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/NCT06035445</url>
    </required_header>
    <id_info>
      <org_study_id>STUDY00004803</org_study_id>
      <secondary_id>1R01MH131434</secondary_id>
      <nct_id>NCT06035445</nct_id>
    </id_info>
    <brief_title>Support for Adolescents Living With HIV in South Africa</brief_title>
    <acronym>InTSHA VIP</acronym>
    <official_title>Interactive Transition Support for Adolescents Living With HIV Comparing Virtual and In-person Delivery Through a Stepped-wedge Cluster Randomized Clinical Trial in South Africa</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Emory University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>University of KwaZulu</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>National Institute of Mental Health (NIMH)</agency>
        <agency_class>NIH</agency_class>
      </collaborator>
    </sponsors>
    <source>Emory 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>
        This is a cluster randomized controlled trial determining the effectiveness of in-person or&#xD;
        mHealth-based adolescent-friendly transition interventions compared to standard care on&#xD;
        retention in care and viral suppression among adolescents living with HIV who have low&#xD;
        transition readiness. Participants are adolescents living with HIV ages 15 to 19 years old in&#xD;
        KwaZulu-Natal, South Africa.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        South Africa has the highest number of adolescents living with HIV in the world, yet&#xD;
        adolescents are poorly prepared for transition from pediatric to adult services. For a large&#xD;
        majority of South Africans living with HIV, antiretroviral therapy (ART) was not available&#xD;
        until 2004. This delay contributed to nearly 500,000 perinatal HIV infections in the late&#xD;
        1990s and early 2000s. With large scale-up efforts and improved access to ART in recent&#xD;
        years, survivors of perinatal HIV infection are now reaching adolescence and beyond. As the&#xD;
        wave of adolescents living with perinatally-acquired HIV matures, an estimated 320,000&#xD;
        adolescents will transfer from pediatric- or adolescent-based clinics to adult services in&#xD;
        the next 10 years in South Africa. Although the mother-to-child HIV transmission rates in&#xD;
        South Africa have decreased to less than 2%, thousands of infants are still being born with&#xD;
        HIV each year ensuring that adolescent HIV will be an issue for many years. Currently,&#xD;
        adolescents living with perinatally-acquired HIV enter adult care at variable ages and&#xD;
        developmental stages, typically without necessary preparation or support through the process.&#xD;
  &#xD;
        The transition from pediatric to adult services for adolescents living with HIV is a&#xD;
        critically vulnerable time during which there is a high risk for disengagement from care and&#xD;
        resultant morbidity and mortality. Despite an overall decrease in global HIV-related&#xD;
        mortality, HIV remains the leading cause of death among adolescents living in South Africa&#xD;
        where less than 50% of adolescents living with HIV are virally suppressed. Globally,&#xD;
        disruptions related to transitioning from pediatric to adult care have been associated with&#xD;
        high rates of HIV drug resistance, virologic failure, progression to AIDS and mortality. In&#xD;
        South Africa, older adolescents (&gt;15 years old) had lower viral suppression rates than&#xD;
        younger adolescents at the time of transfer to general clinics.&#xD;
  &#xD;
        Studies of in-person adolescent support groups (teen/adherence clubs) and adolescent-friendly&#xD;
        services have shown mixed results in mitigating the poor outcomes of adolescents living with&#xD;
        HIV. In-person adherence clubs have improved long-term adherence to ART among adults.&#xD;
        However, the adherence or teen club models among adolescents living with HIV have shown mixed&#xD;
        results.&#xD;
  &#xD;
        The delivery of healthcare through portable mobile devices (mHealth) interventions have&#xD;
        potential to remedy the challenges along the HIV continuum of care faced by adolescents&#xD;
        living with HIV but larger, adequately powered randomized trials are needed. Adolescents in&#xD;
        South Africa commonly communicate via social media to gain social support and health&#xD;
        information from their peers and the use of social media for health expanded during the&#xD;
        coronavirus infection 2019 (COVID-19) pandemic. mHealth strategies thus provides the&#xD;
        opportunity to reach adolescents regularly using a preferred format, which could be utilized&#xD;
        to improve the reach and impact of adolescent-focused interventions.&#xD;
  &#xD;
        The Social-ecological Model of Adolescent and Young Adult Readiness to Transition (SMART)&#xD;
        highlights modifiable targets of intervention that can improve transition care for&#xD;
        adolescents living with HIV. The SMART model incorporates modifiable factors such as&#xD;
        knowledge, skills/self-efficacy, relationships, and social support that can be targets of&#xD;
        interventions to improve transition care. Medical care during adolescence is typically&#xD;
        complicated by increased risk-taking behavior, as well as decreased caregiver involvement,&#xD;
        which occur during a time of rapid physical, emotional, and cognitive development. When&#xD;
        adolescents transition to adult care, they often do not receive the coordinated services that&#xD;
        they received under pediatric care. The SMART model emphasizes eight modifiable factors,&#xD;
        three key stakeholders (adolescents, caregivers, and clinicians) and their interconnected&#xD;
        relationship in influencing successful transition to adult care. Using the SMART model,&#xD;
        interventions delivered in-person or virtually can address the modifiable factors in the&#xD;
        model to improve transition care for adolescents living with HIV but rigorous clinical trials&#xD;
        are needed to prove effectiveness.&#xD;
  &#xD;
        The researchers have developed and validated the first transition readiness assessment for&#xD;
        adolescents living with HIV in South Africa and demonstrated its utility in predicting viral&#xD;
        suppression in adult care. Through the development and validation of the HIV Adolescent&#xD;
        Readiness to Transition Scale (HARTS) the researchers found that higher ratings reflecting&#xD;
        HIV disclosure, healthcare navigation, self-advocacy, and health literacy were predictive of&#xD;
        viral suppression after transition to adult care for adolescents living with HIV in South&#xD;
        Africa. Using the HARTS in addition to demographic data associated with viral suppression&#xD;
        after transition to adult care, the researchers created a transition readiness score to&#xD;
        assist clinicians in determining which adolescents may benefit from additional services prior&#xD;
        to transitioning to adult care.&#xD;
  &#xD;
        Clinics in KwaZulu-Natal, South Africa are randomized to deliver an in-person&#xD;
        adolescent-friendly service (iPAS) intervention, mHealth InTSHA intervention, or standard of&#xD;
        care to adolescents receiving care at those clinics who score low or intermediate when&#xD;
        screened for transition readiness. After the first 9 months of the study, the clinics&#xD;
        randomized to deliver standard of care will begin delivering either the iPAS or InTSHA&#xD;
        interventions for the next 9 month period. Adolescents participate in the intervention&#xD;
        occurring at the clinic they attend for 9 months and complete surveys at baseline, after the&#xD;
        9 month intervention, and a final survey at the end of the study (15 or 24 months after&#xD;
        enrollment). Adolescents with high scores when screened for transition readiness will&#xD;
        comprise an observational cohort where data will be abstracted from medical records and they&#xD;
        will complete questionnaires at 9, 18, and 24 months.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">November 1, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2027</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2027</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>This study uses a stepped-wedge, delayed implementation randomized clinical trial design, to measure the effectiveness of the interventions compared to standard of care.</intervention_model_description>
      <primary_purpose>Supportive Care</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Number of Participants Retained in Care</measure>
      <time_frame>After the 9 month intervention (Month 9 or Month 18)</time_frame>
      <description>Clinic patients are considered to be retained in care if 80% of ART pharmacy refills are filled on time (&lt; 7days from scheduled date) and 80% of scheduled clinic appointments are attended.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in Number of Participants with Viral Suppression</measure>
      <time_frame>Baseline, After the 9 month intervention (Month 9 or Month 18)</time_frame>
      <description>HIV-1 viral load is measured in viral copies per milliliter (mL) of blood and viral suppression is defined as &lt;200 copies/ml.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Change in Acceptability of Intervention Measure (AIM) Score</measure>
      <time_frame>Baseline, After the 9 month intervention (Month 9 or Month 18)</time_frame>
      <description>Acceptability of the intervention is assessed with the AIM questionnaire. The AIM questionnaire has 4 items asking respondents how much they agree with statements such as &quot;the intervention is appealing to me&quot;. Responses are given on a 5-point scale where &quot;completely disagree&quot; = 1 and &quot;completely agree&quot; = 5. Total scores range from 4 to 20 where higher scores indicate greater feelings of acceptability.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Intervention Appropriateness Measure (IAM) Score</measure>
      <time_frame>Baseline, After the 9 month intervention (Month 9 or Month 18)</time_frame>
      <description>Appropriateness of the intervention is assessed with the IAM questionnaire. The IAM questionnaire has 4 items asking respondents how much they agree with statements such as &quot;the intervention seems applicable&quot;. Responses are given on a 5-point scale where &quot;completely disagree&quot; = 1 and &quot;completely agree&quot; = 5. Total scores range from 4 to 20 where higher scores indicate greater feelings that the intervention is appropriate.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Feasibility of Intervention Measure (FIM) Score</measure>
      <time_frame>Baseline, After the 9 month intervention (Month 9 or Month 18)</time_frame>
      <description>Feasibility of the intervention is assessed with the FIM questionnaire. The FIM questionnaire has 4 items asking respondents how much they agree with statements such as &quot;the intervention seems possible&quot;. Responses are given on a 5-point scale where &quot;completely disagree&quot; = 1 and &quot;completely agree&quot; = 5. Total scores range from 4 to 20 where higher scores indicate greater feelings that the intervention is feasible.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in HIV Adolescent Readiness for Transition Scale (HARTS) Score</measure>
      <time_frame>Baseline, Month 9, Month 18, Month 24</time_frame>
      <description>The HIV Adolescent Readiness for Transition Scale (HARTS) includes 16 items that are responded to on a 5-point scale where 0 = no, 1 = no, but I am learning, 2 = yes, a little bit, 3 = yes, almost always, and 4 = yes, always. Total scores range from 0 to 64 and higher scores indicate greater readiness to transition to adult care.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Participation Rate</measure>
      <time_frame>Baseline, After the 9 month intervention (Month 9 or Month 18)</time_frame>
      <description>Adoption of the intervention is examined as the number of adolescent patients enrolling in the study. Adoption of the intervention is considered successful with a participation rate threshold of &gt;70%.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Intervention Fidelity</measure>
      <time_frame>Up to Month 24</time_frame>
      <description>Healthcare providers will complete an intervention checklist monthly during the intervention. A threshold of &gt;80% of intervention checklist items is considered to be fidelity to the intervention.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Cost of the Intervention</measure>
      <time_frame>After the 9 month intervention (Month 9 or Month 18)</time_frame>
      <description>Cost of the intervention is assessed through time and motions studies. Time and motion studies involve counting the time a healthcare provider takes to prepare and deliver the intervention and how long (in hours) each session takes.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Intervention Completion Rate</measure>
      <time_frame>After the 9 month intervention (Month 9 or Month 18)</time_frame>
      <description>Completion of the intervention is examined as the number of adolescent participants who complete the study.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Attendance to Clinic Visits</measure>
      <time_frame>Month 18, Month 24</time_frame>
      <description>Sustained effectiveness of the study is examined as attendance to clinic visits post-transitioning to care through an adult clinic.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Pharmacy Refills</measure>
      <time_frame>Month 18, Month 24</time_frame>
      <description>Sustained effectiveness of the study is examined as pharmacy refills post-transitioning to care through an adult clinic.</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Change in Child and Adolescent Social Support Scale (CASSS) Score</measure>
      <time_frame>Baseline, After the 9 month intervention (Month 9 or Month 18)</time_frame>
      <description>Social support from peers is assessed using 10 items of the Child and Adolescent Social Support Scale (friend support subscale). Responses are given on a 6-point scale where 1 = never and 6 = always. Total scores range from 10 to 60, where higher scores represent greater social support from peers.</description>
    </other_outcome>
    <other_outcome>
      <measure>Change in Rosenberg's Self-Esteem Scale Score</measure>
      <time_frame>Baseline, After the 9 month intervention (Month 9 or Month 18)</time_frame>
      <description>The Rosenberg's Self-Esteem Scale is a 10-item instrument assessing self-esteem. Responses are given on a 4-point scale where 0 = strongly disagree and 3 = strongly agree. Total scores range 0 to 30 and higher scores indicate greater self-esteem.</description>
    </other_outcome>
    <other_outcome>
      <measure>Change in Patient Health Questionnaire (PHQ-9) Score</measure>
      <time_frame>Baseline, After the 9 month intervention (Month 9 or Month 18)</time_frame>
      <description>The PHQ-9 is a 9-item self-report questionnaire developed to identify patients at risk for depression. Participants report how often they have been bothered by specific symptoms of depression on a scale of 0 (not at all) to 3 (nearly every day). Higher scores indicate greater symptoms of depression. A score of ≥ 9 indicates clinically significant symptoms.</description>
    </other_outcome>
    <other_outcome>
      <measure>Change in Internalized AIDS-Related Stigma Scale (IA-RSS) Score</measure>
      <time_frame>Baseline, After the 9 month intervention (Month 9 or Month 18)</time_frame>
      <description>The IA-RSS assesses several dimensions of stigma concerning HIV status. The instrument includes 6 items adapted form the AIDS-Related Stigma scale. Statements about hesitancy to disclose HIV status and feelings of shame are responded to as 0 = Disagree and 1 = Agree. Total scores range from 0 to 6 with higher scores indicating increased internalized stigma.</description>
    </other_outcome>
    <other_outcome>
      <measure>Change in Working Alliance Inventory (WAI) Score</measure>
      <time_frame>Baseline, After the 9 month intervention (Month 9 or Month 18)</time_frame>
      <description>connection to clinic (Working Alliance Inventory) A modified version of the Working Alliance Inventory is used to measure how connected participants feel to the clinical staff and medical team. Ten items are responded to on a 4-point scale where 0 = strongly disagree and 3 = strongly agree. Total scores range from 0 to 30 where higher scores indicate increased feelings of connection with clinical staff.</description>
    </other_outcome>
    <number_of_arms>5</number_of_arms>
    <enrollment type="Anticipated">1000</enrollment>
    <condition>Human Immunodeficiency Virus</condition>
    <condition>HIV</condition>
    <arm_group>
      <arm_group_label>In-person adolescent-friendly service (iPAS) intervention:</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Adolescents at study clinics who score low or intermediate on transition readiness during screening will be invited to enroll in the study. Adolescents attending clinics randomized to the in-person supported adolescent friendly services will attend their clinic after school hours on a designated day or on weekends dedicated for adolescent care monthly for 9 months.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>mHealth (InTSHA) intervention</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Adolescents at study clinics who score low or intermediate on transition readiness during screening will be invited to enroll in the study. Adolescents attending clinics randomized to the mHealth intervention will receive the InTSHA intervention based in the Got Transition elements and the SMART model for 9 months.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Standard of Care/Delayed Intervention</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Adolescents at study clinics who score low or intermediate on transition readiness during screening will be invited to enroll in the study. Adolescents attending clinics randomized to deliver the standard of care before transitioning to adult care in their standard local adult clinic. Participants will be invited to receive the intervention the clinic is randomized to deliver when the 9 month period of administering the standard of care is complete.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Healthcare Providers</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Healthcare providers working at one of study clinics, administering the study intervention selected for that clinic.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Observational cohort</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Adolescents at study clinics who score high on transition readiness during screening will not be invited to enroll in the study but will be asked for their consent to have their clinic records reviewed for medical records, retention data and transition readiness data. They will also complete a questionnaire at Months 9, 18, and 24.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>In-person adolescent-friendly service (iPAS) intervention</intervention_name>
      <description>Monthly visits take place in a group setting with sessions led by peer educators. Clinical staff and peer educators are trained in care of adolescents using the Right to Care training materials. During their clinic visit, adolescents are evaluated individually by a healthcare provider and receive their supply of ART. In addition, adolescents participate in scheduled group team-building activities including dancing, sports, music and receive group counseling facilitated by peer educators. Nine group counseling sessions will discuss the topics of: HIV disclosure, alcohol and substance abuse, HIV knowledge, ART adherence and HIV resistance, goal setting and career planning, sexual and reproductive health, HIV stigma, healthcare navigation and self-advocacy, and healthy relationships. The half-day sessions will end with the provision of a meal. After completion of the 9-month intervention, adolescents will transition to adult care in their standard local adult clinic.</description>
      <arm_group_label>In-person adolescent-friendly service (iPAS) intervention:</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>mHealth (InTSHA) intervention</intervention_name>
      <description>The InTSHA intervention is based on Got Transition elements (two-way messaging between adolescents and healthcare providers) and the SMART model. The SMART model focuses on modifiable factors of transition preparation through content delivery, facilitated discussions, online meet ups and consultation with the healthcare team. The intervention consists of 9 modules delivered monthly by group chat. The topics of the modules are: HIV disclosure, alcohol and substance abuse, HIV knowledge, ART adherence and HIV resistance, goal setting and career planning, sexual and reproductive health, HIV stigma, healthcare navigation and self-advocacy, and healthy relationships. Outside of scheduled group chat sessions, adolescents have access to the chat group to check in with members, review content of the sessions, or to comment or ask additional questions. After completion of the 9-month intervention, adolescents will transition to adult care in their standard local adult clinic.</description>
      <arm_group_label>mHealth (InTSHA) intervention</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Standard of Care</intervention_name>
      <description>Adolescents in standard of care are seen every three months by clinicians and collect medication monthly at an on-site pharmacy during regular weekdays. Individual counseling delivered by counselors or social workers is available when necessary. Staff at all clinics receive training in adolescent-friendly services (AFS) through the Right to Care training materials.</description>
      <arm_group_label>Standard of Care/Delayed Intervention</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria for Adolescent Participants:&#xD;
  &#xD;
            -  Aged 15 to 19 years at enrollment&#xD;
  &#xD;
            -  Living with perinatally-acquired HIV&#xD;
  &#xD;
            -  Receiving ART for at least 6 months&#xD;
  &#xD;
            -  Aware of their HIV status&#xD;
  &#xD;
            -  Scoring low to intermediate on transition readiness assessment (intervention cohort&#xD;
               only)&#xD;
  &#xD;
          Inclusion Criteria for Healthcare Providers:&#xD;
  &#xD;
            -  Profession as a healthcare provider&#xD;
  &#xD;
            -  Working at one of the designated clinics&#xD;
  &#xD;
            -  Involvement with adolescents before, during or after transition to adult care&#xD;
  &#xD;
          Exclusion Criteria for all participants:&#xD;
  &#xD;
            -  Inability to read and/or speak English or Zulu&#xD;
  &#xD;
            -  Severe mental or physical illness preventing participation in informed consent&#xD;
               activities&#xD;
  &#xD;
            -  Anticipated move out of clinic area in the next 12 months&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>15 Years</minimum_age>
      <maximum_age>19 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Brian C Zanoni, MD, MPH</last_name>
      <role>Principal Investigator</role>
      <affiliation>Emory University</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Mohendran Archary, MBchB</last_name>
      <role>Principal Investigator</role>
      <affiliation>King Edward VIII Hospital</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Brian C Zanoni, MD, MPH</last_name>
      <phone>404-727-0284</phone>
      <email>brian.christopher.zanoni@emory.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Thobe Sibaya</last_name>
      <phone>071-378-2271</phone>
    </overall_contact_backup>
    <location>
      <facility>
        <name>King Edward VIII Hospital</name>
        <address>
          <city>Congella</city>
          <country>South Africa</country>
        </address>
      </facility>
      <contact>
        <last_name>Mohendran Archary, MBchB</last_name>
        <phone>031-260-4318</phone>
      </contact>
      <investigator>
        <last_name>Mohendran Archary, MBChB</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>South Africa</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>September 6, 2023</study_first_submitted>
    <study_first_submitted_qc>September 6, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 6, 2023</last_update_submitted>
    <last_update_submitted_qc>September 6, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Emory University</investigator_affiliation>
      <investigator_full_name>Brian Zanoni</investigator_full_name>
      <investigator_title>Associate Professor</investigator_title>
    </responsible_party>
    <keyword>transition of care</keyword>
    <keyword>adolescent</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>De-identified, individual participant data will be made available for sharing, including demographic information, clinic information, and study and survey data.</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_time_frame>Data will be made available for sharing following publication of results from this study.</ipd_time_frame>
      <ipd_access_criteria>Data will be made available for sharing through the Emory Dataverse. The Dataverse website can be accessed by any researcher for secondary analyses.</ipd_access_criteria>
    </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/NCT06035445
  org study id: STUDY00004803
  secondary id: 1R01MH131434
  nct id: NCT06035445
  lead sponsor: 
  collaborator: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  This is a cluster randomized controlled trial determining the effectiveness of in-person or
        mHealth-based adolescent-friendly transition interventions compared to standard care on
        retention in care and viral suppression among adolescents living with HIV who have low
        transition readiness. Participants are adolescents living with HIV ages 15 to 19 years old in
        KwaZulu-Natal, South Africa.
  South Africa has the highest number of adolescents living with HIV in the world, yet
        adolescents are poorly prepared for transition from pediatric to adult services. For a large
        majority of South Africans living with HIV, antiretroviral therapy (ART) was not available
        until 2004. This delay contributed to nearly 500,000 perinatal HIV infections in the late
        1990s and early 2000s. With large scale-up efforts and improved access to ART in recent
        years, survivors of perinatal HIV infection are now reaching adolescence and beyond. As the
        wave of adolescents living with perinatally-acquired HIV matures, an estimated 320,000
        adolescents will transfer from pediatric- or adolescent-based clinics to adult services in
        the next 10 years in South Africa. Although the mother-to-child HIV transmission rates in
        South Africa have decreased to less than 2%, thousands of infants are still being born with
        HIV each year ensuring that adolescent HIV will be an issue for many years. Currently,
        adolescents living with perinatally-acquired HIV enter adult care at variable ages and
        developmental stages, typically without necessary preparation or support through the process.
  
        The transition from pediatric to adult services for adolescents living with HIV is a
        critically vulnerable time during which there is a high risk for disengagement from care and
        resultant morbidity and mortality. Despite an overall decrease in global HIV-related
        mortality, HIV remains the leading cause of death among adolescents living in South Africa
        where less than 50% of adolescents living with HIV are virally suppressed. Globally,
        disruptions related to transitioning from pediatric to adult care have been associated with
        high rates of HIV drug resistance, virologic failure, progression to AIDS and mortality. In
        South Africa, older adolescents (>15 years old) had lower viral suppression rates than
        younger adolescents at the time of transfer to general clinics.
  
        Studies of in-person adolescent support groups (teen/adherence clubs) and adolescent-friendly
        services have shown mixed results in mitigating the poor outcomes of adolescents living with
        HIV. In-person adherence clubs have improved long-term adherence to ART among adults.
        However, the adherence or teen club models among adolescents living with HIV have shown mixed
        results.
  
        The delivery of healthcare through portable mobile devices (mHealth) interventions have
        potential to remedy the challenges along the HIV continuum of care faced by adolescents
        living with HIV but larger, adequately powered randomized trials are needed. Adolescents in
        South Africa commonly communicate via social media to gain social support and health
        information from their peers and the use of social media for health expanded during the
        coronavirus infection 2019 (COVID-19) pandemic. mHealth strategies thus provides the
        opportunity to reach adolescents regularly using a preferred format, which could be utilized
        to improve the reach and impact of adolescent-focused interventions.
  
        The Social-ecological Model of Adolescent and Young Adult Readiness to Transition (SMART)
        highlights modifiable targets of intervention that can improve transition care for
        adolescents living with HIV. The SMART model incorporates modifiable factors such as
        knowledge, skills/self-efficacy, relationships, and social support that can be targets of
        interventions to improve transition care. Medical care during adolescence is typically
        complicated by increased risk-taking behavior, as well as decreased caregiver involvement,
        which occur during a time of rapid physical, emotional, and cognitive development. When
        adolescents transition to adult care, they often do not receive the coordinated services that
        they received under pediatric care. The SMART model emphasizes eight modifiable factors,
        three key stakeholders (adolescents, caregivers, and clinicians) and their interconnected
        relationship in influencing successful transition to adult care. Using the SMART model,
        interventions delivered in-person or virtually can address the modifiable factors in the
        model to improve transition care for adolescents living with HIV but rigorous clinical trials
        are needed to prove effectiveness.
  
        The researchers have developed and validated the first transition readiness assessment for
        adolescents living with HIV in South Africa and demonstrated its utility in predicting viral
        suppression in adult care. Through the development and validation of the HIV Adolescent
        Readiness to Transition Scale (HARTS) the researchers found that higher ratings reflecting
        HIV disclosure, healthcare navigation, self-advocacy, and health literacy were predictive of
        viral suppression after transition to adult care for adolescents living with HIV in South
        Africa. Using the HARTS in addition to demographic data associated with viral suppression
        after transition to adult care, the researchers created a transition readiness score to
        assist clinicians in determining which adolescents may benefit from additional services prior
        to transitioning to adult care.
  
        Clinics in KwaZulu-Natal, South Africa are randomized to deliver an in-person
        adolescent-friendly service (iPAS) intervention, mHealth InTSHA intervention, or standard of
        care to adolescents receiving care at those clinics who score low or intermediate when
        screened for transition readiness. After the first 9 months of the study, the clinics
        randomized to deliver standard of care will begin delivering either the iPAS or InTSHA
        interventions for the next 9 month period. Adolescents participate in the intervention
        occurring at the clinic they attend for 9 months and complete surveys at baseline, after the
        9 month intervention, and a final survey at the end of the study (15 or 24 months after
        enrollment). Adolescents with high scores when screened for transition readiness will
        comprise an observational cohort where data will be abstracted from medical records and they
        will complete questionnaires at 9, 18, and 24 months.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: This study uses a stepped-wedge, delayed implementation randomized clinical trial design, to measure the effectiveness of the interventions compared to standard of care.
  primary purpose: Supportive Care
  masking: None (Open Label)
  measure: Number of Participants Retained in Care
  time frame: After the 9 month intervention (Month 9 or Month 18)
  description: Clinic patients are considered to be retained in care if 80% of ART pharmacy refills are filled on time (< 7days from scheduled date) and 80% of scheduled clinic appointments are attended.
  measure: Change in Number of Participants with Viral Suppression
  time frame: Baseline, After the 9 month intervention (Month 9 or Month 18)
  description: HIV-1 viral load is measured in viral copies per milliliter (mL) of blood and viral suppression is defined as <200 copies/ml.
  measure: Change in Acceptability of Intervention Measure (AIM) Score
  time frame: Baseline, After the 9 month intervention (Month 9 or Month 18)
  description: Acceptability of the intervention is assessed with the AIM questionnaire. The AIM questionnaire has 4 items asking respondents how much they agree with statements such as "the intervention is appealing to me". Responses are given on a 5-point scale where "completely disagree" = 1 and "completely agree" = 5. Total scores range from 4 to 20 where higher scores indicate greater feelings of acceptability.
  measure: Change in Intervention Appropriateness Measure (IAM) Score
  time frame: Baseline, After the 9 month intervention (Month 9 or Month 18)
  description: Appropriateness of the intervention is assessed with the IAM questionnaire. The IAM questionnaire has 4 items asking respondents how much they agree with statements such as "the intervention seems applicable". Responses are given on a 5-point scale where "completely disagree" = 1 and "completely agree" = 5. Total scores range from 4 to 20 where higher scores indicate greater feelings that the intervention is appropriate.
  measure: Change in Feasibility of Intervention Measure (FIM) Score
  time frame: Baseline, After the 9 month intervention (Month 9 or Month 18)
  description: Feasibility of the intervention is assessed with the FIM questionnaire. The FIM questionnaire has 4 items asking respondents how much they agree with statements such as "the intervention seems possible". Responses are given on a 5-point scale where "completely disagree" = 1 and "completely agree" = 5. Total scores range from 4 to 20 where higher scores indicate greater feelings that the intervention is feasible.
  measure: Change in HIV Adolescent Readiness for Transition Scale (HARTS) Score
  time frame: Baseline, Month 9, Month 18, Month 24
  description: The HIV Adolescent Readiness for Transition Scale (HARTS) includes 16 items that are responded to on a 5-point scale where 0 = no, 1 = no, but I am learning, 2 = yes, a little bit, 3 = yes, almost always, and 4 = yes, always. Total scores range from 0 to 64 and higher scores indicate greater readiness to transition to adult care.
  measure: Change in Participation Rate
  time frame: Baseline, After the 9 month intervention (Month 9 or Month 18)
  description: Adoption of the intervention is examined as the number of adolescent patients enrolling in the study. Adoption of the intervention is considered successful with a participation rate threshold of >70%.
  measure: Change in Intervention Fidelity
  time frame: Up to Month 24
  description: Healthcare providers will complete an intervention checklist monthly during the intervention. A threshold of >80% of intervention checklist items is considered to be fidelity to the intervention.
  measure: Cost of the Intervention
  time frame: After the 9 month intervention (Month 9 or Month 18)
  description: Cost of the intervention is assessed through time and motions studies. Time and motion studies involve counting the time a healthcare provider takes to prepare and deliver the intervention and how long (in hours) each session takes.
  measure: Intervention Completion Rate
  time frame: After the 9 month intervention (Month 9 or Month 18)
  description: Completion of the intervention is examined as the number of adolescent participants who complete the study.
  measure: Change in Attendance to Clinic Visits
  time frame: Month 18, Month 24
  description: Sustained effectiveness of the study is examined as attendance to clinic visits post-transitioning to care through an adult clinic.
  measure: Change in Pharmacy Refills
  time frame: Month 18, Month 24
  description: Sustained effectiveness of the study is examined as pharmacy refills post-transitioning to care through an adult clinic.
  measure: Change in Child and Adolescent Social Support Scale (CASSS) Score
  time frame: Baseline, After the 9 month intervention (Month 9 or Month 18)
  description: Social support from peers is assessed using 10 items of the Child and Adolescent Social Support Scale (friend support subscale). Responses are given on a 6-point scale where 1 = never and 6 = always. Total scores range from 10 to 60, where higher scores represent greater social support from peers.
  measure: Change in Rosenberg's Self-Esteem Scale Score
  time frame: Baseline, After the 9 month intervention (Month 9 or Month 18)
  description: The Rosenberg's Self-Esteem Scale is a 10-item instrument assessing self-esteem. Responses are given on a 4-point scale where 0 = strongly disagree and 3 = strongly agree. Total scores range 0 to 30 and higher scores indicate greater self-esteem.
  measure: Change in Patient Health Questionnaire (PHQ-9) Score
  time frame: Baseline, After the 9 month intervention (Month 9 or Month 18)
  description: The PHQ-9 is a 9-item self-report questionnaire developed to identify patients at risk for depression. Participants report how often they have been bothered by specific symptoms of depression on a scale of 0 (not at all) to 3 (nearly every day). Higher scores indicate greater symptoms of depression. A score of ≥ 9 indicates clinically significant symptoms.
  measure: Change in Internalized AIDS-Related Stigma Scale (IA-RSS) Score
  time frame: Baseline, After the 9 month intervention (Month 9 or Month 18)
  description: The IA-RSS assesses several dimensions of stigma concerning HIV status. The instrument includes 6 items adapted form the AIDS-Related Stigma scale. Statements about hesitancy to disclose HIV status and feelings of shame are responded to as 0 = Disagree and 1 = Agree. Total scores range from 0 to 6 with higher scores indicating increased internalized stigma.
  measure: Change in Working Alliance Inventory (WAI) Score
  time frame: Baseline, After the 9 month intervention (Month 9 or Month 18)
  description: connection to clinic (Working Alliance Inventory) A modified version of the Working Alliance Inventory is used to measure how connected participants feel to the clinical staff and medical team. Ten items are responded to on a 4-point scale where 0 = strongly disagree and 3 = strongly agree. Total scores range from 0 to 30 where higher scores indicate increased feelings of connection with clinical staff.
  arm group label: In-person adolescent-friendly service (iPAS) intervention:
  arm group type: Experimental
  description: Adolescents at study clinics who score low or intermediate on transition readiness during screening will be invited to enroll in the study. Adolescents attending clinics randomized to the in-person supported adolescent friendly services will attend their clinic after school hours on a designated day or on weekends dedicated for adolescent care monthly for 9 months.
  arm group label: mHealth (InTSHA) intervention
  arm group type: Experimental
  description: Adolescents at study clinics who score low or intermediate on transition readiness during screening will be invited to enroll in the study. Adolescents attending clinics randomized to the mHealth intervention will receive the InTSHA intervention based in the Got Transition elements and the SMART model for 9 months.
  arm group label: Standard of Care/Delayed Intervention
  arm group type: Active Comparator
  description: Adolescents at study clinics who score low or intermediate on transition readiness during screening will be invited to enroll in the study. Adolescents attending clinics randomized to deliver the standard of care before transitioning to adult care in their standard local adult clinic. Participants will be invited to receive the intervention the clinic is randomized to deliver when the 9 month period of administering the standard of care is complete.
  arm group label: Healthcare Providers
  arm group type: No Intervention
  description: Healthcare providers working at one of study clinics, administering the study intervention selected for that clinic.
  arm group label: Observational cohort
  arm group type: No Intervention
  description: Adolescents at study clinics who score high on transition readiness during screening will not be invited to enroll in the study but will be asked for their consent to have their clinic records reviewed for medical records, retention data and transition readiness data. They will also complete a questionnaire at Months 9, 18, and 24.
  intervention type: Behavioral
  intervention name: In-person adolescent-friendly service (iPAS) intervention
  description: Monthly visits take place in a group setting with sessions led by peer educators. Clinical staff and peer educators are trained in care of adolescents using the Right to Care training materials. During their clinic visit, adolescents are evaluated individually by a healthcare provider and receive their supply of ART. In addition, adolescents participate in scheduled group team-building activities including dancing, sports, music and receive group counseling facilitated by peer educators. Nine group counseling sessions will discuss the topics of: HIV disclosure, alcohol and substance abuse, HIV knowledge, ART adherence and HIV resistance, goal setting and career planning, sexual and reproductive health, HIV stigma, healthcare navigation and self-advocacy, and healthy relationships. The half-day sessions will end with the provision of a meal. After completion of the 9-month intervention, adolescents will transition to adult care in their standard local adult clinic.
  arm group label: In-person adolescent-friendly service (iPAS) intervention:
  intervention type: Behavioral
  intervention name: mHealth (InTSHA) intervention
  description: The InTSHA intervention is based on Got Transition elements (two-way messaging between adolescents and healthcare providers) and the SMART model. The SMART model focuses on modifiable factors of transition preparation through content delivery, facilitated discussions, online meet ups and consultation with the healthcare team. The intervention consists of 9 modules delivered monthly by group chat. The topics of the modules are: HIV disclosure, alcohol and substance abuse, HIV knowledge, ART adherence and HIV resistance, goal setting and career planning, sexual and reproductive health, HIV stigma, healthcare navigation and self-advocacy, and healthy relationships. Outside of scheduled group chat sessions, adolescents have access to the chat group to check in with members, review content of the sessions, or to comment or ask additional questions. After completion of the 9-month intervention, adolescents will transition to adult care in their standard local adult clinic.
  arm group label: mHealth (InTSHA) intervention
  intervention type: Behavioral
  intervention name: Standard of Care
  description: Adolescents in standard of care are seen every three months by clinicians and collect medication monthly at an on-site pharmacy during regular weekdays. Individual counseling delivered by counselors or social workers is available when necessary. Staff at all clinics receive training in adolescent-friendly services (AFS) through the Right to Care training materials.
  arm group label: Standard of Care/Delayed Intervention
  criteria: 
  gender: All
  minimum age: 15 Years
  maximum age: 19 Years
  healthy volunteers: No
  last name: Brian C Zanoni, MD, MPH
  role: Principal Investigator
  affiliation: Emory University
  last name: Mohendran Archary, MBchB
  role: Principal Investigator
  affiliation: King Edward VIII Hospital
  last name: Brian C Zanoni, MD, MPH
  phone: 404-727-0284
  email: brian.christopher.zanoni@emory.edu
  last name: Thobe Sibaya
  phone: 071-378-2271
  facility: 
  contact: 
  investigator: 
  country: South Africa
  responsible party type: Principal Investigator
  investigator affiliation: Emory University
  investigator full name: Brian Zanoni
  investigator title: Associate Professor
  mesh term: Acquired Immunodeficiency Syndrome
  mesh term: HIV Infections
  sharing ipd: Yes
  ipd description: De-identified, individual participant data will be made available for sharing, including demographic information, clinic information, and study and survey data.
  ipd info type: Study Protocol
  ipd time frame: Data will be made available for sharing following publication of results from this study.
  ipd access criteria: Data will be made available for sharing through the Emory Dataverse. The Dataverse website can be accessed by any researcher for secondary analyses.