<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/NCT03004170</url>
  </required_header>
  <id_info>
    <org_study_id>NIA-R01AG053081</org_study_id>
    <nct_id>NCT03004170</nct_id>
  </id_info>
  <brief_title>Telephone Counseling to Enhance the Quality and Safety of Romantic and Sexual Relationships in People Living and Aging With HIV</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Oregon Health and Science University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Georgia</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Oregon Health and Science University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine if a brief behavioral intervention delivered over&#xD;
      the telephone is effective at reducing occasions of condomless sex in persons living and&#xD;
      aging with HIV.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Estimated rates of condomless anal and vaginal intercourse among HIV-positive older adults&#xD;
      remain high. Brief motivational interventions delivered face-to-face have demonstrated&#xD;
      efficacy at reducing condomless sex in HIV-positive persons. However, these interventions are&#xD;
      not contextualized to the unique sexual health needs of HIV-positive older adults. Further,&#xD;
      many HIV-positive older adults have difficulty accessing face-to-face services due to&#xD;
      transportation, stigma, and other barriers. Telehealth interventions represent one delivery&#xD;
      approach that overcomes such barriers.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">December 2016</start_date>
  <completion_date type="Anticipated">December 2021</completion_date>
  <primary_completion_date type="Anticipated">April 2021</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 (Outcomes Assessor)</masking>
    <masking_description>Outcome Assessor is blind to participant condition.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change in number of condomless sex acts from baseline to 12-month follow-up</measure>
    <time_frame>Baseline, 12-month follow-up</time_frame>
    <description>Self-reported condomless anal and/or vaginal sex acts with HIV-negative or unknown HIV serostatus sex partners based on the Timeline Followback Interview.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in depressive symptom severity from baseline to 12-month follow-up</measure>
    <time_frame>Baseline, 12-month follow-up</time_frame>
    <description>Self-reported depressive symptom severity using the Patient Health Questionnaire 9-item Depression Module (PHQ-9). This outcome will be assessed among the approximately one-third of participants who report mild levels of depression at study enrollment.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Change in knowledge of HIV viral load from baseline to 12-month follow-up</measure>
    <time_frame>Baseline, 12-month follow-up</time_frame>
    <description>Self-reported knowledge of one's HIV viral load status (i.e., test result and date of most recent viral load test)</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">343</enrollment>
  <condition>HIV Seropositivity</condition>
  <arm_group>
    <arm_group_label>Tele-Motivational Interviewing Plus Behavioral Skills Training</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The Telephone-Administered Motivational Interviewing Plus Behavioral Skills Training (teleMI+BST) intervention comprises 5 sessions lasting approximately 45-50 minutes each. Sessions occur in weeks 3, 4, 8, and 12 post-enrollment, with a follow-up booster session in week 24. The Information-Motivation-Behavioral Skills (IMB) Model (Fisher &amp; Fisher, 1992) provides the theoretical framework for behavior change mechanisms of teleMI+BST. The IMB posits that knowledge about condom use practices, condom use motivation, and acquisition and application of requisite condom use skills lead to engagement in condom-protected sex. The focus of this intervention is to help participants process ambivalence about engaging in condomless sex acts that risk HIV transmission.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Tele-Coping Effectiveness Training</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The Telephone-Administered Coping Effectiveness Training (teleCET) intervention is the attention-equivalent comparator and also comprises 5 sessions lasting approximately 45-50 minutes each. The teleCET intervention is based on the Lazarus and Folkman Transactional Model of Stress and Coping (Lazarus &amp; Folkman, 1984) and uses cognitive-behavioral principles to: (a) appraise stressor severity, (b) develop problem- and emotion-focused coping skills, (c) determine the match between coping strategies and stressor controllability, and (d) optimize coping through use of social support resources.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Telephone-Administered Motivational Interviewing Plus Behavioral Skills Training</intervention_name>
    <arm_group_label>Tele-Motivational Interviewing Plus Behavioral Skills Training</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Telephone-Administered Coping Effectiveness Training</intervention_name>
    <arm_group_label>Tele-Coping Effectiveness Training</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  English speaking&#xD;
&#xD;
          -  Have access to a landline or cellular telephone&#xD;
&#xD;
          -  Be 50 years of age or older at some point during study participation&#xD;
&#xD;
          -  Report engaging in one or more occasions of condomless anal and/or vaginal intercourse&#xD;
             with an HIV-negative or unknown HIV serostatus sex partner in the 3 months prior to&#xD;
             study enrollment. An exception to this criterion is participants whose HIV viral load&#xD;
             is undetectable and whose only condomless sex is in the context of a monogamous sexual&#xD;
             relationship with an HIV-negative partner.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Active suicidal ideation as determined by the Patient Health Questionnaire 9-item&#xD;
             Depression Module&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Travis Lovejoy, PhD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Oregon Health and Science University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Oregon Health &amp; Science University</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97239</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <results_reference>
    <citation>Fisher JD, Fisher WA. Changing AIDS-risk behavior. Psychol Bull. 1992 May;111(3):455-74. doi: 10.1037/0033-2909.111.3.455.</citation>
    <PMID>1594721</PMID>
  </results_reference>
  <results_reference>
    <citation>Lazarus RS, Susan Folkman. Stress, appraisal, and coping. New York, NY: Springer; 1984.</citation>
  </results_reference>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>December 20, 2016</study_first_submitted>
  <study_first_submitted_qc>December 22, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 28, 2016</study_first_posted>
  <last_update_submitted>April 8, 2021</last_update_submitted>
  <last_update_submitted_qc>April 8, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 9, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Oregon Health and Science University</investigator_affiliation>
    <investigator_full_name>Travis Lovejoy</investigator_full_name>
    <investigator_title>Associate Professor of Psychiatry</investigator_title>
  </responsible_party>
  <keyword>HIV</keyword>
  <keyword>Motivational Interviewing</keyword>
  <keyword>Telephone</keyword>
  <keyword>Telehealth</keyword>
  <keyword>Risky Sex</keyword>
  <keyword>Unprotected Sex</keyword>
  <keyword>Condoms</keyword>
  <keyword>Older Adults</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>HIV Seropositivity</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Raw de-identified data will be made publicly available to the scientific community upon request after the trial is complete and data have been published. Data requests should be directed to the study principal investigator.</ipd_description>
  </patient_data>
  <!-- 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/NCT03004170
org study id: NIA-R01AG053081
nct id: NCT03004170
lead sponsor: 
collaborator: 
has dmc: Yes
The purpose of this study is to determine if a brief behavioral intervention delivered over
      the telephone is effective at reducing occasions of condomless sex in persons living and
      aging with HIV.
Estimated rates of condomless anal and vaginal intercourse among HIV-positive older adults
      remain high. Brief motivational interventions delivered face-to-face have demonstrated
      efficacy at reducing condomless sex in HIV-positive persons. However, these interventions are
      not contextualized to the unique sexual health needs of HIV-positive older adults. Further,
      many HIV-positive older adults have difficulty accessing face-to-face services due to
      transportation, stigma, and other barriers. Telehealth interventions represent one delivery
      approach that overcomes such barriers.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
masking description: Outcome Assessor is blind to participant condition.
measure: Change in number of condomless sex acts from baseline to 12-month follow-up
time frame: Baseline, 12-month follow-up
description: Self-reported condomless anal and/or vaginal sex acts with HIV-negative or unknown HIV serostatus sex partners based on the Timeline Followback Interview.
measure: Change in depressive symptom severity from baseline to 12-month follow-up
time frame: Baseline, 12-month follow-up
description: Self-reported depressive symptom severity using the Patient Health Questionnaire 9-item Depression Module (PHQ-9). This outcome will be assessed among the approximately one-third of participants who report mild levels of depression at study enrollment.
measure: Change in knowledge of HIV viral load from baseline to 12-month follow-up
time frame: Baseline, 12-month follow-up
description: Self-reported knowledge of one's HIV viral load status (i.e., test result and date of most recent viral load test)
arm group label: Tele-Motivational Interviewing Plus Behavioral Skills Training
arm group type: Experimental
description: The Telephone-Administered Motivational Interviewing Plus Behavioral Skills Training (teleMI+BST) intervention comprises 5 sessions lasting approximately 45-50 minutes each. Sessions occur in weeks 3, 4, 8, and 12 post-enrollment, with a follow-up booster session in week 24. The Information-Motivation-Behavioral Skills (IMB) Model (Fisher & Fisher, 1992) provides the theoretical framework for behavior change mechanisms of teleMI+BST. The IMB posits that knowledge about condom use practices, condom use motivation, and acquisition and application of requisite condom use skills lead to engagement in condom-protected sex. The focus of this intervention is to help participants process ambivalence about engaging in condomless sex acts that risk HIV transmission.
arm group label: Tele-Coping Effectiveness Training
arm group type: Active Comparator
description: The Telephone-Administered Coping Effectiveness Training (teleCET) intervention is the attention-equivalent comparator and also comprises 5 sessions lasting approximately 45-50 minutes each. The teleCET intervention is based on the Lazarus and Folkman Transactional Model of Stress and Coping (Lazarus & Folkman, 1984) and uses cognitive-behavioral principles to: (a) appraise stressor severity, (b) develop problem- and emotion-focused coping skills, (c) determine the match between coping strategies and stressor controllability, and (d) optimize coping through use of social support resources.
intervention type: Behavioral
intervention name: Telephone-Administered Motivational Interviewing Plus Behavioral Skills Training
arm group label: Tele-Motivational Interviewing Plus Behavioral Skills Training
intervention type: Behavioral
intervention name: Telephone-Administered Coping Effectiveness Training
arm group label: Tele-Coping Effectiveness Training
criteria: 
gender: All
minimum age: 50 Years
maximum age: N/A
healthy volunteers: No
last name: Travis Lovejoy, PhD, MPH
role: Principal Investigator
affiliation: Oregon Health and Science University
facility: 
country: United States
citation: Fisher JD, Fisher WA. Changing AIDS-risk behavior. Psychol Bull. 1992 May;111(3):455-74. doi: 10.1037/0033-2909.111.3.455.
PMID: 1594721
citation: Lazarus RS, Susan Folkman. Stress, appraisal, and coping. New York, NY: Springer; 1984.
responsible party type: Principal Investigator
investigator affiliation: Oregon Health and Science University
investigator full name: Travis Lovejoy
investigator title: Associate Professor of Psychiatry
mesh term: HIV Seropositivity
sharing ipd: Yes
ipd description: Raw de-identified data will be made publicly available to the scientific community upon request after the trial is complete and data have been published. Data requests should be directed to the study principal investigator.