<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/NCT03307226</url>
  </required_header>
  <id_info>
    <org_study_id>201703102</org_study_id>
    <secondary_id>1R01MH113486-01</secondary_id>
    <nct_id>NCT03307226</nct_id>
  </id_info>
  <brief_title>Suubi4Her: A Combination Intervention Addressing HIV Risk Behaviors Among Older Adolescent Girls Transitioning Into Adulthood in Uganda</brief_title>
  <official_title>Suubi4Her: A Combination Intervention Addressing HIV Risk Behaviors Among Older Adolescent Girls Transitioning Into Adulthood in Uganda</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Washington University School of Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of Mental Health (NIMH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Washington University School of Medicine</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 examines the impact and cost associated with Suubi4Her, an innovative combination&#xD;
      intervention that aims to prevent HIV risk behaviors among 15-17 year-old girls living in&#xD;
      communities heavily affected by poverty and HIV/AIDS in Uganda. Participants will be randomly&#xD;
      assigned at the school level into one of three study conditions: 1) Savings (Youth&#xD;
      Development Accounts - YDA) - with a 1:1 incentive match rate - for education and&#xD;
      microenterprise development; 2) Savings (YDA) + Multiple Family Groups intervention; 3)&#xD;
      Control condition receiving standard health and sex education provided in schools. The&#xD;
      intervention will last for 24 months. Assessments will be conducted at baseline, 12, 24 and&#xD;
      36 months. Assessments will include biologically confirmed STIs, proportion of HIV infections&#xD;
      during the study period, and for HIV+ participants markers for ART adherence. The study aims&#xD;
      to examine the impact of the Suubi4Her intervention on behavioral health functioning, and&#xD;
      protecting adolescent girls against known HIV risk factors. The study will also examine the&#xD;
      cost-effectiveness of each intervention condition.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Aligned with the NIH priority of addressing disparities in new HIV infections and the UNAIDS&#xD;
      call for implementing combination HIV prevention approaches, the proposed study will examine&#xD;
      the impact and cost associated with Suubi4Her, an innovative combination intervention that&#xD;
      aims to prevent HIV risk behaviors among 14-17 year-old girls living in communities heavily&#xD;
      affected by poverty and HIV/AIDS in Uganda. In sub-Saharan Africa (SSA), family financial&#xD;
      stress can compromise the support available to adolescents, with girls living in poverty&#xD;
      exhibiting higher rates of risky sexual behavior increasing their vulnerability in acquiring&#xD;
      HIV and other STIs. At the same time, internalizing mental health disorders such as&#xD;
      depression and low self-esteem disproportionately affect girls and may be contributing to HIV&#xD;
      risk behavior. Against that backdrop, support over and above health and sex education is&#xD;
      needed to help adolescent girls in SSA successfully transition into young adulthood. The&#xD;
      proposed study is informed by two previously tested interventions - asset-based matched&#xD;
      savings accounts (YDA) and family strengthening through Multiple Family Groups (MFG) which&#xD;
      have successfully been implemented with younger primary school-going adolescents. Suubi4Her&#xD;
      will test the theory that youth cognitive and behavioral change is influenced by economic&#xD;
      stability while examining if enhanced intra-familial support and communication are needed to&#xD;
      maintain positive behavioral health functioning and reinforce engagement in protective health&#xD;
      behaviors. Nested within 47 secondary schools across four districts of Uganda heavily&#xD;
      impacted by HIV/AIDS, 1260 older girls (ages 14-17 at enrollment) will be randomly assigned&#xD;
      (at school level) to one of three study conditions: 1) Savings (Youth Development Accounts -&#xD;
      YDA)- with a 1:1 incentive match rate - for education and microenterprise development; 2)&#xD;
      Savings (YDA) + MFG intervention; 3) Control condition receiving standard health and sex&#xD;
      education provided in schools. The intervention will be provided for 24 months. Assessments&#xD;
      at baseline,12, 24, and 36-months will include biomedical data to measure our primary&#xD;
      sexual-risk outcome:1) proportion of girls' biologically confirmed STIs (Gonorrhea,&#xD;
      Trichomonas and Chlamydia); and secondary outcomes: 2) the proportion of new HIV infections&#xD;
      during the study period, and 3) for HIV+ girls, viral load and CD4 as markers of ART&#xD;
      adherence. The study aims are to: 1) Examine whether the Suubi4Her intervention is effective&#xD;
      in protecting adolescent girls against known HIV risk factors (including&#xD;
      economically-motivated sex and intimate partner violence). 2) Elucidate the effects of the&#xD;
      Suubi4Her intervention on behavioral health functioning (i.e., depression, self-efficacy and&#xD;
      hopelessness) and examine the effects of these variables as potential mechanisms of change,&#xD;
      mediating the relationship between each intervention and HIV risk reduction. 3) Evaluate the&#xD;
      cost-effectiveness of each intervention condition. The study will also use the Child&#xD;
      Depression Index and Beck Hopelessness Scale to examine the efficacy of interventions in&#xD;
      improving mental health in this vulnerable population.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 23, 2018</start_date>
  <completion_date type="Actual">March 30, 2021</completion_date>
  <primary_completion_date type="Actual">February 10, 2021</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>Prevention</primary_purpose>
    <masking>Double (Participant, Care Provider)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in proportion of STIs from baseline to follow-up assessments</measure>
    <time_frame>Every assessment time point (Baseline, 12-, 24-, and 36-month follow-up)</time_frame>
    <description>Change in proportion of girls biologically confirmed STIs (Gonorrhea, Tirchomonas, and Chlamydia) at each assessment time point (Baseline, 12-, 24-, and 36-month follow-up)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in proportion of new HIV infections</measure>
    <time_frame>Every assessment time point (Baseline, 12-, 24-, and 36-month follow-up)</time_frame>
    <description>Change in the proportion of new HIV infections at each assessment time point (Baseline, 12-, 24-, and 36-month follow-up)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in adherence to HIV treatment from baseline to follow-up assessments</measure>
    <time_frame>Every assessment time point (Baseline, 12-, 24-, and 36-month follow-up)</time_frame>
    <description>For HIV+ participants, adherence to HIV treatment regimen outcomes as measured through viral load and CD4 counts</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cost-Effectiveness Analyses</measure>
    <time_frame>Every year for five years</time_frame>
    <description>Cost-effectiveness analyses measuring the cost of achieving an agreed upon benefit, such as an additional year of schooling, employment, or a reduction in a disease. Costs will be measured on a per person basis. The costs of the intervention will include all program costs. Research costs will not be included.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">1260</enrollment>
  <condition>HIV/AIDS</condition>
  <arm_group>
    <arm_group_label>Youth Development Accounts (YDA)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Youth Development Accounts (YDA)&#xD;
Youth Development Accounts (YDA) with 1:1 incentive match rate to be used for education and microenterprise development&#xD;
Financial workshops on asset-building, saving and investing in Income Generating Activities (IGAs) Behavioral: Youth Development Accounts (YDA)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>YDA + Multiple Family Groups (MFG)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>YDA + Multiple Family Groups (MFG)&#xD;
Youth Development Accounts (YDA) with 1:1 incentive match rate to be used for education and microenterprise development&#xD;
Financial workshops on asset-building, saving and investing in Income Generating Activities (IGAs)&#xD;
Multiple Family Groups sessions focused on strengthening family relationships and mental health</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual Care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Usual Care consisting of curricula delivered at secondary schools in Uganda including Life Planning Skills, and Adolescent Sexual Reproductive Health</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Youth Development Accounts (YDA)</intervention_name>
    <description>Youth Development Accounts (YDA) with 1:1 incentive match rate to be used for education and microenterprise development Financial workshops on asset-building, saving and investing in Income Generating Activities (IGAs) Behavioral: Youth Development Accounts (YDA)</description>
    <arm_group_label>Youth Development Accounts (YDA)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>YDA + Multiple Family Groups (MFG)</intervention_name>
    <description>Youth Development Accounts (YDA) with 1:1 incentive match rate to be used for education and microenterprise development 12 Financial Management workshops on asset-building, saving and investing in Income Generating Activities (IGAs) 18 Multiple Family Groups sessions focused on strengthening family relationships and mental health</description>
    <arm_group_label>YDA + Multiple Family Groups (MFG)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        (1) female; (2) enrolled in first year of secondary school in Rakai, Masaka, Lwengo or&#xD;
        Kalungu districts; (3) age 14-17 years; (4) living within a family (broadly defined and not&#xD;
        an institution or orphanage, as those in institutions have different familial needs)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        (5) they have a cognitive or severe psychiatric impairment that would prevent comprehension&#xD;
        of study procedures as assessed during the Informed Consent process or; (6) they are&#xD;
        unwilling or unable to commit to completing the study.&#xD;
&#xD;
        We will not exclude girls because of their HIV, STI and/or pregnancy status. Analysis will&#xD;
        be adjusted to account for these baseline factors. Girls testing positive for HIV, STI or&#xD;
        pregnancy will be referred for care and support.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Participants must be female.</gender_description>
    <minimum_age>14 Years</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Fred Ssewamala, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Washington University School of Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>International Center for Child Health and Development</name>
      <address>
        <city>Masaka</city>
        <zip>256</zip>
        <country>Uganda</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>International Center for Child Health and Development</name>
      <address>
        <city>Masaka</city>
        <country>Uganda</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Uganda</country>
  </location_countries>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>October 2, 2017</study_first_submitted>
  <study_first_submitted_qc>October 5, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 11, 2017</study_first_posted>
  <last_update_submitted>May 2, 2022</last_update_submitted>
  <last_update_submitted_qc>May 2, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 6, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Washington University School of Medicine</investigator_affiliation>
    <investigator_full_name>Fred Ssewamala</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Suubi</keyword>
  <keyword>Adolescent Girls</keyword>
  <keyword>Poverty</keyword>
  <keyword>Economic Empowement Interventions</keyword>
  <keyword>Adherence to HIV antiretroviral therapy</keyword>
  <keyword>HIV/AIDS-impacted girls</keyword>
  <keyword>Uganda</keyword>
  <keyword>Cost-effectiveness</keyword>
  <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>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Once all of the data has been de-identified, cleaned, and validated, and main findings have been published, the Investigators expect to share data with the scientific community. The research team will make datasets available to any individual who makes a direct request to the PI and indicates the data will be used for the purposes of research (per CFR Title 45 Part 46: &quot;Research is defined as a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.&quot;). In sharing participant data, the team will follow Columbia University School of Social Work Office of Sponsored Projects' data sharing agreement.</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/NCT03307226
org study id: 201703102
secondary id: 1R01MH113486-01
nct id: NCT03307226
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study examines the impact and cost associated with Suubi4Her, an innovative combination
      intervention that aims to prevent HIV risk behaviors among 15-17 year-old girls living in
      communities heavily affected by poverty and HIV/AIDS in Uganda. Participants will be randomly
      assigned at the school level into one of three study conditions: 1) Savings (Youth
      Development Accounts - YDA) - with a 1:1 incentive match rate - for education and
      microenterprise development; 2) Savings (YDA) + Multiple Family Groups intervention; 3)
      Control condition receiving standard health and sex education provided in schools. The
      intervention will last for 24 months. Assessments will be conducted at baseline, 12, 24 and
      36 months. Assessments will include biologically confirmed STIs, proportion of HIV infections
      during the study period, and for HIV+ participants markers for ART adherence. The study aims
      to examine the impact of the Suubi4Her intervention on behavioral health functioning, and
      protecting adolescent girls against known HIV risk factors. The study will also examine the
      cost-effectiveness of each intervention condition.
Aligned with the NIH priority of addressing disparities in new HIV infections and the UNAIDS
      call for implementing combination HIV prevention approaches, the proposed study will examine
      the impact and cost associated with Suubi4Her, an innovative combination intervention that
      aims to prevent HIV risk behaviors among 14-17 year-old girls living in communities heavily
      affected by poverty and HIV/AIDS in Uganda. In sub-Saharan Africa (SSA), family financial
      stress can compromise the support available to adolescents, with girls living in poverty
      exhibiting higher rates of risky sexual behavior increasing their vulnerability in acquiring
      HIV and other STIs. At the same time, internalizing mental health disorders such as
      depression and low self-esteem disproportionately affect girls and may be contributing to HIV
      risk behavior. Against that backdrop, support over and above health and sex education is
      needed to help adolescent girls in SSA successfully transition into young adulthood. The
      proposed study is informed by two previously tested interventions - asset-based matched
      savings accounts (YDA) and family strengthening through Multiple Family Groups (MFG) which
      have successfully been implemented with younger primary school-going adolescents. Suubi4Her
      will test the theory that youth cognitive and behavioral change is influenced by economic
      stability while examining if enhanced intra-familial support and communication are needed to
      maintain positive behavioral health functioning and reinforce engagement in protective health
      behaviors. Nested within 47 secondary schools across four districts of Uganda heavily
      impacted by HIV/AIDS, 1260 older girls (ages 14-17 at enrollment) will be randomly assigned
      (at school level) to one of three study conditions: 1) Savings (Youth Development Accounts -
      YDA)- with a 1:1 incentive match rate - for education and microenterprise development; 2)
      Savings (YDA) + MFG intervention; 3) Control condition receiving standard health and sex
      education provided in schools. The intervention will be provided for 24 months. Assessments
      at baseline,12, 24, and 36-months will include biomedical data to measure our primary
      sexual-risk outcome:1) proportion of girls' biologically confirmed STIs (Gonorrhea,
      Trichomonas and Chlamydia); and secondary outcomes: 2) the proportion of new HIV infections
      during the study period, and 3) for HIV+ girls, viral load and CD4 as markers of ART
      adherence. The study aims are to: 1) Examine whether the Suubi4Her intervention is effective
      in protecting adolescent girls against known HIV risk factors (including
      economically-motivated sex and intimate partner violence). 2) Elucidate the effects of the
      Suubi4Her intervention on behavioral health functioning (i.e., depression, self-efficacy and
      hopelessness) and examine the effects of these variables as potential mechanisms of change,
      mediating the relationship between each intervention and HIV risk reduction. 3) Evaluate the
      cost-effectiveness of each intervention condition. The study will also use the Child
      Depression Index and Beck Hopelessness Scale to examine the efficacy of interventions in
      improving mental health in this vulnerable population.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Participant, Care Provider)
measure: Change in proportion of STIs from baseline to follow-up assessments
time frame: Every assessment time point (Baseline, 12-, 24-, and 36-month follow-up)
description: Change in proportion of girls biologically confirmed STIs (Gonorrhea, Tirchomonas, and Chlamydia) at each assessment time point (Baseline, 12-, 24-, and 36-month follow-up)
measure: Change in proportion of new HIV infections
time frame: Every assessment time point (Baseline, 12-, 24-, and 36-month follow-up)
description: Change in the proportion of new HIV infections at each assessment time point (Baseline, 12-, 24-, and 36-month follow-up)
measure: Change in adherence to HIV treatment from baseline to follow-up assessments
time frame: Every assessment time point (Baseline, 12-, 24-, and 36-month follow-up)
description: For HIV+ participants, adherence to HIV treatment regimen outcomes as measured through viral load and CD4 counts
measure: Cost-Effectiveness Analyses
time frame: Every year for five years
description: Cost-effectiveness analyses measuring the cost of achieving an agreed upon benefit, such as an additional year of schooling, employment, or a reduction in a disease. Costs will be measured on a per person basis. The costs of the intervention will include all program costs. Research costs will not be included.
arm group label: Youth Development Accounts (YDA)
arm group type: Experimental
description: Youth Development Accounts (YDA)
Youth Development Accounts (YDA) with 1:1 incentive match rate to be used for education and microenterprise development
Financial workshops on asset-building, saving and investing in Income Generating Activities (IGAs) Behavioral: Youth Development Accounts (YDA)
arm group label: YDA + Multiple Family Groups (MFG)
arm group type: Experimental
description: YDA + Multiple Family Groups (MFG)
Youth Development Accounts (YDA) with 1:1 incentive match rate to be used for education and microenterprise development
Financial workshops on asset-building, saving and investing in Income Generating Activities (IGAs)
Multiple Family Groups sessions focused on strengthening family relationships and mental health
arm group label: Usual Care
arm group type: No Intervention
description: Usual Care consisting of curricula delivered at secondary schools in Uganda including Life Planning Skills, and Adolescent Sexual Reproductive Health
intervention type: Behavioral
intervention name: Youth Development Accounts (YDA)
description: Youth Development Accounts (YDA) with 1:1 incentive match rate to be used for education and microenterprise development Financial workshops on asset-building, saving and investing in Income Generating Activities (IGAs) Behavioral: Youth Development Accounts (YDA)
arm group label: Youth Development Accounts (YDA)
intervention type: Behavioral
intervention name: YDA + Multiple Family Groups (MFG)
description: Youth Development Accounts (YDA) with 1:1 incentive match rate to be used for education and microenterprise development 12 Financial Management workshops on asset-building, saving and investing in Income Generating Activities (IGAs) 18 Multiple Family Groups sessions focused on strengthening family relationships and mental health
arm group label: YDA + Multiple Family Groups (MFG)
criteria: 
gender: Female
gender based: Yes
gender description: Participants must be female.
minimum age: 14 Years
maximum age: 17 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Fred Ssewamala, PhD
role: Principal Investigator
affiliation: Washington University School of Medicine
facility: 
facility: 
country: Uganda
responsible party type: Principal Investigator
investigator affiliation: Washington University School of Medicine
investigator full name: Fred Ssewamala
investigator title: Professor
mesh term: Acquired Immunodeficiency Syndrome
mesh term: HIV Infections
sharing ipd: Yes
ipd description: Once all of the data has been de-identified, cleaned, and validated, and main findings have been published, the Investigators expect to share data with the scientific community. The research team will make datasets available to any individual who makes a direct request to the PI and indicates the data will be used for the purposes of research (per CFR Title 45 Part 46: "Research is defined as a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge."). In sharing participant data, the team will follow Columbia University School of Social Work Office of Sponsored Projects' data sharing agreement.