<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/NCT01671501</url>
  </required_header>
  <id_info>
    <org_study_id>P0048609_Satre</org_study_id>
    <nct_id>NCT01671501</nct_id>
  </id_info>
  <brief_title>Primary Care-Based Interventions to Reduce Alcohol Use Among HIV Patients</brief_title>
  <official_title>Primary Care-Based Interventions to Reduce Alcohol Use Among HIV Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, San Francisco</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Kaiser Foundation Research Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of California, San Francisco</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This randomized clinical trial uses a health plan's electronic medical record (EMR) alcohol&#xD;
      screen; and examines innovative behavioral interventions, and their cost effectiveness, for&#xD;
      hazardous drinking within a large HIV primary care clinic. We will compare Motivational&#xD;
      Interviewing (MI) and Email Feedback (EF) to usual care; and evaluate the effect of the&#xD;
      interventions on unhealthy drinking, comorbid drug use, enrollment in substance use treatment&#xD;
      programs, and HIV outcomes including antiretroviral therapy adherence, HIV RNA control, and&#xD;
      unsafe sex. Given the well-known adverse effects of unhealthy drinking on HIV care and&#xD;
      outcomes, the proposed study has the potential to make a significant impact in the care of&#xD;
      HIV patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This application responds to RFA-AA12-009, Interventions to Improve HIV/AIDS and&#xD;
      Alcohol-Related Outcomes (U01). The proposed study takes place in a HIV primary care clinic&#xD;
      and uses the health plan's electronic medical record (EMR) for screening; it has the&#xD;
      potential to provide a significant benefit to HIV-infected individuals by reducing unhealthy&#xD;
      drinking and the associated complications. Prior studies have identified high rates of&#xD;
      co-occurrence of HIV and unhealthy drinking (defined as drinking over threshold limits, i.e.,&#xD;
      4+ daily or 14+ weekly drinks for men and 3+ daily or 7+ weekly drinks for women). Drinking&#xD;
      at these levels can compromise antiretroviral (ART) treatment, and increase rates of drug&#xD;
      use, depression, unsafe sex, and mortality. The proposed randomized trial examines the&#xD;
      comparative effectiveness of two highly implementable behavioral interventions for reducing&#xD;
      unhealthy drinking, each with an adaptive, stepped-care component: 1) Motivational&#xD;
      Interviewing (MI), consisting of one in-person session with a study clinician and two phone&#xD;
      sessions, with three additional phone sessions for those who report unhealthy drinking at 6&#xD;
      months; and 2) Interactive Email Feedback (EF) on alcohol use risks using a secure messaging&#xD;
      system integrated into the Electronic Medical Record (EMR), with additional emailed feedback&#xD;
      for those who report unhealthy drinking at 6 months. MI and EF are delivered by study staff.&#xD;
      A third arm will be usual care only. Participants in all three arms are eligible to receive&#xD;
      alcohol screening, brief intervention, and referral to treatment (SBIRT) from usual care&#xD;
      clinic staff. We will also evaluate the cost-effectiveness of the two interventions which&#xD;
      have the potential for wide adoption in other similar healthcare settings. The two proposed&#xD;
      interventions, MI and EF, are promising approaches for reducing unhealthy drinking in the&#xD;
      setting of behavioral health and/or primary care. EF also uses secure messaging, an emerging&#xD;
      technology that has been tested in other health, behavior change and mental health treatment&#xD;
      settings, for problems including alcohol use but not among HIV-infected individuals. In this&#xD;
      trial, 600 patients (200 in each arm) will be recruited from Kaiser Permanente Northern&#xD;
      California (KPNC) San Francisco. The study population and clinic are ideal to examine such&#xD;
      interventions since NIAAA-based screening questions are recorded in the EMR, and&#xD;
      comprehensive data are available on health care utilization, ART adherence, and HIV clinical&#xD;
      outcomes, including the Veterans Aging Cohort Study (VACS) index, a recently validated&#xD;
      prognostic index based on routine clinical laboratory measures. The research team is&#xD;
      well-qualified with complementary expertise in clinical psychology, drug and alcohol abuse&#xD;
      treatment, HIV epidemiology, and biostatistics. Thus, the team and study setting provide the&#xD;
      ideal environment to test MI and EF, two innovative approaches for reducing unhealthy alcohol&#xD;
      use in this population, and may provide powerful, and generalizable tools for assisting&#xD;
      individuals with HIV infection.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>March 2013</start_date>
  <completion_date type="Actual">August 2017</completion_date>
  <primary_completion_date type="Actual">August 2016</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>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Impact of motivational interviewing on unhealthy drinking and alcohol related problems</measure>
    <time_frame>3 Years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Impact of e-mail feedback on unhealthy drinking and alcohol related problems</measure>
    <time_frame>3 Years</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Impact of motivational interviewing and emailed feedback interventions on comorbid drug use</measure>
    <time_frame>3 years</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Impact of motivational interviewing and emailed feedback on interventions on antiretroviral adherence</measure>
    <time_frame>3 years</time_frame>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">614</enrollment>
  <condition>HIV</condition>
  <condition>Acquired Immunodeficiency Syndrome</condition>
  <condition>Alcoholism</condition>
  <condition>Alcoholic Intoxication</condition>
  <condition>Substance-Related Disorders</condition>
  <arm_group>
    <arm_group_label>Motivational Interviewing</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The intervention consists of one 45-minute in-person session followed by two 20-minute telephone sessions.The first telephone MI session will occur approximately 10 days after the in-person session. The second call will occur 30 days after the first call. The same research clinician will conduct both the in-person session and phone sessions. The calls will include a review of material covered in the initial session, questions on alcohol use, open-ended questions regarding patients' current motivational level, and a review of the patient's initial goals regarding alcohol consumption and will last about 20 minutes. If after six months hazardous drinking is noted, three more motivational interviewing phone sessions will be delivered by the research clinician.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Email Feedback</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Each participant will receive up to three detailed emails, (if participants respond to a first, initial email with information on alcohol use risks). The initial and subsequent emails will be brief in length, and will include specific information on hazardous drinking levels, standard drink size; as well as advice to reduce drinking to non-hazardous levels. Each email will conclude with contact numbers for patients to receive further information and assistance if needed, including information on how to easily access SU treatment; and will encourage participants to respond to the research clinician with questions. If after six months hazardous drinking is detected, up to 3 more detailed emails will be delivered to the participant.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual Care</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Participants in this arm will receive routine primary care services only. Usual care in this health care setting may include alcohol screening, brief intervention and referral to treatment (SBIRT) delivered by usual care clinic staff</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Motivational Interviewing</intervention_name>
    <arm_group_label>Motivational Interviewing</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Email Feedback</intervention_name>
    <arm_group_label>Email Feedback</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Usual Care</intervention_name>
    <arm_group_label>Usual Care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adults ages 18 and over seeking HIV services at the KPNC San Francisco medical center&#xD;
&#xD;
          -  Report of any unhealthy drinking in the previous year (≥ 3 drinks in a day or 7+ per&#xD;
             week for women and ≥ 4 drinks in a day or 14+ per week for men) and,&#xD;
&#xD;
          -  Report of web access at time of recruitment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Clinical recommendation from providers that patients are not appropriate due to:&#xD;
&#xD;
          -  Acute psychiatric problems; OR&#xD;
&#xD;
          -  Inability to understand consent procedures&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Derek Satre, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Associate Professor, University of California, San Francisco and Adjunct Investigator, Division of Research, Kaiser Permanente, Northern California</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Michael J Silverberg, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Research Scientist II, Division of Research, Kaiser Permanente, Northern California</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Kaiser Permanente Northern California San Francisco Medical Center; 2238 Geary Blvd</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
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  <verification_date>October 2018</verification_date>
  <study_first_submitted>August 20, 2012</study_first_submitted>
  <study_first_submitted_qc>August 22, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 23, 2012</study_first_posted>
  <last_update_submitted>October 8, 2018</last_update_submitted>
  <last_update_submitted_qc>October 8, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">October 10, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>HIV</keyword>
  <keyword>Acquired Immunodeficiency Syndrome</keyword>
  <keyword>Alcoholism</keyword>
  <keyword>Alcoholic Intoxication</keyword>
  <keyword>Substance-Related Disorders</keyword>
  <keyword>Intervention Studies</keyword>
  <keyword>Primary Health Care</keyword>
  <keyword>therapy</keyword>
  <keyword>prevention &amp; control</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>
    <mesh_term>Immunologic Deficiency Syndromes</mesh_term>
    <mesh_term>Alcoholism</mesh_term>
    <mesh_term>Substance-Related Disorders</mesh_term>
    <mesh_term>Alcoholic Intoxication</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01671501
org study id: P0048609_Satre
nct id: NCT01671501
lead sponsor: 
collaborator: 
has dmc: Yes
This randomized clinical trial uses a health plan's electronic medical record (EMR) alcohol
      screen; and examines innovative behavioral interventions, and their cost effectiveness, for
      hazardous drinking within a large HIV primary care clinic. We will compare Motivational
      Interviewing (MI) and Email Feedback (EF) to usual care; and evaluate the effect of the
      interventions on unhealthy drinking, comorbid drug use, enrollment in substance use treatment
      programs, and HIV outcomes including antiretroviral therapy adherence, HIV RNA control, and
      unsafe sex. Given the well-known adverse effects of unhealthy drinking on HIV care and
      outcomes, the proposed study has the potential to make a significant impact in the care of
      HIV patients.
This application responds to RFA-AA12-009, Interventions to Improve HIV/AIDS and
      Alcohol-Related Outcomes (U01). The proposed study takes place in a HIV primary care clinic
      and uses the health plan's electronic medical record (EMR) for screening; it has the
      potential to provide a significant benefit to HIV-infected individuals by reducing unhealthy
      drinking and the associated complications. Prior studies have identified high rates of
      co-occurrence of HIV and unhealthy drinking (defined as drinking over threshold limits, i.e.,
      4+ daily or 14+ weekly drinks for men and 3+ daily or 7+ weekly drinks for women). Drinking
      at these levels can compromise antiretroviral (ART) treatment, and increase rates of drug
      use, depression, unsafe sex, and mortality. The proposed randomized trial examines the
      comparative effectiveness of two highly implementable behavioral interventions for reducing
      unhealthy drinking, each with an adaptive, stepped-care component: 1) Motivational
      Interviewing (MI), consisting of one in-person session with a study clinician and two phone
      sessions, with three additional phone sessions for those who report unhealthy drinking at 6
      months; and 2) Interactive Email Feedback (EF) on alcohol use risks using a secure messaging
      system integrated into the Electronic Medical Record (EMR), with additional emailed feedback
      for those who report unhealthy drinking at 6 months. MI and EF are delivered by study staff.
      A third arm will be usual care only. Participants in all three arms are eligible to receive
      alcohol screening, brief intervention, and referral to treatment (SBIRT) from usual care
      clinic staff. We will also evaluate the cost-effectiveness of the two interventions which
      have the potential for wide adoption in other similar healthcare settings. The two proposed
      interventions, MI and EF, are promising approaches for reducing unhealthy drinking in the
      setting of behavioral health and/or primary care. EF also uses secure messaging, an emerging
      technology that has been tested in other health, behavior change and mental health treatment
      settings, for problems including alcohol use but not among HIV-infected individuals. In this
      trial, 600 patients (200 in each arm) will be recruited from Kaiser Permanente Northern
      California (KPNC) San Francisco. The study population and clinic are ideal to examine such
      interventions since NIAAA-based screening questions are recorded in the EMR, and
      comprehensive data are available on health care utilization, ART adherence, and HIV clinical
      outcomes, including the Veterans Aging Cohort Study (VACS) index, a recently validated
      prognostic index based on routine clinical laboratory measures. The research team is
      well-qualified with complementary expertise in clinical psychology, drug and alcohol abuse
      treatment, HIV epidemiology, and biostatistics. Thus, the team and study setting provide the
      ideal environment to test MI and EF, two innovative approaches for reducing unhealthy alcohol
      use in this population, and may provide powerful, and generalizable tools for assisting
      individuals with HIV infection.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Impact of motivational interviewing on unhealthy drinking and alcohol related problems
time frame: 3 Years
measure: Impact of e-mail feedback on unhealthy drinking and alcohol related problems
time frame: 3 Years
measure: Impact of motivational interviewing and emailed feedback interventions on comorbid drug use
time frame: 3 years
measure: Impact of motivational interviewing and emailed feedback on interventions on antiretroviral adherence
time frame: 3 years
arm group label: Motivational Interviewing
arm group type: Experimental
description: The intervention consists of one 45-minute in-person session followed by two 20-minute telephone sessions.The first telephone MI session will occur approximately 10 days after the in-person session. The second call will occur 30 days after the first call. The same research clinician will conduct both the in-person session and phone sessions. The calls will include a review of material covered in the initial session, questions on alcohol use, open-ended questions regarding patients' current motivational level, and a review of the patient's initial goals regarding alcohol consumption and will last about 20 minutes. If after six months hazardous drinking is noted, three more motivational interviewing phone sessions will be delivered by the research clinician.
arm group label: Email Feedback
arm group type: Experimental
description: Each participant will receive up to three detailed emails, (if participants respond to a first, initial email with information on alcohol use risks). The initial and subsequent emails will be brief in length, and will include specific information on hazardous drinking levels, standard drink size; as well as advice to reduce drinking to non-hazardous levels. Each email will conclude with contact numbers for patients to receive further information and assistance if needed, including information on how to easily access SU treatment; and will encourage participants to respond to the research clinician with questions. If after six months hazardous drinking is detected, up to 3 more detailed emails will be delivered to the participant.
arm group label: Usual Care
arm group type: Other
description: Participants in this arm will receive routine primary care services only. Usual care in this health care setting may include alcohol screening, brief intervention and referral to treatment (SBIRT) delivered by usual care clinic staff
intervention type: Behavioral
intervention name: Motivational Interviewing
arm group label: Motivational Interviewing
intervention type: Behavioral
intervention name: Email Feedback
arm group label: Email Feedback
intervention type: Other
intervention name: Usual Care
arm group label: Usual Care
criteria: 
gender: All
minimum age: 18 Years
maximum age: 100 Years
healthy volunteers: No
last name: Derek Satre, PhD
role: Principal Investigator
affiliation: Associate Professor, University of California, San Francisco and Adjunct Investigator, Division of Research, Kaiser Permanente, Northern California
last name: Michael J Silverberg, PhD
role: Principal Investigator
affiliation: Research Scientist II, Division of Research, Kaiser Permanente, Northern California
facility: 
country: United States
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responsible party type: Sponsor
mesh term: Acquired Immunodeficiency Syndrome
mesh term: HIV Infections
mesh term: Immunologic Deficiency Syndromes
mesh term: Alcoholism
mesh term: Substance-Related Disorders
mesh term: Alcoholic Intoxication