<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/NCT01701635</url>
  </required_header>
  <id_info>
    <org_study_id>1205010310</org_study_id>
    <secondary_id>NIH/NICHD</secondary_id>
    <secondary_id>R01HD074253</secondary_id>
    <nct_id>NCT01701635</nct_id>
  </id_info>
  <brief_title>SANKOFA Pediatric HIV Disclosure Intervention</brief_title>
  <official_title>A Bioecological Pediatric HIV Disclosure Intervention in Ghana - &quot;SANKOFA&quot;</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yale University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Purdue University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Ghana</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Kwame Nkrumah University of Science and Technology</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Yale University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      A culturally-relevant, theoretically and empirically sound, patient-centered, standardized&#xD;
      disclosure intervention that can be integrated into routine clinical pediatric HIV care has&#xD;
      potential to prevent transmission and improve the welfare of children and their caregivers in&#xD;
      Ghana and other resource-limited settings. Results from this project will also further an&#xD;
      understanding of factors and processes driving pediatric HIV disclosure.The study hypothesis&#xD;
      is that several key barriers to disclosure of HIV status can be modified and the process of&#xD;
      disclosure promoted with an intervention approach that is grounded in a traditional Ghanaian&#xD;
      concept.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The project aims to provide information on a structured disclosure intervention that can be&#xD;
      integrated into usual care in Ghana and other resource-limited settings to improve the&#xD;
      welfare of HIV-infected children and their caregivers. This area of investigation is&#xD;
      profoundly understudied and of high importance to millions of children and their families in&#xD;
      sub-Saharan Africa. While widely recognized as vital to better health outcomes, especially in&#xD;
      the era of better access to HIV treatment, many children are not informed of their HIV&#xD;
      diagnosis. A variety of sociocultural contextual barriers and deficient skills drive the&#xD;
      persistent reluctance of caregivers and health care providers to inform children of the&#xD;
      diagnosis. Our preliminary work shows that several key factors can be modified and the&#xD;
      process of disclosure promoted with an intervention approach that is grounded in a&#xD;
      traditional Ghanaian concept, &quot;SANKOFA&quot;, and behavioral and bioecological systems theory. The&#xD;
      patient-centered intervention approach uses an Adherence and Disclosure specialist model&#xD;
      where a designated specialist familiar with the socio-cultural norms of the community is well&#xD;
      trained to target modifiable information, motivation and behavioral skills of caregivers to&#xD;
      facilitate their engagement in the process of disclosure (i.e., pre-disclosure, disclosure,&#xD;
      and post-disclosure phases) in a manner suitable to the needs of the child.&#xD;
&#xD;
      The primary aims are: (1) To evaluate the effect of a structured, culturally-relevant&#xD;
      disclosure intervention to caregivers delivered by a specialist as an integral component of&#xD;
      routine HIV healthcare on the rate of caregiver disclosure of pediatric HIV at 1 year&#xD;
      follow-up compared to treatment as usual, control condition, in a randomized trial and (2) To&#xD;
      identify baseline characteristics (e.g., caregiver knowledge &amp; motivation, child's age)&#xD;
      predictive of caregiver disclosure of pediatric HIV independent of and in the presence of the&#xD;
      structured disclosure intervention at 1 year follow-up.&#xD;
&#xD;
      Secondary aims are: (3) To assess whether the effect of HIV pediatric disclosure on&#xD;
      medication adherence and health outcomes of children (virologic, immunologic, psychosocial,&#xD;
      and behavioral) and the caregiver (psychosocial) varies by exposure vs non-exposure to the&#xD;
      structured disclosure intervention and (4) To assess the fidelity and acceptability of the&#xD;
      disclosure intervention over time among the clinic personnel designated disclosure&#xD;
      specialist, caregiver, and children to whom HIV status has been disclosed. Provider,&#xD;
      caregiver and child participants will be enrolled from tertiary HIV clinics in Ghana with&#xD;
      longitudinal outcomes evaluated every 3 months post-randomization to 24 months post&#xD;
      disclosure.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2013</start_date>
  <completion_date type="Actual">June 30, 2017</completion_date>
  <primary_completion_date type="Actual">June 30, 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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>HIV disclosure rate</measure>
    <time_frame>one year after intervention</time_frame>
    <description>Structured and caregiver-centered and culturally-relevant disclosure intervention will be delivered by an adherence and disclosure specialist to the caregiver. After one year, the rate of disclosure of the HIV status of the children will be assessed.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Baseline characteristics of caregiver predictive of disclosure to the child his/her HIV status</measure>
    <time_frame>one year</time_frame>
    <description>Baseline characteristics (e.g., caregiver knowledge &amp; motivation, child's age) predictive of caregiver disclosure of pediatric HIV independent of and in the presence of the structured disclosure intervention at 1 year follow-up.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Medication adherence of children</measure>
    <time_frame>two years</time_frame>
    <description>The effect of HIV pediatric disclosure on medication adherence will be evaluated and compared between the two study arms - exposure vs non-exposure to the structured disclosure intervention.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health outcomes of children</measure>
    <time_frame>2 years</time_frame>
    <description>The effect of HIV pediatric disclosure on health outcomes of children (virologic - viral load, immunologic - CD4 count, psychosocial, and behavioral) will be evaluated and compared between the two study arms - exposure vs non-exposure to the structured disclosure intervention.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health outcomes of caregiver</measure>
    <time_frame>2 years</time_frame>
    <description>The effect of HIV pediatric disclosure on the psychosocial well being of the caregiver will be evaluated and compared between the two study arms - exposure vs non-exposure to the structured disclosure intervention.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Fidelity of the disclosure intervention</measure>
    <time_frame>5 years</time_frame>
    <description>The fidelity of the disclosure intervention over time among the clinic personnel designated disclosure specialist, caregiver, and children to whom HIV status has been disclosed will be assessed over the study period.</description>
  </other_outcome>
  <other_outcome>
    <measure>Acceptability of the disclosure intervention</measure>
    <time_frame>5 years</time_frame>
    <description>The acceptability of the disclosure intervention over time among the clinic personnel designated disclosure specialist, caregiver, and children to whom HIV status has been disclosed will be assessed over the study period.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">446</enrollment>
  <condition>HIV</condition>
  <arm_group>
    <arm_group_label>Disclosure intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In the disclosure intervention plus usual care arm the adherence and disclosure specialist will meet with caregiver at each clinic visit and provide information, education, disclosure skills, and support till disclosure occurs.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual care</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>In the &quot;enhanced usual care (control)&quot; arm the disclosure specialist will meet with caregiver at each clinic visit and provide them will general health education and no mention or effort will be made to improve disclosure skills of caregiver.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Disclosure intervention</intervention_name>
    <description>An adherence and disclosure specialist will meet with caregiver-child dyad at each clinic visit and provide caregiver information and skills for HIV disclosure till the caregiver discloses the HIV status to the child.</description>
    <arm_group_label>Disclosure intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>usual care</intervention_name>
    <description>An adherence and disclosure specialist will meet with caregiver-child dyad at each clinic visit and provide caregiver with general health information without referencing HIV disclosure in their conversations till the caregiver discloses the HIV status to the child.</description>
    <arm_group_label>Usual care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  HIV-infected children receiving care at the study sites&#xD;
&#xD;
          -  started on antiretroviral therapy (ART) for the first time within 12 months of&#xD;
             screening&#xD;
&#xD;
          -  Or Child is going on ART at the time of screening&#xD;
&#xD;
          -  Or child had achieved and maintained at least 25% of CD4+ T-lymphocytes according to&#xD;
             age on treatment irrespective of duration of ART within 6 months prior to enrollment&#xD;
&#xD;
          -  do not know their HIV diagnosis (based on caregiver account and medical records&#xD;
             confirmation)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  HIV-infected children less than 7 years&#xD;
&#xD;
          -  HIV-infected children with congenital or developmental disorders&#xD;
&#xD;
          -  HIV-infected children with comorbidities such as sickle cell disease or diabetes that&#xD;
             require frequent clinic visits or hospitalizations&#xD;
&#xD;
          -  Children with AIDS-defining illness or end stage AIDS.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>7 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Elijah Pantsil, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Yale University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Komfo Anoky Teaching Hospital</name>
      <address>
        <city>Kumasi</city>
        <state>Ashanti Region</state>
        <country>Ghana</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Korle-Bu Teaching Hospital</name>
      <address>
        <city>Accra</city>
        <state>Greater Accra Region</state>
        <country>Ghana</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Ghana</country>
  </location_countries>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>October 2, 2012</study_first_submitted>
  <study_first_submitted_qc>October 3, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 5, 2012</study_first_posted>
  <last_update_submitted>March 4, 2020</last_update_submitted>
  <last_update_submitted_qc>March 4, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 9, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Disclosure</keyword>
  <keyword>HIV-infected children</keyword>
  <keyword>Resource-limited settings</keyword>
  <!-- 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/NCT01701635
org study id: 1205010310
secondary id: NIH/NICHD
secondary id: R01HD074253
nct id: NCT01701635
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
A culturally-relevant, theoretically and empirically sound, patient-centered, standardized
      disclosure intervention that can be integrated into routine clinical pediatric HIV care has
      potential to prevent transmission and improve the welfare of children and their caregivers in
      Ghana and other resource-limited settings. Results from this project will also further an
      understanding of factors and processes driving pediatric HIV disclosure.The study hypothesis
      is that several key barriers to disclosure of HIV status can be modified and the process of
      disclosure promoted with an intervention approach that is grounded in a traditional Ghanaian
      concept.
The project aims to provide information on a structured disclosure intervention that can be
      integrated into usual care in Ghana and other resource-limited settings to improve the
      welfare of HIV-infected children and their caregivers. This area of investigation is
      profoundly understudied and of high importance to millions of children and their families in
      sub-Saharan Africa. While widely recognized as vital to better health outcomes, especially in
      the era of better access to HIV treatment, many children are not informed of their HIV
      diagnosis. A variety of sociocultural contextual barriers and deficient skills drive the
      persistent reluctance of caregivers and health care providers to inform children of the
      diagnosis. Our preliminary work shows that several key factors can be modified and the
      process of disclosure promoted with an intervention approach that is grounded in a
      traditional Ghanaian concept, "SANKOFA", and behavioral and bioecological systems theory. The
      patient-centered intervention approach uses an Adherence and Disclosure specialist model
      where a designated specialist familiar with the socio-cultural norms of the community is well
      trained to target modifiable information, motivation and behavioral skills of caregivers to
      facilitate their engagement in the process of disclosure (i.e., pre-disclosure, disclosure,
      and post-disclosure phases) in a manner suitable to the needs of the child.

      The primary aims are: (1) To evaluate the effect of a structured, culturally-relevant
      disclosure intervention to caregivers delivered by a specialist as an integral component of
      routine HIV healthcare on the rate of caregiver disclosure of pediatric HIV at 1 year
      follow-up compared to treatment as usual, control condition, in a randomized trial and (2) To
      identify baseline characteristics (e.g., caregiver knowledge & motivation, child's age)
      predictive of caregiver disclosure of pediatric HIV independent of and in the presence of the
      structured disclosure intervention at 1 year follow-up.

      Secondary aims are: (3) To assess whether the effect of HIV pediatric disclosure on
      medication adherence and health outcomes of children (virologic, immunologic, psychosocial,
      and behavioral) and the caregiver (psychosocial) varies by exposure vs non-exposure to the
      structured disclosure intervention and (4) To assess the fidelity and acceptability of the
      disclosure intervention over time among the clinic personnel designated disclosure
      specialist, caregiver, and children to whom HIV status has been disclosed. Provider,
      caregiver and child participants will be enrolled from tertiary HIV clinics in Ghana with
      longitudinal outcomes evaluated every 3 months post-randomization to 24 months post
      disclosure.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: HIV disclosure rate
time frame: one year after intervention
description: Structured and caregiver-centered and culturally-relevant disclosure intervention will be delivered by an adherence and disclosure specialist to the caregiver. After one year, the rate of disclosure of the HIV status of the children will be assessed.
measure: Baseline characteristics of caregiver predictive of disclosure to the child his/her HIV status
time frame: one year
description: Baseline characteristics (e.g., caregiver knowledge & motivation, child's age) predictive of caregiver disclosure of pediatric HIV independent of and in the presence of the structured disclosure intervention at 1 year follow-up.
measure: Medication adherence of children
time frame: two years
description: The effect of HIV pediatric disclosure on medication adherence will be evaluated and compared between the two study arms - exposure vs non-exposure to the structured disclosure intervention.
measure: Health outcomes of children
time frame: 2 years
description: The effect of HIV pediatric disclosure on health outcomes of children (virologic - viral load, immunologic - CD4 count, psychosocial, and behavioral) will be evaluated and compared between the two study arms - exposure vs non-exposure to the structured disclosure intervention.
measure: Health outcomes of caregiver
time frame: 2 years
description: The effect of HIV pediatric disclosure on the psychosocial well being of the caregiver will be evaluated and compared between the two study arms - exposure vs non-exposure to the structured disclosure intervention.
measure: Fidelity of the disclosure intervention
time frame: 5 years
description: The fidelity of the disclosure intervention over time among the clinic personnel designated disclosure specialist, caregiver, and children to whom HIV status has been disclosed will be assessed over the study period.
measure: Acceptability of the disclosure intervention
time frame: 5 years
description: The acceptability of the disclosure intervention over time among the clinic personnel designated disclosure specialist, caregiver, and children to whom HIV status has been disclosed will be assessed over the study period.
arm group label: Disclosure intervention
arm group type: Experimental
description: In the disclosure intervention plus usual care arm the adherence and disclosure specialist will meet with caregiver at each clinic visit and provide information, education, disclosure skills, and support till disclosure occurs.
arm group label: Usual care
arm group type: Active Comparator
description: In the "enhanced usual care (control)" arm the disclosure specialist will meet with caregiver at each clinic visit and provide them will general health education and no mention or effort will be made to improve disclosure skills of caregiver.
intervention type: Behavioral
intervention name: Disclosure intervention
description: An adherence and disclosure specialist will meet with caregiver-child dyad at each clinic visit and provide caregiver information and skills for HIV disclosure till the caregiver discloses the HIV status to the child.
arm group label: Disclosure intervention
intervention type: Behavioral
intervention name: usual care
description: An adherence and disclosure specialist will meet with caregiver-child dyad at each clinic visit and provide caregiver with general health information without referencing HIV disclosure in their conversations till the caregiver discloses the HIV status to the child.
arm group label: Usual care
criteria: 
gender: All
minimum age: 7 Years
maximum age: 18 Years
healthy volunteers: No
last name: Elijah Pantsil, MD
role: Principal Investigator
affiliation: Yale University
facility: 
facility: 
country: Ghana
responsible party type: Sponsor