xml: <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/NCT05965245</url>
    </required_header>
    <id_info>
      <org_study_id>R21MH131044</org_study_id>
      <nct_id>NCT05965245</nct_id>
    </id_info>
    <brief_title>Suubi-Mhealth: A Mobile Health Intervention to Address Depression Among Youth</brief_title>
    <official_title>Suubi-Mhealth: A Mobile Health Intervention to Address Depression and Improve ART Adherence Among Youth Living With HIV (YLHIV) 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>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 overall goal of this study is to develop an mHealth intervention (Suubi-Mhealth) for use&#xD;
        among Ugandan youth (14-17 years) with comorbid HIV and depression, taking into account their&#xD;
        unique contextual, cultural, and developmental needs. This digital therapy intervention&#xD;
        delivered via a mobile application, will utilize the core tenets of cognitive-behavioral&#xD;
        therapy (CBT) found to improve depression and ART adherence.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Approximately 1.7 million children under 15 years old were living with HIV in 2020; and most&#xD;
        new HIV infections (85%) occurred in Sub-Saharan Africa (SSA). People living with HIV (PLHIV)&#xD;
        often struggle with mental health comorbidities that lower their antiretroviral therapy (ART)&#xD;
        adherence. However, 76% to 85% of PLHIV in SSA receive no treatment for serious mental health&#xD;
        disorders, especially depression. Depression reduces ART adherence, which negatively impacts&#xD;
        health and increases HIV transmission risks. Older adolescents (≥14 years) living with HIV&#xD;
        are particularly vulnerable to these risks as caregivers withdraw or lessen their support&#xD;
        during their transition to young adulthood. Moreover, older adolescents are also moving into&#xD;
        larger and less accommodating adult HIV clinic settings and are at risk for dropping out of&#xD;
        ART programs. Given that mental health services are severely under equipped in SSA, including&#xD;
        in Uganda, and are inaccessible by many YLHIV, new solutions to increase access to mental&#xD;
        health care and close the treatment gap are urgently needed. The overall goal of this study&#xD;
        is to develop an mHealth intervention (Suubi-mhealth) for use among Ugandan youth (14-17&#xD;
        years) with comorbid HIV and depression, taking into account their unique contextual,&#xD;
        cultural, and developmental needs. This digital therapy intervention delivered via a mobile&#xD;
        application, will utilize the core tenets of cognitive-behavioral therapy (CBT) found to&#xD;
        improve depression and ART adherence. The study will specifically: Phase 1. R21 Aim 1:&#xD;
        Develop and iteratively refine an intervention protocol for Suubi-Mhealth based on formative&#xD;
        work to understand needs of youth living with HIV (YLHIV). Four focus groups with youth and&#xD;
        two focus groups with health care providers (6-8 youth each) will be conducted for feedback&#xD;
        on intervention content and methods to increase participation and retention. R21 Aim 2: Based&#xD;
        on results of Aim 1, explore the feasibility and acceptability of Suubi-Mhealth on a small&#xD;
        scale (N=30), to inform subsequent refinement for the larger R33 phase. Phase 2. R33 Aim 1:&#xD;
        Test the preliminary impact of Suubi-Mhealth versus a waitlist control group (N=200), on&#xD;
        youth outcomes (depression, ART adherence, mental health functioning, quality of life,&#xD;
        stigma). R33 Aim 2: Examine barriers and facilitators for integrating Suubi-Mhealth into&#xD;
        health care settings for YLHIV. The study will be conducted in 10 health clinics in the&#xD;
        greater Masaka region in Southern Uganda. Suubi-Mhealth is expected to be an acceptable and&#xD;
        feasible mHealth tool to reduce depression, improve ART adherence and overall mental health&#xD;
        functioning among YLHIV. If the results of this pilot are promising, then the next step is an&#xD;
        R01 to rigorously test Suubi-Mhealth in a larger trial, spanning multiple sites across&#xD;
        Uganda.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">November 23, 2022</start_date>
    <completion_date type="Anticipated">August 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">August 31, 2024</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>Single (Participant)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Patient Health Questionnaire (PHQ-9) Health Questionnaire (PHQ-9)</measure>
      <time_frame>Baseline, 1 month, 2 months, 6 months</time_frame>
      <description>Depression will be assessed using the Patient Health Questionnaire (PHQ-9). Change in the mean score on the PHQ-9 over time will be assessed. The total score ranges between 0-27, with higher scores indicating higher levels of depressive symptoms.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>ART Treatment Adherence</measure>
      <time_frame>Baseline, 1 month, 2 months, 6 months</time_frame>
      <description>Change in ART adherence over time will be assessed by three items that have been:1) number of days that participants report taking their medication in the past month relative to the total number of days they were prescribed the medication; 2) frequency of taking the medicine in the way they were supposed to in the past month; and 3) how good a job they did at taking the medicine in the way they were supposed to in the past month. Responses from each item will be linearized into a continuous scale ranging from 0-100, with low scores representing poor adherence and 100 representing perfect adherence.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Brief Symptoms Index (BSI)</measure>
      <time_frame>Baseline, 1 month, 2 months, 6 months</time_frame>
      <description>Psychological distress will be measured using the Brief Symptoms Index, which has been used globally and validated for use among adolescents. Change in mean score on the BSI over time will be assessed. The total score ranges between 53-212, with higher score indicating higher levels of psychological distress.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Pediatric Quality of Life Inventory (PedsQL)</measure>
      <time_frame>Baseline, 1 month, 2 months, 6 months</time_frame>
      <description>Quality of Life will be measured by the Pediatric Quality of Life Inventory which includes items assessing general well-being, stress levels, functioning impairment, and cognitive functioning. Change in mean score on the PedsQL over time will be assessed. The total score ranges between 43-132, with higher scores indicating poor quality of life.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Medical Outcomes Study HIV Health Survey (MOSHIV)</measure>
      <time_frame>Baseline, 1 month, 2 months, 6 months</time_frame>
      <description>Medical Outcomes Study HIV Health Survey (MOSHIV) will be used to assess physical health and HIV symptom impact. Change in symptoms and physical health over time will be measured.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>HIV/AIDS Stigma and Discrimination Scale</measure>
      <time_frame>Baseline, 1 month, 2 months, 6 months</time_frame>
      <description>HIV Stigma will be measured using the HIV/AIDS Stigma and Discrimination Scale. Change in the mean score over time will be assessed. The total score ranges between 22-88, with higher score indicating higher levels of HIV stigma.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Shame Questionnaire</measure>
      <time_frame>Baseline, 1 month, 2 months, 6 months</time_frame>
      <description>Shame related to living with HIV will be measured using the Shame Questionnaire. Change in the mean score over time will be assessed. The total score range between 0 and 16 with a higher score indicating higher levels of HIV-associated shame.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Multidimensional Scale of Perceived Social Support</measure>
      <time_frame>Baseline, 1 month, 2 months, 6 months</time_frame>
      <description>Multidimensional social support from friends, family members and community members will be measured using the Multidimensional Scale of Perceived Social Support. Change in the mean score on the MSPSS over time will be assessed. The total score ranges between 40-240, with higher score indicating higher levels of Multidimensional social support.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Social Support Behavioral Scale (SS-B)</measure>
      <time_frame>Baseline, 1 month, 2 months, 6 months</time_frame>
      <description>Additional social support from family members and friends will be measured using the Social Support Behaviors Scale (SSBS). Change in the mean score on the SSBS over time will be assessed. The total score ranges between 45-225, with higher score indicating higher levels of social support.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">278</enrollment>
    <condition>Depression</condition>
    <condition>HIV Infection</condition>
    <arm_group>
      <arm_group_label>Suubi-Mhealth</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants in this condition will receive the Suubi-Mhealth intervention delivered via a smart phone app.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Waitlist Control</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>Participants in this condition will receive the Suubi-Mhealth intervention after the active treatment group. They will also receive a smart phone without the Suubi-Mhealth app at the same time as the intervention group.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Suubi-Mhealth</intervention_name>
      <description>Suubi-Mhealth is a theoretically-based digital therapeutics tool that aims to provide educational content on depression while considering the unique needs of SSA youth living with HIV. This educational content will be aligned with scientific recommendations for cognitive-behavioral therapy for adherence and depression as applied to HIV medication adherence. Core instruction will include psychoeducation on the interplay between HIV and depression; minimizing cognitive distortions related to ART adherence and stigma, as well as depression; challenging negative automatic thoughts; analysis and development of behavioral skills; reducing environmental stressors. Suubi-Mhealth will also have a social networking center in which patients can contact the research team, peers who are also taking part in this intervention, and other trusted individuals such as loved ones. Other features include tools for setting and monitoring goals, and a clinical management dashboard for the research team.</description>
      <arm_group_label>Suubi-Mhealth</arm_group_label>
      <arm_group_label>Waitlist Control</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Ages 14-17 years&#xD;
  &#xD;
            -  HIV positive and aware of their status i.e., disclosed to&#xD;
  &#xD;
            -  Prescribed antiretroviral therapy&#xD;
  &#xD;
            -  Living within a family, including with extended family members (not in institutions)&#xD;
  &#xD;
            -  Health care providers who work with youth at participating clinics who agree to&#xD;
               participate in the study.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  A significant cognitive impairment that interferes with the participant's&#xD;
               understanding of the informed consent process, or inability/unwillingness to commit to&#xD;
               completing the study&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>14 Years</minimum_age>
      <maximum_age>17 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Washington University in St. Louis</name>
        <address>
          <city>Saint Louis</city>
          <state>Missouri</state>
          <zip>63130</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Proscovia Nabunya, PhD</last_name>
        <phone>314-935-9087</phone>
        <email>nabunyap@wustl.edu</email>
      </contact>
      <contact_backup>
        <last_name>Patricia Cavazos-Rehg, PhD</last_name>
        <phone>314-3622152</phone>
        <email>pcavazos@wustl.edu</email>
      </contact_backup>
    </location>
    <location>
      <facility>
        <name>International Center for Child Health and Development (ICHAD)</name>
        <address>
          <city>Masaka</city>
          <country>Uganda</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Anita Kabarambi</last_name>
        <phone>256-752389564</phone>
        <email>akabarambi@gmail.com</email>
      </contact>
    </location>
    <location_countries>
      <country>Uganda</country>
      <country>United States</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 12, 2023</study_first_submitted>
    <study_first_submitted_qc>July 19, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 28, 2023</study_first_posted>
    <last_update_submitted>July 19, 2023</last_update_submitted>
    <last_update_submitted_qc>July 19, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">July 28, 2023</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>Proscovia Nabunya</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>Depression</mesh_term>
      <mesh_term>Depressive Disorder</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 Code of Federal Regulations 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 Washington University in St. Louis' Office of Sponsored Projects' data sharing agreement.</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Analytic Code</ipd_info_type>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05965245
  org study id: R21MH131044
  nct id: NCT05965245
  lead sponsor: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  The overall goal of this study is to develop an mHealth intervention (Suubi-Mhealth) for use
        among Ugandan youth (14-17 years) with comorbid HIV and depression, taking into account their
        unique contextual, cultural, and developmental needs. This digital therapy intervention
        delivered via a mobile application, will utilize the core tenets of cognitive-behavioral
        therapy (CBT) found to improve depression and ART adherence.
  Approximately 1.7 million children under 15 years old were living with HIV in 2020; and most
        new HIV infections (85%) occurred in Sub-Saharan Africa (SSA). People living with HIV (PLHIV)
        often struggle with mental health comorbidities that lower their antiretroviral therapy (ART)
        adherence. However, 76% to 85% of PLHIV in SSA receive no treatment for serious mental health
        disorders, especially depression. Depression reduces ART adherence, which negatively impacts
        health and increases HIV transmission risks. Older adolescents (≥14 years) living with HIV
        are particularly vulnerable to these risks as caregivers withdraw or lessen their support
        during their transition to young adulthood. Moreover, older adolescents are also moving into
        larger and less accommodating adult HIV clinic settings and are at risk for dropping out of
        ART programs. Given that mental health services are severely under equipped in SSA, including
        in Uganda, and are inaccessible by many YLHIV, new solutions to increase access to mental
        health care and close the treatment gap are urgently needed. The overall goal of this study
        is to develop an mHealth intervention (Suubi-mhealth) for use among Ugandan youth (14-17
        years) with comorbid HIV and depression, taking into account their unique contextual,
        cultural, and developmental needs. This digital therapy intervention delivered via a mobile
        application, will utilize the core tenets of cognitive-behavioral therapy (CBT) found to
        improve depression and ART adherence. The study will specifically: Phase 1. R21 Aim 1:
        Develop and iteratively refine an intervention protocol for Suubi-Mhealth based on formative
        work to understand needs of youth living with HIV (YLHIV). Four focus groups with youth and
        two focus groups with health care providers (6-8 youth each) will be conducted for feedback
        on intervention content and methods to increase participation and retention. R21 Aim 2: Based
        on results of Aim 1, explore the feasibility and acceptability of Suubi-Mhealth on a small
        scale (N=30), to inform subsequent refinement for the larger R33 phase. Phase 2. R33 Aim 1:
        Test the preliminary impact of Suubi-Mhealth versus a waitlist control group (N=200), on
        youth outcomes (depression, ART adherence, mental health functioning, quality of life,
        stigma). R33 Aim 2: Examine barriers and facilitators for integrating Suubi-Mhealth into
        health care settings for YLHIV. The study will be conducted in 10 health clinics in the
        greater Masaka region in Southern Uganda. Suubi-Mhealth is expected to be an acceptable and
        feasible mHealth tool to reduce depression, improve ART adherence and overall mental health
        functioning among YLHIV. If the results of this pilot are promising, then the next step is an
        R01 to rigorously test Suubi-Mhealth in a larger trial, spanning multiple sites across
        Uganda.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Single (Participant)
  measure: Patient Health Questionnaire (PHQ-9) Health Questionnaire (PHQ-9)
  time frame: Baseline, 1 month, 2 months, 6 months
  description: Depression will be assessed using the Patient Health Questionnaire (PHQ-9). Change in the mean score on the PHQ-9 over time will be assessed. The total score ranges between 0-27, with higher scores indicating higher levels of depressive symptoms.
  measure: ART Treatment Adherence
  time frame: Baseline, 1 month, 2 months, 6 months
  description: Change in ART adherence over time will be assessed by three items that have been:1) number of days that participants report taking their medication in the past month relative to the total number of days they were prescribed the medication; 2) frequency of taking the medicine in the way they were supposed to in the past month; and 3) how good a job they did at taking the medicine in the way they were supposed to in the past month. Responses from each item will be linearized into a continuous scale ranging from 0-100, with low scores representing poor adherence and 100 representing perfect adherence.
  measure: Brief Symptoms Index (BSI)
  time frame: Baseline, 1 month, 2 months, 6 months
  description: Psychological distress will be measured using the Brief Symptoms Index, which has been used globally and validated for use among adolescents. Change in mean score on the BSI over time will be assessed. The total score ranges between 53-212, with higher score indicating higher levels of psychological distress.
  measure: Pediatric Quality of Life Inventory (PedsQL)
  time frame: Baseline, 1 month, 2 months, 6 months
  description: Quality of Life will be measured by the Pediatric Quality of Life Inventory which includes items assessing general well-being, stress levels, functioning impairment, and cognitive functioning. Change in mean score on the PedsQL over time will be assessed. The total score ranges between 43-132, with higher scores indicating poor quality of life.
  measure: Medical Outcomes Study HIV Health Survey (MOSHIV)
  time frame: Baseline, 1 month, 2 months, 6 months
  description: Medical Outcomes Study HIV Health Survey (MOSHIV) will be used to assess physical health and HIV symptom impact. Change in symptoms and physical health over time will be measured.
  measure: HIV/AIDS Stigma and Discrimination Scale
  time frame: Baseline, 1 month, 2 months, 6 months
  description: HIV Stigma will be measured using the HIV/AIDS Stigma and Discrimination Scale. Change in the mean score over time will be assessed. The total score ranges between 22-88, with higher score indicating higher levels of HIV stigma.
  measure: Shame Questionnaire
  time frame: Baseline, 1 month, 2 months, 6 months
  description: Shame related to living with HIV will be measured using the Shame Questionnaire. Change in the mean score over time will be assessed. The total score range between 0 and 16 with a higher score indicating higher levels of HIV-associated shame.
  measure: Multidimensional Scale of Perceived Social Support
  time frame: Baseline, 1 month, 2 months, 6 months
  description: Multidimensional social support from friends, family members and community members will be measured using the Multidimensional Scale of Perceived Social Support. Change in the mean score on the MSPSS over time will be assessed. The total score ranges between 40-240, with higher score indicating higher levels of Multidimensional social support.
  measure: Social Support Behavioral Scale (SS-B)
  time frame: Baseline, 1 month, 2 months, 6 months
  description: Additional social support from family members and friends will be measured using the Social Support Behaviors Scale (SSBS). Change in the mean score on the SSBS over time will be assessed. The total score ranges between 45-225, with higher score indicating higher levels of social support.
  arm group label: Suubi-Mhealth
  arm group type: Experimental
  description: Participants in this condition will receive the Suubi-Mhealth intervention delivered via a smart phone app.
  arm group label: Waitlist Control
  arm group type: Other
  description: Participants in this condition will receive the Suubi-Mhealth intervention after the active treatment group. They will also receive a smart phone without the Suubi-Mhealth app at the same time as the intervention group.
  intervention type: Behavioral
  intervention name: Suubi-Mhealth
  description: Suubi-Mhealth is a theoretically-based digital therapeutics tool that aims to provide educational content on depression while considering the unique needs of SSA youth living with HIV. This educational content will be aligned with scientific recommendations for cognitive-behavioral therapy for adherence and depression as applied to HIV medication adherence. Core instruction will include psychoeducation on the interplay between HIV and depression; minimizing cognitive distortions related to ART adherence and stigma, as well as depression; challenging negative automatic thoughts; analysis and development of behavioral skills; reducing environmental stressors. Suubi-Mhealth will also have a social networking center in which patients can contact the research team, peers who are also taking part in this intervention, and other trusted individuals such as loved ones. Other features include tools for setting and monitoring goals, and a clinical management dashboard for the research team.
  arm group label: Suubi-Mhealth
  arm group label: Waitlist Control
  criteria: 
  gender: All
  minimum age: 14 Years
  maximum age: 17 Years
  healthy volunteers: No
  facility: 
  status: Not yet recruiting
  contact: 
  contact backup: 
  facility: 
  status: Recruiting
  contact: 
  country: Uganda
  country: United States
  responsible party type: Principal Investigator
  investigator affiliation: Washington University School of Medicine
  investigator full name: Proscovia Nabunya
  investigator title: Assistant Professor
  mesh term: Depression
  mesh term: Depressive Disorder
  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 Code of Federal Regulations 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 Washington University in St. Louis' Office of Sponsored Projects' data sharing agreement.
  ipd info type: Study Protocol
  ipd info type: Analytic Code