study_id>
    <secondary_id>R34MH102001</secondary_id>
    <nct_id>NCT02223390</nct_id>
  </id_info>
  <brief_title>Improving the Health of South African Women With Traumatic Stress in HIV Care</brief_title>
  <acronym>ImpACT</acronym>
  <official_title>Improving the Health of South African Women With Traumatic Stress in HIV Care</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Duke University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of Mental Health (NIMH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Cape Town</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Duke University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      In this study, the investigators propose to develop Improving AIDS Care after Trauma&#xD;
      (ImpACT), an intervention based on theories of stress and coping and evidence-based treatment&#xD;
      for traumatic stress. The intervention will target women in South Africa who have histories&#xD;
      of sexual trauma and are newly initiating antiretroviral therapy (ART) in order to reduce&#xD;
      avoidant coping and traumatic stress, improve care engagement, and reduce HIV risk behaviors.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      HIV-infected women in South Africa report high rates of sexual trauma, which negatively&#xD;
      impacts their mental health and potentially influences engagement in HIV care (retention in&#xD;
      care and adherence to antiretroviral therapy) and risk behaviors. Addressing the traumatic&#xD;
      stress resulting from sexual trauma could improve these HIV-related outcomes, which in turn&#xD;
      may prevent HIV transmission through suppression of the virus and reduction in HIV risk&#xD;
      behaviors. Intervention research among HIV-infected populations with trauma histories in the&#xD;
      U.S. demonstrates that a coping approach, particularly one that reduces the use of avoidant&#xD;
      coping strategies, is efficacious in reducing traumatic stress and improving health&#xD;
      behaviors. Although South Africa faces dual epidemics of HIV and sexual violence, trauma&#xD;
      treatment has not been well-integrated into the HIV care setting. The proposed 3-year study&#xD;
      will develop and pilot test an intervention called ImpACT (Improving AIDS Care after Trauma)&#xD;
      to reduce avoidant coping, traumatic stress, and risk behaviors, and increase engagement in&#xD;
      care. The intervention will take place in a public ART clinic and will target women during&#xD;
      the critical period when they initiate ART in order to maximize the impact on engagement in&#xD;
      care. Qualitative data collection with staff, providers, and HIV-infected female patients at&#xD;
      the study clinic will elicit feedback on the content and delivery of ImpACT and key aspects&#xD;
      of the study protocol. ImpACT will then be piloted with 60 women who are new ART enrollees&#xD;
      with a history of sexual trauma and elevated traumatic stress. Participants will be&#xD;
      randomized to the control condition (standard of care, or SoC: 3 adherence counseling&#xD;
      sessions required of all patients initiating ART at the clinic) or the intervention condition&#xD;
      (SoC + ImpACT), and will complete assessments at baseline, 3, and 6 months&#xD;
      post-randomization, with care engagement data extracted from medical records at the end of&#xD;
      the study period. The study has three specific aims: 1) to develop a brief and scalable&#xD;
      coping intervention for delivery in the South African HIV care setting for women with sexual&#xD;
      trauma histories; 2) to establish the methodological details of an experimental protocol for&#xD;
      a robust randomized control trial; and 3) to pilot test the ImpACT intervention with 60&#xD;
      HIV-infected women with histories of sexual trauma who are initiating ART in order to&#xD;
      determine feasibility and acceptability in the HIV care setting, and explore the impact on&#xD;
      avoidant coping, traumatic stress, engagement in care, and HIV risk behaviors. The goal at&#xD;
      the completion of this study is to have a structured intervention curriculum that is&#xD;
      culturally relevant for HIV infected women in South Africa, a full experimental protocol that&#xD;
      is appropriate for the South African care setting, and data on feasibility, acceptability,&#xD;
      and target outcomes. These products can be leveraged to inform an R01 application for&#xD;
      rigorous evaluation of the ImpACT intervention. We are confident that this developmental work&#xD;
      will significantly enhance the probability of success of a larger randomized control trial.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>March 2016</start_date>
  <completion_date type="Actual">July 2017</completion_date>
  <primary_completion_date type="Actual">July 2017</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>PTSD Symptoms</measure>
    <time_frame>90 Days, 180 days</time_frame>
    <description>Self-report, measured by the PTSD checklist, civilian version (PCL-5). 20-item self-report questionnaire, assessed severity of symptoms that parallel the DSM-5 (Diagnostic and Statistical Manual of Mental Disorders) diagnostic criteria for PTSD. Participants were asked to indicate the extent to which they were bothered by problems experienced in the past month in relation to a traumatic experience of abuse or act of violence (0 = not at all to 4 = extremely). Total severity score (range: 0-80; higher scores indicating higher symptom severity, &gt;= 33 indicating PTSD) and subscale totals (Avoidance - Cluster C, range: 0-8, higher scores indicating higher avoidance symptom severity; and Hyperarousal - Cluster E, range: 0-24, higher scores indicating higher hyperarousal symptom severity) were examined.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>HIV Medication Adherence (% Adherent)</measure>
    <time_frame>180 days</time_frame>
    <description>Assessed through biomarkers of dried blood spots (DBS) testing for presence of antiretroviral therapy (ART) (tenofovir, emtricitabine, and efavirenz) at 6 month assessment, supplemented by viral load (VL; considered adherent if VL &lt;=40 copies/ml) when DBS unavailable. Outcome dichotomized.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">64</enrollment>
  <condition>HIV</condition>
  <condition>Trauma Exposure</condition>
  <arm_group>
    <arm_group_label>Mental health treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The experimental condition, ImpACT, was developed in the pilot phase of the study. The intervention will be 4 sessions of individual psychological treatment related to stress, coping, and HIV adherence, followed by three group sessions. Sessions will follow an intervention manual and be delivered by a psychiatric nurse (or equivalent nonspecialist in mental health) who is supervised by a trained clinical psychologist.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard of Care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants in standard of care will receive the three-session adherence counseling delivered in the clinic, along with referrals for trauma treatment.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Improving AIDS Care after Trauma (ImpACT)</intervention_name>
    <arm_group_label>Mental health treatment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  HIV infected women who are newly initiating ART at the study clinic&#xD;
&#xD;
          -  History of sexual trauma&#xD;
&#xD;
          -  Meets criteria for traumatic stress&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Immediate suicide risk&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kathleen Sikkema, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Duke University (Currently at Columbia University)</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Cape Town</name>
      <address>
        <city>Cape Town</city>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>South Africa</country>
  </location_countries>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>August 20, 2014</study_first_submitted>
  <study_first_submitted_qc>August 21, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 22, 2014</study_first_posted>
  <results_first_submitted>August 23, 2018</results_first_submitted>
  <results_first_submitted_qc>September 28, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">October 24, 2018</results_first_posted>
  <last_update_submitted>November 6, 2020</last_update_submitted>
  <last_update_submitted_qc>November 6, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 23, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Duke University</investigator_affiliation>
    <investigator_full_name>Kathleen Sikkema</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>South Africa</keyword>
  <keyword>HIV</keyword>
  <keyword>Mental health</keyword>
  <keyword>Trauma</keyword>
  <keyword>Women</keyword>
  <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>October 16, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/90/NCT02223390/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Mental Health Treatment</title>
          <description>The experimental condition, ImpACT, was developed in the pilot phase of the study. The intervention will be 4 sessions of individual psychological treatment related to stress, coping, and HIV adherence, followed by three group sessions. Sessions will follow an intervention manual and be delivered by a psychiatric nurse (or equivalent nonspecialist in mental health) who is supervised by a trained clinical psychologist.&#xD;
Improving AIDS Care after Trauma (ImpACT)</description>
        </group>
        <group group_id="P2">
          <title>Standard of Care</title>
          <description>Participants in standard of care will receive the three-session adherence counseling delivered in the clinic, along with referrals for trauma treatment.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="32"/>
                <participants group_id="P2" count="32"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="23"/>
                <participants group_id="P2" count="28"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="4"/>
              </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="9"/>
                <participants group_id="P2" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Mental Health Treatment</title>
          <description>The experimental condition, ImpACT, was developed in the pilot phase of the study. The intervention will be 4 sessions of individual psychological treatment related to stress, coping, and HIV adherence, followed by three group sessions. Sessions will follow an intervention manual and be delivered by a psychiatric nurse (or equivalent nonspecialist in mental health) who is supervised by a trained clinical psychologist.&#xD;
Improving AIDS Care after Trauma (ImpACT)</description>
        </group>
        <group group_id="B2">
          <title>Standard of Care</title>
          <description>Participants in standard of care will receive the three-session adherence counseling delivered in the clinic, along with referrals for trauma treatment.</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="32"/>
            <count group_id="B2" value="32"/>
            <count group_id="B3" value="64"/>
          </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="29.2" spread="6.6"/>
                    <measurement group_id="B2" value="29.0" spread="8.4"/>
                    <measurement group_id="B3" value="29.1" spread="7.5"/>
                  </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="32"/>
                    <measurement group_id="B2" value="32"/>
                    <measurement group_id="B3" value="64"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</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>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="32"/>
                    <measurement group_id="B2" value="32"/>
                    <measurement group_id="B3" value="64"/>
                  </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="32"/>
                    <measurement group_id="B2" value="32"/>
                    <measurement group_id="B3" value="64"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>PTSD Symptoms (PCL-5)</title>
          <description>Self-report, measured by the PTSD checklist, civilian version (PCL-5). 20-item self-report questionnaire. Participants were asked to indicate the extent to which they were bothered by problems experienced in the past month in relation to a traumatic experience of abuse or act of violence (0 = not at all to 4 = extremely). Total severity score (range: 0-80; higher scores indicating higher symptom severity, &gt;= 33 indicating PTSD) and subscale totals (Avoidance - Cluster C, range: 0-8; and Hyperarousal - Cluster E, range: 0-24) were examined.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <title>PCL - total symptom severity score</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="43.28" spread="21.94"/>
                    <measurement group_id="B2" value="30.72" spread="20.27"/>
                    <measurement group_id="B3" value="37.00" spread="21.89"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PCL - Cluster C Avoidance</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4.53" spread="2.93"/>
                    <measurement group_id="B2" value="3.03" spread="2.62"/>
                    <measurement group_id="B3" value="3.78" spread="2.86"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PCL - Cluster E Arousal</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="12.88" spread="7.25"/>
                    <measurement group_id="B2" value="8.31" spread="6.34"/>
                    <measurement group_id="B3" value="10.59" spread="7.15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>PTSD Symptoms</title>
        <description>Self-report, measured by the PTSD checklist, civilian version (PCL-5). 20-item self-report questionnaire, assessed severity of symptoms that parallel the DSM-5 (Diagnostic and Statistical Manual of Mental Disorders) diagnostic criteria for PTSD. Participants were asked to indicate the extent to which they were bothered by problems experienced in the past month in relation to a traumatic experience of abuse or act of violence (0 = not at all to 4 = extremely). Total severity score (range: 0-80; higher scores indicating higher symptom severity, &gt;= 33 indicating PTSD) and subscale totals (Avoidance - Cluster C, range: 0-8, higher scores indicating higher avoidance symptom severity; and Hyperarousal - Cluster E, range: 0-24, higher scores indicating higher hyperarousal symptom severity) were examined.</description>
        <time_frame>90 Days, 180 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Mental Health Treatment</title>
            <description>The experimental condition, ImpACT, was developed in the pilot phase of the study. The intervention will be 4 sessions of individual psychological treatment related to stress, coping, and HIV adherence, followed by three group sessions. Sessions will follow an intervention manual and be delivered by a psychiatric nurse (or equivalent nonspecialist in mental health) who is supervised by a trained clinical psychologist.&#xD;
Improving AIDS Care after Trauma (ImpACT)</description>
          </group>
          <group group_id="O2">
            <title>Standard of Care</title>
            <description>Participants in standard of care will receive the three-session adherence counseling delivered in the clinic, along with referrals for trauma treatment.</description>
          </group>
        </group_list>
        <measure>
          <title>PTSD Symptoms</title>
          <description>Self-report, measured by the PTSD checklist, civilian version (PCL-5). 20-item self-report questionnaire, assessed severity of symptoms that parallel the DSM-5 (Diagnostic and Statistical Manual of Mental Disorders) diagnostic criteria for PTSD. Participants were asked to indicate the extent to which they were bothered by problems experienced in the past month in relation to a traumatic experience of abuse or act of violence (0 = not at all to 4 = extremely). Total severity score (range: 0-80; higher scores indicating higher symptom severity, &gt;= 33 indicating PTSD) and subscale totals (Avoidance - Cluster C, range: 0-8, higher scores indicating higher avoidance symptom severity; and Hyperarousal - Cluster E, range: 0-24, higher scores indicating higher hyperarousal symptom severity) were examined.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="32"/>
                <count group_id="O2" value="32"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>PCL - total symptom severity (3 mos)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25.79" spread="5.40"/>
                    <measurement group_id="O2" value="23.04" spread="3.60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PCL - total symptom severity (6 mos)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28.61" spread="5.04"/>
                    <measurement group_id="O2" value="22.50" spread="3.47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PCL - Cluster C Avoidance (3 mos)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.21" spread="0.63"/>
                    <measurement group_id="O2" value="2.23" spread="0.39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PCL - Cluster C Avoidance (6 mos)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.96" spread="0.60"/>
                    <measurement group_id="O2" value="2.71" spread="0.47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PCL - Cluster E Hyperarousal (3 mos)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.47" spread="1.36"/>
                    <measurement group_id="O2" value="8.00" spread="1.21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PCL - Cluster E Hyperarousal (6 mos)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.91" spread="1.54"/>
                    <measurement group_id="O2" value="6.75" spread="1.10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Statistical analyses reported below is for PCL - Total at 3 months.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>A sample size of 60 was chosen as adequate to examine the feasibility and acceptability of a pilot randomized controlled trial (RCT) with two conditions.</non_inferiority_desc>
            <p_value>0.08</p_value>
            <p_value_desc>A priori threshold for statistical significance was p&lt;.05. The p-value presented corresponds to the time by condition interaction parameter.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <method_desc>To assess changes in PTSD symptoms over time by intervention condition, linear mixed models were fit using the PROC MIXED procedure in SAS.</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>HIV Medication Adherence (% Adherent)</title>
        <description>Assessed through biomarkers of dried blood spots (DBS) testing for presence of antiretroviral therapy (ART) (tenofovir, emtricitabine, and efavirenz) at 6 month assessment, supplemented by viral load (VL; considered adherent if VL &lt;=40 copies/ml) when DBS unavailable. Outcome dichotomized.</description>
        <time_frame>180 days</time_frame>
        <population>Subset of participants newly initiating ART (excluding re-initiators and non-initiators; n=54, 49 with biomarker data)</population>
        <group_list>
          <group group_id="O1">
            <title>Mental Health Treatment</title>
            <description>The experimental condition, ImpACT, was developed in the pilot phase of the study. The intervention will be 4 sessions of individual psychological treatment related to stress, coping, and HIV adherence, followed by three group sessions. Sessions will follow an intervention manual and be delivered by a psychiatric nurse (or equivalent nonspecialist in mental health) who is supervised by a trained clinical psychologist.&#xD;
Improving AIDS Care after Trauma (ImpACT)</description>
          </group>
          <group group_id="O2">
            <title>Standard of Care</title>
            <description>Participants in standard of care will receive the three-session adherence counseling delivered in the clinic, along with referrals for trauma treatment.</description>
          </group>
        </group_list>
        <measure>
          <title>HIV Medication Adherence (% Adherent)</title>
          <description>Assessed through biomarkers of dried blood spots (DBS) testing for presence of antiretroviral therapy (ART) (tenofovir, emtricitabine, and efavirenz) at 6 month assessment, supplemented by viral load (VL; considered adherent if VL &lt;=40 copies/ml) when DBS unavailable. Outcome dichotomized.</description>
          <population>Subset of participants newly initiating ART (excluding re-initiators and non-initiators; n=54, 49 with biomarker data)</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="23"/>
                <count group_id="O2" value="26"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19"/>
                    <measurement group_id="O2" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>A sample size of 60 was chosen as adequate to examine the feasibility and acceptability of a pilot RCT with two conditions.</non_inferiority_desc>
            <p_value>0.05</p_value>
            <p_value_desc>A priori threshold was defined as p&lt;0.05.</p_value_desc>
            <method>Chi-squared</method>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>6 months</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Mental Health Treatment</title>
          <description>The experimental condition, ImpACT, was developed in the pilot phase of the study. The intervention will be 4 sessions of individual psychological treatment related to stress, coping, and HIV adherence, followed by three group sessions. Sessions will follow an intervention manual and be delivered by a psychiatric nurse (or equivalent nonspecialist in mental health) who is supervised by a trained clinical psychologist.&#xD;
Improving AIDS Care after Trauma (ImpACT)</description>
        </group>
        <group group_id="E2">
          <title>Standard of Care</title>
          <description>Participants in standard of care will receive the three-session adherence counseling delivered in the clinic, along with referrals for trauma treatment.</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="32"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="32"/>
              </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="32"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="32"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE 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>Kathleen Sikkema, PhD</name_or_title>
      <organization>Duke University (Currently at Columbia University)</organization>
      <phone>212-305-8236</phone>
      <email>ks3364@cumc.columbia.edu</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/NCT02223390
org study id: C147
secondary id: R34MH102001
nct id: NCT02223390
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
In this study, the investigators propose to develop Improving AIDS Care after Trauma
      (ImpACT), an intervention based on theories of stress and coping and evidence-based treatment
      for traumatic stress. The intervention will target women in South Africa who have histories
      of sexual trauma and are newly initiating antiretroviral therapy (ART) in order to reduce
      avoidant coping and traumatic stress, improve care engagement, and reduce HIV risk behaviors.
HIV-infected women in South Africa report high rates of sexual trauma, which negatively
      impacts their mental health and potentially influences engagement in HIV care (retention in
      care and adherence to antiretroviral therapy) and risk behaviors. Addressing the traumatic
      stress resulting from sexual trauma could improve these HIV-related outcomes, which in turn
      may prevent HIV transmission through suppression of the virus and reduction in HIV risk
      behaviors. Intervention research among HIV-infected populations with trauma histories in the
      U.S. demonstrates that a coping approach, particularly one that reduces the use of avoidant
      coping strategies, is efficacious in reducing traumatic stress and improving health
      behaviors. Although South Africa faces dual epidemics of HIV and sexual violence, trauma
      treatment has not been well-integrated into the HIV care setting. The proposed 3-year study
      will develop and pilot test an intervention called ImpACT (Improving AIDS Care after Trauma)
      to reduce avoidant coping, traumatic stress, and risk behaviors, and increase engagement in
      care. The intervention will take place in a public ART clinic and will target women during
      the critical period when they initiate ART in order to maximize the impact on engagement in
      care. Qualitative data collection with staff, providers, and HIV-infected female patients at
      the study clinic will elicit feedback on the content and delivery of ImpACT and key aspects
      of the study protocol. ImpACT will then be piloted with 60 women who are new ART enrollees
      with a history of sexual trauma and elevated traumatic stress. Participants will be
      randomized to the control condition (standard of care, or SoC: 3 adherence counseling
      sessions required of all patients initiating ART at the clinic) or the intervention condition
      (SoC + ImpACT), and will complete assessments at baseline, 3, and 6 months
      post-randomization, with care engagement data extracted from medical records at the end of
      the study period. The study has three specific aims: 1) to develop a brief and scalable
      coping intervention for delivery in the South African HIV care setting for women with sexual
      trauma histories; 2) to establish the methodological details of an experimental protocol for
      a robust randomized control trial; and 3) to pilot test the ImpACT intervention with 60
      HIV-infected women with histories of sexual trauma who are initiating ART in order to
      determine feasibility and acceptability in the HIV care setting, and explore the impact on
      avoidant coping, traumatic stress, engagement in care, and HIV risk behaviors. The goal at
      the completion of this study is to have a structured intervention curriculum that is
      culturally relevant for HIV infected women in South Africa, a full experimental protocol that
      is appropriate for the South African care setting, and data on feasibility, acceptability,
      and target outcomes. These products can be leveraged to inform an R01 application for
      rigorous evaluation of the ImpACT intervention. We are confident that this developmental work
      will significantly enhance the probability of success of a larger randomized control trial.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: PTSD Symptoms
time frame: 90 Days, 180 days
description: Self-report, measured by the PTSD checklist, civilian version (PCL-5). 20-item self-report questionnaire, assessed severity of symptoms that parallel the DSM-5 (Diagnostic and Statistical Manual of Mental Disorders) diagnostic criteria for PTSD. Participants were asked to indicate the extent to which they were bothered by problems experienced in the past month in relation to a traumatic experience of abuse or act of violence (0 = not at all to 4 = extremely). Total severity score (range: 0-80; higher scores indicating higher symptom severity, >= 33 indicating PTSD) and subscale totals (Avoidance - Cluster C, range: 0-8, higher scores indicating higher avoidance symptom severity; and Hyperarousal - Cluster E, range: 0-24, higher scores indicating higher hyperarousal symptom severity) were examined.
measure: HIV Medication Adherence (% Adherent)
time frame: 180 days
description: Assessed through biomarkers of dried blood spots (DBS) testing for presence of antiretroviral therapy (ART) (tenofovir, emtricitabine, and efavirenz) at 6 month assessment, supplemented by viral load (VL; considered adherent if VL <=40 copies/ml) when DBS unavailable. Outcome dichotomized.
arm group label: Mental health treatment
arm group type: Experimental
description: The experimental condition, ImpACT, was developed in the pilot phase of the study. The intervention will be 4 sessions of individual psychological treatment related to stress, coping, and HIV adherence, followed by three group sessions. Sessions will follow an intervention manual and be delivered by a psychiatric nurse (or equivalent nonspecialist in mental health) who is supervised by a trained clinical psychologist.
arm group label: Standard of Care
arm group type: No Intervention
description: Participants in standard of care will receive the three-session adherence counseling delivered in the clinic, along with referrals for trauma treatment.
intervention type: Behavioral
intervention name: Improving AIDS Care after Trauma (ImpACT)
arm group label: Mental health treatment
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Kathleen Sikkema, PhD
role: Principal Investigator
affiliation: Duke University (Currently at Columbia University)
facility: 
country: South Africa
responsible party type: Principal Investigator
investigator affiliation: Duke University
investigator full name: Kathleen Sikkema
investigator title: Professor
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 