<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/NCT01686750</url>
  </required_header>
  <id_info>
    <org_study_id>NA_00047702</org_study_id>
    <secondary_id>R01DA032059</secondary_id>
    <secondary_id>R01MH089266</secondary_id>
    <nct_id>NCT01686750</nct_id>
  </id_info>
  <brief_title>Integrated Care Centers to Improve HIV Outcomes in Vulnerable Indian Populations</brief_title>
  <official_title>A Cluster Randomized Trial of Integrated Care Centers to Improve Access to HIV Prevention, Testing, and Treatment Services Among High-Risk Vulnerable 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>National Institute of Mental Health (NIMH)</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>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a cluster randomized trial to evaluate the effectiveness of integrated care centers&#xD;
      (ICC) to improve access to HIV testing, prevention services, and treatment among high-risk&#xD;
      populations of injection drug users (IDU) and men who have sex with men (MSM) in India. We&#xD;
      will collect baseline ethnographic and survey data from approximately 27 IDU or MSM sites in&#xD;
      India. We will use baseline data to select 22 sites for the trial (12 IDU and 10 MSM) and to&#xD;
      stratify sites according to key baseline characteristics. We will perform stratified&#xD;
      randomization to assign sites to either the ICC intervention or to standard services. ICCs,&#xD;
      which will be either IDU or MSM-focused, will provide an accepting atmosphere in which&#xD;
      members of vulnerable groups can drop-in, receive rapid HIV voluntary counselling and&#xD;
      testing, risk reduction counseling and services, and antiretroviral therapy. ICCs will be&#xD;
      scaled-up from existing governmental or non-governmental organizations and services provided&#xD;
      at ICCs will be supported by the National AIDS Control Organization (NACO) of India. After&#xD;
      providing services in communities for two years, we will conduct an evaluation survey (with&#xD;
      biological and behavioral measures) of approximately 1000 subjects in the target populations&#xD;
      in each of the 22 study sites. Integrated care centers have the potential to improve access&#xD;
      to HIV prevention and treatment services among vulnerable, high-risk populations.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 2012</start_date>
  <completion_date type="Actual">June 2017</completion_date>
  <primary_completion_date type="Actual">June 2017</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>Proportion Reporting HIV Testing in the Prior 12 Months</measure>
    <time_frame>2 years</time_frame>
    <description>Self-reported HIV testing in the prior 12 months among all survey participants, excluding those who reported being diagnosed with HIV more than 12 months previously.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Proportion of HIV-infected Participants Aware of Status</measure>
    <time_frame>2 years</time_frame>
    <description>Proportion of HIV-positive participants that were aware of their status at the time of the visit</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of HIV-infected Participants Visiting an HIV Treatment Provider in Prior 6 Months</measure>
    <time_frame>2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of Antiretroviral Therapy-eligible HIV-infected Participants Using Antiretroviral Therapy</measure>
    <time_frame>2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Community Viral Load</measure>
    <time_frame>2 years</time_frame>
    <description>Average log(10) HIV RNA concentration among HIV-infected participants</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of HIV-infected Participants With Suppressed HIV RNA</measure>
    <time_frame>2 years</time_frame>
    <description>Proportion of HIV-positive participants meeting criteria for antiretroviral therapy [cluster of differentiation 4 (CD4) count &lt;350 cells/mm3 or current or past use of antiretroviral therapy)] who have a suppressed viral load (HIV RNA &lt;150 copies/mL)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Prevalence of Recent HIV Infection</measure>
    <time_frame>2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of IDU Reporting Needle or Syringe Sharing in Prior 6 Months</measure>
    <time_frame>2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of IDU Reporting Drug Abstinence in Prior 6 Months</measure>
    <time_frame>2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of MSM Reporting Unprotected Anal Intercourse With Non-main Partner in Prior 6 Months</measure>
    <time_frame>2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Non-main Male Partners in Prior 6 Months in MSM</measure>
    <time_frame>2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion Reporting Substance Abuse Among MSM</measure>
    <time_frame>2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion With Depressive Symptoms</measure>
    <time_frame>2 years</time_frame>
    <description>Participants with Score &gt;=10 on Patient Health Questionnaire-9</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Unprotected Sexual Acts Reported by MSM</measure>
    <time_frame>2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vicarious Stigma as Assessed by 6-item Stigma Scale</measure>
    <time_frame>2 years</time_frame>
    <description>Summed score from a 6-item stigma scale (range 0-18), with higher values indicating more perceived stigma</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion Reporting Spouse Ever Tested for HIV</measure>
    <time_frame>2 years</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">21726</enrollment>
  <condition>HIV Infection</condition>
  <arm_group>
    <arm_group_label>Integrated care centers</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Integrated care centers will provide HIV prevention and treatment services to high risk populations of IDU or MSM in an accepting and supportive environment.&#xD;
HIV voluntary counseling and testing &amp; staging&#xD;
Risk reduction services including free condoms, needle and syringe exchange, opiate substitution therapy&#xD;
Substance abuse counseling&#xD;
Sexually transmitted infection screening and treatment&#xD;
Access to free antiretroviral therapy and adherence support&#xD;
Peer community outreach</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard services</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>In Standard Services sites, HIV testing, prevention, and treatment services will be available through standard venues. Government centers typically provide most HIV testing services and are the only source for free antiretroviral therapy. Non-governmental organizations typically provide prevention and risk reduction services.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Integrated care centers</intervention_name>
    <arm_group_label>Integrated care centers</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Key Informant Interviews:&#xD;
&#xD;
        Persons may be included in the key informant interviews if they meet all of the following&#xD;
        criteria:&#xD;
&#xD;
          1. 18 years of age or older&#xD;
&#xD;
          2. Knowledge of the local HIV risk group of interest (IDU or MSM)&#xD;
&#xD;
          3. Psychologically fit to participate in the study and to understand the consent&#xD;
&#xD;
          4. Ability to comprehend one of the consent translation languages&#xD;
&#xD;
          5. Provide informed consent&#xD;
&#xD;
        Focus groups:&#xD;
&#xD;
        Persons may be included in the focus groups if they meet all of the following criteria:&#xD;
&#xD;
          1. 18 years of age or older&#xD;
&#xD;
          2. Member of a target HIV risk group, meeting criterion 2a or 2b&#xD;
&#xD;
               1. IDU: self-reported injection drug use in prior 12 months&#xD;
&#xD;
               2. MSM: self-identify as male and report oral/anal sex with another male in prior 12&#xD;
                  months&#xD;
&#xD;
          3. Psychologically fit to participate in the study and to understand the consent&#xD;
&#xD;
          4. Ability to comprehend one of the consent translation languages&#xD;
&#xD;
          5. Provide informed consent&#xD;
&#xD;
        Baseline or evaluation respondent-driven sampling (RDS) survey&#xD;
&#xD;
        Persons may be included in the baseline or evaluation RDS survey if they meet all of the&#xD;
        following criteria:&#xD;
&#xD;
          1. 18 years of age or older&#xD;
&#xD;
          2. Member of a target HIV risk group, meeting criterion 2a or 2b&#xD;
&#xD;
               1. IDU: self-reported injection drug use in prior 24 months&#xD;
&#xD;
               2. MSM: self-identify as male and report oral/anal sex with another male in prior 12&#xD;
                  months&#xD;
&#xD;
          3. Psychologically fit to participate in the study and to understand the consent&#xD;
&#xD;
          4. Ability to comprehend one of the consent translation languages&#xD;
&#xD;
          5. Present a valid RDS referral coupon (unless a seed)&#xD;
&#xD;
          6. Provide informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Key Informant Interviews:&#xD;
&#xD;
        Persons will be excluded from the key informant interviews if they meet any of the&#xD;
        following criteria:&#xD;
&#xD;
          1. Younger than 18 years&#xD;
&#xD;
          2. Do not have knowledge of the local HIV risk group of interest (IDU or MSM)&#xD;
&#xD;
          3. Are not psychologically fit to participate in the study or to understand the consent&#xD;
&#xD;
          4. Do not have ability to comprehend one of the consent translation languages&#xD;
&#xD;
          5. Do not provide informed consent&#xD;
&#xD;
        Focus groups:&#xD;
&#xD;
        Persons will be excluded from the focus groups if they meet any of the following criteria:&#xD;
&#xD;
          1. Younger than 18 years&#xD;
&#xD;
          2. Are not a member of a target HIV risk group, meeting neither criterion 2a nor 2b&#xD;
&#xD;
               1. IDU: self-reported injection drug use in prior 12 months&#xD;
&#xD;
               2. MSM: self-identify as male and report oral/anal sex with another male in prior 12&#xD;
                  months&#xD;
&#xD;
          3. Are not psychologically fit to participate in the study or to understand the consent&#xD;
&#xD;
          4. Do not have ability to comprehend one of the consent translation languages&#xD;
&#xD;
          5. Do not provide informed consent&#xD;
&#xD;
        Baseline or evaluation RDS survey&#xD;
&#xD;
        Persons will be excluded in the baseline or evaluation RDS survey if they meet any of the&#xD;
        following criteria:&#xD;
&#xD;
          1. Younger than 18 years&#xD;
&#xD;
          2. Are not a member of a target HIV risk group, meeting neither criterion 2a nor 2b&#xD;
&#xD;
               1. IDU: self-reported injection drug use in prior 24 months&#xD;
&#xD;
               2. MSM: self-identify as male and report oral/anal sex with another male in prior 12&#xD;
                  months&#xD;
&#xD;
          3. Are not psychologically fit to participate in the study or to understand the consent&#xD;
&#xD;
          4. Do not have ability to comprehend one of the consent translation languages&#xD;
&#xD;
          5. Do not present a valid RDS referral coupon and are not a seed&#xD;
&#xD;
          6. Do not provide informed consent&#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>Gregory M Lucas, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Johns Hopkins University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Shruti Mehta, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Johns Hopkins University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>David D Celentano, ScD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Johns Hopkins University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Suniti Solomon, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>YR Gaitonde Centre for AIDS Research and Education</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Aylur Srikrishnan, BA</last_name>
    <role>Principal Investigator</role>
    <affiliation>YR Gaitonde Centre for AIDS Research and Education</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Suresh Kumar, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>YR Gaitonde Centre for AIDS Research and Education</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Sunil S Solomon, PhD</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>600113</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>India</country>
  </location_countries>
  <reference>
    <citation>Solomon SS, Mehta SH, Srikrishnan AK, Vasudevan CK, Mcfall AM, Balakrishnan P, Anand S, Nandagopal P, Ogburn EL, Laeyendecker O, Lucas GM, Solomon S, Celentano DD. High HIV prevalence and incidence among MSM across 12 cities in India. AIDS. 2015 Mar 27;29(6):723-31. doi: 10.1097/QAD.0000000000000602.</citation>
    <PMID>25849835</PMID>
  </reference>
  <reference>
    <citation>Lucas GM, Solomon SS, Srikrishnan AK, Agrawal A, Iqbal S, Laeyendecker O, McFall AM, Kumar MS, Ogburn EL, Celentano DD, Solomon S, Mehta SH. High HIV burden among people who inject drugs in 15 Indian cities. AIDS. 2015 Mar 13;29(5):619-28. doi: 10.1097/QAD.0000000000000592.</citation>
    <PMID>25715105</PMID>
  </reference>
  <reference>
    <citation>Solomon SS, Mehta SH, Srikrishnan AK, Solomon S, McFall AM, Laeyendecker O, Celentano DD, Iqbal SH, Anand S, Vasudevan CK, Saravanan S, Lucas GM, Kumar MS, Sulkowski MS, Quinn TC. Burden of hepatitis C virus disease and access to hepatitis C virus services in people who inject drugs in India: a cross-sectional study. Lancet Infect Dis. 2015 Jan;15(1):36-45. doi: 10.1016/S1473-3099(14)71045-X. Epub 2014 Dec 3.</citation>
    <PMID>25486851</PMID>
  </reference>
  <reference>
    <citation>Solomon SS, Lucas GM, Celentano DD, Sifakis F, Mehta SH. Beyond surveillance: a role for respondent-driven sampling in implementation science. Am J Epidemiol. 2013 Jul 15;178(2):260-7. doi: 10.1093/aje/kws432. Epub 2013 Jun 25.</citation>
    <PMID>23801014</PMID>
  </reference>
  <reference>
    <citation>Solomon SS, Lucas GM, Celentano DD, McFall AM, Ogburn E, Moulton LH, Srikrishnan AK, Kumar MS, Anand S, Solomon S, Mehta SH. Design of the Indian NCA study (Indian national collaboration on AIDS): a cluster randomized trial to evaluate the effectiveness of integrated care centers to improve HIV outcomes among men who have sex with men and persons who inject drugs in India. BMC Health Serv Res. 2016 Nov 14;16(1):652. doi: 10.1186/s12913-016-1905-5.</citation>
    <PMID>27842543</PMID>
  </reference>
  <reference>
    <citation>Mehta SH, Lucas GM, Solomon S, Srikrishnan AK, McFall AM, Dhingra N, Nandagopal P, Kumar MS, Celentano DD, Solomon SS. HIV care continuum among men who have sex with men and persons who inject drugs in India: barriers to successful engagement. Clin Infect Dis. 2015 Dec 1;61(11):1732-41. doi: 10.1093/cid/civ669. Epub 2015 Aug 6.</citation>
    <PMID>26251048</PMID>
  </reference>
  <results_reference>
    <citation>Solomon SS, Solomon S, McFall AM, Srikrishnan AK, Anand S, Verma V, Vasudevan CK, Balakrishnan P, Ogburn EL, Moulton LH, Kumar MS, Sachdeva KS, Laeyendecker O, Celentano DD, Lucas GM, Mehta SH; Indian National Collaboration on AIDS Study. Integrated HIV testing, prevention, and treatment intervention for key populations in India: a cluster-randomised trial. Lancet HIV. 2019 May;6(5):e283-e296. doi: 10.1016/S2352-3018(19)30034-7. Epub 2019 Apr 2.</citation>
    <PMID>30952565</PMID>
  </results_reference>
  <verification_date>June 2019</verification_date>
  <study_first_submitted>September 13, 2012</study_first_submitted>
  <study_first_submitted_qc>September 13, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 18, 2012</study_first_posted>
  <results_first_submitted>May 28, 2019</results_first_submitted>
  <results_first_submitted_qc>June 26, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">July 16, 2019</results_first_posted>
  <last_update_submitted>June 26, 2019</last_update_submitted>
  <last_update_submitted_qc>June 26, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 16, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>HIV</keyword>
  <keyword>injection drug use</keyword>
  <keyword>men who have sex with men</keyword>
  <keyword>voluntary counselling and testing</keyword>
  <keyword>risk reduction</keyword>
  <keyword>sexually transmitted infections</keyword>
  <keyword>community viral load</keyword>
  <keyword>antiretroviral therapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>HIV Infections</mesh_term>
  </condition_browse>
  <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>November 14, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/50/NCT01686750/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Recruited by respondent-driven sampling in 22 sites in India.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Integrated Care Centers</title>
          <description>Integrated care centers will provide HIV prevention and treatment services to high risk populations of injecting drug users (IDU) or MSM in an accepting and supportive environment.&#xD;
HIV voluntary counseling and testing &amp; staging&#xD;
Risk reduction services including free condoms, needle and syringe exchange, opiate substitution therapy&#xD;
Substance abuse counseling&#xD;
Sexually transmitted infection screening and treatment&#xD;
Access to free antiretroviral therapy and adherence support&#xD;
Peer community outreach</description>
        </group>
        <group group_id="P2">
          <title>Standard Services</title>
          <description>In Standard Services sites, HIV testing, prevention, and treatment services will be available through standard venues. Government centers typically provide most HIV testing services and are the only source for free antiretroviral therapy. Non-governmental organizations typically provide prevention and risk reduction 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="11001"/>
                <participants group_id="P2" count="10725"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="11001"/>
                <participants group_id="P2" count="10725"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Integrated Care Centers</title>
          <description>Integrated care centers will provide HIV prevention and treatment services to high risk populations of IDU or MSM in an accepting and supportive environment.&#xD;
HIV voluntary counseling and testing &amp; staging&#xD;
Risk reduction services including free condoms, needle and syringe exchange, opiate substitution therapy&#xD;
Substance abuse counseling&#xD;
Sexually transmitted infection screening and treatment&#xD;
Access to free antiretroviral therapy and adherence support&#xD;
Peer community outreach</description>
        </group>
        <group group_id="B2">
          <title>Standard Services</title>
          <description>In Standard Services sites, HIV testing, prevention, and treatment services will be available through standard venues. Government centers typically provide most HIV testing services and are the only source for free antiretroviral therapy. Non-governmental organizations typically provide prevention and risk reduction services.</description>
        </group>
        <group group_id="B3">
          <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="11001"/>
            <count group_id="B2" value="10725"/>
            <count group_id="B3" value="21726"/>
          </count_list>
        </analyzed>
        <analyzed>
          <units>Clusters</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="11"/>
            <count group_id="B2" value="11"/>
            <count group_id="B3" value="22"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <units_analyzed>Clusters</units_analyzed>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="30" lower_limit="24" upper_limit="34"/>
                    <measurement group_id="B2" value="29" lower_limit="26" upper_limit="35"/>
                    <measurement group_id="B3" value="29" lower_limit="24" upper_limit="35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <units_analyzed>Participants</units_analyzed>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="221"/>
                    <measurement group_id="B2" value="272"/>
                    <measurement group_id="B3" value="493"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10780"/>
                    <measurement group_id="B2" value="10453"/>
                    <measurement group_id="B3" value="21233"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <units_analyzed>Participants</units_analyzed>
          <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_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11001"/>
                    <measurement group_id="B2" value="10725"/>
                    <measurement group_id="B3" value="21726"/>
                  </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_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_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_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_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_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>At least secondary school education</title>
          <description>Participants who have had at least a secondary school education.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <units_analyzed>Participants</units_analyzed>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8729"/>
                    <measurement group_id="B2" value="7455"/>
                    <measurement group_id="B3" value="16184"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Proportion Reporting HIV Testing in the Prior 12 Months</title>
        <description>Self-reported HIV testing in the prior 12 months among all survey participants, excluding those who reported being diagnosed with HIV more than 12 months previously.</description>
        <time_frame>2 years</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Integrated Care Centers</title>
            <description>Integrated care centers will provide HIV prevention and treatment services to high risk populations of IDU or MSM in an accepting and supportive environment.&#xD;
HIV voluntary counseling and testing &amp; staging&#xD;
Risk reduction services including free condoms, needle and syringe exchange, opiate substitution therapy&#xD;
Substance abuse counseling&#xD;
Sexually transmitted infection screening and treatment&#xD;
Access to free antiretroviral therapy and adherence support&#xD;
Peer community outreach</description>
          </group>
          <group group_id="O2">
            <title>Standard Services</title>
            <description>In Standard Services sites, HIV testing, prevention, and treatment services will be available through standard venues. Government centers typically provide most HIV testing services and are the only source for free antiretroviral therapy. Non-governmental organizations typically provide prevention and risk reduction services.</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion Reporting HIV Testing in the Prior 12 Months</title>
          <description>Self-reported HIV testing in the prior 12 months among all survey participants, excluding those who reported being diagnosed with HIV more than 12 months previously.</description>
          <units>percentage of participants</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <units_analyzed>clusters</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11001"/>
                <count group_id="O2" value="10725"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>clusters</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11"/>
                <count group_id="O2" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="36.9" lower_limit="20.5" upper_limit="53.3"/>
                    <measurement group_id="O2" value="26.2" lower_limit="4.7" upper_limit="37.3"/>
                  </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>
            <groups_desc>We compared the sampling-weighted prevalence of outcomes at Integrated Care Centers (ICCs) and usual care from the evaluation survey. We used linear regression models that had terms for intervention status (integrated care vs usual care), stratum (PWID and MSM), and the baseline proportion of the outcome being assessed. Site-level proportions from both evaluation and baseline respondent-driven sampling were log transformed before being entered into the regression model.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.09</p_value>
            <method>Prevalence ratio</method>
            <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>0.95</ci_lower_limit>
            <ci_upper_limit>1.81</ci_upper_limit>
            <estimate_desc>Therefore, the exponentiated coefficients for intervention status represent the prevalence ratio with 95% confidence interval (CI) and are interpreted as the relative percentage difference in the outcome associated with the intervention.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Proportion of HIV-infected Participants Aware of Status</title>
        <description>Proportion of HIV-positive participants that were aware of their status at the time of the visit</description>
        <time_frame>2 years</time_frame>
        <population>Participants who tested HIV-positive at the survey visit</population>
        <group_list>
          <group group_id="O1">
            <title>Integrated Care Centers</title>
            <description>Integrated care centers will provide HIV prevention and treatment services to high risk populations of IDU or MSM in an accepting and supportive environment.&#xD;
HIV voluntary counseling and testing &amp; staging&#xD;
Risk reduction services including free condoms, needle and syringe exchange, opiate substitution therapy&#xD;
Substance abuse counseling&#xD;
Sexually transmitted infection screening and treatment&#xD;
Access to free antiretroviral therapy and adherence support&#xD;
Peer community outreach</description>
          </group>
          <group group_id="O2">
            <title>Standard Services</title>
            <description>In Standard Services sites, HIV testing, prevention, and treatment services will be available through standard venues. Government centers typically provide most HIV testing services and are the only source for free antiretroviral therapy. Non-governmental organizations typically provide prevention and risk reduction services.</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion of HIV-infected Participants Aware of Status</title>
          <description>Proportion of HIV-positive participants that were aware of their status at the time of the visit</description>
          <population>Participants who tested HIV-positive at the survey visit</population>
          <units>percentage of participants</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <units_analyzed>clusters</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1974"/>
                <count group_id="O2" value="2306"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>clusters</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11"/>
                <count group_id="O2" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="65.2" lower_limit="24" upper_limit="86.5"/>
                    <measurement group_id="O2" value="59.4" lower_limit="14.4" upper_limit="97.4"/>
                  </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>1.08</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.80</ci_lower_limit>
            <ci_upper_limit>1.50</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Proportion of HIV-infected Participants Visiting an HIV Treatment Provider in Prior 6 Months</title>
        <time_frame>2 years</time_frame>
        <population>HIV-positive survey participants</population>
        <group_list>
          <group group_id="O1">
            <title>Integrated Care Centers</title>
            <description>Integrated care centers will provide HIV prevention and treatment services to high risk populations of IDU or MSM in an accepting and supportive environment.&#xD;
HIV voluntary counseling and testing &amp; staging&#xD;
Risk reduction services including free condoms, needle and syringe exchange, opiate substitution therapy&#xD;
Substance abuse counseling&#xD;
Sexually transmitted infection screening and treatment&#xD;
Access to free antiretroviral therapy and adherence support&#xD;
Peer community outreach&#xD;
Integrated care centers</description>
          </group>
          <group group_id="O2">
            <title>Standard Services</title>
            <description>In Standard Services sites, HIV testing, prevention, and treatment services will be available through standard venues. Government centers typically provide most HIV testing services and are the only source for free antiretroviral therapy. Non-governmental organizations typically provide prevention and risk reduction services.</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion of HIV-infected Participants Visiting an HIV Treatment Provider in Prior 6 Months</title>
          <population>HIV-positive survey participants</population>
          <units>percentage of participants</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <units_analyzed>clusters</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1974"/>
                <count group_id="O2" value="2306"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>clusters</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11"/>
                <count group_id="O2" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="45.7" lower_limit="3.5" upper_limit="73.9"/>
                    <measurement group_id="O2" value="40.8" lower_limit="3.1" upper_limit="88.0"/>
                  </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>1.05</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.61</ci_lower_limit>
            <ci_upper_limit>1.81</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Proportion of Antiretroviral Therapy-eligible HIV-infected Participants Using Antiretroviral Therapy</title>
        <time_frame>2 years</time_frame>
        <population>HIV-positive participants that meet criteria for antiretroviral therapy in India at the time of the study</population>
        <group_list>
          <group group_id="O1">
            <title>Integrated Care Centers</title>
            <description>Integrated care centers will provide HIV prevention and treatment services to high risk populations of injecting drug users (IDU) or MSM in an accepting and supportive environment.&#xD;
HIV voluntary counseling and testing &amp; staging&#xD;
Risk reduction services including free condoms, needle and syringe exchange, opiate substitution therapy&#xD;
Substance abuse counseling&#xD;
Sexually transmitted infection screening and treatment&#xD;
Access to free antiretroviral therapy and adherence support&#xD;
Peer community outreach</description>
          </group>
          <group group_id="O2">
            <title>Standard Services</title>
            <description>In Standard Services sites, HIV testing, prevention, and treatment services will be available through standard venues. Government centers typically provide most HIV testing services and are the only source for free antiretroviral therapy. Non-governmental organizations typically provide prevention and risk reduction services.</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion of Antiretroviral Therapy-eligible HIV-infected Participants Using Antiretroviral Therapy</title>
          <population>HIV-positive participants that meet criteria for antiretroviral therapy in India at the time of the study</population>
          <units>percentage of participants</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <units_analyzed>clusters</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1647"/>
                <count group_id="O2" value="1749"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>clusters</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11"/>
                <count group_id="O2" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="57" lower_limit="11.4" upper_limit="87"/>
                    <measurement group_id="O2" value="46.8" lower_limit="2" upper_limit="95.1"/>
                  </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>1.36</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>2.41</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Community Viral Load</title>
        <description>Average log(10) HIV RNA concentration among HIV-infected participants</description>
        <time_frame>2 years</time_frame>
        <population>Samples were not collected therefore there is no data to report.</population>
        <group_list>
          <group group_id="O1">
            <title>Integrated Care Centers</title>
            <description>Integrated care centers will provide HIV prevention and treatment services to high risk populations of injecting drug users (IDU) or MSM in an accepting and supportive environment.&#xD;
HIV voluntary counseling and testing &amp; staging&#xD;
Risk reduction services including free condoms, needle and syringe exchange, opiate substitution therapy&#xD;
Substance abuse counseling&#xD;
Sexually transmitted infection screening and treatment&#xD;
Access to free antiretroviral therapy and adherence support&#xD;
Peer community outreach</description>
          </group>
          <group group_id="O2">
            <title>Standard Services</title>
            <description>In Standard Services sites, HIV testing, prevention, and treatment services will be available through standard venues. Government centers typically provide most HIV testing services and are the only source for free antiretroviral therapy. Non-governmental organizations typically provide prevention and risk reduction services.</description>
          </group>
        </group_list>
        <measure>
          <title>Community Viral Load</title>
          <description>Average log(10) HIV RNA concentration among HIV-infected participants</description>
          <population>Samples were not collected therefore there is no data to report.</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>Secondary</type>
        <title>Proportion of HIV-infected Participants With Suppressed HIV RNA</title>
        <description>Proportion of HIV-positive participants meeting criteria for antiretroviral therapy [cluster of differentiation 4 (CD4) count &lt;350 cells/mm3 or current or past use of antiretroviral therapy)] who have a suppressed viral load (HIV RNA &lt;150 copies/mL)</description>
        <time_frame>2 years</time_frame>
        <population>HIV-positive participants who meet criteria for antiretroviral therapy</population>
        <group_list>
          <group group_id="O1">
            <title>Integrated Care Centers</title>
            <description>Integrated care centers will provide HIV prevention and treatment services to high risk populations of IDU or MSM in an accepting and supportive environment.&#xD;
HIV voluntary counseling and testing &amp; staging&#xD;
Risk reduction services including free condoms, needle and syringe exchange, opiate substitution therapy&#xD;
Substance abuse counseling&#xD;
Sexually transmitted infection screening and treatment&#xD;
Access to free antiretroviral therapy and adherence support&#xD;
Peer community outreach</description>
          </group>
          <group group_id="O2">
            <title>Standard Services</title>
            <description>In Standard Services sites, HIV testing, prevention, and treatment services will be available through standard venues. Government centers typically provide most HIV testing services and are the only source for free antiretroviral therapy. Non-governmental organizations typically provide prevention and risk reduction services.</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion of HIV-infected Participants With Suppressed HIV RNA</title>
          <description>Proportion of HIV-positive participants meeting criteria for antiretroviral therapy [cluster of differentiation 4 (CD4) count &lt;350 cells/mm3 or current or past use of antiretroviral therapy)] who have a suppressed viral load (HIV RNA &lt;150 copies/mL)</description>
          <population>HIV-positive participants who meet criteria for antiretroviral therapy</population>
          <units>percentage of participants</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <units_analyzed>clusters</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1647"/>
                <count group_id="O2" value="1749"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>clusters</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11"/>
                <count group_id="O2" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="47.3" lower_limit="6.7" upper_limit="78.6"/>
                    <measurement group_id="O2" value="46.7" lower_limit="7.4" upper_limit="82.9"/>
                  </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>0.91</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.65</ci_lower_limit>
            <ci_upper_limit>1.28</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Prevalence of Recent HIV Infection</title>
        <time_frame>2 years</time_frame>
        <population>Samples were not collected therefore there is no data to report.</population>
        <group_list>
          <group group_id="O1">
            <title>Integrated Care Centers</title>
            <description>Integrated care centers will provide HIV prevention and treatment services to high risk populations of injecting drug users (IDU) or MSM in an accepting and supportive environment.&#xD;
HIV voluntary counseling and testing &amp; staging&#xD;
Risk reduction services including free condoms, needle and syringe exchange, opiate substitution therapy&#xD;
Substance abuse counseling&#xD;
Sexually transmitted infection screening and treatment&#xD;
Access to free antiretroviral therapy and adherence support&#xD;
Peer community outreach</description>
          </group>
          <group group_id="O2">
            <title>Standard Services</title>
            <description>In Standard Services sites, HIV testing, prevention, and treatment services will be available through standard venues. Government centers typically provide most HIV testing services and are the only source for free antiretroviral therapy. Non-governmental organizations typically provide prevention and risk reduction services.</description>
          </group>
        </group_list>
        <measure>
          <title>Prevalence of Recent HIV Infection</title>
          <population>Samples were not collected therefore there is no data to report.</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>Secondary</type>
        <title>Proportion of IDU Reporting Needle or Syringe Sharing in Prior 6 Months</title>
        <time_frame>2 years</time_frame>
        <population>Participants from the PWID sites</population>
        <group_list>
          <group group_id="O1">
            <title>Integrated Care Centers</title>
            <description>Integrated care centers will provide HIV prevention and treatment services to high risk populations of injecting drug users (IDU) or MSM in an accepting and supportive environment.&#xD;
HIV voluntary counseling and testing &amp; staging&#xD;
Risk reduction services including free condoms, needle and syringe exchange, opiate substitution therapy&#xD;
Substance abuse counseling&#xD;
Sexually transmitted infection screening and treatment&#xD;
Access to free antiretroviral therapy and adherence support&#xD;
Peer community outreach</description>
          </group>
          <group group_id="O2">
            <title>Standard Services</title>
            <description>In Standard Services sites, HIV testing, prevention, and treatment services will be available through standard venues. Government centers typically provide most HIV testing services and are the only source for free antiretroviral therapy. Non-governmental organizations typically provide prevention and risk reduction services.</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion of IDU Reporting Needle or Syringe Sharing in Prior 6 Months</title>
          <population>Participants from the PWID sites</population>
          <units>percentage of participants</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <units_analyzed>clusters</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6000"/>
                <count group_id="O2" value="5721"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>clusters</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30.1" lower_limit="2.4" upper_limit="30.8"/>
                    <measurement group_id="O2" value="31.8" lower_limit="6.8" upper_limit="56.9"/>
                  </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>1.44</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.42</ci_lower_limit>
            <ci_upper_limit>4.93</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Proportion of IDU Reporting Drug Abstinence in Prior 6 Months</title>
        <time_frame>2 years</time_frame>
        <population>Participants at PWID sites</population>
        <group_list>
          <group group_id="O1">
            <title>Integrated Care Centers</title>
            <description>Integrated care centers will provide HIV prevention and treatment services to high risk populations of injecting drug users (IDU) or MSM in an accepting and supportive environment.&#xD;
HIV voluntary counseling and testing &amp; staging&#xD;
Risk reduction services including free condoms, needle and syringe exchange, opiate substitution therapy&#xD;
Substance abuse counseling&#xD;
Sexually transmitted infection screening and treatment&#xD;
Access to free antiretroviral therapy and adherence support&#xD;
Peer community outreach</description>
          </group>
          <group group_id="O2">
            <title>Standard Services</title>
            <description>In Standard Services sites, HIV testing, prevention, and treatment services will be available through standard venues. Government centers typically provide most HIV testing services and are the only source for free antiretroviral therapy. Non-governmental organizations typically provide prevention and risk reduction services.</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion of IDU Reporting Drug Abstinence in Prior 6 Months</title>
          <population>Participants at PWID sites</population>
          <units>percentage of participants</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <units_analyzed>clusters</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6000"/>
                <count group_id="O2" value="5721"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>clusters</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28.2" lower_limit="10.4" upper_limit="72.9"/>
                    <measurement group_id="O2" value="16.5" lower_limit="1.7" upper_limit="42.3"/>
                  </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>1.87</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.49</ci_lower_limit>
            <ci_upper_limit>7.16</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Proportion of MSM Reporting Unprotected Anal Intercourse With Non-main Partner in Prior 6 Months</title>
        <time_frame>2 years</time_frame>
        <population>Participants at MSM sites</population>
        <group_list>
          <group group_id="O1">
            <title>Integrated Care Centers</title>
            <description>Integrated care centers will provide HIV prevention and treatment services to high risk populations of injecting drug users (IDU) or MSM in an accepting and supportive environment.&#xD;
HIV voluntary counseling and testing &amp; staging&#xD;
Risk reduction services including free condoms, needle and syringe exchange, opiate substitution therapy&#xD;
Substance abuse counseling&#xD;
Sexually transmitted infection screening and treatment&#xD;
Access to free antiretroviral therapy and adherence support&#xD;
Peer community outreach</description>
          </group>
          <group group_id="O2">
            <title>Standard Services</title>
            <description>In Standard Services sites, HIV testing, prevention, and treatment services will be available through standard venues. Government centers typically provide most HIV testing services and are the only source for free antiretroviral therapy. Non-governmental organizations typically provide prevention and risk reduction services.</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion of MSM Reporting Unprotected Anal Intercourse With Non-main Partner in Prior 6 Months</title>
          <population>Participants at MSM sites</population>
          <units>percentage of participants</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <units_analyzed>clusters</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="5001"/>
                <count group_id="O2" value="5004"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>clusters</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="5"/>
                <count group_id="O2" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="56.2" lower_limit="39.8" upper_limit="78.9"/>
                    <measurement group_id="O2" value="69.3" lower_limit="41.7" upper_limit="84"/>
                  </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>0.91</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.53</ci_lower_limit>
            <ci_upper_limit>1.56</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Non-main Male Partners in Prior 6 Months in MSM</title>
        <time_frame>2 years</time_frame>
        <population>Participants at MSM sites</population>
        <group_list>
          <group group_id="O1">
            <title>Integrated Care Centers</title>
            <description>Integrated care centers will provide HIV prevention and treatment services to high risk populations of injecting drug users (IDU) or MSM in an accepting and supportive environment.&#xD;
HIV voluntary counseling and testing &amp; staging&#xD;
Risk reduction services including free condoms, needle and syringe exchange, opiate substitution therapy&#xD;
Substance abuse counseling&#xD;
Sexually transmitted infection screening and treatment&#xD;
Access to free antiretroviral therapy and adherence support&#xD;
Peer community outreach</description>
          </group>
          <group group_id="O2">
            <title>Standard Services</title>
            <description>In Standard Services sites, HIV testing, prevention, and treatment services will be available through standard venues. Government centers typically provide most HIV testing services and are the only source for free antiretroviral therapy. Non-governmental organizations typically provide prevention and risk reduction services.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Non-main Male Partners in Prior 6 Months in MSM</title>
          <population>Participants at MSM sites</population>
          <units>partners</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <units_analyzed>clusters</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="5001"/>
                <count group_id="O2" value="5004"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>clusters</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="5"/>
                <count group_id="O2" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.0" lower_limit="0.6" upper_limit="6.4"/>
                    <measurement group_id="O2" value="3.1" lower_limit="1.5" upper_limit="8.0"/>
                  </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>Mean Difference (Final Values)</param_type>
            <param_value>0.03</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-4.2</ci_lower_limit>
            <ci_upper_limit>4.2</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Proportion Reporting Substance Abuse Among MSM</title>
        <time_frame>2 years</time_frame>
        <population>Samples were not collected therefore there is no data to report.</population>
        <group_list>
          <group group_id="O1">
            <title>Integrated Care Centers</title>
            <description>Integrated care centers will provide HIV prevention and treatment services to high risk populations of injecting drug users (IDU) or MSM in an accepting and supportive environment.&#xD;
HIV voluntary counseling and testing &amp; staging&#xD;
Risk reduction services including free condoms, needle and syringe exchange, opiate substitution therapy&#xD;
Substance abuse counseling&#xD;
Sexually transmitted infection screening and treatment&#xD;
Access to free antiretroviral therapy and adherence support&#xD;
Peer community outreach</description>
          </group>
          <group group_id="O2">
            <title>Standard Services</title>
            <description>In Standard Services sites, HIV testing, prevention, and treatment services will be available through standard venues. Government centers typically provide most HIV testing services and are the only source for free antiretroviral therapy. Non-governmental organizations typically provide prevention and risk reduction services.</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion Reporting Substance Abuse Among MSM</title>
          <population>Samples were not collected therefore there is no data to report.</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>Secondary</type>
        <title>Proportion With Depressive Symptoms</title>
        <description>Participants with Score &gt;=10 on Patient Health Questionnaire-9</description>
        <time_frame>2 years</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Integrated Care Centers</title>
            <description>Integrated care centers will provide HIV prevention and treatment services to high risk populations of injecting drug users (IDU) or MSM in an accepting and supportive environment.&#xD;
HIV voluntary counseling and testing &amp; staging&#xD;
Risk reduction services including free condoms, needle and syringe exchange, opiate substitution therapy&#xD;
Substance abuse counseling&#xD;
Sexually transmitted infection screening and treatment&#xD;
Access to free antiretroviral therapy and adherence support&#xD;
Peer community outreach</description>
          </group>
          <group group_id="O2">
            <title>Standard Services</title>
            <description>In Standard Services sites, HIV testing, prevention, and treatment services will be available through standard venues. Government centers typically provide most HIV testing services and are the only source for free antiretroviral therapy. Non-governmental organizations typically provide prevention and risk reduction services.</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion With Depressive Symptoms</title>
          <description>Participants with Score &gt;=10 on Patient Health Questionnaire-9</description>
          <units>percentage of participants</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <units_analyzed>clusters</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11001"/>
                <count group_id="O2" value="10725"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>clusters</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11"/>
                <count group_id="O2" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.4" lower_limit="1.2" upper_limit="26.9"/>
                    <measurement group_id="O2" value="18.2" lower_limit="3.7" upper_limit="35.1"/>
                  </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>0.84</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.47</ci_lower_limit>
            <ci_upper_limit>1.52</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Unprotected Sexual Acts Reported by MSM</title>
        <time_frame>2 years</time_frame>
        <population>Samples were not collected therefore there is no data to report.</population>
        <group_list>
          <group group_id="O1">
            <title>Integrated Care Centers</title>
            <description>Integrated care centers will provide HIV prevention and treatment services to high risk populations of injecting drug users (IDU) or MSM in an accepting and supportive environment.&#xD;
HIV voluntary counseling and testing &amp; staging&#xD;
Risk reduction services including free condoms, needle and syringe exchange, opiate substitution therapy&#xD;
Substance abuse counseling&#xD;
Sexually transmitted infection screening and treatment&#xD;
Access to free antiretroviral therapy and adherence support&#xD;
Peer community outreach</description>
          </group>
          <group group_id="O2">
            <title>Standard Services</title>
            <description>In Standard Services sites, HIV testing, prevention, and treatment services will be available through standard venues. Government centers typically provide most HIV testing services and are the only source for free antiretroviral therapy. Non-governmental organizations typically provide prevention and risk reduction services.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Unprotected Sexual Acts Reported by MSM</title>
          <population>Samples were not collected therefore there is no data to report.</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>Secondary</type>
        <title>Vicarious Stigma as Assessed by 6-item Stigma Scale</title>
        <description>Summed score from a 6-item stigma scale (range 0-18), with higher values indicating more perceived stigma</description>
        <time_frame>2 years</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Integrated Care Centers</title>
            <description>Integrated care centers will provide HIV prevention and treatment services to high risk populations of injecting drug users (IDU) or MSM in an accepting and supportive environment.&#xD;
HIV voluntary counseling and testing &amp; staging&#xD;
Risk reduction services including free condoms, needle and syringe exchange, opiate substitution therapy&#xD;
Substance abuse counseling&#xD;
Sexually transmitted infection screening and treatment&#xD;
Access to free antiretroviral therapy and adherence support&#xD;
Peer community outreach</description>
          </group>
          <group group_id="O2">
            <title>Standard Services</title>
            <description>In Standard Services sites, HIV testing, prevention, and treatment services will be available through standard venues. Government centers typically provide most HIV testing services and are the only source for free antiretroviral therapy. Non-governmental organizations typically provide prevention and risk reduction services.</description>
          </group>
        </group_list>
        <measure>
          <title>Vicarious Stigma as Assessed by 6-item Stigma Scale</title>
          <description>Summed score from a 6-item stigma scale (range 0-18), with higher values indicating more perceived stigma</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <units_analyzed>clusters</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11001"/>
                <count group_id="O2" value="10725"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>clusters</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11"/>
                <count group_id="O2" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.9" lower_limit="2.1" upper_limit="4.2"/>
                    <measurement group_id="O2" value="4.6" lower_limit="1.5" upper_limit="7.1"/>
                  </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>Mean Difference (Final Values)</param_type>
            <param_value>-1.8</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.0</ci_lower_limit>
            <ci_upper_limit>-0.6</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Proportion Reporting Spouse Ever Tested for HIV</title>
        <time_frame>2 years</time_frame>
        <population>Participants with a spouse (opposite sex)</population>
        <group_list>
          <group group_id="O1">
            <title>Integrated Care Centers</title>
            <description>Integrated care centers will provide HIV prevention and treatment services to high risk populations of injecting drug users (IDU) or MSM in an accepting and supportive environment.&#xD;
HIV voluntary counseling and testing &amp; staging&#xD;
Risk reduction services including free condoms, needle and syringe exchange, opiate substitution therapy&#xD;
Substance abuse counseling&#xD;
Sexually transmitted infection screening and treatment&#xD;
Access to free antiretroviral therapy and adherence support&#xD;
Peer community outreach</description>
          </group>
          <group group_id="O2">
            <title>Standard Services</title>
            <description>In Standard Services sites, HIV testing, prevention, and treatment services will be available through standard venues. Government centers typically provide most HIV testing services and are the only source for free antiretroviral therapy. Non-governmental organizations typically provide prevention and risk reduction services.</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion Reporting Spouse Ever Tested for HIV</title>
          <population>Participants with a spouse (opposite sex)</population>
          <units>percentage of participants</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <units_analyzed>clusters</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="5550"/>
                <count group_id="O2" value="4439"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>clusters</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11"/>
                <count group_id="O2" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="45.9" lower_limit="19.2" upper_limit="74.3"/>
                    <measurement group_id="O2" value="46.8" lower_limit="7.7" upper_limit="79.9"/>
                  </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>0.93</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>1.36</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>This study was based on cross-sectional surveys. Therefore adverse events were only documented at the time of the survey visit (1 day).</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Integrated Care Centers</title>
          <description>Integrated care centers will provide HIV prevention and treatment services to high risk populations of IDU or MSM in an accepting and supportive environment.&#xD;
HIV voluntary counseling and testing &amp; staging&#xD;
Risk reduction services including free condoms, needle and syringe exchange, opiate substitution therapy&#xD;
Substance abuse counseling&#xD;
Sexually transmitted infection screening and treatment&#xD;
Access to free antiretroviral therapy and adherence support&#xD;
Peer community outreach</description>
        </group>
        <group group_id="E2">
          <title>Standard Services</title>
          <description>In Standard Services sites, HIV testing, prevention, and treatment services will be available through standard venues. Government centers typically provide most HIV testing services and are the only source for free antiretroviral therapy. Non-governmental organizations typically provide prevention and risk reduction services.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="11001"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10725"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="11001"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10725"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</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="11001"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10725"/>
              </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>Dr. 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/NCT01686750
org study id: NA_00047702
secondary id: R01DA032059
secondary id: R01MH089266
nct id: NCT01686750
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
This is a cluster randomized trial to evaluate the effectiveness of integrated care centers
      (ICC) to improve access to HIV testing, prevention services, and treatment among high-risk
      populations of injection drug users (IDU) and men who have sex with men (MSM) in India. We
      will collect baseline ethnographic and survey data from approximately 27 IDU or MSM sites in
      India. We will use baseline data to select 22 sites for the trial (12 IDU and 10 MSM) and to
      stratify sites according to key baseline characteristics. We will perform stratified
      randomization to assign sites to either the ICC intervention or to standard services. ICCs,
      which will be either IDU or MSM-focused, will provide an accepting atmosphere in which
      members of vulnerable groups can drop-in, receive rapid HIV voluntary counselling and
      testing, risk reduction counseling and services, and antiretroviral therapy. ICCs will be
      scaled-up from existing governmental or non-governmental organizations and services provided
      at ICCs will be supported by the National AIDS Control Organization (NACO) of India. After
      providing services in communities for two years, we will conduct an evaluation survey (with
      biological and behavioral measures) of approximately 1000 subjects in the target populations
      in each of the 22 study sites. Integrated care centers have the potential to improve access
      to HIV prevention and treatment services among vulnerable, high-risk populations.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Proportion Reporting HIV Testing in the Prior 12 Months
time frame: 2 years
description: Self-reported HIV testing in the prior 12 months among all survey participants, excluding those who reported being diagnosed with HIV more than 12 months previously.
measure: Proportion of HIV-infected Participants Aware of Status
time frame: 2 years
description: Proportion of HIV-positive participants that were aware of their status at the time of the visit
measure: Proportion of HIV-infected Participants Visiting an HIV Treatment Provider in Prior 6 Months
time frame: 2 years
measure: Proportion of Antiretroviral Therapy-eligible HIV-infected Participants Using Antiretroviral Therapy
time frame: 2 years
measure: Community Viral Load
time frame: 2 years
description: Average log(10) HIV RNA concentration among HIV-infected participants
measure: Proportion of HIV-infected Participants With Suppressed HIV RNA
time frame: 2 years
description: Proportion of HIV-positive participants meeting criteria for antiretroviral therapy [cluster of differentiation 4 (CD4) count <350 cells/mm3 or current or past use of antiretroviral therapy)] who have a suppressed viral load (HIV RNA <150 copies/mL)
measure: Prevalence of Recent HIV Infection
time frame: 2 years
measure: Proportion of IDU Reporting Needle or Syringe Sharing in Prior 6 Months
time frame: 2 years
measure: Proportion of IDU Reporting Drug Abstinence in Prior 6 Months
time frame: 2 years
measure: Proportion of MSM Reporting Unprotected Anal Intercourse With Non-main Partner in Prior 6 Months
time frame: 2 years
measure: Number of Non-main Male Partners in Prior 6 Months in MSM
time frame: 2 years
measure: Proportion Reporting Substance Abuse Among MSM
time frame: 2 years
measure: Proportion With Depressive Symptoms
time frame: 2 years
description: Participants with Score >=10 on Patient Health Questionnaire-9
measure: Number of Unprotected Sexual Acts Reported by MSM
time frame: 2 years
measure: Vicarious Stigma as Assessed by 6-item Stigma Scale
time frame: 2 years
description: Summed score from a 6-item stigma scale (range 0-18), with higher values indicating more perceived stigma
measure: Proportion Reporting Spouse Ever Tested for HIV
time frame: 2 years
arm group label: Integrated care centers
arm group type: Experimental
description: Integrated care centers will provide HIV prevention and treatment services to high risk populations of IDU or MSM in an accepting and supportive environment.
HIV voluntary counseling and testing & staging
Risk reduction services including free condoms, needle and syringe exchange, opiate substitution therapy
Substance abuse counseling
Sexually transmitted infection screening and treatment
Access to free antiretroviral therapy and adherence support
Peer community outreach
arm group label: Standard services
arm group type: No Intervention
description: In Standard Services sites, HIV testing, prevention, and treatment services will be available through standard venues. Government centers typically provide most HIV testing services and are the only source for free antiretroviral therapy. Non-governmental organizations typically provide prevention and risk reduction services.
intervention type: Behavioral
intervention name: Integrated care centers
arm group label: Integrated care centers
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Gregory M Lucas, MD
role: Principal Investigator
affiliation: Johns Hopkins University
last name: Shruti Mehta, PhD
role: Principal Investigator
affiliation: Johns Hopkins University
last name: David D Celentano, ScD
role: Principal Investigator
affiliation: Johns Hopkins University
last name: Suniti Solomon, MD
role: Principal Investigator
affiliation: YR Gaitonde Centre for AIDS Research and Education
last name: Aylur Srikrishnan, BA
role: Principal Investigator
affiliation: YR Gaitonde Centre for AIDS Research and Education
last name: Suresh Kumar, MPH
role: Principal Investigator
affiliation: YR Gaitonde Centre for AIDS Research and Education
last name: Sunil S Solomon, PhD
role: Principal Investigator
affiliation: Johns Hopkins University
facility: 
country: India
citation: Solomon SS, Mehta SH, Srikrishnan AK, Vasudevan CK, Mcfall AM, Balakrishnan P, Anand S, Nandagopal P, Ogburn EL, Laeyendecker O, Lucas GM, Solomon S, Celentano DD. High HIV prevalence and incidence among MSM across 12 cities in India. AIDS. 2015 Mar 27;29(6):723-31. doi: 10.1097/QAD.0000000000000602.
PMID: 25849835
citation: Lucas GM, Solomon SS, Srikrishnan AK, Agrawal A, Iqbal S, Laeyendecker O, McFall AM, Kumar MS, Ogburn EL, Celentano DD, Solomon S, Mehta SH. High HIV burden among people who inject drugs in 15 Indian cities. AIDS. 2015 Mar 13;29(5):619-28. doi: 10.1097/QAD.0000000000000592.
PMID: 25715105
citation: Solomon SS, Mehta SH, Srikrishnan AK, Solomon S, McFall AM, Laeyendecker O, Celentano DD, Iqbal SH, Anand S, Vasudevan CK, Saravanan S, Lucas GM, Kumar MS, Sulkowski MS, Quinn TC. Burden of hepatitis C virus disease and access to hepatitis C virus services in people who inject drugs in India: a cross-sectional study. Lancet Infect Dis. 2015 Jan;15(1):36-45. doi: 10.1016/S1473-3099(14)71045-X. Epub 2014 Dec 3.
PMID: 25486851
citation: Solomon SS, Lucas GM, Celentano DD, Sifakis F, Mehta SH. Beyond surveillance: a role for respondent-driven sampling in implementation science. Am J Epidemiol. 2013 Jul 15;178(2):260-7. doi: 10.1093/aje/kws432. Epub 2013 Jun 25.
PMID: 23801014
citation: Solomon SS, Lucas GM, Celentano DD, McFall AM, Ogburn E, Moulton LH, Srikrishnan AK, Kumar MS, Anand S, Solomon S, Mehta SH. Design of the Indian NCA study (Indian national collaboration on AIDS): a cluster randomized trial to evaluate the effectiveness of integrated care centers to improve HIV outcomes among men who have sex with men and persons who inject drugs in India. BMC Health Serv Res. 2016 Nov 14;16(1):652. doi: 10.1186/s12913-016-1905-5.
PMID: 27842543
citation: Mehta SH, Lucas GM, Solomon S, Srikrishnan AK, McFall AM, Dhingra N, Nandagopal P, Kumar MS, Celentano DD, Solomon SS. HIV care continuum among men who have sex with men and persons who inject drugs in India: barriers to successful engagement. Clin Infect Dis. 2015 Dec 1;61(11):1732-41. doi: 10.1093/cid/civ669. Epub 2015 Aug 6.
PMID: 26251048
citation: Solomon SS, Solomon S, McFall AM, Srikrishnan AK, Anand S, Verma V, Vasudevan CK, Balakrishnan P, Ogburn EL, Moulton LH, Kumar MS, Sachdeva KS, Laeyendecker O, Celentano DD, Lucas GM, Mehta SH; Indian National Collaboration on AIDS Study. Integrated HIV testing, prevention, and treatment intervention for key populations in India: a cluster-randomised trial. Lancet HIV. 2019 May;6(5):e283-e296. doi: 10.1016/S2352-3018(19)30034-7. Epub 2019 Apr 2.
PMID: 30952565
responsible party type: Sponsor
mesh term: HIV Infections
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 