<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/NCT03762187</url>
  </required_header>
  <id_info>
    <org_study_id>13-0333</org_study_id>
    <nct_id>NCT03762187</nct_id>
  </id_info>
  <brief_title>A Brief Affirmation Intervention on HIV-related Distress and Positive Living in Lesotho</brief_title>
  <official_title>Effects of a Brief Affirmation Intervention on HIV-related Distress and Positive Living Intentions Among Individuals Recently Diagnosed With HIV in Lesotho</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, Santa Barbara</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Fulbright</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Ministry of Health, Lesotho</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of California, Santa Barbara</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 is interested in the stress associated with being HIV positive and looking at ways&#xD;
      to reduce that stress. Individuals who are HIV positive face a number of nontrivial threats&#xD;
      and stressors: the burden of illness, loss of work, stigmatization, and the chance of death.&#xD;
      The study investigates the use of self-affirmation to reduce some of these threats and&#xD;
      stressors. Self-affirmation may helping people to cope with these threats and stressors by&#xD;
      reminding individuals of other valued aspects of themselves, thus reducing the impact, both&#xD;
      psychologically and physiologically, of these threats. Experimentally induced affirmations in&#xD;
      which individuals are asked to write about values that are important to the self have been&#xD;
      shown to reduce physiological stress among healthy student populations (Sherman, Bunyan,&#xD;
      Creswell, &amp; Jaremka, 2009).&#xD;
&#xD;
      This research will be conducted in collaboration with the global health organizations, PSI&#xD;
      who is already providing counseling to those living with HIV on how to reduce the spread of&#xD;
      HIV and how to live a healthy life with HIV. These counseling sessions take place at local&#xD;
      clinics and hospitals while individuals are waiting to be seen for treatment and are&#xD;
      completely voluntary.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 1, 2014</start_date>
  <completion_date type="Actual">January 31, 2015</completion_date>
  <primary_completion_date type="Actual">January 31, 2015</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>Factorial Assignment</intervention_model>
    <intervention_model_description>Participants are randomized to one of the two conditions.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Care Provider)</masking>
    <masking_description>Neither patients nor counselors were aware of participants' assigned condition</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Perceived Stress Scale</measure>
    <time_frame>Post-intervention survey conducted immediately after intervention session</time_frame>
    <description>Participants were asked to complete an abbreviated version of the Perceived Stress Scale (Cohen, Kamarck, &amp; Mermelstein, 1983), a well validated measure of participants' current stress. For this scale, participants are asked to rate their agreement with statements such as &quot;Today, I feel nervous and stressed&quot; or &quot;Today I feel that difficulties are piling up so high that I cannot overcome them&quot; using a 6-point Likert scale anchored from 1= &quot;Very Much Disagree&quot; to 6 = &quot;Very Much Agree&quot;.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Intrusion subscale of impact of events scale</measure>
    <time_frame>Post-intervention survey conducted immediately after intervention session</time_frame>
    <description>Participants completed questions regarding their current experience of intrusive thoughts related to HIV adapted from the intrusion subscale of the Impact of Events Scale (Horowitz, Wilner, &amp; Alvarez, 1979). This measure was designed to assess distress caused by traumatic events. The impact of events scale is a well-validated measure that is often used (in combination with the DSM-IV) to assess post-traumatic stress disorder. In essence, this measure was designed to assess how traumatized participants felt by their HIV diagnosis. Participants rated their agreement with statements such as &quot;Today, any reminder of HIV brings back feelings about it&quot; and &quot;Today, I think about HIV even when I don't mean to&quot; using a 1= &quot;Very Much Disagree&quot; to 6 = &quot;Very Much Agree&quot; scale.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Concerns about dying</measure>
    <time_frame>Post-intervention survey conducted immediately after intervention session</time_frame>
    <description>Participants indicated to what extent they were currently concerned about dying using a single item, &quot;Today, I find myself worrying about dying&quot;. Participants indicated their agreement with that statement using a 6-point Likert scale from 1= &quot;Very Much Disagree&quot; to 6 = &quot;Very Much Agree&quot;, with higher numbers indicating greater worries about dying.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Distressing emotions related to HIV</measure>
    <time_frame>Post-intervention survey conducted immediately after intervention session</time_frame>
    <description>Participants indicated to what extent they were experiencing distressing emotions related to HIV on a 5-point Likert scale from 1=&quot;Never&quot; to 5=&quot;Always&quot;, with higher numbers indicating a greater frequency of distressing emotions related to HIV.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Future behavioral intentions</measure>
    <time_frame>Post-intervention survey conducted immediately after intervention session</time_frame>
    <description>Participants were asked to rate their agreement with statements regarding their future intentions to engage in positive living behaviors using a 6-point Likert scale from from 1= &quot;Very Much Disagree&quot; to 6 = &quot;Very Much Agree&quot;. In particular, participants were asked to indicate their intention to use condoms in the future by indicating their agreement with statements such as, &quot;If a sexual partner didn't want to use condoms, we would have sex without using condoms&quot; or &quot;It is a hassle to use condoms&quot;. Participants indicated their intention to take their medications by indicating their agreement with the statements, &quot;I will take my medication regularly&quot; and &quot;I have trouble taking my medication as I am supposed to (reversed)&quot;. Additionally, participants indicated their intention to have non-concurrent sexual partners using the statement &quot;I will only have one sexual relationship at a time&quot;.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Physical health measures</measure>
    <time_frame>Post-intervention survey conducted immediately after intervention session</time_frame>
    <description>In order to assess participants' baseline self-reported health, participants completed the general health subscale of the RAND 36-item Short Form Health Survey, a well-validated measure designed to assess health that is utilized by many health organizations, including Medicare, to assess and monitor healthcare outcomes. Participants were asked to answer five questions regarding their current health using a 5-point Likert scale.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">389</enrollment>
  <condition>Self-affirmation Plus Positive Living Counseling</condition>
  <condition>Counseling</condition>
  <arm_group>
    <arm_group_label>Self-affirmation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants completed a written self-affirmation manipulation before completing the standard counseling provided by the clinic.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Positive living counseling</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants completed the standard counseling provided by the clinic (treatment as usual control condition).</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Self-affirmation</intervention_name>
    <description>Individuals select important values and then write about why that value is important to them.</description>
    <arm_group_label>Self-affirmation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Positive living counseling</intervention_name>
    <description>Each of the clinics from which participants were recruited conducts positive living counseling as part of their treatment programs. This counseling is conducted by counselors who are trained and monitored by the Lesotho Network of AIDS Support Organizations (LENASO) and consistent with the positive prevention framework (see Bunnell et al., 2005 for description). Each counseling session focused on addressing positive living goals such as the importance of taking one's medications on time and every day, using protection with every partner, and the importance of maintaining a healthy lifestyle.</description>
    <arm_group_label>Positive living counseling</arm_group_label>
    <arm_group_label>Self-affirmation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  HIV+&#xD;
&#xD;
          -  A CD4 count of less than or equal to 500 cells/mm3 or have significant symptomatology&#xD;
             and HIV co-illness (WHO HIV clinical stage 3 or 4) to be eligible to start&#xD;
             antiretroviral therapy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>November 1, 2018</study_first_submitted>
  <study_first_submitted_qc>November 30, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 3, 2018</study_first_posted>
  <last_update_submitted>November 30, 2018</last_update_submitted>
  <last_update_submitted_qc>November 30, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 3, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of California, Santa Barbara</investigator_affiliation>
    <investigator_full_name>David Sherman</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT03762187
org study id: 13-0333
nct id: NCT03762187
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study is interested in the stress associated with being HIV positive and looking at ways
      to reduce that stress. Individuals who are HIV positive face a number of nontrivial threats
      and stressors: the burden of illness, loss of work, stigmatization, and the chance of death.
      The study investigates the use of self-affirmation to reduce some of these threats and
      stressors. Self-affirmation may helping people to cope with these threats and stressors by
      reminding individuals of other valued aspects of themselves, thus reducing the impact, both
      psychologically and physiologically, of these threats. Experimentally induced affirmations in
      which individuals are asked to write about values that are important to the self have been
      shown to reduce physiological stress among healthy student populations (Sherman, Bunyan,
      Creswell, & Jaremka, 2009).

      This research will be conducted in collaboration with the global health organizations, PSI
      who is already providing counseling to those living with HIV on how to reduce the spread of
      HIV and how to live a healthy life with HIV. These counseling sessions take place at local
      clinics and hospitals while individuals are waiting to be seen for treatment and are
      completely voluntary.
allocation: Randomized
intervention model: Factorial Assignment
intervention model description: Participants are randomized to one of the two conditions.
primary purpose: Treatment
masking: Double (Participant, Care Provider)
masking description: Neither patients nor counselors were aware of participants' assigned condition
measure: Perceived Stress Scale
time frame: Post-intervention survey conducted immediately after intervention session
description: Participants were asked to complete an abbreviated version of the Perceived Stress Scale (Cohen, Kamarck, & Mermelstein, 1983), a well validated measure of participants' current stress. For this scale, participants are asked to rate their agreement with statements such as "Today, I feel nervous and stressed" or "Today I feel that difficulties are piling up so high that I cannot overcome them" using a 6-point Likert scale anchored from 1= "Very Much Disagree" to 6 = "Very Much Agree".
measure: Intrusion subscale of impact of events scale
time frame: Post-intervention survey conducted immediately after intervention session
description: Participants completed questions regarding their current experience of intrusive thoughts related to HIV adapted from the intrusion subscale of the Impact of Events Scale (Horowitz, Wilner, & Alvarez, 1979). This measure was designed to assess distress caused by traumatic events. The impact of events scale is a well-validated measure that is often used (in combination with the DSM-IV) to assess post-traumatic stress disorder. In essence, this measure was designed to assess how traumatized participants felt by their HIV diagnosis. Participants rated their agreement with statements such as "Today, any reminder of HIV brings back feelings about it" and "Today, I think about HIV even when I don't mean to" using a 1= "Very Much Disagree" to 6 = "Very Much Agree" scale.
measure: Concerns about dying
time frame: Post-intervention survey conducted immediately after intervention session
description: Participants indicated to what extent they were currently concerned about dying using a single item, "Today, I find myself worrying about dying". Participants indicated their agreement with that statement using a 6-point Likert scale from 1= "Very Much Disagree" to 6 = "Very Much Agree", with higher numbers indicating greater worries about dying.
measure: Distressing emotions related to HIV
time frame: Post-intervention survey conducted immediately after intervention session
description: Participants indicated to what extent they were experiencing distressing emotions related to HIV on a 5-point Likert scale from 1="Never" to 5="Always", with higher numbers indicating a greater frequency of distressing emotions related to HIV.
measure: Future behavioral intentions
time frame: Post-intervention survey conducted immediately after intervention session
description: Participants were asked to rate their agreement with statements regarding their future intentions to engage in positive living behaviors using a 6-point Likert scale from from 1= "Very Much Disagree" to 6 = "Very Much Agree". In particular, participants were asked to indicate their intention to use condoms in the future by indicating their agreement with statements such as, "If a sexual partner didn't want to use condoms, we would have sex without using condoms" or "It is a hassle to use condoms". Participants indicated their intention to take their medications by indicating their agreement with the statements, "I will take my medication regularly" and "I have trouble taking my medication as I am supposed to (reversed)". Additionally, participants indicated their intention to have non-concurrent sexual partners using the statement "I will only have one sexual relationship at a time".
measure: Physical health measures
time frame: Post-intervention survey conducted immediately after intervention session
description: In order to assess participants' baseline self-reported health, participants completed the general health subscale of the RAND 36-item Short Form Health Survey, a well-validated measure designed to assess health that is utilized by many health organizations, including Medicare, to assess and monitor healthcare outcomes. Participants were asked to answer five questions regarding their current health using a 5-point Likert scale.
arm group label: Self-affirmation
arm group type: Experimental
description: Participants completed a written self-affirmation manipulation before completing the standard counseling provided by the clinic.
arm group label: Positive living counseling
arm group type: Active Comparator
description: Participants completed the standard counseling provided by the clinic (treatment as usual control condition).
intervention type: Behavioral
intervention name: Self-affirmation
description: Individuals select important values and then write about why that value is important to them.
arm group label: Self-affirmation
intervention type: Behavioral
intervention name: Positive living counseling
description: Each of the clinics from which participants were recruited conducts positive living counseling as part of their treatment programs. This counseling is conducted by counselors who are trained and monitored by the Lesotho Network of AIDS Support Organizations (LENASO) and consistent with the positive prevention framework (see Bunnell et al., 2005 for description). Each counseling session focused on addressing positive living goals such as the importance of taking one's medications on time and every day, using protection with every partner, and the importance of maintaining a healthy lifestyle.
arm group label: Positive living counseling
arm group label: Self-affirmation
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: University of California, Santa Barbara
investigator full name: David Sherman
investigator title: Professor
sharing ipd: No