<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/NCT03248778</url>
  </required_header>
  <id_info>
    <org_study_id>2000020567</org_study_id>
    <nct_id>NCT03248778</nct_id>
  </id_info>
  <brief_title>Readiness to Disclose Mother's HIV Diagnosis to Their Children in Beijing, China</brief_title>
  <official_title>Readiness to Disclose Mother's HIV Diagnosis to Their Children in Beijing, China</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yale University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Yale University</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>
      Specific aims of the 1-year project are to pilot test the disclosure support intervention by&#xD;
      (a) evaluating acceptability and feasibility with a preliminary randomized trial among 10&#xD;
      HIV+ mothers (5 in the intervention group and 5 in the treatment as usual (TAU) group) and&#xD;
      (b) assessing outcomes in mothers (quality of life and mental health indicators, adherence,&#xD;
      social support, and disclosure stress, efficacy, readiness, and completion). The intervention&#xD;
      will be compared to treatment as usual, with baseline (0 weeks), immediate post-intervention&#xD;
      (4 weeks), and 12-week follow-up (16 weeks) assessments.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      HIV disclosure to children has been shown to strengthen family relations and increase&#xD;
      assistance with medical care, reinforcing the parent's willingness to live. Some Chinese&#xD;
      children aware of their parents HIV diagnosis do exhibit emotional and social dysfunction;&#xD;
      however, adequate support from caregivers (e.g., grandparents or even their HIV+ parents) can&#xD;
      improve the children's quality of life and academic performance. There is a clear need for&#xD;
      practical interventions to address parental distress around HIV disclosure in China, where&#xD;
      cultural norms often emphasize family identity and cohesion and underscore the need for&#xD;
      family-based programs, which have been shown to be feasible and efficacious for HIV-affected&#xD;
      families.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 8, 2017</start_date>
  <completion_date type="Actual">December 31, 2017</completion_date>
  <primary_completion_date type="Actual">December 31, 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>
    <intervention_model_description>The investigators will assess feasibility and acceptability and get a broad sense of the initial efficacy of the intervention with a two-arm RCT implemented with 10 HIV+ mothers: 5 will be randomly assigned to the disclosure-support counseling intervention and 5 to a treatment-as-usual (TAU) condition.</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>readiness to disclose</measure>
    <time_frame>16 weeks</time_frame>
    <description>This data will be collected and evaluated with qualitative methods using the Disclosure Distress Questionnaire</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>quality of life via Medical Outcomes Study HIV Health Survey</measure>
    <time_frame>16 weeks</time_frame>
    <description>The Medical Outcomes Study HIV Health Survey (MOS-HIV) is a brief, comprehensive health status measure that has been used extensively in studies of human immunodeficiency virus/acquired immune deficiency syndrome (HIV/AIDS). MOS-HIV for quality of life is ranges from 0-60. The higher the score the better the quality of life.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>depression via the Center for Epidemiologic Studies Depression Scale (CES-D)</measure>
    <time_frame>16 weeks</time_frame>
    <description>Depression is measured by CES-D, ranged from 0-40. A score higher than 16 is considered as depressed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>adherence</measure>
    <time_frame>16 weeks</time_frame>
    <description>Measured using a visual analog scale. Acceptable adherence is equal or higher than 95%.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>social support using the HIV Social Support tool</measure>
    <time_frame>16 weeks</time_frame>
    <description>social support will ranged from 0-20. The higher the score, shown more support in life.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">5</enrollment>
  <condition>HIV</condition>
  <arm_group>
    <arm_group_label>disclosure-support counseling</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment as Usual</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>disclosure-support counseling intervention</intervention_name>
    <description>The intervention will include three components: (a) assessment; (b) decision-making and support; and (c) disclosure, planning, and action. The individualized assessment comprehensively will consider the family's history, experiences with disclosure, communication skills, coping resources, and factors likely to affect disclosure (e.g., familial, psychological, social, cultural, and medical issues). The second component of decision-making and support focused on developing communication skills and strategies, with role-play and practice outside of the sessions as necessary. Costs and benefits of disclosure were considered along with the range of disclosure options. Materials, including a pros and cons chart of disclosure and a disclosure continuum worksheet, were used to stimulate discussions of possible plans and consequences. In the third component, parents were encouraged to formulate and practice a disclosure plan for later use.</description>
    <arm_group_label>disclosure-support counseling</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  HIV+ mother ≥18 years of age,&#xD;
&#xD;
          -  not psychotic or demented;&#xD;
&#xD;
          -  receiving clinical care at the Ditan hospital,&#xD;
&#xD;
          -  a mother of an HIV-negative child of age 13-25 years who does not know about the&#xD;
             mother's infection;&#xD;
&#xD;
          -  well enough to attend study sessions as the clinic.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  no psychotic or demented&#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>Wei-Ti Chen, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Yale School of Nursing</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Beijing Ditan Hospital</name>
      <address>
        <city>Beijing</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>July 2019</verification_date>
  <study_first_submitted>August 10, 2017</study_first_submitted>
  <study_first_submitted_qc>August 10, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 14, 2017</study_first_posted>
  <last_update_submitted>July 5, 2019</last_update_submitted>
  <last_update_submitted_qc>July 5, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 8, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>disclosure</keyword>
  <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/NCT03248778
org study id: 2000020567
nct id: NCT03248778
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Specific aims of the 1-year project are to pilot test the disclosure support intervention by
      (a) evaluating acceptability and feasibility with a preliminary randomized trial among 10
      HIV+ mothers (5 in the intervention group and 5 in the treatment as usual (TAU) group) and
      (b) assessing outcomes in mothers (quality of life and mental health indicators, adherence,
      social support, and disclosure stress, efficacy, readiness, and completion). The intervention
      will be compared to treatment as usual, with baseline (0 weeks), immediate post-intervention
      (4 weeks), and 12-week follow-up (16 weeks) assessments.
HIV disclosure to children has been shown to strengthen family relations and increase
      assistance with medical care, reinforcing the parent's willingness to live. Some Chinese
      children aware of their parents HIV diagnosis do exhibit emotional and social dysfunction;
      however, adequate support from caregivers (e.g., grandparents or even their HIV+ parents) can
      improve the children's quality of life and academic performance. There is a clear need for
      practical interventions to address parental distress around HIV disclosure in China, where
      cultural norms often emphasize family identity and cohesion and underscore the need for
      family-based programs, which have been shown to be feasible and efficacious for HIV-affected
      families.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: The investigators will assess feasibility and acceptability and get a broad sense of the initial efficacy of the intervention with a two-arm RCT implemented with 10 HIV+ mothers: 5 will be randomly assigned to the disclosure-support counseling intervention and 5 to a treatment-as-usual (TAU) condition.
primary purpose: Supportive Care
masking: None (Open Label)
measure: readiness to disclose
time frame: 16 weeks
description: This data will be collected and evaluated with qualitative methods using the Disclosure Distress Questionnaire
measure: quality of life via Medical Outcomes Study HIV Health Survey
time frame: 16 weeks
description: The Medical Outcomes Study HIV Health Survey (MOS-HIV) is a brief, comprehensive health status measure that has been used extensively in studies of human immunodeficiency virus/acquired immune deficiency syndrome (HIV/AIDS). MOS-HIV for quality of life is ranges from 0-60. The higher the score the better the quality of life.
measure: depression via the Center for Epidemiologic Studies Depression Scale (CES-D)
time frame: 16 weeks
description: Depression is measured by CES-D, ranged from 0-40. A score higher than 16 is considered as depressed.
measure: adherence
time frame: 16 weeks
description: Measured using a visual analog scale. Acceptable adherence is equal or higher than 95%.
measure: social support using the HIV Social Support tool
time frame: 16 weeks
description: social support will ranged from 0-20. The higher the score, shown more support in life.
arm group label: disclosure-support counseling
arm group type: Experimental
arm group label: Treatment as Usual
arm group type: No Intervention
intervention type: Behavioral
intervention name: disclosure-support counseling intervention
description: The intervention will include three components: (a) assessment; (b) decision-making and support; and (c) disclosure, planning, and action. The individualized assessment comprehensively will consider the family's history, experiences with disclosure, communication skills, coping resources, and factors likely to affect disclosure (e.g., familial, psychological, social, cultural, and medical issues). The second component of decision-making and support focused on developing communication skills and strategies, with role-play and practice outside of the sessions as necessary. Costs and benefits of disclosure were considered along with the range of disclosure options. Materials, including a pros and cons chart of disclosure and a disclosure continuum worksheet, were used to stimulate discussions of possible plans and consequences. In the third component, parents were encouraged to formulate and practice a disclosure plan for later use.
arm group label: disclosure-support counseling
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Wei-Ti Chen, PhD
role: Principal Investigator
affiliation: Yale School of Nursing
facility: 
country: China
responsible party type: Sponsor
sharing ipd: No