<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/NCT03231358</url>
  </required_header>
  <id_info>
    <org_study_id>R01MH114843</org_study_id>
    <nct_id>NCT03231358</nct_id>
  </id_info>
  <brief_title>Our Family Our Future: A Resilience-oriented Family Intervention to Prevent Adolescent HIV/STI Infection and Depression in South Africa</brief_title>
  <official_title>Our Family Our Future: A Resilience-oriented Family Intervention to Prevent Adolescent HIV/STI Infection and Depression in South Africa</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Brown University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Cape Town</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Desmond Tutu HIV Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Medical Research Council, South Africa</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Rhode Island Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Brown University</source>
  <oversight_info>
    <has_dmc>Yes</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 purpose of this study is to test the efficacy of Our Family Our Future, an integrated&#xD;
      intervention for preventing HIV and depression onset among adolescents.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Adolescent human immunodeficiency virus (HIV) and depression present significant public&#xD;
      health challenges for South Africa, a country with the largest HIV epidemic globally and&#xD;
      where structural factors including violence and poverty increase susceptibility for poor&#xD;
      mental health. In families already experiencing psychological distress, adolescents face&#xD;
      elevated risk for sexually transmitted infections (STIs) including HIV and depression.&#xD;
      Preventive interventions are urgently needed during adolescence when risks for HIV, STIs, and&#xD;
      depression in-crease exponentially. Preventive intervention strategies for adolescents should&#xD;
      substantively involve families who can tailor prevention content to meet the unique needs of&#xD;
      individual adolescents and reinforce formation and habituation of prevention behaviors.&#xD;
      Moreover, evidence indicates common family risk and protective factors for adolescent HIV/STI&#xD;
      risk behaviors and depression, underscoring the need for a family prevention approach.&#xD;
      However, key gaps exist in family prevention science. In South Africa, few empirically&#xD;
      supported family interventions integrate prevention of HIV/STI with depression for&#xD;
      adolescents. This intervention (called Our Family Our Future) uses a resilience-oriented&#xD;
      approach engages families in adolescent prevention from low-resource settings facing high&#xD;
      adversity. The study will focus on adolescents (14-16 years) who are at an ideal&#xD;
      developmental transition for family engagement in prevention. The age- and&#xD;
      developmentally-tailored intervention - called Our Family Our Future - is based off of two&#xD;
      empirically supported interventions that have been integrated and adapted to South Africa. In&#xD;
      a pilot randomized trial, Our Family Our Future exhibited outstanding acceptability,&#xD;
      feasibility and promising direction of effects including reductions of depressive symptoms;&#xD;
      lower rates of sex; decreased unprotected sex; increased HIV testing; increased knowledge,&#xD;
      motivation, intentions and self-efficacy for protective HIV/STI behaviors; improved family&#xD;
      interactions; and increased resilience. Now investigators propose the next phase of this&#xD;
      research program, an efficacy study of Our Family Our Future with three aims: (1) test the&#xD;
      efficacy of the Our Family Our Future intervention in preventing HIV/STI acquisition among&#xD;
      adolescents (14-16) with depressive symptoms by reducing HIV/STI risk behavior, and reducing&#xD;
      depressive symptoms. The project will randomize N=880 adolescents to Our Family Our Future&#xD;
      intervention or usual care with 6- and 12-month outcome assessments; (2) examine the extent&#xD;
      to which the impact of the Our Family Our Future intervention is a) mediated by changes in&#xD;
      resilience; behavioral skills; norms and attitudes relating to sex, condom use, gender; and&#xD;
      family communication and functioning and b) moderated by the effect of sociodemographics,&#xD;
      family HIV, and social protections; (3) identify barriers and facilitators to implementing&#xD;
      Our Family Our Future within a large community-based organization setting with wide reach to&#xD;
      provide data for future dissemination and scale-up.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">November 21, 2018</start_date>
  <completion_date type="Anticipated">August 31, 2023</completion_date>
  <primary_completion_date type="Actual">August 31, 2022</primary_completion_date>
  <phase>Phase 3</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>We will randomize adolescents (with parents) to an intervention arm (testing Our Family Our Future, n=440) or a control arm (n=440) of usual care (consisting of a packet of existing available brochures on HIV, STIs, mental health including places to access care). We will randomize based on permuted blocked randomization.</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>incidence of composite HIV/STIs</measure>
    <time_frame>12 months</time_frame>
    <description>We will examine whether the intervention produces reductions in HIV and STI incidence using biological tests for HIV, Chlamydia trachomatis, and Neisseria gonorrhoeae.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>rates of sexual risk behavior</measure>
    <time_frame>12 months</time_frame>
    <description>We will examine whether the intervention produces reductions in rates of actual and intended sexual risk behavior, as measured through the number of unprotected sex acts.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>depressive symptoms</measure>
    <time_frame>12 months</time_frame>
    <description>We will examine whether the intervention produces reductions in depressive symptoms. Depressive symptoms will be measured through symptom scores on the Center for Epidemiologic Studies Depression Scale - Child Version (CES-DC)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Resilience</measure>
    <time_frame>12 months</time_frame>
    <description>We examine whether resilience mediates the the efficacy of Our Family Our Future on prevention of HIV/STI acquisition, reducing HIV/STI risk behavior, and reductions in depressive symptoms. We measure resilience using a sum score on a resilience measure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>protective sex behavioral skills</measure>
    <time_frame>12 months</time_frame>
    <description>We examine whether protective sex behavioral skills - for condom use, sex refusal - mediates the the efficacy of Our Family Our Future on prevention of HIV/STI acquisition, reducing HIV/STI risk behavior, and reductions in depressive symptoms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>self efficacy for protective behavioral skills</measure>
    <time_frame>12 months</time_frame>
    <description>We examine whether self efficacy for protective sex behavioral skills - for condom use, sex refusal - mediates the the efficacy of Our Family Our Future on prevention of HIV/STI acquisition, reducing HIV/STI risk behavior, and reductions in depressive symptoms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>intolerant or tolerant attitudes relating to sex, condom use, and gender equitable relationships</measure>
    <time_frame>12 months</time_frame>
    <description>We examine whether attitudes around sex, condom use, and gender equity mediates the the efficacy of Our Family Our Future on prevention of HIV/STI acquisition, reducing HIV/STI risk behavior, and reductions in depressive symptoms. These are measured through likert scales.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>intolerant or tolerant social norms relating to sex, condom use, and gender equitable relationships</measure>
    <time_frame>12 months</time_frame>
    <description>We examine whether intolerant or tolerant social norms around sex, condom use, and gender mediates the the efficacy of Our Family Our Future on prevention of HIV/STI acquisition, reducing HIV/STI risk behavior, and reductions in depressive symptoms. We measure these through likert scales.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>family communication</measure>
    <time_frame>12 months</time_frame>
    <description>We examine whether family communication mediates the the efficacy of Our Family Our Future on prevention of HIV/STI acquisition, reducing HIV/STI risk behavior, and reductions in depressive symptoms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>access to social support</measure>
    <time_frame>12 months</time_frame>
    <description>We examine whether social support - the the form of a sum score of social support on a social support measure called the Multidimensional Scale of Perceived Social Support - mediates the the efficacy of Our Family Our Future on prevention of HIV/STI acquisition, reducing HIV/STI risk behavior, and reductions in depressive symptoms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sociodemographic characteristics of the participant</measure>
    <time_frame>12 months</time_frame>
    <description>We examine whether the extent of impact of the intervention on outcomes is moderated by the effect of sociodemographics of the adolescent participant including gender, age, race and ethnicity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sociodemographic characteristics of the parent</measure>
    <time_frame>12 months</time_frame>
    <description>We examine whether the extent of impact of the intervention on outcomes is moderated by the effect of sociodemographics of the parent including gender, age, race and ethnicity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Severity of parental depressive symptoms</measure>
    <time_frame>12 months</time_frame>
    <description>We examine whether the extent of impact of the intervention on outcomes is moderated by the effect of parental depressive symptoms as measured by the Center for Epidemiologic Studies Depression Scale.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>presence of HIV in the family</measure>
    <time_frame>12 months</time_frame>
    <description>We examine whether the extent of impact of the intervention on outcomes is moderated by the effect of family HIV including HIV infection among family members.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>orphanhood of adolescent participant</measure>
    <time_frame>12 months</time_frame>
    <description>We examine whether the extent of impact of the intervention on outcomes is moderated by the adolescent participant's orphanhood status answered by a self-report item asking about orphanhood status, defined as maternal or paternal or double orphanhood.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>presence of food insecurity</measure>
    <time_frame>12 months</time_frame>
    <description>We examine whether the extent of impact of the intervention on outcomes is moderated by the effect of structural disparities such as the presence of food insecurity. We use a likert scale measure of food insecurity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>receipt of social protection grants</measure>
    <time_frame>12 months</time_frame>
    <description>We examine whether the extent of impact of the intervention on outcomes is moderated by the receipt of social protection grants as measured by self-report on whether the family receives any South African government social protection grants.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>treatment fidelity</measure>
    <time_frame>12 months</time_frame>
    <description>We will gather data on treatment fidelity (what % of time the intervention facilitators abide by core elements of a standardized implementation protocol) to evaluate how rigorous the intervention is being implemented.</description>
  </other_outcome>
  <other_outcome>
    <measure>intervention optimization</measure>
    <time_frame>12 months</time_frame>
    <description>We examine recruitment, retention, and attrition data by examining how many participants are involved in each timepoint of data collection as compared to the original number of enrolled participants.</description>
  </other_outcome>
  <other_outcome>
    <measure>intervention satisfaction</measure>
    <time_frame>12 months</time_frame>
    <description>We examine how much participants like and dislike the intervention by gathering satisfaction data using likert scales on open responses.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">880</enrollment>
  <condition>Human Immunodeficiency Virus</condition>
  <condition>Depression</condition>
  <condition>Sexually Transmitted Diseases</condition>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants randomized to the behavioral intervention called &quot;Our Family Our Future.&quot; These participants will receive an intervention to prevent sexually transmitted infections (STIs) including HIV, Chlamydia trachomatis and Neisseria gonorrhoeae; sexual risk behavior; and depression onset. This is a behavioral intervention involving adolescent-parent dyads, delivered in a group setting over 3-4 consecutive weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The control arm will receive usual care (consisting of a packet of existing available brochures on HIV, STIs, mental health including places to access care).</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Our Family Our Future</intervention_name>
    <description>Our Family Our Future is a 'selective' behavioral prevention program, designed to address HIV/STI acquisition, sexual risk behavior, and depression among adolescents (ages 14-16) in communities with high HIV prevalence and from families where adolescents and parents already exhibit mild, potentially troublesome, depressive symptoms but do not reach the threshold for further screening for a significant clinical depressive disorder. This intervention involves parent-child dyads who receive the intervention in a community setting, in a facilitated group format. The intervention is comprised of 3-hour sessions, held weekly for 3 consecutive weeks with an individual family meeting in the third or fourth week depending on family desires.</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  14-16 years&#xD;
&#xD;
          -  adolescent concurs that the adult identified is their parent (to also include primary&#xD;
             caregivers in the pa-rental role)&#xD;
&#xD;
          -  when more than one child in the family falls within the eligible age range, one child&#xD;
             will be chosen at random&#xD;
&#xD;
          -  lives in the household at least 4 days a week&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  no or low symptoms (&lt;6) or clinically significant thresholds of depression (16+)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>14 Years</minimum_age>
    <maximum_age>16 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Caroline Kuo, DPhil, MPhil</last_name>
    <role>Principal Investigator</role>
    <affiliation>Brown University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Linda-Gail Bekker, MBChB, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Desmond Tutu HIV Foundation</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Dan J Stein, MBChB, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Cape Town</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Masiphumelele</name>
      <address>
        <city>Cape Town</city>
        <state>Western Cape</state>
        <zip>7975</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>South Africa</country>
  </location_countries>
  <removed_countries>
    <country>United States</country>
  </removed_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>July 21, 2017</study_first_submitted>
  <study_first_submitted_qc>July 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 27, 2017</study_first_posted>
  <last_update_submitted>May 11, 2023</last_update_submitted>
  <last_update_submitted_qc>May 11, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 12, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Brown University</investigator_affiliation>
    <investigator_full_name>Caroline Kuo</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acquired Immunodeficiency Syndrome</mesh_term>
    <mesh_term>HIV Infections</mesh_term>
    <mesh_term>Sexually Transmitted Diseases</mesh_term>
    <mesh_term>Depression</mesh_term>
    <mesh_term>Depressive Disorder</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03231358
org study id: R01MH114843
nct id: NCT03231358
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to test the efficacy of Our Family Our Future, an integrated
      intervention for preventing HIV and depression onset among adolescents.
Adolescent human immunodeficiency virus (HIV) and depression present significant public
      health challenges for South Africa, a country with the largest HIV epidemic globally and
      where structural factors including violence and poverty increase susceptibility for poor
      mental health. In families already experiencing psychological distress, adolescents face
      elevated risk for sexually transmitted infections (STIs) including HIV and depression.
      Preventive interventions are urgently needed during adolescence when risks for HIV, STIs, and
      depression in-crease exponentially. Preventive intervention strategies for adolescents should
      substantively involve families who can tailor prevention content to meet the unique needs of
      individual adolescents and reinforce formation and habituation of prevention behaviors.
      Moreover, evidence indicates common family risk and protective factors for adolescent HIV/STI
      risk behaviors and depression, underscoring the need for a family prevention approach.
      However, key gaps exist in family prevention science. In South Africa, few empirically
      supported family interventions integrate prevention of HIV/STI with depression for
      adolescents. This intervention (called Our Family Our Future) uses a resilience-oriented
      approach engages families in adolescent prevention from low-resource settings facing high
      adversity. The study will focus on adolescents (14-16 years) who are at an ideal
      developmental transition for family engagement in prevention. The age- and
      developmentally-tailored intervention - called Our Family Our Future - is based off of two
      empirically supported interventions that have been integrated and adapted to South Africa. In
      a pilot randomized trial, Our Family Our Future exhibited outstanding acceptability,
      feasibility and promising direction of effects including reductions of depressive symptoms;
      lower rates of sex; decreased unprotected sex; increased HIV testing; increased knowledge,
      motivation, intentions and self-efficacy for protective HIV/STI behaviors; improved family
      interactions; and increased resilience. Now investigators propose the next phase of this
      research program, an efficacy study of Our Family Our Future with three aims: (1) test the
      efficacy of the Our Family Our Future intervention in preventing HIV/STI acquisition among
      adolescents (14-16) with depressive symptoms by reducing HIV/STI risk behavior, and reducing
      depressive symptoms. The project will randomize N=880 adolescents to Our Family Our Future
      intervention or usual care with 6- and 12-month outcome assessments; (2) examine the extent
      to which the impact of the Our Family Our Future intervention is a) mediated by changes in
      resilience; behavioral skills; norms and attitudes relating to sex, condom use, gender; and
      family communication and functioning and b) moderated by the effect of sociodemographics,
      family HIV, and social protections; (3) identify barriers and facilitators to implementing
      Our Family Our Future within a large community-based organization setting with wide reach to
      provide data for future dissemination and scale-up.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: We will randomize adolescents (with parents) to an intervention arm (testing Our Family Our Future, n=440) or a control arm (n=440) of usual care (consisting of a packet of existing available brochures on HIV, STIs, mental health including places to access care). We will randomize based on permuted blocked randomization.
primary purpose: Prevention
masking: Single (Outcomes Assessor)
measure: incidence of composite HIV/STIs
time frame: 12 months
description: We will examine whether the intervention produces reductions in HIV and STI incidence using biological tests for HIV, Chlamydia trachomatis, and Neisseria gonorrhoeae.
measure: rates of sexual risk behavior
time frame: 12 months
description: We will examine whether the intervention produces reductions in rates of actual and intended sexual risk behavior, as measured through the number of unprotected sex acts.
measure: depressive symptoms
time frame: 12 months
description: We will examine whether the intervention produces reductions in depressive symptoms. Depressive symptoms will be measured through symptom scores on the Center for Epidemiologic Studies Depression Scale - Child Version (CES-DC)
measure: Resilience
time frame: 12 months
description: We examine whether resilience mediates the the efficacy of Our Family Our Future on prevention of HIV/STI acquisition, reducing HIV/STI risk behavior, and reductions in depressive symptoms. We measure resilience using a sum score on a resilience measure.
measure: protective sex behavioral skills
time frame: 12 months
description: We examine whether protective sex behavioral skills - for condom use, sex refusal - mediates the the efficacy of Our Family Our Future on prevention of HIV/STI acquisition, reducing HIV/STI risk behavior, and reductions in depressive symptoms.
measure: self efficacy for protective behavioral skills
time frame: 12 months
description: We examine whether self efficacy for protective sex behavioral skills - for condom use, sex refusal - mediates the the efficacy of Our Family Our Future on prevention of HIV/STI acquisition, reducing HIV/STI risk behavior, and reductions in depressive symptoms.
measure: intolerant or tolerant attitudes relating to sex, condom use, and gender equitable relationships
time frame: 12 months
description: We examine whether attitudes around sex, condom use, and gender equity mediates the the efficacy of Our Family Our Future on prevention of HIV/STI acquisition, reducing HIV/STI risk behavior, and reductions in depressive symptoms. These are measured through likert scales.
measure: intolerant or tolerant social norms relating to sex, condom use, and gender equitable relationships
time frame: 12 months
description: We examine whether intolerant or tolerant social norms around sex, condom use, and gender mediates the the efficacy of Our Family Our Future on prevention of HIV/STI acquisition, reducing HIV/STI risk behavior, and reductions in depressive symptoms. We measure these through likert scales.
measure: family communication
time frame: 12 months
description: We examine whether family communication mediates the the efficacy of Our Family Our Future on prevention of HIV/STI acquisition, reducing HIV/STI risk behavior, and reductions in depressive symptoms.
measure: access to social support
time frame: 12 months
description: We examine whether social support - the the form of a sum score of social support on a social support measure called the Multidimensional Scale of Perceived Social Support - mediates the the efficacy of Our Family Our Future on prevention of HIV/STI acquisition, reducing HIV/STI risk behavior, and reductions in depressive symptoms.
measure: Sociodemographic characteristics of the participant
time frame: 12 months
description: We examine whether the extent of impact of the intervention on outcomes is moderated by the effect of sociodemographics of the adolescent participant including gender, age, race and ethnicity.
measure: Sociodemographic characteristics of the parent
time frame: 12 months
description: We examine whether the extent of impact of the intervention on outcomes is moderated by the effect of sociodemographics of the parent including gender, age, race and ethnicity.
measure: Severity of parental depressive symptoms
time frame: 12 months
description: We examine whether the extent of impact of the intervention on outcomes is moderated by the effect of parental depressive symptoms as measured by the Center for Epidemiologic Studies Depression Scale.
measure: presence of HIV in the family
time frame: 12 months
description: We examine whether the extent of impact of the intervention on outcomes is moderated by the effect of family HIV including HIV infection among family members.
measure: orphanhood of adolescent participant
time frame: 12 months
description: We examine whether the extent of impact of the intervention on outcomes is moderated by the adolescent participant's orphanhood status answered by a self-report item asking about orphanhood status, defined as maternal or paternal or double orphanhood.
measure: presence of food insecurity
time frame: 12 months
description: We examine whether the extent of impact of the intervention on outcomes is moderated by the effect of structural disparities such as the presence of food insecurity. We use a likert scale measure of food insecurity.
measure: receipt of social protection grants
time frame: 12 months
description: We examine whether the extent of impact of the intervention on outcomes is moderated by the receipt of social protection grants as measured by self-report on whether the family receives any South African government social protection grants.
measure: treatment fidelity
time frame: 12 months
description: We will gather data on treatment fidelity (what % of time the intervention facilitators abide by core elements of a standardized implementation protocol) to evaluate how rigorous the intervention is being implemented.
measure: intervention optimization
time frame: 12 months
description: We examine recruitment, retention, and attrition data by examining how many participants are involved in each timepoint of data collection as compared to the original number of enrolled participants.
measure: intervention satisfaction
time frame: 12 months
description: We examine how much participants like and dislike the intervention by gathering satisfaction data using likert scales on open responses.
arm group label: Intervention
arm group type: Experimental
description: Participants randomized to the behavioral intervention called "Our Family Our Future." These participants will receive an intervention to prevent sexually transmitted infections (STIs) including HIV, Chlamydia trachomatis and Neisseria gonorrhoeae; sexual risk behavior; and depression onset. This is a behavioral intervention involving adolescent-parent dyads, delivered in a group setting over 3-4 consecutive weeks.
arm group label: Control
arm group type: No Intervention
description: The control arm will receive usual care (consisting of a packet of existing available brochures on HIV, STIs, mental health including places to access care).
intervention type: Behavioral
intervention name: Our Family Our Future
description: Our Family Our Future is a 'selective' behavioral prevention program, designed to address HIV/STI acquisition, sexual risk behavior, and depression among adolescents (ages 14-16) in communities with high HIV prevalence and from families where adolescents and parents already exhibit mild, potentially troublesome, depressive symptoms but do not reach the threshold for further screening for a significant clinical depressive disorder. This intervention involves parent-child dyads who receive the intervention in a community setting, in a facilitated group format. The intervention is comprised of 3-hour sessions, held weekly for 3 consecutive weeks with an individual family meeting in the third or fourth week depending on family desires.
arm group label: Intervention
criteria: 
gender: All
minimum age: 14 Years
maximum age: 16 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Caroline Kuo, DPhil, MPhil
role: Principal Investigator
affiliation: Brown University
last name: Linda-Gail Bekker, MBChB, PhD
role: Principal Investigator
affiliation: Desmond Tutu HIV Foundation
last name: Dan J Stein, MBChB, PhD
role: Principal Investigator
affiliation: University of Cape Town
facility: 
country: South Africa
country: United States
responsible party type: Principal Investigator
investigator affiliation: Brown University
investigator full name: Caroline Kuo
investigator title: Assistant Professor
mesh term: Acquired Immunodeficiency Syndrome
mesh term: HIV Infections
mesh term: Sexually Transmitted Diseases
mesh term: Depression
mesh term: Depressive Disorder
sharing ipd: Undecided