<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/NCT02969915</url>
  </required_header>
  <id_info>
    <org_study_id>IRB00082575</org_study_id>
    <secondary_id>R01DA041034</secondary_id>
    <secondary_id>K24DA035684</secondary_id>
    <nct_id>NCT02969915</nct_id>
  </id_info>
  <brief_title>Strategies to Improve the HIV Care Continuum Among Key Populations in India</brief_title>
  <official_title>Strategies to Improve the HIV Care Continuum Among Key Populations in India</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Johns Hopkins University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute on Drug Abuse (NIDA)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>YR Gaitonde Centre for AIDS Research and Education</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Elton John AIDS Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Johns Hopkins University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This clinical trial will compare the effectiveness of integrated care centers vs. integrated&#xD;
      care centers plus HIV patient treatment incentives for achieving HIV treatment targets among&#xD;
      people who inject drugs and men who have sex with men in India. The investigators will also&#xD;
      assess cost-effectiveness and barriers and facilitators to implementation through targeted&#xD;
      mixed-methods approaches. This study is a model for improving HIV treatment outcomes in key&#xD;
      populations in low to middle-income countries.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The trajectory of the HIV epidemic in coming decades will be determined by the degree to&#xD;
      which we can identify infected persons and engage them in care - a point implicit in the&#xD;
      ambitious UNAIDS &quot;90-90-90&quot; target, which sets 90% goals for HIV diagnosis, linkage of&#xD;
      infected persons to sustained antiretroviral therapy (ART), and viral suppression in those&#xD;
      treated. Meeting this target requires successful engagement of difficult to reach&#xD;
      populations, such as people who inject drugs (PWID) and men who have sex with men (MSM), who&#xD;
      bear a disproportionate share of the epidemic, particularly in low to middle income&#xD;
      countries. Our team is nearing completion of a multi-site cluster-randomized trial in India&#xD;
      to assess the effectiveness of integrated care centers (ICCs) for PWID and MSM compared to&#xD;
      usual care. ICC process measures from the first year show robust uptake of HIV counseling and&#xD;
      testing, the primary outcome for that trial, but slower than anticipated ART uptake.&#xD;
      Demand-side interventions in public health (such as treatment incentives) can be particularly&#xD;
      effective when paired with optimized treatment accessibility (i.e., supply). Consequently,&#xD;
      the investigators propose to examine whether provision of HIV care and treatment incentives&#xD;
      to ICC clients will improve overall utilization of the clinics and downstream HIV care&#xD;
      continuum outcomes.&#xD;
&#xD;
      The investigators propose a hybrid effectiveness-implementation design. This will include a&#xD;
      16-site, pair-matched cluster randomized trial to compare the effectiveness of adding of HIV&#xD;
      care incentives to ICCs (ICC+) versus standard ICCs on HIV care continuum outcomes, including&#xD;
      ART initiation, adherence and viral suppression. Effectiveness will be compared at the ICC&#xD;
      level (from a cohort of HIV-infected ART-eligible clients followed in each ICC and process&#xD;
      measures deriving from all ICC clients) and at the community-level through a cross-sectional&#xD;
      sample accrued via respondent-driven sampling (RDS) 2 years after initiation of the&#xD;
      intervention. Because PWID and MSM will be sampled independently from the ICCs in the RDS, it&#xD;
      provides an opportunity to characterize outcomes like community viral load and HIV incidence,&#xD;
      reflecting impact within the broader PWID/MSM communities. As an exploratory sub-aim, we will&#xD;
      use a rigorous scientific design to assess the effects of withdrawing (vs. continuing)&#xD;
      incentives beyond the initial intervention phase. Additionally, the investigators will&#xD;
      determine the cost-effectiveness of the ICC+ intervention.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">October 30, 2017</start_date>
  <completion_date type="Anticipated">April 2024</completion_date>
  <primary_completion_date type="Actual">March 23, 2020</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>Matched-pair cluster-randomized trial</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Proportion of Participants Surviving With Viral Suppression</measure>
    <time_frame>12 months</time_frame>
    <description>Viral suppression defined as HIV RNA &lt;150 copies/mL</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Proportion of Participants Surviving With Viral Suppression</measure>
    <time_frame>6 months</time_frame>
    <description>Viral suppression defined as HIV RNA &lt;150 copies/mL</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of Participants Surviving With Viral Suppression</measure>
    <time_frame>18 months</time_frame>
    <description>Viral suppression defined as HIV RNA &lt;150 copies/mL</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of Participants Surviving With Viral Suppression</measure>
    <time_frame>24 months</time_frame>
    <description>Viral suppression defined as HIV RNA &lt;150 copies/mL</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of Participants With Viral Suppression at One or More Follow-up Visits</measure>
    <time_frame>24 months</time_frame>
    <description>Proportion with viral suppression (HIV RNA &lt;150 copies/mL) at one or more follow-up visits</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Antiretroviral Therapy (ART) Initiation</measure>
    <time_frame>12 months</time_frame>
    <description>Rate of ART initiation among those naive to ART at baseline. This is reported as the proportion of participants who initiated ART.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Retention to HIV Care</measure>
    <time_frame>12 months</time_frame>
    <description>Proportion of participants who attended one or more visits to a government ART clinic in both the 0 to 6 month period and the 6 to 12 month period.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ART Adherence</measure>
    <time_frame>12 months</time_frame>
    <description>Proportion of participants who had a medication possession ratio of 0.9 or higher after starting ART</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mortality</measure>
    <time_frame>12 months</time_frame>
    <description>All-cause mortality</description>
  </secondary_outcome>
  <other_outcome>
    <measure>HIV Testing Rate in Integrated Care Centers (ICCs)</measure>
    <time_frame>6, 12, 18, and 24 months</time_frame>
    <description>HIV tests done per unit time</description>
  </other_outcome>
  <other_outcome>
    <measure>Rate of New HIV Diagnoses at ICCs</measure>
    <time_frame>6, 12, 18, and 24 months</time_frame>
    <description>New HIV diagnoses per unit time</description>
  </other_outcome>
  <other_outcome>
    <measure>Qualitative Evaluation of Incentive Intervention</measure>
    <time_frame>24-36 months</time_frame>
    <description>In-depth interviews with study participants and ICC staff</description>
  </other_outcome>
  <other_outcome>
    <measure>Recent HIV Testing, Community-level (Respondent-driven Sampling [RDS] Survey)</measure>
    <time_frame>36-48 months</time_frame>
    <description>Proportion reporting HIV test in prior 12 months among RDS survey participants</description>
  </other_outcome>
  <other_outcome>
    <measure>Awareness of HIV-positive Status, Community-level (RDS Survey)</measure>
    <time_frame>36-48 months</time_frame>
    <description>Proportion of HIV-positive participants aware of their status</description>
  </other_outcome>
  <other_outcome>
    <measure>Recent HIV Care Visit, Community-level (RDS Survey)</measure>
    <time_frame>36-48 months</time_frame>
    <description>Proportion of HIV-positive participants with treatment visit in prior 6 months</description>
  </other_outcome>
  <other_outcome>
    <measure>Current ART Use, Community-level (RDS Survey)</measure>
    <time_frame>36-48 months</time_frame>
    <description>Proportion of HIV-positive participants with ART use in prior 30 days</description>
  </other_outcome>
  <other_outcome>
    <measure>Viral Load Suppression, Community-level (RDS Survey)</measure>
    <time_frame>36-48 months</time_frame>
    <description>Proportion of HIV-positive participants with suppressed viral load (HIV RNA &lt;150 c/mL)</description>
  </other_outcome>
  <other_outcome>
    <measure>Prevalence of Viremic Persons, Community-level (RDS Survey)</measure>
    <time_frame>36-48 months</time_frame>
    <description>Proportion of all participants (HIV-negative and HIV-positive) with a measured HIV RNA ≥150 copies/mL.</description>
  </other_outcome>
  <other_outcome>
    <measure>HIV Incidence, Community-level (RDS Survey)</measure>
    <time_frame>36-48 months</time_frame>
    <description>Estimated with a validated multi-assay algorithm measured in HIV-positive participants</description>
  </other_outcome>
  <other_outcome>
    <measure>Costs Per Quality-adjusted Life Year Gained</measure>
    <time_frame>6, 12, 18, and 24 months</time_frame>
    <description>Evaluation of intervention costs and cost-effectiveness</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">2314</enrollment>
  <condition>HIV Infections</condition>
  <arm_group>
    <arm_group_label>Integrated care centers</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants in the active comparator arm have access to integrated care centers (ICCs)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ICC + incentives</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants in the experimental arm have access to the ICC intervention and the incentive intervention</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Incentives</intervention_name>
    <description>Treatment incentives are offered to HIV-positive participants for reaching treatment targets, including retention to medical follow-up, initiating antiretroviral therapy, and maintaining high adherence with antiretroviral therapy.</description>
    <arm_group_label>ICC + incentives</arm_group_label>
    <other_name>ICC+</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Integrated Care Centers</intervention_name>
    <description>ICCs offer key-population-oriented, vertically-integrated harm reduction, HIV testing, and HIV treatment services</description>
    <arm_group_label>ICC + incentives</arm_group_label>
    <arm_group_label>Integrated care centers</arm_group_label>
    <other_name>ICC</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Speaks Hindi, English, or local language&#xD;
&#xD;
          -  HIV-positive&#xD;
&#xD;
          -  Antiretroviral therapy (ART) naive or has used ART less than 12 months&#xD;
&#xD;
          -  Registered client at the local integrated care center (ICC), which serves either&#xD;
             people who inject drugs (PWID) or men who have sex with men (MSM).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Not competent to provide informed consent or participate in the study.&#xD;
&#xD;
          -  Receives HIV care in the private sector&#xD;
&#xD;
          -  Plans to migrate in next 12 months&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Shruti H Mehta, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Johns Hopkins University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Gregory M Lucas, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Johns Hopkins University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>YR Gaitonde Center for AIDS Research and Education</name>
      <address>
        <city>Chennai</city>
        <state>Tamil Nadu</state>
        <zip>600010</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>India</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>November 18, 2016</study_first_submitted>
  <study_first_submitted_qc>November 18, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 21, 2016</study_first_posted>
  <results_first_submitted>November 1, 2022</results_first_submitted>
  <results_first_submitted_qc>November 29, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">December 22, 2022</results_first_posted>
  <last_update_submitted>August 7, 2023</last_update_submitted>
  <last_update_submitted_qc>August 7, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 22, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>people who inject drugs</keyword>
  <keyword>men who have sex with men</keyword>
  <keyword>HIV</keyword>
  <keyword>India</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>HIV Infections</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>The investigators will require prospective collaborators to submit concept sheets to the study PIs that include a brief summary of the proposed hypothesis, summary of research methods, specific data or specimens that are being requested, and plans for analysis. Reasonable requests that address relevant scientific questions will be welcomed and supported to the extent possible.</ipd_description>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>October 20, 2022</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/15/NCT02969915/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>22 sites were considered for the trial and 16 were selected on the basis of high HIV prevalence. The 16 study sites were matched into pairs and randomized to incentives or usual care. Sites were matched according to key population (people who inject drugs or men who have sex with men) and HIV burden.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Incentives</title>
          <description>Participants in the experimental arm have access to the ICC intervention and the incentive intervention&#xD;
Incentives: Treatment incentives are offered to HIV-positive participants for reaching treatment targets, including retention to medical follow-up, initiating antiretroviral therapy, and maintaining high adherence with antiretroviral therapy.&#xD;
Integrated Care Centers: ICCs offer key-population-oriented, vertically-integrated harm reduction, HIV testing, and HIV treatment services</description>
        </group>
        <group group_id="P2">
          <title>Usual Care</title>
          <description>Participants in the active comparator arm have access to integrated care centers (ICCs)&#xD;
Integrated Care Centers: ICCs offer key-population-oriented, vertically-integrated harm reduction, HIV testing, and HIV treatment services</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="1114"/>
                <participants group_id="P2" count="1200"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>6-month Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="901"/>
                <participants group_id="P2" count="968"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>12-month Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="826"/>
                <participants group_id="P2" count="885"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>18-month Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="778"/>
                <participants group_id="P2" count="824"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="421"/>
                <participants group_id="P2" count="492"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="693"/>
                <participants group_id="P2" count="708"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="104"/>
                <participants group_id="P2" count="125"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="108"/>
                <participants group_id="P2" count="112"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Censored due to COVID-19</title>
              <participants_list>
                <participants group_id="P1" count="481"/>
                <participants group_id="P2" count="471"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Data are stratified by key population (PWID and MSM). 600 PWID and 514 MSM were at sites assigned to the incentive intervention (1114 total), and 600 PWID and 600 MSM were at sites assigned to usual care (1200 total).</population>
      <group_list>
        <group group_id="B1">
          <title>PWID [Usual Care]</title>
          <description>People who inject drugs (PWID) in 4 sites assigned to usual care</description>
        </group>
        <group group_id="B2">
          <title>PWID [Incentives]</title>
          <description>People who inject drugs (PWID) in 4 sites assigned to the incentives intervention</description>
        </group>
        <group group_id="B3">
          <title>MSM [Usual Care]</title>
          <description>Men who have sex with men (MSM) in 4 sites assigned to usual care</description>
        </group>
        <group group_id="B4">
          <title>MSM [Incentives]</title>
          <description>Men who have sex with men (MSM) in 4 sites assigned to the incentives intervention</description>
        </group>
        <group group_id="B5">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="600"/>
            <count group_id="B2" value="600"/>
            <count group_id="B3" value="600"/>
            <count group_id="B4" value="514"/>
            <count group_id="B5" value="2314"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="28" lower_limit="24" upper_limit="33"/>
                    <measurement group_id="B2" value="30" lower_limit="25" upper_limit="35"/>
                    <measurement group_id="B3" value="30" lower_limit="25" upper_limit="40"/>
                    <measurement group_id="B4" value="32" lower_limit="26" upper_limit="40"/>
                    <measurement group_id="B5" value="30" lower_limit="25" upper_limit="37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="152"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="154"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="598"/>
                    <measurement group_id="B2" value="448"/>
                    <measurement group_id="B3" value="600"/>
                    <measurement group_id="B4" value="514"/>
                    <measurement group_id="B5" value="2160"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="600"/>
                    <measurement group_id="B2" value="600"/>
                    <measurement group_id="B3" value="600"/>
                    <measurement group_id="B4" value="514"/>
                    <measurement group_id="B5" value="2314"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>HIV RNA &lt;150 copies/mL</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="61"/>
                    <measurement group_id="B2" value="153"/>
                    <measurement group_id="B3" value="108"/>
                    <measurement group_id="B4" value="138"/>
                    <measurement group_id="B5" value="460"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>CD4 cell count</title>
          <description>Normal is &gt;/= 500 cells/microliter.</description>
          <units>cells/microliter</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="391" lower_limit="282" upper_limit="499"/>
                    <measurement group_id="B2" value="384" lower_limit="242" upper_limit="514"/>
                    <measurement group_id="B3" value="314" lower_limit="183" upper_limit="477"/>
                    <measurement group_id="B4" value="276" lower_limit="147" upper_limit="434"/>
                    <measurement group_id="B5" value="347" lower_limit="210" upper_limit="491"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Secondary school education or beyond</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="336"/>
                    <measurement group_id="B2" value="381"/>
                    <measurement group_id="B3" value="375"/>
                    <measurement group_id="B4" value="352"/>
                    <measurement group_id="B5" value="1444"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Proportion of Participants Surviving With Viral Suppression</title>
        <description>Viral suppression defined as HIV RNA &lt;150 copies/mL</description>
        <time_frame>12 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Incentives</title>
            <description>Participants in the experimental arm have access to the ICC intervention and the incentive intervention&#xD;
Incentives: Treatment incentives are offered to HIV-positive participants for reaching treatment targets, including retention to medical follow-up, initiating antiretroviral therapy, and maintaining high adherence with antiretroviral therapy.&#xD;
Integrated Care Centers: ICCs offer key-population-oriented, vertically-integrated harm reduction, HIV testing, and HIV treatment services</description>
          </group>
          <group group_id="O2">
            <title>Usual Care</title>
            <description>Participants in the active comparator arm have access to integrated care centers (ICCs)&#xD;
Integrated Care Centers: ICCs offer key-population-oriented, vertically-integrated harm reduction, HIV testing, and HIV treatment services</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion of Participants Surviving With Viral Suppression</title>
          <description>Viral suppression defined as HIV RNA &lt;150 copies/mL</description>
          <units>Proportion of participants</units>
          <param>Number</param>
          <units_analyzed>Study sites</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1114"/>
                <count group_id="O2" value="1200"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Study sites</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.494"/>
                    <measurement group_id="O2" value="0.353"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Risk Ratio (RR)</param_type>
            <param_value>1.21</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.64</ci_lower_limit>
            <ci_upper_limit>2.26</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Proportion of Participants Surviving With Viral Suppression</title>
        <description>Viral suppression defined as HIV RNA &lt;150 copies/mL</description>
        <time_frame>6 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Incentives</title>
            <description>Participants in the experimental arm have access to the ICC intervention and the incentive intervention&#xD;
Incentives: Treatment incentives are offered to HIV-positive participants for reaching treatment targets, including retention to medical follow-up, initiating antiretroviral therapy, and maintaining high adherence with antiretroviral therapy.&#xD;
Integrated Care Centers: ICCs offer key-population-oriented, vertically-integrated harm reduction, HIV testing, and HIV treatment services</description>
          </group>
          <group group_id="O2">
            <title>Usual Care</title>
            <description>Participants in the active comparator arm have access to integrated care centers (ICCs)&#xD;
Integrated Care Centers: ICCs offer key-population-oriented, vertically-integrated harm reduction, HIV testing, and HIV treatment services</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion of Participants Surviving With Viral Suppression</title>
          <description>Viral suppression defined as HIV RNA &lt;150 copies/mL</description>
          <units>Proportion of participants</units>
          <param>Number</param>
          <units_analyzed>Study sites</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1114"/>
                <count group_id="O2" value="1200"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Study sites</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.509"/>
                    <measurement group_id="O2" value="0.365"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Risk Ratio (RR)</param_type>
            <param_value>1.31</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.91</ci_lower_limit>
            <ci_upper_limit>1.90</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Proportion of Participants Surviving With Viral Suppression</title>
        <description>Viral suppression defined as HIV RNA &lt;150 copies/mL</description>
        <time_frame>18 months</time_frame>
        <population>Overall number of participants analyzed is equal to enrolled cohort minus participants who were censored at the 18-month visit due to COVID-related stoppage.</population>
        <group_list>
          <group group_id="O1">
            <title>Incentives</title>
            <description>Participants in the experimental arm have access to the ICC intervention and the incentive intervention&#xD;
Incentives: Treatment incentives are offered to HIV-positive participants for reaching treatment targets, including retention to medical follow-up, initiating antiretroviral therapy, and maintaining high adherence with antiretroviral therapy.&#xD;
Integrated Care Centers: ICCs offer key-population-oriented, vertically-integrated harm reduction, HIV testing, and HIV treatment services</description>
          </group>
          <group group_id="O2">
            <title>Usual Care</title>
            <description>Participants in the active comparator arm have access to integrated care centers (ICCs)&#xD;
Integrated Care Centers: ICCs offer key-population-oriented, vertically-integrated harm reduction, HIV testing, and HIV treatment services</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion of Participants Surviving With Viral Suppression</title>
          <description>Viral suppression defined as HIV RNA &lt;150 copies/mL</description>
          <population>Overall number of participants analyzed is equal to enrolled cohort minus participants who were censored at the 18-month visit due to COVID-related stoppage.</population>
          <units>Proportion of participants</units>
          <param>Number</param>
          <units_analyzed>Study sites</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1105"/>
                <count group_id="O2" value="1166"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Study sites</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.497"/>
                    <measurement group_id="O2" value="0.358"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Risk Ratio (RR)</param_type>
            <param_value>1.16</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.70</ci_lower_limit>
            <ci_upper_limit>1.95</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Proportion of Participants Surviving With Viral Suppression</title>
        <description>Viral suppression defined as HIV RNA &lt;150 copies/mL</description>
        <time_frame>24 months</time_frame>
        <population>Overall number of participants analyzed is equal to enrolled cohort minus participants who were censored at the 24-month visit due to COVID-related stoppage.</population>
        <group_list>
          <group group_id="O1">
            <title>Incentives</title>
            <description>Participants in the experimental arm have access to the ICC intervention and the incentive intervention&#xD;
Incentives: Treatment incentives are offered to HIV-positive participants for reaching treatment targets, including retention to medical follow-up, initiating antiretroviral therapy, and maintaining high adherence with antiretroviral therapy.&#xD;
Integrated Care Centers: ICCs offer key-population-oriented, vertically-integrated harm reduction, HIV testing, and HIV treatment services</description>
          </group>
          <group group_id="O2">
            <title>Usual Care</title>
            <description>Participants in the active comparator arm have access to integrated care centers (ICCs)&#xD;
Integrated Care Centers: ICCs offer key-population-oriented, vertically-integrated harm reduction, HIV testing, and HIV treatment services</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion of Participants Surviving With Viral Suppression</title>
          <description>Viral suppression defined as HIV RNA &lt;150 copies/mL</description>
          <population>Overall number of participants analyzed is equal to enrolled cohort minus participants who were censored at the 24-month visit due to COVID-related stoppage.</population>
          <units>Proportion of participants</units>
          <param>Number</param>
          <units_analyzed>Study sites</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="633"/>
                <count group_id="O2" value="729"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Study sites</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.471"/>
                    <measurement group_id="O2" value="0.325"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Risk Ratio (RR)</param_type>
            <param_value>1.29</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.85</ci_lower_limit>
            <ci_upper_limit>1.95</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Proportion of Participants With Viral Suppression at One or More Follow-up Visits</title>
        <description>Proportion with viral suppression (HIV RNA &lt;150 copies/mL) at one or more follow-up visits</description>
        <time_frame>24 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Incentives</title>
            <description>Participants in the experimental arm have access to the ICC intervention and the incentive intervention&#xD;
Incentives: Treatment incentives are offered to HIV-positive participants for reaching treatment targets, including retention to medical follow-up, initiating antiretroviral therapy, and maintaining high adherence with antiretroviral therapy.&#xD;
Integrated Care Centers: ICCs offer key-population-oriented, vertically-integrated harm reduction, HIV testing, and HIV treatment services</description>
          </group>
          <group group_id="O2">
            <title>Usual Care</title>
            <description>Participants in the active comparator arm have access to integrated care centers (ICCs)&#xD;
Integrated Care Centers: ICCs offer key-population-oriented, vertically-integrated harm reduction, HIV testing, and HIV treatment services</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion of Participants With Viral Suppression at One or More Follow-up Visits</title>
          <description>Proportion with viral suppression (HIV RNA &lt;150 copies/mL) at one or more follow-up visits</description>
          <units>Proportion of participants</units>
          <param>Number</param>
          <units_analyzed>Study sites</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1114"/>
                <count group_id="O2" value="1200"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Study sites</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.640"/>
                    <measurement group_id="O2" value="0.498"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Risk Ratio (RR)</param_type>
            <param_value>1.17</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.79</ci_lower_limit>
            <ci_upper_limit>1.75</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Antiretroviral Therapy (ART) Initiation</title>
        <description>Rate of ART initiation among those naive to ART at baseline. This is reported as the proportion of participants who initiated ART.</description>
        <time_frame>12 months</time_frame>
        <population>This analysis includes only participants who had never started ART previously</population>
        <group_list>
          <group group_id="O1">
            <title>Incentives</title>
            <description>Participants in the experimental arm have access to the ICC intervention and the incentive intervention&#xD;
Incentives: Treatment incentives are offered to HIV-positive participants for reaching treatment targets, including retention to medical follow-up, initiating antiretroviral therapy, and maintaining high adherence with antiretroviral therapy.&#xD;
Integrated Care Centers: ICCs offer key-population-oriented, vertically-integrated harm reduction, HIV testing, and HIV treatment services</description>
          </group>
          <group group_id="O2">
            <title>Usual Care</title>
            <description>Participants in the active comparator arm have access to integrated care centers (ICCs)&#xD;
Integrated Care Centers: ICCs offer key-population-oriented, vertically-integrated harm reduction, HIV testing, and HIV treatment services</description>
          </group>
        </group_list>
        <measure>
          <title>Antiretroviral Therapy (ART) Initiation</title>
          <description>Rate of ART initiation among those naive to ART at baseline. This is reported as the proportion of participants who initiated ART.</description>
          <population>This analysis includes only participants who had never started ART previously</population>
          <units>Proportion of participants</units>
          <param>Number</param>
          <units_analyzed>Study site</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="716"/>
                <count group_id="O2" value="935"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Study site</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.721"/>
                    <measurement group_id="O2" value="0.708"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Risk Ratio (RR)</param_type>
            <param_value>1.48</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.38</ci_lower_limit>
            <ci_upper_limit>5.76</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Retention to HIV Care</title>
        <description>Proportion of participants who attended one or more visits to a government ART clinic in both the 0 to 6 month period and the 6 to 12 month period.</description>
        <time_frame>12 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Incentives</title>
            <description>Participants in the experimental arm have access to the ICC intervention and the incentive intervention&#xD;
Incentives: Treatment incentives are offered to HIV-positive participants for reaching treatment targets, including retention to medical follow-up, initiating antiretroviral therapy, and maintaining high adherence with antiretroviral therapy.&#xD;
Integrated Care Centers: ICCs offer key-population-oriented, vertically-integrated harm reduction, HIV testing, and HIV treatment services</description>
          </group>
          <group group_id="O2">
            <title>Usual Care</title>
            <description>Participants in the active comparator arm have access to integrated care centers (ICCs)&#xD;
Integrated Care Centers: ICCs offer key-population-oriented, vertically-integrated harm reduction, HIV testing, and HIV treatment services</description>
          </group>
        </group_list>
        <measure>
          <title>Retention to HIV Care</title>
          <description>Proportion of participants who attended one or more visits to a government ART clinic in both the 0 to 6 month period and the 6 to 12 month period.</description>
          <units>Proportion of participants</units>
          <param>Number</param>
          <units_analyzed>Study site</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1114"/>
                <count group_id="O2" value="1200"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Study site</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.702"/>
                    <measurement group_id="O2" value="0.664"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Risk Ratio (RR)</param_type>
            <param_value>0.96</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.68</ci_lower_limit>
            <ci_upper_limit>1.36</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>ART Adherence</title>
        <description>Proportion of participants who had a medication possession ratio of 0.9 or higher after starting ART</description>
        <time_frame>12 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Incentives</title>
            <description>Participants in the experimental arm have access to the ICC intervention and the incentive intervention&#xD;
Incentives: Treatment incentives are offered to HIV-positive participants for reaching treatment targets, including retention to medical follow-up, initiating antiretroviral therapy, and maintaining high adherence with antiretroviral therapy.&#xD;
Integrated Care Centers: ICCs offer key-population-oriented, vertically-integrated harm reduction, HIV testing, and HIV treatment services</description>
          </group>
          <group group_id="O2">
            <title>Usual Care</title>
            <description>Participants in the active comparator arm have access to integrated care centers (ICCs)&#xD;
Integrated Care Centers: ICCs offer key-population-oriented, vertically-integrated harm reduction, HIV testing, and HIV treatment services</description>
          </group>
        </group_list>
        <measure>
          <title>ART Adherence</title>
          <description>Proportion of participants who had a medication possession ratio of 0.9 or higher after starting ART</description>
          <units>proportion of participants</units>
          <param>Number</param>
          <units_analyzed>Study sites</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1114"/>
                <count group_id="O2" value="1200"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Study sites</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.645"/>
                    <measurement group_id="O2" value="0.463"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Risk Ratio, log</param_type>
            <param_value>1.38</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.77</ci_lower_limit>
            <ci_upper_limit>2.46</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mortality</title>
        <description>All-cause mortality</description>
        <time_frame>12 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Incentives</title>
            <description>Participants in the experimental arm have access to the ICC intervention and the incentive intervention&#xD;
Incentives: Treatment incentives are offered to HIV-positive participants for reaching treatment targets, including retention to medical follow-up, initiating antiretroviral therapy, and maintaining high adherence with antiretroviral therapy.&#xD;
Integrated Care Centers: ICCs offer key-population-oriented, vertically-integrated harm reduction, HIV testing, and HIV treatment services</description>
          </group>
          <group group_id="O2">
            <title>Usual Care</title>
            <description>Participants in the active comparator arm have access to integrated care centers (ICCs)&#xD;
Integrated Care Centers: ICCs offer key-population-oriented, vertically-integrated harm reduction, HIV testing, and HIV treatment services</description>
          </group>
        </group_list>
        <measure>
          <title>Mortality</title>
          <description>All-cause mortality</description>
          <units>Proportion of participants</units>
          <param>Number</param>
          <units_analyzed>Study sites</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1114"/>
                <count group_id="O2" value="1200"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Study sites</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.051"/>
                    <measurement group_id="O2" value="0.068"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Risk Ratio (RR)</param_type>
            <param_value>0.39</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.09</ci_lower_limit>
            <ci_upper_limit>1.80</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>HIV Testing Rate in Integrated Care Centers (ICCs)</title>
        <description>HIV tests done per unit time</description>
        <time_frame>6, 12, 18, and 24 months</time_frame>
        <population>Collected data were not considered valid due to COVID effects on access to services</population>
        <group_list>
          <group group_id="O1">
            <title>Incentives</title>
            <description>Participants in the experimental arm have access to the ICC intervention and the incentive intervention&#xD;
Incentives: Treatment incentives are offered to HIV-positive participants for reaching treatment targets, including retention to medical follow-up, initiating antiretroviral therapy, and maintaining high adherence with antiretroviral therapy.&#xD;
Integrated Care Centers: ICCs offer key-population-oriented, vertically-integrated harm reduction, HIV testing, and HIV treatment services</description>
          </group>
          <group group_id="O2">
            <title>Usual Care</title>
            <description>Participants in the active comparator arm have access to integrated care centers (ICCs)&#xD;
Integrated Care Centers: ICCs offer key-population-oriented, vertically-integrated harm reduction, HIV testing, and HIV treatment services</description>
          </group>
        </group_list>
        <measure>
          <title>HIV Testing Rate in Integrated Care Centers (ICCs)</title>
          <description>HIV tests done per unit time</description>
          <population>Collected data were not considered valid due to COVID effects on access to services</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Rate of New HIV Diagnoses at ICCs</title>
        <description>New HIV diagnoses per unit time</description>
        <time_frame>6, 12, 18, and 24 months</time_frame>
        <population>Collected data were not considered to be valid due to COVID effects on access to services</population>
        <group_list>
          <group group_id="O1">
            <title>Incentives</title>
            <description>Participants in the experimental arm have access to the ICC intervention and the incentive intervention&#xD;
Incentives: Treatment incentives are offered to HIV-positive participants for reaching treatment targets, including retention to medical follow-up, initiating antiretroviral therapy, and maintaining high adherence with antiretroviral therapy.&#xD;
Integrated Care Centers: ICCs offer key-population-oriented, vertically-integrated harm reduction, HIV testing, and HIV treatment services</description>
          </group>
          <group group_id="O2">
            <title>Usual Care</title>
            <description>Participants in the active comparator arm have access to integrated care centers (ICCs)&#xD;
Integrated Care Centers: ICCs offer key-population-oriented, vertically-integrated harm reduction, HIV testing, and HIV treatment services</description>
          </group>
        </group_list>
        <measure>
          <title>Rate of New HIV Diagnoses at ICCs</title>
          <description>New HIV diagnoses per unit time</description>
          <population>Collected data were not considered to be valid due to COVID effects on access to services</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Qualitative Evaluation of Incentive Intervention</title>
        <description>In-depth interviews with study participants and ICC staff</description>
        <time_frame>24-36 months</time_frame>
        <population>Data were not collected due to COVID restrictions</population>
        <group_list>
          <group group_id="O1">
            <title>Incentives</title>
            <description>Participants in the experimental arm have access to the ICC intervention and the incentive intervention&#xD;
Incentives: Treatment incentives are offered to HIV-positive participants for reaching treatment targets, including retention to medical follow-up, initiating antiretroviral therapy, and maintaining high adherence with antiretroviral therapy.&#xD;
Integrated Care Centers: ICCs offer key-population-oriented, vertically-integrated harm reduction, HIV testing, and HIV treatment services</description>
          </group>
          <group group_id="O2">
            <title>Usual Care</title>
            <description>Participants in the active comparator arm have access to integrated care centers (ICCs)&#xD;
Integrated Care Centers: ICCs offer key-population-oriented, vertically-integrated harm reduction, HIV testing, and HIV treatment services</description>
          </group>
        </group_list>
        <measure>
          <title>Qualitative Evaluation of Incentive Intervention</title>
          <description>In-depth interviews with study participants and ICC staff</description>
          <population>Data were not collected due to COVID restrictions</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Recent HIV Testing, Community-level (Respondent-driven Sampling [RDS] Survey)</title>
        <description>Proportion reporting HIV test in prior 12 months among RDS survey participants</description>
        <time_frame>36-48 months</time_frame>
        <posting_date>07/2025</posting_date>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Awareness of HIV-positive Status, Community-level (RDS Survey)</title>
        <description>Proportion of HIV-positive participants aware of their status</description>
        <time_frame>36-48 months</time_frame>
        <posting_date>07/2025</posting_date>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Recent HIV Care Visit, Community-level (RDS Survey)</title>
        <description>Proportion of HIV-positive participants with treatment visit in prior 6 months</description>
        <time_frame>36-48 months</time_frame>
        <posting_date>07/2025</posting_date>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Current ART Use, Community-level (RDS Survey)</title>
        <description>Proportion of HIV-positive participants with ART use in prior 30 days</description>
        <time_frame>36-48 months</time_frame>
        <posting_date>07/2025</posting_date>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Viral Load Suppression, Community-level (RDS Survey)</title>
        <description>Proportion of HIV-positive participants with suppressed viral load (HIV RNA &lt;150 c/mL)</description>
        <time_frame>36-48 months</time_frame>
        <posting_date>07/2025</posting_date>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Prevalence of Viremic Persons, Community-level (RDS Survey)</title>
        <description>Proportion of all participants (HIV-negative and HIV-positive) with a measured HIV RNA ≥150 copies/mL.</description>
        <time_frame>36-48 months</time_frame>
        <posting_date>07/2025</posting_date>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>HIV Incidence, Community-level (RDS Survey)</title>
        <description>Estimated with a validated multi-assay algorithm measured in HIV-positive participants</description>
        <time_frame>36-48 months</time_frame>
        <posting_date>07/2025</posting_date>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Costs Per Quality-adjusted Life Year Gained</title>
        <description>Evaluation of intervention costs and cost-effectiveness</description>
        <time_frame>6, 12, 18, and 24 months</time_frame>
        <posting_date>07/2025</posting_date>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>24 months</time_frame>
      <desc>The research procedures are minimal risk (involve only a blood draw) and the intervention is behavioral. Given these considerations, our reporting obligations for the trial focus only on events that are more likely than not to be associated with i) study procedures, or ii) participation in the intervention. Adverse events are reported through complete (24-month) follow-up.</desc>
      <group_list>
        <group group_id="E1">
          <title>Incentives</title>
          <description>Participants in the experimental arm have access to the ICC intervention and the incentive intervention&#xD;
Incentives: Treatment incentives are offered to HIV-positive participants for reaching treatment targets, including retention to medical follow-up, initiating antiretroviral therapy, and maintaining high adherence with antiretroviral therapy.&#xD;
Integrated Care Centers: ICCs offer key-population-oriented, vertically-integrated harm reduction, HIV testing, and HIV treatment services</description>
        </group>
        <group group_id="E2">
          <title>Usual Care</title>
          <description>Participants in the active comparator arm have access to integrated care centers (ICCs)&#xD;
Integrated Care Centers: ICCs offer key-population-oriented, vertically-integrated harm reduction, HIV testing, and HIV treatment services</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="104" subjects_at_risk="1114"/>
                <counts group_id="E2" subjects_affected="125" subjects_at_risk="1200"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="104" subjects_at_risk="1114"/>
                <counts group_id="E2" subjects_affected="125" subjects_at_risk="1200"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Death</sub_title>
                <counts group_id="E1" events="104" subjects_affected="104" subjects_at_risk="1114"/>
                <counts group_id="E2" events="125" subjects_affected="125" subjects_at_risk="1200"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1114"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1200"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Gregory M. Lucas</name_or_title>
      <organization>Johns Hopkins University</organization>
      <phone>410 614 0560</phone>
      <email>glucas@jhmi.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02969915
org study id: IRB00082575
secondary id: R01DA041034
secondary id: K24DA035684
nct id: NCT02969915
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This clinical trial will compare the effectiveness of integrated care centers vs. integrated
      care centers plus HIV patient treatment incentives for achieving HIV treatment targets among
      people who inject drugs and men who have sex with men in India. The investigators will also
      assess cost-effectiveness and barriers and facilitators to implementation through targeted
      mixed-methods approaches. This study is a model for improving HIV treatment outcomes in key
      populations in low to middle-income countries.
The trajectory of the HIV epidemic in coming decades will be determined by the degree to
      which we can identify infected persons and engage them in care - a point implicit in the
      ambitious UNAIDS "90-90-90" target, which sets 90% goals for HIV diagnosis, linkage of
      infected persons to sustained antiretroviral therapy (ART), and viral suppression in those
      treated. Meeting this target requires successful engagement of difficult to reach
      populations, such as people who inject drugs (PWID) and men who have sex with men (MSM), who
      bear a disproportionate share of the epidemic, particularly in low to middle income
      countries. Our team is nearing completion of a multi-site cluster-randomized trial in India
      to assess the effectiveness of integrated care centers (ICCs) for PWID and MSM compared to
      usual care. ICC process measures from the first year show robust uptake of HIV counseling and
      testing, the primary outcome for that trial, but slower than anticipated ART uptake.
      Demand-side interventions in public health (such as treatment incentives) can be particularly
      effective when paired with optimized treatment accessibility (i.e., supply). Consequently,
      the investigators propose to examine whether provision of HIV care and treatment incentives
      to ICC clients will improve overall utilization of the clinics and downstream HIV care
      continuum outcomes.

      The investigators propose a hybrid effectiveness-implementation design. This will include a
      16-site, pair-matched cluster randomized trial to compare the effectiveness of adding of HIV
      care incentives to ICCs (ICC+) versus standard ICCs on HIV care continuum outcomes, including
      ART initiation, adherence and viral suppression. Effectiveness will be compared at the ICC
      level (from a cohort of HIV-infected ART-eligible clients followed in each ICC and process
      measures deriving from all ICC clients) and at the community-level through a cross-sectional
      sample accrued via respondent-driven sampling (RDS) 2 years after initiation of the
      intervention. Because PWID and MSM will be sampled independently from the ICCs in the RDS, it
      provides an opportunity to characterize outcomes like community viral load and HIV incidence,
      reflecting impact within the broader PWID/MSM communities. As an exploratory sub-aim, we will
      use a rigorous scientific design to assess the effects of withdrawing (vs. continuing)
      incentives beyond the initial intervention phase. Additionally, the investigators will
      determine the cost-effectiveness of the ICC+ intervention.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Matched-pair cluster-randomized trial
primary purpose: Treatment
masking: None (Open Label)
measure: Proportion of Participants Surviving With Viral Suppression
time frame: 12 months
description: Viral suppression defined as HIV RNA <150 copies/mL
measure: Proportion of Participants Surviving With Viral Suppression
time frame: 6 months
description: Viral suppression defined as HIV RNA <150 copies/mL
measure: Proportion of Participants Surviving With Viral Suppression
time frame: 18 months
description: Viral suppression defined as HIV RNA <150 copies/mL
measure: Proportion of Participants Surviving With Viral Suppression
time frame: 24 months
description: Viral suppression defined as HIV RNA <150 copies/mL
measure: Proportion of Participants With Viral Suppression at One or More Follow-up Visits
time frame: 24 months
description: Proportion with viral suppression (HIV RNA <150 copies/mL) at one or more follow-up visits
measure: Antiretroviral Therapy (ART) Initiation
time frame: 12 months
description: Rate of ART initiation among those naive to ART at baseline. This is reported as the proportion of participants who initiated ART.
measure: Retention to HIV Care
time frame: 12 months
description: Proportion of participants who attended one or more visits to a government ART clinic in both the 0 to 6 month period and the 6 to 12 month period.
measure: ART Adherence
time frame: 12 months
description: Proportion of participants who had a medication possession ratio of 0.9 or higher after starting ART
measure: Mortality
time frame: 12 months
description: All-cause mortality
measure: HIV Testing Rate in Integrated Care Centers (ICCs)
time frame: 6, 12, 18, and 24 months
description: HIV tests done per unit time
measure: Rate of New HIV Diagnoses at ICCs
time frame: 6, 12, 18, and 24 months
description: New HIV diagnoses per unit time
measure: Qualitative Evaluation of Incentive Intervention
time frame: 24-36 months
description: In-depth interviews with study participants and ICC staff
measure: Recent HIV Testing, Community-level (Respondent-driven Sampling [RDS] Survey)
time frame: 36-48 months
description: Proportion reporting HIV test in prior 12 months among RDS survey participants
measure: Awareness of HIV-positive Status, Community-level (RDS Survey)
time frame: 36-48 months
description: Proportion of HIV-positive participants aware of their status
measure: Recent HIV Care Visit, Community-level (RDS Survey)
time frame: 36-48 months
description: Proportion of HIV-positive participants with treatment visit in prior 6 months
measure: Current ART Use, Community-level (RDS Survey)
time frame: 36-48 months
description: Proportion of HIV-positive participants with ART use in prior 30 days
measure: Viral Load Suppression, Community-level (RDS Survey)
time frame: 36-48 months
description: Proportion of HIV-positive participants with suppressed viral load (HIV RNA <150 c/mL)
measure: Prevalence of Viremic Persons, Community-level (RDS Survey)
time frame: 36-48 months
description: Proportion of all participants (HIV-negative and HIV-positive) with a measured HIV RNA ≥150 copies/mL.
measure: HIV Incidence, Community-level (RDS Survey)
time frame: 36-48 months
description: Estimated with a validated multi-assay algorithm measured in HIV-positive participants
measure: Costs Per Quality-adjusted Life Year Gained
time frame: 6, 12, 18, and 24 months
description: Evaluation of intervention costs and cost-effectiveness
arm group label: Integrated care centers
arm group type: Active Comparator
description: Participants in the active comparator arm have access to integrated care centers (ICCs)
arm group label: ICC + incentives
arm group type: Experimental
description: Participants in the experimental arm have access to the ICC intervention and the incentive intervention
intervention type: Behavioral
intervention name: Incentives
description: Treatment incentives are offered to HIV-positive participants for reaching treatment targets, including retention to medical follow-up, initiating antiretroviral therapy, and maintaining high adherence with antiretroviral therapy.
arm group label: ICC + incentives
other name: ICC+
intervention type: Behavioral
intervention name: Integrated Care Centers
description: ICCs offer key-population-oriented, vertically-integrated harm reduction, HIV testing, and HIV treatment services
arm group label: ICC + incentives
arm group label: Integrated care centers
other name: ICC
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Shruti H Mehta, PhD
role: Principal Investigator
affiliation: Johns Hopkins University
last name: Gregory M Lucas, MD
role: Principal Investigator
affiliation: Johns Hopkins University
facility: 
country: India
responsible party type: Sponsor
mesh term: HIV Infections
sharing ipd: Yes
ipd description: The investigators will require prospective collaborators to submit concept sheets to the study PIs that include a brief summary of the proposed hypothesis, summary of research methods, specific data or specimens that are being requested, and plans for analysis. Reasonable requests that address relevant scientific questions will be welcomed and supported to the extent possible.
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 