<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/NCT04432571</url>
  </required_header>
  <id_info>
    <org_study_id>201910133</org_study_id>
    <nct_id>NCT04432571</nct_id>
  </id_info>
  <brief_title>ADAPT for Adolescents Adolescents</brief_title>
  <acronym>A4A</acronym>
  <official_title>An Adaptive Strategy for Preventing and Treating Lapses of Retention in HIV Care for Adolescents</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Washington University School of Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Colorado, Denver</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of California, San Francisco</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of California, Berkeley</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Kenya Medical Research Institute</agency>
      <agency_class>Other</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>
      Adolescents and young adults (AYA) with HIV face unique challenges to engagement in care and&#xD;
      their ability to achieve optimal health outcomes. The investigators hypothesize that&#xD;
      developmentally-tailored behavioral interventions will improve engagement in HIV care and&#xD;
      viral suppression (per current MOH guidelines) among AYA with HIV in Kenya. This two stage&#xD;
      study will initially randomize 880 AYA with HIV to either standard of care (SOC) or&#xD;
      electronic navigation to prevent treatment lapse. Participants who have a lapse will be&#xD;
      re-randomized to SOC, in-person peer navigation, or conditional cash transfers. Formative&#xD;
      work will be conducted initially to tailor the interventions to AYA and then later to assess&#xD;
      AYA perception, experience, and satisfaction with the interventions. We will evaluate the&#xD;
      most effective and cost-effective intervention and sequence of interventions to inform HIV&#xD;
      program managers, public policy makers, and other key stakeholders the best approaches to&#xD;
      improve engagement of care of AYA with HIV.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      While the global response to HIV has reached close to 20 million persons with life-saving&#xD;
      antiretroviral therapy (ART) and saved upwards of 60 million life-years, progress has been&#xD;
      uneven and adolescents and young adults (AYA) aged 14-24 years represent a key group left&#xD;
      behind. Compared to adults, AYA with HIV face more numerous, more diverse and more intense&#xD;
      barriers to adherence and retention. The investigators will utilize a SMART study design in&#xD;
      two stages among 880 AYA with HIV in Kenya to improve retention and viral suppression per the&#xD;
      current MOH guidelines. In stage 1 AYA will be randomized 1:1 to either (1) standard of care&#xD;
      education or counseling vs. (2) electronic navigation. Participants who do well (no lapses in&#xD;
      retention, medication pick up and viral suppression) will be maintained on these&#xD;
      low-intensity interventions, whereas those who fail will be re-randomized a second time to&#xD;
      one of three re-engagement interventions (stage 2): (1) standard of care tracing, (2) a&#xD;
      conditional cash transfer and (3) in-person peer navigation. The primary outcomes include (1)&#xD;
      for prevention: lapse in engagement or viral non-suppression following current MOH&#xD;
      guidelines; (2) for re-engagement: viral suppression six months after re-randomization; and&#xD;
      (3) across six strategies: sustained viral suppression and sustained engagement in care at&#xD;
      two years. The investigators anticipate that enrolling 880 AYA will result in 99% power to&#xD;
      detect a 15% difference in the primary outcome between intervention groups. The investigators&#xD;
      believe this study will yield evidence specific to AYA with HIV, quantify the relative&#xD;
      magnitude of different sequenced interventions, capture the costs, and have direct relevance&#xD;
      for public health programming to end the AIDS epidemic through engaging adolescents and young&#xD;
      adults with HIV.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">April 6, 2021</start_date>
  <completion_date type="Anticipated">July 31, 2024</completion_date>
  <primary_completion_date type="Anticipated">July 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>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Care engagement failure</measure>
    <time_frame>24 months</time_frame>
    <description>Experiencing any of the following three events within the first year of follow-up: lapse in retention (defined as 14 days late for a scheduled visit) or unsuppressed HIV RNA following current MOH guidelines during routine monitoring, or death.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Re-engagement</measure>
    <time_frame>24 months</time_frame>
    <description>Viral suppression (per current MOH guidelines) six months after re-randomization</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Sustained viral suppression and engagement in care</measure>
    <time_frame>24 months</time_frame>
    <description>Sustained viral suppression (per current MOH guidelines) and sustained engagement in care at 24 months</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Compare survival between arms</measure>
    <time_frame>24 months</time_frame>
    <description>Use log rank test to compare survival curves between arms</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Explore alternative outcome definitions: Mean visit adherence</measure>
    <time_frame>24 months</time_frame>
    <description>mean number of scheduled clinic visits attended</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Explore alternative outcome definitions: Medication possession ratio</measure>
    <time_frame>24 months</time_frame>
    <description>Proportion of scheduled pharmacy/medication visits attended</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Explore alternative outcome definitions: HIV RNA levels</measure>
    <time_frame>24 months</time_frame>
    <description>Viral suppression threshold (following current MOH guidelines)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Composite of time to return and time to viral resuppression</measure>
    <time_frame>24 months</time_frame>
    <description>Composite of time to return for the subset of patients failing Stage 1 treatments through missed visits, and time to viral resuppression for those who failed through an elevated viral load</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cost effectiveness</measure>
    <time_frame>24 months</time_frame>
    <description>We will compute unit cost for intervention activity and use information on activities for each participant to compute intervention cost per participant for each intervention strategy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Qualitative evaluation of how interventions work</measure>
    <time_frame>24 months</time_frame>
    <description>Qualitative methods will be used to identify major themes to understand how interventions worked (or did not work).</description>
  </secondary_outcome>
  <number_of_arms>6</number_of_arms>
  <enrollment type="Actual">880</enrollment>
  <condition>HIV/AIDS</condition>
  <arm_group>
    <arm_group_label>SOC-REC/SOC-OIC</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Standard of care - routine education and counseling (SOC-REC)/SOC-Outreach and Intensified Counseling (OIC)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>SOC-REC/CCT</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>SOC-REC/Conditional Cash Transfer (CCT)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>SOC-REC/IP-NAV</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>SOC-REC/In-Person Peer Navigation (IP-NAV)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>E-NAV/SOC-OIC</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Electronic Navigation/SOC-OIC</description>
  </arm_group>
  <arm_group>
    <arm_group_label>E-NAV/CCT</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>E-Nav/Conditional cash transfer</description>
  </arm_group>
  <arm_group>
    <arm_group_label>E-NAV/IP-NAV</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>E-Nav/In-Person Peer Navigation</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>SOC-REC/SOC-OIC</intervention_name>
    <description>Standard of care - routine education and counseling (SOC-REC)/SOC-Outreach and Intensified Counseling (OIC). SOC-REC is a stage 1 intervention to prevent lapses in HIV engagement through routine care. If an adolescent (1) misses an appointment &gt;14 days, or (2) who have unsuppressed HIV RNA as per current MOH viral load threshold or (3) clinically documented non-adherence after &gt;3 months of treatment he/she is re-randomized to a stage 2 intervention. SOC-OIC is a stage 2 intervention to treat lapses in HIV engagement through routine care which may include tracing and counseling to return to the clinic.</description>
    <arm_group_label>SOC-REC/SOC-OIC</arm_group_label>
    <other_name>Standard of care-routine education and counseling/Outreach and Intensified Counselling</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>SOC-REC/CCT</intervention_name>
    <description>SOC-REC/Conditional Cash Transfer (CCT). SOC-REC is a stage 1 intervention to prevent lapses in HIV engagement through routine care. If an adolescent (1) misses an appointment &gt;14 days, or (2) who have unsuppressed HIV RNA as per current MOH viral load threshold or (3) clinically documented non-adherence after &gt;3 months of treatment he/she is re-randomized to a stage 2 intervention. CCT is a stage 2 intervention to treat lapses in HIV engagement by providing a small cash incentive for on-time clinic attendance and/or viral load suppression (following per current MOH guidelines).</description>
    <arm_group_label>SOC-REC/CCT</arm_group_label>
    <other_name>Standard of care-routine education and counseling/Conditional Cash Transfer</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>SOC-REC/IP-NAV</intervention_name>
    <description>SOC-REC/In-Person Peer Navigation (IP-NAV). SOC-REC is a stage 1 intervention (routine care) to prevent lapses in HIV engagement. If an adolescent (1) misses an appointment &gt;14 days, or (2) who have unsuppressed HIV RNA as per current MOH viral load threshold or (3) clinically documented non-adherence after &gt;3 months of treatment he/she is re-randomized to a stage 2 intervention. IP-NAV is a stage 2 intervention to treat lapses in HIV engagement. Trained peer navigators will develop rapport with the participants and provide psychosocial support, case management, and assess retention and adherence barriers in a systematic manner and work with the participant to develop social support and clear, feasible plans to address barriers. The peer navigator will meet with the participant at least monthly, and no more than weekly, until HIV care engagement is demonstrated.</description>
    <arm_group_label>SOC-REC/IP-NAV</arm_group_label>
    <other_name>Standard of care-routine education and counseling/In-Person Peer Navigation</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>E-NAV/SOC-OIC</intervention_name>
    <description>E-Nav is a stage 1 intervention to prevent lapses in HIV engagement. Trained e-peer navigators will develop rapport and provide support through phone calls and/or patient preferred social media platforms. They will meet once in person and then weekly electronically for 8 weeks, and then monthly. If an adolescent (1) misses an appointment &gt;14 days, or (2) who have unsuppressed HIV RNA as per current MOH viral load threshold or (3) clinically documented non-adherence after &gt;3 months of treatment he/she is re-randomized to a stage 2 intervention. SOC-OIC is a stage 2 intervention to treat lapses in HIV engagement through routine care which may include tracing and counseling to return to the clinic.</description>
    <arm_group_label>E-NAV/SOC-OIC</arm_group_label>
    <other_name>Electronic-Navigation/SOC-Outreach and Intensified Counseling</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>E-NAV/CCT</intervention_name>
    <description>E-Nav is a stage 1 intervention to prevent lapses in HIV engagement. Trained e-peer navigators will develop rapport and provide support through phone calls and/or patient preferred social media platforms. They will meet once in person and then weekly electronically for 8 weeks, and then monthly. If an adolescent (1) misses an appointment &gt;14 days, or (2) who have unsuppressed HIV RNA as per current MOH viral load threshold or (3) clinically documented non-adherence after &gt;3 months of treatment he/she is re-randomized to a stage 2 intervention. CCT is a stage 2 intervention to treat lapses in HIV engagement by providing a small cash incentive for on-time clinic attendance and/or viral load suppression (following current MOH guidelines).</description>
    <arm_group_label>E-NAV/CCT</arm_group_label>
    <other_name>Electronic-Navigation/Conditional cash transfer</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>E-Nav/IP-NAV</intervention_name>
    <description>E-Nav is a stage 1 intervention to prevent lapses in HIV engagement. Trained e-peer navigators will develop rapport and provide support through phone calls and/or patient preferred social media platforms. They will meet once in person and then weekly electronically for 8 weeks, and then monthly. If an adolescent (1) misses an appointment &gt;14 days, or (2) has unsuppressed HIV RNA as per current MOH viral load threshold or (3) clinically documented non-adherence after &gt;3 months of treatment he/she is re-randomized to a stage 2 intervention. IP-NAV is a stage 2 intervention to treat lapses in HIV engagement by providing in person navigation and counseling to a cash incentive for on-time clinic attendance and/or viral load suppression (MOH guidelines). Trained peer navigators will provide psychosocial support, case management, assess retention and adherence barriers in a systematic manner and work with the participant to develop social support and clear, feasible plans to address barriers</description>
    <arm_group_label>E-NAV/IP-NAV</arm_group_label>
    <other_name>Electronic-Navigation/In-Person Peer Navigation</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  HIV-infection, on or initiating ART,&#xD;
&#xD;
          -  14-24 years of age,&#xD;
&#xD;
          -  Living &gt; 6 months in Kisumu County, Kenya in previous year,&#xD;
&#xD;
          -  Capable of informed consent (&gt; 18 years) or with a legal caregiver available for&#xD;
             consent (14-&lt;18 years),&#xD;
&#xD;
          -  Access to a cell phone,&#xD;
&#xD;
          -  Ability to read or be read short message service (SMS) messages,&#xD;
&#xD;
          -  Willingness to be contacted by clinic upon missed appointment,&#xD;
&#xD;
          -  For AYA who report phone sharing must have disclosed to the person sharing the phone.&#xD;
&#xD;
          -  Additionally, we will include AYA who are aware of their HIV status or whose&#xD;
             caregivers agree to assisted disclosure.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  AYA who participated in ADAPT-R,&#xD;
&#xD;
          -  Those planning to move out of Kisumu County, those acutely ill and requiring&#xD;
             hospitalization,&#xD;
&#xD;
          -  Those who report sharing phones but have not disclosed to the person sharing the phone&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>14 Years</minimum_age>
    <maximum_age>24 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Kenya Medical Research Institute</name>
      <address>
        <city>Kisumu</city>
        <country>Kenya</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Kenya</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>June 4, 2020</study_first_submitted>
  <study_first_submitted_qc>June 12, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 16, 2020</study_first_posted>
  <last_update_submitted>February 15, 2023</last_update_submitted>
  <last_update_submitted_qc>February 15, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 21, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Adolescents</keyword>
  <keyword>Retention</keyword>
  <keyword>Engagement in Care</keyword>
  <keyword>Lost to follow-up</keyword>
  <keyword>Kenya</keyword>
  <keyword>Adaptive strategies</keyword>
  <keyword>Sequentially randomized trial</keyword>
  <keyword>Sequential Multiple Assignment Randomized Trial</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>
  <!-- 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/NCT04432571
org study id: 201910133
nct id: NCT04432571
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Adolescents and young adults (AYA) with HIV face unique challenges to engagement in care and
      their ability to achieve optimal health outcomes. The investigators hypothesize that
      developmentally-tailored behavioral interventions will improve engagement in HIV care and
      viral suppression (per current MOH guidelines) among AYA with HIV in Kenya. This two stage
      study will initially randomize 880 AYA with HIV to either standard of care (SOC) or
      electronic navigation to prevent treatment lapse. Participants who have a lapse will be
      re-randomized to SOC, in-person peer navigation, or conditional cash transfers. Formative
      work will be conducted initially to tailor the interventions to AYA and then later to assess
      AYA perception, experience, and satisfaction with the interventions. We will evaluate the
      most effective and cost-effective intervention and sequence of interventions to inform HIV
      program managers, public policy makers, and other key stakeholders the best approaches to
      improve engagement of care of AYA with HIV.
While the global response to HIV has reached close to 20 million persons with life-saving
      antiretroviral therapy (ART) and saved upwards of 60 million life-years, progress has been
      uneven and adolescents and young adults (AYA) aged 14-24 years represent a key group left
      behind. Compared to adults, AYA with HIV face more numerous, more diverse and more intense
      barriers to adherence and retention. The investigators will utilize a SMART study design in
      two stages among 880 AYA with HIV in Kenya to improve retention and viral suppression per the
      current MOH guidelines. In stage 1 AYA will be randomized 1:1 to either (1) standard of care
      education or counseling vs. (2) electronic navigation. Participants who do well (no lapses in
      retention, medication pick up and viral suppression) will be maintained on these
      low-intensity interventions, whereas those who fail will be re-randomized a second time to
      one of three re-engagement interventions (stage 2): (1) standard of care tracing, (2) a
      conditional cash transfer and (3) in-person peer navigation. The primary outcomes include (1)
      for prevention: lapse in engagement or viral non-suppression following current MOH
      guidelines; (2) for re-engagement: viral suppression six months after re-randomization; and
      (3) across six strategies: sustained viral suppression and sustained engagement in care at
      two years. The investigators anticipate that enrolling 880 AYA will result in 99% power to
      detect a 15% difference in the primary outcome between intervention groups. The investigators
      believe this study will yield evidence specific to AYA with HIV, quantify the relative
      magnitude of different sequenced interventions, capture the costs, and have direct relevance
      for public health programming to end the AIDS epidemic through engaging adolescents and young
      adults with HIV.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Care engagement failure
time frame: 24 months
description: Experiencing any of the following three events within the first year of follow-up: lapse in retention (defined as 14 days late for a scheduled visit) or unsuppressed HIV RNA following current MOH guidelines during routine monitoring, or death.
measure: Re-engagement
time frame: 24 months
description: Viral suppression (per current MOH guidelines) six months after re-randomization
measure: Sustained viral suppression and engagement in care
time frame: 24 months
description: Sustained viral suppression (per current MOH guidelines) and sustained engagement in care at 24 months
measure: Compare survival between arms
time frame: 24 months
description: Use log rank test to compare survival curves between arms
measure: Explore alternative outcome definitions: Mean visit adherence
time frame: 24 months
description: mean number of scheduled clinic visits attended
measure: Explore alternative outcome definitions: Medication possession ratio
time frame: 24 months
description: Proportion of scheduled pharmacy/medication visits attended
measure: Explore alternative outcome definitions: HIV RNA levels
time frame: 24 months
description: Viral suppression threshold (following current MOH guidelines)
measure: Composite of time to return and time to viral resuppression
time frame: 24 months
description: Composite of time to return for the subset of patients failing Stage 1 treatments through missed visits, and time to viral resuppression for those who failed through an elevated viral load
measure: Cost effectiveness
time frame: 24 months
description: We will compute unit cost for intervention activity and use information on activities for each participant to compute intervention cost per participant for each intervention strategy.
measure: Qualitative evaluation of how interventions work
time frame: 24 months
description: Qualitative methods will be used to identify major themes to understand how interventions worked (or did not work).
arm group label: SOC-REC/SOC-OIC
arm group type: Active Comparator
description: Standard of care - routine education and counseling (SOC-REC)/SOC-Outreach and Intensified Counseling (OIC)
arm group label: SOC-REC/CCT
arm group type: Experimental
description: SOC-REC/Conditional Cash Transfer (CCT)
arm group label: SOC-REC/IP-NAV
arm group type: Experimental
description: SOC-REC/In-Person Peer Navigation (IP-NAV)
arm group label: E-NAV/SOC-OIC
arm group type: Experimental
description: Electronic Navigation/SOC-OIC
arm group label: E-NAV/CCT
arm group type: Experimental
description: E-Nav/Conditional cash transfer
arm group label: E-NAV/IP-NAV
arm group type: Experimental
description: E-Nav/In-Person Peer Navigation
intervention type: Behavioral
intervention name: SOC-REC/SOC-OIC
description: Standard of care - routine education and counseling (SOC-REC)/SOC-Outreach and Intensified Counseling (OIC). SOC-REC is a stage 1 intervention to prevent lapses in HIV engagement through routine care. If an adolescent (1) misses an appointment >14 days, or (2) who have unsuppressed HIV RNA as per current MOH viral load threshold or (3) clinically documented non-adherence after >3 months of treatment he/she is re-randomized to a stage 2 intervention. SOC-OIC is a stage 2 intervention to treat lapses in HIV engagement through routine care which may include tracing and counseling to return to the clinic.
arm group label: SOC-REC/SOC-OIC
other name: Standard of care-routine education and counseling/Outreach and Intensified Counselling
intervention type: Behavioral
intervention name: SOC-REC/CCT
description: SOC-REC/Conditional Cash Transfer (CCT). SOC-REC is a stage 1 intervention to prevent lapses in HIV engagement through routine care. If an adolescent (1) misses an appointment >14 days, or (2) who have unsuppressed HIV RNA as per current MOH viral load threshold or (3) clinically documented non-adherence after >3 months of treatment he/she is re-randomized to a stage 2 intervention. CCT is a stage 2 intervention to treat lapses in HIV engagement by providing a small cash incentive for on-time clinic attendance and/or viral load suppression (following per current MOH guidelines).
arm group label: SOC-REC/CCT
other name: Standard of care-routine education and counseling/Conditional Cash Transfer
intervention type: Behavioral
intervention name: SOC-REC/IP-NAV
description: SOC-REC/In-Person Peer Navigation (IP-NAV). SOC-REC is a stage 1 intervention (routine care) to prevent lapses in HIV engagement. If an adolescent (1) misses an appointment >14 days, or (2) who have unsuppressed HIV RNA as per current MOH viral load threshold or (3) clinically documented non-adherence after >3 months of treatment he/she is re-randomized to a stage 2 intervention. IP-NAV is a stage 2 intervention to treat lapses in HIV engagement. Trained peer navigators will develop rapport with the participants and provide psychosocial support, case management, and assess retention and adherence barriers in a systematic manner and work with the participant to develop social support and clear, feasible plans to address barriers. The peer navigator will meet with the participant at least monthly, and no more than weekly, until HIV care engagement is demonstrated.
arm group label: SOC-REC/IP-NAV
other name: Standard of care-routine education and counseling/In-Person Peer Navigation
intervention type: Behavioral
intervention name: E-NAV/SOC-OIC
description: E-Nav is a stage 1 intervention to prevent lapses in HIV engagement. Trained e-peer navigators will develop rapport and provide support through phone calls and/or patient preferred social media platforms. They will meet once in person and then weekly electronically for 8 weeks, and then monthly. If an adolescent (1) misses an appointment >14 days, or (2) who have unsuppressed HIV RNA as per current MOH viral load threshold or (3) clinically documented non-adherence after >3 months of treatment he/she is re-randomized to a stage 2 intervention. SOC-OIC is a stage 2 intervention to treat lapses in HIV engagement through routine care which may include tracing and counseling to return to the clinic.
arm group label: E-NAV/SOC-OIC
other name: Electronic-Navigation/SOC-Outreach and Intensified Counseling
intervention type: Behavioral
intervention name: E-NAV/CCT
description: E-Nav is a stage 1 intervention to prevent lapses in HIV engagement. Trained e-peer navigators will develop rapport and provide support through phone calls and/or patient preferred social media platforms. They will meet once in person and then weekly electronically for 8 weeks, and then monthly. If an adolescent (1) misses an appointment >14 days, or (2) who have unsuppressed HIV RNA as per current MOH viral load threshold or (3) clinically documented non-adherence after >3 months of treatment he/she is re-randomized to a stage 2 intervention. CCT is a stage 2 intervention to treat lapses in HIV engagement by providing a small cash incentive for on-time clinic attendance and/or viral load suppression (following current MOH guidelines).
arm group label: E-NAV/CCT
other name: Electronic-Navigation/Conditional cash transfer
intervention type: Behavioral
intervention name: E-Nav/IP-NAV
description: E-Nav is a stage 1 intervention to prevent lapses in HIV engagement. Trained e-peer navigators will develop rapport and provide support through phone calls and/or patient preferred social media platforms. They will meet once in person and then weekly electronically for 8 weeks, and then monthly. If an adolescent (1) misses an appointment >14 days, or (2) has unsuppressed HIV RNA as per current MOH viral load threshold or (3) clinically documented non-adherence after >3 months of treatment he/she is re-randomized to a stage 2 intervention. IP-NAV is a stage 2 intervention to treat lapses in HIV engagement by providing in person navigation and counseling to a cash incentive for on-time clinic attendance and/or viral load suppression (MOH guidelines). Trained peer navigators will provide psychosocial support, case management, assess retention and adherence barriers in a systematic manner and work with the participant to develop social support and clear, feasible plans to address barriers
arm group label: E-NAV/IP-NAV
other name: Electronic-Navigation/In-Person Peer Navigation
criteria: 
gender: All
minimum age: 14 Years
maximum age: 24 Years
healthy volunteers: No
facility: 
country: Kenya
responsible party type: Sponsor
mesh term: Acquired Immunodeficiency Syndrome
mesh term: HIV Infections