xml: <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/NCT06036238</url>
    </required_header>
    <id_info>
      <org_study_id>22-37054-2</org_study_id>
      <secondary_id>1R01AA030464-01</secondary_id>
      <nct_id>NCT06036238</nct_id>
    </id_info>
    <brief_title>The Outreach and Prevention at ALcohol Venues in East Africa Study (OPAL-East Africa- Aim 2) (OPAL-Aim 2)</brief_title>
    <acronym>OPAL-Aim 2</acronym>
    <official_title>Innovative Strategies to Promote Biomedical HIV Prevention Uptake and Retention Among High-risk Adults at Drinking Venues in Kenya and Uganda</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of California, San Francisco</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>University of California, Berkeley</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Makerere University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Infectious Diseases Research Collaboration, Uganda</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Kenya Medical Research Institute</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>National Institute on Alcohol Abuse and Alcoholism (NIAAA)</agency>
        <agency_class>NIH</agency_class>
      </collaborator>
    </sponsors>
    <source>University of California, San Francisco</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>
        This study will evaluate the effect of a brief alcohol counseling intervention on PrEP and&#xD;
        PEP adherence among adults with heavy alcohol use at high risk for HIV, while gaining&#xD;
        insights into the facilitators, barriers, and cost-effectiveness of this approach.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        We have developed a mobilization strategy of integrating HIV testing within multi-disease&#xD;
        screening to recruit &gt;2,000 people from drinking venues in Kenya and Uganda and invite them&#xD;
        to begin biomedical HIV prevention if eligible (OPAL Aim 1; NCT05862857)&#xD;
  &#xD;
        Following uptake of biomedical HIV prevention, persons with heavy alcohol use face challenges&#xD;
        with retention in care and adherence to PrEP/PEP. We have adapted a brief alcohol counseling&#xD;
        intervention (Health Living Intervention) to reduce alcohol use and promote antiretroviral&#xD;
        therapy (ART) adherence and HIV viral suppression among persons with HIV in Kenya and Uganda.&#xD;
        We now need to determine whether this intervention can promote retention in biomedical&#xD;
        prevention and PrEP/PEP adherence among adults with heavy alcohol use.&#xD;
  &#xD;
        Specific Aims:&#xD;
  &#xD;
          -  Determine the efficacy of the Healthy Living Intervention (HLI) to reduce heavy alcohol&#xD;
             use vs. standard care (control) on retention in biomedical HIV prevention in a&#xD;
             randomized trial among adults with heavy alcohol use.&#xD;
  &#xD;
          -  Determine the cost-effectiveness of interventions that increase biomedical HIV&#xD;
             prevention retention among adults at high-risk for HIV who attend drinking venues.&#xD;
  &#xD;
        The proposed research will address the critical intersection of alcohol use and HIV risk in&#xD;
        SSA, by promoting retention of biomedical HIV prevention and exploring associated&#xD;
        facilitators and barriers.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">May 2024</start_date>
    <completion_date type="Anticipated">May 2026</completion_date>
    <primary_completion_date type="Anticipated">May 2026</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>Biomedical HIV Prevention coverage</measure>
      <time_frame>Measured 48 weeks after PrEP or PEP initiation</time_frame>
      <description>The proportion of time during the 48 weeks after PrEP/PEP initiation that a person is protected from HIV with PrEP/PEP, assessed by prescription refill data. Prescription refill data will be collected from MoH medical and pharmacy records, augmented by OPAL case report forms. Secondary analysis of the primary outcome will integrate drug levels measured in hair samples collected at 48 weeks.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Alcohol use</measure>
      <time_frame>Measured 48 weeks after PrEP or PEP initiation</time_frame>
      <description>Study staff will assess AUDIT-C scores (modified to refer to the prior 3 months) with a standard drink guide adapted to local context at baseline and every 12-weeks post-baseline. Blood will also be collected, and dried blood spots prepared for phosphatidylethanol (PEth) testing at baseline and 48-weeks for confirmation of self-reported alcohol use.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>HIV seroconversion</measure>
      <time_frame>Measured 48 weeks after PrEP or PEP initiation</time_frame>
      <description>HIV seroconversion will be measured as documented rapid HIV antibody test positivity with Geenius confirmation or documented detectable HIV viral load, with rapid HIV testing. HIV testing will occur at PrEP refill and injection visits, or completion of a course of PEP.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">400</enrollment>
    <condition>HIV/AIDS</condition>
    <arm_group>
      <arm_group_label>Standard of Care (Control)</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Standard of care; alcohol counseling per Ministry of Health (MoH) guidelines</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Healthy Living Intervention</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Healthy Living Intervention in-person alcohol counseling with booster phone calls</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Healthy Living Intervention (HLI)</intervention_name>
      <description>The Healthy Living Intervention (HLI) is a brief alcohol counseling intervention developed using the Information, Motivation, and Behavioral skills (IMB) model, a framework in which information, motivation, and behavioral skills are key determinants of health behavior. Participants initiating PrEP will be randomized to either HLI or standard of care alcohol counseling.</description>
      <arm_group_label>Healthy Living Intervention</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Standard of Care</intervention_name>
      <description>Participants who are randomized to the control arm will receive basic alcohol counseling through the Ministry of Health if it is provided as standard of care.</description>
      <arm_group_label>Standard of Care (Control)</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Adult (≥18 years)&#xD;
  &#xD;
            -  HIV-uninfected (by rapid HIV antibody test)&#xD;
  &#xD;
            -  AUDIT-C score of &gt;=4 for men and &gt;=3 for women&#xD;
  &#xD;
            -  Attending a clinical visit for initiation of biomedical HIV prevention with oral or&#xD;
               injectable PrEP or oral PEP (or the dapivirine vaginal ring, if available)&#xD;
  &#xD;
            -  Has access to a mobile phone&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Ineligible for PrEP based on MoH guidelines&#xD;
  &#xD;
            -  Intention to move away from the study community in the coming year&#xD;
  &#xD;
            -  Gross inebriation or inability to provide informed consent&#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>Gabriel Chamie, MD, MPH</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of California, San Francisco</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Kara Marson, MPH</last_name>
      <phone>650-346-5774</phone>
      <email>kara.marson@ucsf.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Gabriel Chamie, MD, MPH</last_name>
      <email>gabriel.chamie@ucsf.edu</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Kenya Medical Research Institute (KEMRI)</name>
        <address>
          <city>Mbita</city>
          <country>Kenya</country>
        </address>
      </facility>
      <contact>
        <last_name>Jaqui Mwango</last_name>
        <email>jabermwango@gmail.com</email>
      </contact>
      <investigator>
        <last_name>James Ayieko, MBChB, MPH, PhD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Infectious Diseases Research Collaboration (IDRC)</name>
        <address>
          <city>Mbarara</city>
          <country>Uganda</country>
        </address>
      </facility>
      <contact>
        <last_name>Brian Beesiga, MBChB</last_name>
        <phone>+256 (0) 312 281 479</phone>
        <email>bbeesiga@idrc-uganda.org</email>
      </contact>
      <investigator>
        <last_name>Moses R Kamya, MBChB, MMed, PhD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Kenya</country>
      <country>Uganda</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 6, 2023</study_first_submitted>
    <study_first_submitted_qc>September 6, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 6, 2023</last_update_submitted>
    <last_update_submitted_qc>September 6, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Alcohol use</keyword>
    <keyword>Biomedical HIV prevention</keyword>
    <keyword>Uganda</keyword>
    <keyword>Kenya</keyword>
    <keyword>Counseling intervention</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Acquired Immunodeficiency Syndrome</mesh_term>
      <mesh_term>HIV Infections</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>Per our Data Sharing agreement with the NIAAA Data Archive, we will share de-identified IPD from our baseline questionnaire, which includes questions about subject demographics, HIV risk, and alcohol use.</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_time_frame>Data requests can be submitted starting 3 months after article publication and the data will be made accessible for up to 36 months. Extensions will be considered on a case-by-case basis.</ipd_time_frame>
      <ipd_access_criteria>Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP).</ipd_access_criteria>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06036238
  org study id: 22-37054-2
  secondary id: 1R01AA030464-01
  nct id: NCT06036238
  lead sponsor: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This study will evaluate the effect of a brief alcohol counseling intervention on PrEP and
        PEP adherence among adults with heavy alcohol use at high risk for HIV, while gaining
        insights into the facilitators, barriers, and cost-effectiveness of this approach.
  We have developed a mobilization strategy of integrating HIV testing within multi-disease
        screening to recruit >2,000 people from drinking venues in Kenya and Uganda and invite them
        to begin biomedical HIV prevention if eligible (OPAL Aim 1; NCT05862857)
  
        Following uptake of biomedical HIV prevention, persons with heavy alcohol use face challenges
        with retention in care and adherence to PrEP/PEP. We have adapted a brief alcohol counseling
        intervention (Health Living Intervention) to reduce alcohol use and promote antiretroviral
        therapy (ART) adherence and HIV viral suppression among persons with HIV in Kenya and Uganda.
        We now need to determine whether this intervention can promote retention in biomedical
        prevention and PrEP/PEP adherence among adults with heavy alcohol use.
  
        Specific Aims:
  
          -  Determine the efficacy of the Healthy Living Intervention (HLI) to reduce heavy alcohol
             use vs. standard care (control) on retention in biomedical HIV prevention in a
             randomized trial among adults with heavy alcohol use.
  
          -  Determine the cost-effectiveness of interventions that increase biomedical HIV
             prevention retention among adults at high-risk for HIV who attend drinking venues.
  
        The proposed research will address the critical intersection of alcohol use and HIV risk in
        SSA, by promoting retention of biomedical HIV prevention and exploring associated
        facilitators and barriers.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Prevention
  masking: None (Open Label)
  measure: Biomedical HIV Prevention coverage
  time frame: Measured 48 weeks after PrEP or PEP initiation
  description: The proportion of time during the 48 weeks after PrEP/PEP initiation that a person is protected from HIV with PrEP/PEP, assessed by prescription refill data. Prescription refill data will be collected from MoH medical and pharmacy records, augmented by OPAL case report forms. Secondary analysis of the primary outcome will integrate drug levels measured in hair samples collected at 48 weeks.
  measure: Alcohol use
  time frame: Measured 48 weeks after PrEP or PEP initiation
  description: Study staff will assess AUDIT-C scores (modified to refer to the prior 3 months) with a standard drink guide adapted to local context at baseline and every 12-weeks post-baseline. Blood will also be collected, and dried blood spots prepared for phosphatidylethanol (PEth) testing at baseline and 48-weeks for confirmation of self-reported alcohol use.
  measure: HIV seroconversion
  time frame: Measured 48 weeks after PrEP or PEP initiation
  description: HIV seroconversion will be measured as documented rapid HIV antibody test positivity with Geenius confirmation or documented detectable HIV viral load, with rapid HIV testing. HIV testing will occur at PrEP refill and injection visits, or completion of a course of PEP.
  arm group label: Standard of Care (Control)
  arm group type: Active Comparator
  description: Standard of care; alcohol counseling per Ministry of Health (MoH) guidelines
  arm group label: Healthy Living Intervention
  arm group type: Experimental
  description: Healthy Living Intervention in-person alcohol counseling with booster phone calls
  intervention type: Behavioral
  intervention name: Healthy Living Intervention (HLI)
  description: The Healthy Living Intervention (HLI) is a brief alcohol counseling intervention developed using the Information, Motivation, and Behavioral skills (IMB) model, a framework in which information, motivation, and behavioral skills are key determinants of health behavior. Participants initiating PrEP will be randomized to either HLI or standard of care alcohol counseling.
  arm group label: Healthy Living Intervention
  intervention type: Behavioral
  intervention name: Standard of Care
  description: Participants who are randomized to the control arm will receive basic alcohol counseling through the Ministry of Health if it is provided as standard of care.
  arm group label: Standard of Care (Control)
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Gabriel Chamie, MD, MPH
  role: Principal Investigator
  affiliation: University of California, San Francisco
  last name: Kara Marson, MPH
  phone: 650-346-5774
  email: kara.marson@ucsf.edu
  last name: Gabriel Chamie, MD, MPH
  email: gabriel.chamie@ucsf.edu
  facility: 
  contact: 
  investigator: 
  facility: 
  contact: 
  investigator: 
  country: Kenya
  country: Uganda
  responsible party type: Sponsor
  mesh term: Acquired Immunodeficiency Syndrome
  mesh term: HIV Infections
  sharing ipd: Yes
  ipd description: Per our Data Sharing agreement with the NIAAA Data Archive, we will share de-identified IPD from our baseline questionnaire, which includes questions about subject demographics, HIV risk, and alcohol use.
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd time frame: Data requests can be submitted starting 3 months after article publication and the data will be made accessible for up to 36 months. Extensions will be considered on a case-by-case basis.
  ipd access criteria: Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP).