<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/NCT04442399</url>
  </required_header>
  <id_info>
    <org_study_id>IRB00006271</org_study_id>
    <nct_id>NCT04442399</nct_id>
  </id_info>
  <brief_title>Family Connection: Pilot of Family-based Self-management for HIV-infected Adolescents</brief_title>
  <official_title>Pilot of Family-based Self-management for HIV-infected Adolescents in Two Clinics in Ndola</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Johns Hopkins Bloomberg School of Public Health</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>FHI 360</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Johns Hopkins Bloomberg School of Public Health</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>
      The study design has two phases. The first phase is the refinement of intervention manual for&#xD;
      an adolescent living with HIV (ALHIV)and their caregiver intervention, followed by a second&#xD;
      phase feasibility pilot study. The study goals are to refine and pilot a feasible&#xD;
      intervention that fosters resiliency and draws upon the strengths of adolescents and their&#xD;
      families. Specific aims include to: (1) Refine activities and an intervention manual for a&#xD;
      family-focused group intervention for adolescents and their caregivers to improve HIV&#xD;
      self-management among adolescents living with HIV; (2) conduct a pilot study to assess the&#xD;
      acceptability and feasibility of the group intervention among 50 adolescent/caregiver pairs&#xD;
      that are randomly assigned to the intervention or the comparison arms, and (sub aim 2a)&#xD;
      examine preliminary trends in outcome measures, including Anti-Retroviral Therapy (ART)&#xD;
      adherence, safer sex behaviors and stigma, comparing the intervention and comparison study&#xD;
      arms.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The need for effective interventions to support adolescent HIV self-management is&#xD;
      particularly pressing in Sub-Saharan Africa (SSA) where the majority of the 2.1 million ALHIV&#xD;
      reside. Highlighting the vulnerability of ALHIV is their increasing HIV-related mortality, up&#xD;
      50% in 2012 compared to 2005, while the global number of HIV-related deaths among all ages&#xD;
      decreased by 30%. In response to the disparate burden of HIV mortality among ALHIV, combined&#xD;
      with the compelling evidence from HIV prevention and chronic illness literature and research&#xD;
      on the influential role of families, the study team propose to refine and pilot test an&#xD;
      ALHIV/caregiver group intervention. This intervention will draw upon principles of Positive&#xD;
      Youth Development (PYD) and Social Cognitive theory (SCT) to emphasize skills building,&#xD;
      self-efficacy, youth participation, and strengthening adult relationships. The intervention&#xD;
      will build upon an existing ALHIV support group guide and utilize trained facilitators to&#xD;
      hold group sessions with ALHIV and their caregivers to: 1) improve understanding of HIV among&#xD;
      ALHIV and caregivers; 2) help ALHIV develop strategies for healthy living including adherence&#xD;
      to ART; 3) build the capacity of ALHIV to make informed decisions about their sexual and&#xD;
      reproductive health; 4) build the capacity of caregivers to support ALHIV; and 5) help ALHIV&#xD;
      develop life skills to communicate their HIV diagnosis effectively, and to plan for their&#xD;
      future. The study design has two phases. The first phase is the refinement of the&#xD;
      ALHIV/caregiver intervention manual followed by a second phase feasibility pilot study. The&#xD;
      Study goals are to refine and pilot a feasible intervention that fosters resiliency and draws&#xD;
      upon the strengths of adolescents and their families. Specific aims include to: (1) Refine&#xD;
      activities and an intervention manual for a family-focused group intervention for adolescents&#xD;
      and their caregivers to improve HIV self-management among adolescents living with HIV; (2)&#xD;
      conduct a pilot study to assess the acceptability and feasibility of the group intervention&#xD;
      among 50 adolescent/caregiver pairs that are randomly assigned to the intervention or the&#xD;
      comparison arms, and (sub aim 2a) examine preliminary trends in outcome measures, including&#xD;
      ART adherence, safer sex behaviors and stigma, comparing the intervention and comparison&#xD;
      study arms.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 2016</start_date>
  <completion_date type="Actual">June 2017</completion_date>
  <primary_completion_date type="Actual">December 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>
    <intervention_model_description>Randomized Controlled Trial</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of adolescent/caregiver pairs who attend Family Connections (feasibility)</measure>
    <time_frame>Attendance over the course of the 6 month intervention collected using attendance log.</time_frame>
    <description>Feasibility was assessed based on attendance at the intervention sessions.We considered the intervention feasible if at least two-thirds of the pairs attended 80% or more of the intervention sessions.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Proportion of participants who would recommend the Family Connections program (acceptability)</measure>
    <time_frame>At the six-month endline data collection</time_frame>
    <description>The proportion of participants who reported during the endline survey that they would recommend the intervention to others.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Youth Participants' mean ART adherence over six months using daily medication electronic monitoring system (MEMS) caps data</measure>
    <time_frame>Collected monthly over the course of the six month intervention</time_frame>
    <description>Medication electronic monitoring system (MEMS) caps data recorded the date and time the pill bottle was opened.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of participants with viral failure (1,000 copies or more per mL)</measure>
    <time_frame>~ 6 months (from baseline to endline)</time_frame>
    <description>Defined as having 1,000 or more RNA copies per mL</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Youth Participants' adolescent internalized stigma measures (yes/no)</measure>
    <time_frame>~ 6 months (from baseline to endline]</time_frame>
    <description>Three agree/disagree statements from the Internalized AIDS Stigma Scale (IA-RSS) as adapted previously in Zambia - low chronbach's alpha resulted in the three measures being analyzed as separate indicators.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>HIV</condition>
  <condition>Adolescent Behavior</condition>
  <condition>Caregivers</condition>
  <condition>Africa</condition>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The intervention was based on the WHO-endorsed manual entitled Positive Connections: Leading Information and Support Groups for Adolescents Living with HIV. For Family Connections, a caregiver companion guide was developed. In brief, adolescent/caregiver pairs attended 10 intervention sessions held every other Saturday at their HIV clinic over a six-month period.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Comparison</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The comparison arm consisted of standard of care for adolescents as offered at the HIV clinics.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Family Connections</intervention_name>
    <description>Ten intervention sessions were covered, ranging form understanding HIV and to handling stigma and discrimination.</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adolescents: 15 and 19 years old, aware of their HIV status, and had been on ART for&#xD;
             at least six months&#xD;
&#xD;
          -  Caregivers:nominated by the adolescents and were at least 20 years old&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        - Caregiver: Being a biological parent is not an eligibility criterion&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>15 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Julie A Denison, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Johns Hopkins Bloomberg School of Public Health</affiliation>
  </overall_official>
  <location>
    <facility>
      <address>
        <city>Ndola</city>
        <country>Zambia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Zambia</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 18, 2020</study_first_submitted>
  <study_first_submitted_qc>June 18, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 22, 2020</study_first_posted>
  <last_update_submitted>March 21, 2023</last_update_submitted>
  <last_update_submitted_qc>March 21, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 22, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>HIV</keyword>
  <keyword>Adolescents</keyword>
  <keyword>Youth</keyword>
  <keyword>Caregivers</keyword>
  <keyword>Africa</keyword>
  <keyword>Intervention</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>We did not get assent/consent from participants to make their data available to a third party, therefore we are not able to make the data publicly available, rather our consent forms specified the following &quot;the study research team will have access to your data. This team includes the study investigators, research assistants and data analysts&quot;.</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/NCT04442399
org study id: IRB00006271
nct id: NCT04442399
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The study design has two phases. The first phase is the refinement of intervention manual for
      an adolescent living with HIV (ALHIV)and their caregiver intervention, followed by a second
      phase feasibility pilot study. The study goals are to refine and pilot a feasible
      intervention that fosters resiliency and draws upon the strengths of adolescents and their
      families. Specific aims include to: (1) Refine activities and an intervention manual for a
      family-focused group intervention for adolescents and their caregivers to improve HIV
      self-management among adolescents living with HIV; (2) conduct a pilot study to assess the
      acceptability and feasibility of the group intervention among 50 adolescent/caregiver pairs
      that are randomly assigned to the intervention or the comparison arms, and (sub aim 2a)
      examine preliminary trends in outcome measures, including Anti-Retroviral Therapy (ART)
      adherence, safer sex behaviors and stigma, comparing the intervention and comparison study
      arms.
The need for effective interventions to support adolescent HIV self-management is
      particularly pressing in Sub-Saharan Africa (SSA) where the majority of the 2.1 million ALHIV
      reside. Highlighting the vulnerability of ALHIV is their increasing HIV-related mortality, up
      50% in 2012 compared to 2005, while the global number of HIV-related deaths among all ages
      decreased by 30%. In response to the disparate burden of HIV mortality among ALHIV, combined
      with the compelling evidence from HIV prevention and chronic illness literature and research
      on the influential role of families, the study team propose to refine and pilot test an
      ALHIV/caregiver group intervention. This intervention will draw upon principles of Positive
      Youth Development (PYD) and Social Cognitive theory (SCT) to emphasize skills building,
      self-efficacy, youth participation, and strengthening adult relationships. The intervention
      will build upon an existing ALHIV support group guide and utilize trained facilitators to
      hold group sessions with ALHIV and their caregivers to: 1) improve understanding of HIV among
      ALHIV and caregivers; 2) help ALHIV develop strategies for healthy living including adherence
      to ART; 3) build the capacity of ALHIV to make informed decisions about their sexual and
      reproductive health; 4) build the capacity of caregivers to support ALHIV; and 5) help ALHIV
      develop life skills to communicate their HIV diagnosis effectively, and to plan for their
      future. The study design has two phases. The first phase is the refinement of the
      ALHIV/caregiver intervention manual followed by a second phase feasibility pilot study. The
      Study goals are to refine and pilot a feasible intervention that fosters resiliency and draws
      upon the strengths of adolescents and their families. Specific aims include to: (1) Refine
      activities and an intervention manual for a family-focused group intervention for adolescents
      and their caregivers to improve HIV self-management among adolescents living with HIV; (2)
      conduct a pilot study to assess the acceptability and feasibility of the group intervention
      among 50 adolescent/caregiver pairs that are randomly assigned to the intervention or the
      comparison arms, and (sub aim 2a) examine preliminary trends in outcome measures, including
      ART adherence, safer sex behaviors and stigma, comparing the intervention and comparison
      study arms.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Randomized Controlled Trial
primary purpose: Supportive Care
masking: None (Open Label)
measure: Number of adolescent/caregiver pairs who attend Family Connections (feasibility)
time frame: Attendance over the course of the 6 month intervention collected using attendance log.
description: Feasibility was assessed based on attendance at the intervention sessions.We considered the intervention feasible if at least two-thirds of the pairs attended 80% or more of the intervention sessions.
measure: Proportion of participants who would recommend the Family Connections program (acceptability)
time frame: At the six-month endline data collection
description: The proportion of participants who reported during the endline survey that they would recommend the intervention to others.
measure: Youth Participants' mean ART adherence over six months using daily medication electronic monitoring system (MEMS) caps data
time frame: Collected monthly over the course of the six month intervention
description: Medication electronic monitoring system (MEMS) caps data recorded the date and time the pill bottle was opened.
measure: Proportion of participants with viral failure (1,000 copies or more per mL)
time frame: ~ 6 months (from baseline to endline)
description: Defined as having 1,000 or more RNA copies per mL
measure: Youth Participants' adolescent internalized stigma measures (yes/no)
time frame: ~ 6 months (from baseline to endline]
description: Three agree/disagree statements from the Internalized AIDS Stigma Scale (IA-RSS) as adapted previously in Zambia - low chronbach's alpha resulted in the three measures being analyzed as separate indicators.
arm group label: Intervention
arm group type: Experimental
description: The intervention was based on the WHO-endorsed manual entitled Positive Connections: Leading Information and Support Groups for Adolescents Living with HIV. For Family Connections, a caregiver companion guide was developed. In brief, adolescent/caregiver pairs attended 10 intervention sessions held every other Saturday at their HIV clinic over a six-month period.
arm group label: Comparison
arm group type: No Intervention
description: The comparison arm consisted of standard of care for adolescents as offered at the HIV clinics.
intervention type: Behavioral
intervention name: Family Connections
description: Ten intervention sessions were covered, ranging form understanding HIV and to handling stigma and discrimination.
arm group label: Intervention
criteria: 
gender: All
minimum age: 15 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Julie A Denison, PhD
role: Principal Investigator
affiliation: Johns Hopkins Bloomberg School of Public Health
facility: 
country: Zambia
responsible party type: Sponsor
sharing ipd: No
ipd description: We did not get assent/consent from participants to make their data available to a third party, therefore we are not able to make the data publicly available, rather our consent forms specified the following "the study research team will have access to your data. This team includes the study investigators, research assistants and data analysts".