<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/NCT03286504</url>
  </required_header>
  <id_info>
    <org_study_id>1504016098</org_study_id>
    <secondary_id>R01HD091935</secondary_id>
    <nct_id>NCT03286504</nct_id>
  </id_info>
  <brief_title>FANMI: Community Cohort Care for HIV-Infected Adolescent Girls in Haiti</brief_title>
  <official_title>FANMI: Community Cohort Care for HIV-Infected Adolescent Girls in Haiti</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Weill Medical College of Cornell University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Haitian Group for the Study of Kaposi's Sarcoma and Opportunistic</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Weill Medical College of Cornell University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators will conduct a randomized controlled trial of Group Care in the GHESKIO&#xD;
      Community Center versus Individual Care in the GHESKIO Adolescent Clinic for 160 HIV-infected&#xD;
      adolescent girls age 16-23 years in Haiti (80 adolescents per arm). Group Care includes&#xD;
      receiving integrated clinical and social support services in groups of 5-8 adolescents at a&#xD;
      monthly visit. The primary outcome is retention in HIV care at 12 months after randomization.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators will conduct a randomized controlled trial of Group Care in the GHESKIO&#xD;
      Community Center versus Individual Care in the GHESKIO Adolescent Clinic for 160 HIV-infected&#xD;
      adolescent girls age 16-23 years in Haiti (80 per arm). Adolescents randomized to Group Care&#xD;
      will receive HIV services including integrated clinical and social support care in groups of&#xD;
      5-10. Adolescents randomized to Individual Care will continue to receive individual care at&#xD;
      the GHESKIO Adolescent Clinic, which is the current standard of care (described below). If a&#xD;
      subject declines to participate in the study they will continue to receive standard HIV care.&#xD;
      Participants will be randomized to either Group Care or Individual Care in a 1:1 ratio using&#xD;
      a computer generated random assignment.&#xD;
&#xD;
      Individual Care (standard of care): Adolescents randomized to Individual Care will receive&#xD;
      care in the GHESKIO Adolescent Clinic which cares for both males and females age 13-23 years.&#xD;
      The Adolescent Clinic waiting room has a television showing educational videos. After seeing&#xD;
      a triage peer counselor and having their vital signs taken, participants see a nurse&#xD;
      practitioner (NP) one-on-one in a private room for a 10-15 minute clinic visit. The NP may&#xD;
      also provide family support counseling including family visits per clinical judgment. Each NP&#xD;
      sees approximately 20 HIV-infected adolescents per day. The adolescent then returns to the&#xD;
      HIV positive peer counselor, who provides one-on-one counseling for 30 minutes on topics&#xD;
      chosen by the adolescent and the counselor. Each counselor sees ~10 adolescents per day.&#xD;
&#xD;
      Group Care (intervention): Adolescent girls randomized to Group Care will join a group within&#xD;
      one week of study enrollment and receive care in the GHESKIO Community Center. The&#xD;
      investigators estimate that it will take 4-6 weeks to constitute a full group of 5-10. During&#xD;
      this enrollment phase, groups will meet weekly, adding new participants each week. The&#xD;
      participants will then meet monthly with an NP and a HIV positive peer counselor. Each&#xD;
      monthly group session will last ~2 hours. This is comparable to the time it takes for a&#xD;
      patient to pass through the Adolescent HIV Clinic. It will start with a 30 minute&#xD;
      unstructured discussion. This time is intentionally unstructured and responds to our previous&#xD;
      research finding that adolescents want to talk about topics of their choosing with their&#xD;
      peers. This will be followed by a 45 minute group counseling session following a structured&#xD;
      curriculum, addressing topics such as social isolation, stigma, family support, sexual risk&#xD;
      behavior, life goals, medication adherence, job skills, and transitions. This is followed by&#xD;
      a 30 minute social activity led by two rotating group leaders who are elected by their peers.&#xD;
      Social activities include crafts, playing cards, and charades. Participants will be seen one&#xD;
      by one by the NP for ~10-15 minutes in a screened in clinical area during the unstructured&#xD;
      discussion and the social activity. All HIV clinical services, including provision of&#xD;
      antiretroviral therapy (ART) medications, CD4 T cell monitoring, screening for symptoms and&#xD;
      OI, medication adherence monitoring, family planning, and general primary care will be&#xD;
      provided by the NP. Girls who become eligible for ART will be provided with individual&#xD;
      counseling and promptly initiated on ART by the NP. The primary hypothesis is that Group Care&#xD;
      will improve retention at 12 months compared with standard Individual Care. The study has &gt;&#xD;
      90% power to detect a difference in retention from 60% to 85%. Participants in both study&#xD;
      arms will complete a questionnaire with a research nurse at enrollment, 6, and 12 months&#xD;
      collecting data on HIV knowledge, HIV-related stigma, HIV disclosure, social and family&#xD;
      support, depression and alcohol use, problem solving skills, and food insecurity.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">May 25, 2018</start_date>
  <completion_date type="Anticipated">October 1, 2023</completion_date>
  <primary_completion_date type="Actual">June 1, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>12 Month Retention</measure>
    <time_frame>12 months</time_frame>
    <description>Retention in care at 12 months will be measured. 12 month retention is defined as being alive at 12 months and having a care visit between 9 and 15 months after enrollment.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>12 Month Viral Suppression</measure>
    <time_frame>12 months</time_frame>
    <description>Viral suppression at 12 months will be measured. Suppressed viral load will be defined as a binary outcome based upon the WHO definition of viral suppression as a plasma HIV-1 RNA level &lt;1000 copies/µl.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Antiretroviral Therapy (ART) Initiation</measure>
    <time_frame>12 months</time_frame>
    <description>Time to ART initiation is the number of calendar days from date of HIV diagnosis to date of ART initiation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Optimal Antiretroviral Therapy (ART) Adherence</measure>
    <time_frame>12 months</time_frame>
    <description>ART adherence will be measured by self-report using two questions: 1) number of pills missed in the past 4 days and 2) forgot to take pills last weekend. A response of no missed pills in the past 4 days and did not forget to take pills last weekend is defined as 'optimal' adherence. All other responses are defined as 'sub-optimal' adherence.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sexual Risk Behavior</measure>
    <time_frame>12 months</time_frame>
    <description>Sexual risk behavior will be measured by regular condom use among those who are sexually active. Regular condom use is defined as a response of 'often' or 'always' when asked about condom use during sexual intercourse.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Sexually Transmitted Infections</measure>
    <time_frame>12 months</time_frame>
    <description>Sexually Transmitted Infections will include syphilis, diagnosed using a serum RPR (HUMAN) followed by a treponemal test if positive (Bioline Standard Diagnostics), chlamydia and gonorrhea, diagnosed by the urine GeneXpert GT/NG assay.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Acceptability</measure>
    <time_frame>12 months</time_frame>
    <description>FANMI Acceptability will be assessed using qualitative interviews conducted at 6 and 12 months after study enrollment with a subset of 30 FANMI participants and clinic providers (nurses and peer educators). A trained qualitative research assistant will interview adolescents to explore attitudes about the FANMI intervention, specifically as it relates to social isolation, stigma, and family rejection, self-esteem and clinic-level factors.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Healthcare Utilization</measure>
    <time_frame>12 months</time_frame>
    <description>Healthcare utilization will be measured. Healthcare utilization will be measured as a composite of attendance at HIV care visits, laboratory services, and use of other specialist services at study sites and use of health services at non-study sites such as hospitalizations or visits to other medical specialists.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">120</enrollment>
  <condition>HIV</condition>
  <arm_group>
    <arm_group_label>Standard-of-care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Adolescents randomized to the standard arm will receive monthly HIV care in the GHESKIO Adolescent Clinic. Clinical care is provided in an individual exam room by a nurse. The patient is sequentially referred to the laboratory, social worker, and pharmacy for medication refills. A typical visit, including wait time, lasts 3 hours.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>FANMI - Cohort Care</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Adolescents randomized to FANMI will receive all monthly HIV care in the community room of the Prince Albert School in Village of God. Adolescents will be grouped in cohorts of 5-10 peers. The entire visit will take ~ 2 hours.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>FANMI - Cohort Care</intervention_name>
    <description>FANMI includes receiving integrated clinical care, group counseling, and social activities in a single session by the same provider to simplify care and strengthen relationships between peers and providers. FANMI groups consist of 5-10 adolescents meeting once per month.</description>
    <arm_group_label>FANMI - Cohort Care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Female&#xD;
&#xD;
          -  Age 16-23 years&#xD;
&#xD;
          -  ART naive, initiated ART in the past 3 months, or defaulted from care for 3 months or&#xD;
             more&#xD;
&#xD;
          -  Participant knowledge of HIV-infection&#xD;
&#xD;
          -  Willing to receive care at the clinic or in the community&#xD;
&#xD;
          -  Willing to provide consent (age 18 -23 years) or assent with parental/guardian consent&#xD;
             (16-17 years)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy at the time of enrollment&#xD;
&#xD;
          -  A severe HIV/AIDS illness requiring hospitalization or intensive medical follow-up&#xD;
&#xD;
          -  Based on the primary clinician's judgement that the adolescent is at a developmental&#xD;
             stage not suited for study participation&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>The HIV epidemic in Haiti disproportionally affects adolescent girls age 16-23. Our study involves recruitment and enrollment of adolescent girls to determine if our intervention is effective in retaining HIV-infected adolescent girls in Haiti.</gender_description>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>23 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Daniel Fitzgerald, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Weill Medical College of Cornell University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>GHESKIO</name>
      <address>
        <city>Port-au-Prince</city>
        <country>Haiti</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Haiti</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>September 13, 2017</study_first_submitted>
  <study_first_submitted_qc>September 15, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 18, 2017</study_first_posted>
  <results_first_submitted>May 8, 2023</results_first_submitted>
  <results_first_submitted_qc>May 8, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">June 2, 2023</results_first_posted>
  <last_update_submitted>May 8, 2023</last_update_submitted>
  <last_update_submitted_qc>May 8, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 2, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Data will be shared once the trial is complete</ipd_description>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>October 12, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/04/NCT03286504/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Standard-of-care</title>
          <description>Adolescents randomized to the standard arm will receive monthly HIV care in the GHESKIO Adolescent Clinic. Clinical care is provided in an individual exam room by a nurse. The patient is sequentially referred to the laboratory, social worker, and pharmacy for medication refills. A typical visit, including wait time, lasts 3 hours.</description>
        </group>
        <group group_id="P2">
          <title>FANMI - Cohort Care</title>
          <description>Adolescents randomized to FANMI will receive all monthly HIV care in the community room of the Prince Albert School in Village of God. Adolescents will be grouped in cohorts of 5-10 peers. The entire visit will take ~ 2 hours.&#xD;
FANMI - Cohort Care: FANMI includes receiving integrated clinical care, group counseling, and social activities in a single session by the same provider to simplify care and strengthen relationships between peers and providers. FANMI groups consist of 5-10 adolescents meeting once per month.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="60"/>
                <participants group_id="P2" count="60"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="41"/>
                <participants group_id="P2" count="44"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="19"/>
                <participants group_id="P2" count="16"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="19"/>
                <participants group_id="P2" count="16"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Standard-of-care</title>
          <description>Adolescents randomized to the standard arm will receive monthly HIV care in the GHESKIO Adolescent Clinic. Clinical care is provided in an individual exam room by a nurse. The patient is sequentially referred to the laboratory, social worker, and pharmacy for medication refills. A typical visit, including wait time, lasts 3 hours.</description>
        </group>
        <group group_id="B2">
          <title>FANMI - Cohort Care</title>
          <description>Adolescents randomized to FANMI will receive all monthly HIV care in the community room of the Prince Albert School in Village of God. Adolescents will be grouped in cohorts of 5-10 peers. The entire visit will take ~ 2 hours.&#xD;
FANMI - Cohort Care: FANMI includes receiving integrated clinical care, group counseling, and social activities in a single session by the same provider to simplify care and strengthen relationships between peers and providers. FANMI groups consist of 5-10 adolescents meeting once per month.</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="60"/>
            <count group_id="B2" value="60"/>
            <count group_id="B3" value="120"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="16"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="54"/>
                    <measurement group_id="B2" value="50"/>
                    <measurement group_id="B3" value="104"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</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>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="60"/>
                    <measurement group_id="B2" value="60"/>
                    <measurement group_id="B3" value="120"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</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>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</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>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="60"/>
                    <measurement group_id="B2" value="60"/>
                    <measurement group_id="B3" value="120"/>
                  </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>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</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>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="60"/>
                    <measurement group_id="B2" value="60"/>
                    <measurement group_id="B3" value="120"/>
                  </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_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>12 Month Retention</title>
        <description>Retention in care at 12 months will be measured. 12 month retention is defined as being alive at 12 months and having a care visit between 9 and 15 months after enrollment.</description>
        <time_frame>12 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Standard-of-care</title>
            <description>Adolescents randomized to the standard arm will receive monthly HIV care in the GHESKIO Adolescent Clinic. Clinical care is provided in an individual exam room by a nurse. The patient is sequentially referred to the laboratory, social worker, and pharmacy for medication refills. A typical visit, including wait time, lasts 3 hours.</description>
          </group>
          <group group_id="O2">
            <title>FANMI - Cohort Care</title>
            <description>Adolescents randomized to FANMI will receive all monthly HIV care in the community room of the Prince Albert School in Village of God. Adolescents will be grouped in cohorts of 5-10 peers. The entire visit will take ~ 2 hours.&#xD;
FANMI - Cohort Care: FANMI includes receiving integrated clinical care, group counseling, and social activities in a single session by the same provider to simplify care and strengthen relationships between peers and providers. FANMI groups consist of 5-10 adolescents meeting once per month.</description>
          </group>
        </group_list>
        <measure>
          <title>12 Month Retention</title>
          <description>Retention in care at 12 months will be measured. 12 month retention is defined as being alive at 12 months and having a care visit between 9 and 15 months after enrollment.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="60"/>
                <count group_id="O2" value="60"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="41"/>
                    <measurement group_id="O2" value="44"/>
                  </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>
            <p_value>0.55</p_value>
            <method>Chi-squared</method>
            <param_type>proportion difference</param_type>
            <param_value>0.05</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.112</ci_lower_limit>
            <ci_upper_limit>0.212</ci_upper_limit>
            <estimate_desc>Direction of proportion difference = FANMI arm minus Standard of Care arm</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>12 Month Viral Suppression</title>
        <description>Viral suppression at 12 months will be measured. Suppressed viral load will be defined as a binary outcome based upon the WHO definition of viral suppression as a plasma HIV-1 RNA level &lt;1000 copies/µl.</description>
        <time_frame>12 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Standard-of-care</title>
            <description>Adolescents randomized to the standard arm will receive monthly HIV care in the GHESKIO Adolescent Clinic. Clinical care is provided in an individual exam room by a nurse. The patient is sequentially referred to the laboratory, social worker, and pharmacy for medication refills. A typical visit, including wait time, lasts 3 hours.</description>
          </group>
          <group group_id="O2">
            <title>FANMI - Cohort Care</title>
            <description>Adolescents randomized to FANMI will receive all monthly HIV care in the community room of the Prince Albert School in Village of God. Adolescents will be grouped in cohorts of 5-10 peers. The entire visit will take ~ 2 hours.&#xD;
FANMI - Cohort Care: FANMI includes receiving integrated clinical care, group counseling, and social activities in a single session by the same provider to simplify care and strengthen relationships between peers and providers. FANMI groups consist of 5-10 adolescents meeting once per month.</description>
          </group>
        </group_list>
        <measure>
          <title>12 Month Viral Suppression</title>
          <description>Viral suppression at 12 months will be measured. Suppressed viral load will be defined as a binary outcome based upon the WHO definition of viral suppression as a plasma HIV-1 RNA level &lt;1000 copies/µl.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="60"/>
                <count group_id="O2" value="60"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26"/>
                    <measurement group_id="O2" value="28"/>
                  </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>
            <p_value>0.71</p_value>
            <method>Chi-squared</method>
            <param_type>proportion difference</param_type>
            <param_value>0.033</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.145</ci_lower_limit>
            <ci_upper_limit>0.211</ci_upper_limit>
            <estimate_desc>Direction of proportion difference = FANMI arm minus Standard of Care arm</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Antiretroviral Therapy (ART) Initiation</title>
        <description>Time to ART initiation is the number of calendar days from date of HIV diagnosis to date of ART initiation.</description>
        <time_frame>12 months</time_frame>
        <population>Participants analyzed were only those who were ART-naïve at study enrollment.</population>
        <group_list>
          <group group_id="O1">
            <title>Standard-of-care</title>
            <description>Adolescents randomized to the standard arm will receive monthly HIV care in the GHESKIO Adolescent Clinic. Clinical care is provided in an individual exam room by a nurse. The patient is sequentially referred to the laboratory, social worker, and pharmacy for medication refills. A typical visit, including wait time, lasts 3 hours.</description>
          </group>
          <group group_id="O2">
            <title>FANMI - Cohort Care</title>
            <description>Adolescents randomized to FANMI will receive all monthly HIV care in the community room of the Prince Albert School in Village of God. Adolescents will be grouped in cohorts of 5-10 peers. The entire visit will take ~ 2 hours.&#xD;
FANMI - Cohort Care: FANMI includes receiving integrated clinical care, group counseling, and social activities in a single session by the same provider to simplify care and strengthen relationships between peers and providers. FANMI groups consist of 5-10 adolescents meeting once per month.</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Antiretroviral Therapy (ART) Initiation</title>
          <description>Time to ART initiation is the number of calendar days from date of HIV diagnosis to date of ART initiation.</description>
          <population>Participants analyzed were only those who were ART-naïve at study enrollment.</population>
          <units>days</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="34"/>
                <count group_id="O2" value="33"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" lower_limit="0" upper_limit="0"/>
                    <measurement group_id="O2" value="0" lower_limit="0" upper_limit="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Optimal Antiretroviral Therapy (ART) Adherence</title>
        <description>ART adherence will be measured by self-report using two questions: 1) number of pills missed in the past 4 days and 2) forgot to take pills last weekend. A response of no missed pills in the past 4 days and did not forget to take pills last weekend is defined as 'optimal' adherence. All other responses are defined as 'sub-optimal' adherence.</description>
        <time_frame>12 months</time_frame>
        <population>There were 18 participants in the SOC arm and 22 participants in the FANMI arm who chose not to respond to the ART adherence assessment and were not included in this analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Standard-of-care</title>
            <description>Adolescents randomized to the standard arm will receive monthly HIV care in the GHESKIO Adolescent Clinic. Clinical care is provided in an individual exam room by a nurse. The patient is sequentially referred to the laboratory, social worker, and pharmacy for medication refills. A typical visit, including wait time, lasts 3 hours.</description>
          </group>
          <group group_id="O2">
            <title>FANMI - Cohort Care</title>
            <description>Adolescents randomized to FANMI will receive all monthly HIV care in the community room of the Prince Albert School in Village of God. Adolescents will be grouped in cohorts of 5-10 peers. The entire visit will take ~ 2 hours.&#xD;
FANMI - Cohort Care: FANMI includes receiving integrated clinical care, group counseling, and social activities in a single session by the same provider to simplify care and strengthen relationships between peers and providers. FANMI groups consist of 5-10 adolescents meeting once per month.</description>
          </group>
        </group_list>
        <measure>
          <title>Optimal Antiretroviral Therapy (ART) Adherence</title>
          <description>ART adherence will be measured by self-report using two questions: 1) number of pills missed in the past 4 days and 2) forgot to take pills last weekend. A response of no missed pills in the past 4 days and did not forget to take pills last weekend is defined as 'optimal' adherence. All other responses are defined as 'sub-optimal' adherence.</description>
          <population>There were 18 participants in the SOC arm and 22 participants in the FANMI arm who chose not to respond to the ART adherence assessment and were not included in this analysis.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="42"/>
                <count group_id="O2" value="38"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22"/>
                    <measurement group_id="O2" value="18"/>
                  </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>
            <p_value>0.65</p_value>
            <method>Chi-squared</method>
            <param_type>proportion difference</param_type>
            <param_value>-0.05</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.269</ci_lower_limit>
            <ci_upper_limit>0.169</ci_upper_limit>
            <estimate_desc>Direction of proportion difference = FANMI arm minus Standard of Care arm</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Sexual Risk Behavior</title>
        <description>Sexual risk behavior will be measured by regular condom use among those who are sexually active. Regular condom use is defined as a response of 'often' or 'always' when asked about condom use during sexual intercourse.</description>
        <time_frame>12 months</time_frame>
        <population>There were 21 participants in the SOC arm and 26 subjects in the FANMI arm that did not receive STI testing and were excluded from this analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Standard-of-care</title>
            <description>Adolescents randomized to the standard arm will receive monthly HIV care in the GHESKIO Adolescent Clinic. Clinical care is provided in an individual exam room by a nurse. The patient is sequentially referred to the laboratory, social worker, and pharmacy for medication refills. A typical visit, including wait time, lasts 3 hours.</description>
          </group>
          <group group_id="O2">
            <title>FANMI - Cohort Care</title>
            <description>Adolescents randomized to FANMI will receive all monthly HIV care in the community room of the Prince Albert School in Village of God. Adolescents will be grouped in cohorts of 5-10 peers. The entire visit will take ~ 2 hours.&#xD;
FANMI - Cohort Care: FANMI includes receiving integrated clinical care, group counseling, and social activities in a single session by the same provider to simplify care and strengthen relationships between peers and providers. FANMI groups consist of 5-10 adolescents meeting once per month.</description>
          </group>
        </group_list>
        <measure>
          <title>Sexual Risk Behavior</title>
          <description>Sexual risk behavior will be measured by regular condom use among those who are sexually active. Regular condom use is defined as a response of 'often' or 'always' when asked about condom use during sexual intercourse.</description>
          <population>There were 21 participants in the SOC arm and 26 subjects in the FANMI arm that did not receive STI testing and were excluded from this analysis.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="39"/>
                <count group_id="O2" value="34"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21"/>
                    <measurement group_id="O2" value="26"/>
                  </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>
            <p_value>0.04</p_value>
            <method>Chi-squared</method>
            <param_type>proportion difference</param_type>
            <param_value>0.226</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.015</ci_lower_limit>
            <ci_upper_limit>0.438</ci_upper_limit>
            <estimate_desc>Direction of proportion difference = FANMI arm minus Standard of Care arm</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Sexually Transmitted Infections</title>
        <description>Sexually Transmitted Infections will include syphilis, diagnosed using a serum RPR (HUMAN) followed by a treponemal test if positive (Bioline Standard Diagnostics), chlamydia and gonorrhea, diagnosed by the urine GeneXpert GT/NG assay.</description>
        <time_frame>12 months</time_frame>
        <population>There were 14 participants in the SOC arm and 13 subjects in the FANMI arm that did not receive STI testing and were excluded from this analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Standard-of-care</title>
            <description>Adolescents randomized to the standard arm will receive monthly HIV care in the GHESKIO Adolescent Clinic. Clinical care is provided in an individual exam room by a nurse. The patient is sequentially referred to the laboratory, social worker, and pharmacy for medication refills. A typical visit, including wait time, lasts 3 hours.</description>
          </group>
          <group group_id="O2">
            <title>FANMI - Cohort Care</title>
            <description>Adolescents randomized to FANMI will receive all monthly HIV care in the community room of the Prince Albert School in Village of God. Adolescents will be grouped in cohorts of 5-10 peers. The entire visit will take ~ 2 hours.&#xD;
FANMI - Cohort Care: FANMI includes receiving integrated clinical care, group counseling, and social activities in a single session by the same provider to simplify care and strengthen relationships between peers and providers. FANMI groups consist of 5-10 adolescents meeting once per month.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Sexually Transmitted Infections</title>
          <description>Sexually Transmitted Infections will include syphilis, diagnosed using a serum RPR (HUMAN) followed by a treponemal test if positive (Bioline Standard Diagnostics), chlamydia and gonorrhea, diagnosed by the urine GeneXpert GT/NG assay.</description>
          <population>There were 14 participants in the SOC arm and 13 subjects in the FANMI arm that did not receive STI testing and were excluded from this analysis.</population>
          <units>incident STI diagnoses</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="46"/>
                <count group_id="O2" value="47"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="20"/>
                  </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>
            <p_value>0.03</p_value>
            <method>Chi-squared</method>
            <param_type>proportion difference</param_type>
            <param_value>0.208</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.023</ci_lower_limit>
            <ci_upper_limit>0.393</ci_upper_limit>
            <estimate_desc>Direction of proportion difference = FANMI arm minus Standard of Care arm.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Acceptability</title>
        <description>FANMI Acceptability will be assessed using qualitative interviews conducted at 6 and 12 months after study enrollment with a subset of 30 FANMI participants and clinic providers (nurses and peer educators). A trained qualitative research assistant will interview adolescents to explore attitudes about the FANMI intervention, specifically as it relates to social isolation, stigma, and family rejection, self-esteem and clinic-level factors.</description>
        <time_frame>12 months</time_frame>
        <population>Data for this outcome was not collected.</population>
        <group_list>
          <group group_id="O1">
            <title>Standard-of-care</title>
            <description>Adolescents randomized to the standard arm will receive monthly HIV care in the GHESKIO Adolescent Clinic. Clinical care is provided in an individual exam room by a nurse. The patient is sequentially referred to the laboratory, social worker, and pharmacy for medication refills. A typical visit, including wait time, lasts 3 hours.</description>
          </group>
          <group group_id="O2">
            <title>FANMI - Cohort Care</title>
            <description>Adolescents randomized to FANMI will receive all monthly HIV care in the community room of the Prince Albert School in Village of God. Adolescents will be grouped in cohorts of 5-10 peers. The entire visit will take ~ 2 hours.&#xD;
FANMI - Cohort Care: FANMI includes receiving integrated clinical care, group counseling, and social activities in a single session by the same provider to simplify care and strengthen relationships between peers and providers. FANMI groups consist of 5-10 adolescents meeting once per month.</description>
          </group>
        </group_list>
        <measure>
          <title>Acceptability</title>
          <description>FANMI Acceptability will be assessed using qualitative interviews conducted at 6 and 12 months after study enrollment with a subset of 30 FANMI participants and clinic providers (nurses and peer educators). A trained qualitative research assistant will interview adolescents to explore attitudes about the FANMI intervention, specifically as it relates to social isolation, stigma, and family rejection, self-esteem and clinic-level factors.</description>
          <population>Data for this outcome was not collected.</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>Healthcare Utilization</title>
        <description>Healthcare utilization will be measured. Healthcare utilization will be measured as a composite of attendance at HIV care visits, laboratory services, and use of other specialist services at study sites and use of health services at non-study sites such as hospitalizations or visits to other medical specialists.</description>
        <time_frame>12 months</time_frame>
        <population>Data not collected.</population>
        <group_list>
          <group group_id="O1">
            <title>Standard-of-care</title>
            <description>Adolescents randomized to the standard arm will receive monthly HIV care in the GHESKIO Adolescent Clinic. Clinical care is provided in an individual exam room by a nurse. The patient is sequentially referred to the laboratory, social worker, and pharmacy for medication refills. A typical visit, including wait time, lasts 3 hours.</description>
          </group>
          <group group_id="O2">
            <title>FANMI - Cohort Care</title>
            <description>Adolescents randomized to FANMI will receive all monthly HIV care in the community room of the Prince Albert School in Village of God. Adolescents will be grouped in cohorts of 5-10 peers. The entire visit will take ~ 2 hours.&#xD;
FANMI - Cohort Care: FANMI includes receiving integrated clinical care, group counseling, and social activities in a single session by the same provider to simplify care and strengthen relationships between peers and providers. FANMI groups consist of 5-10 adolescents meeting once per month.</description>
          </group>
        </group_list>
        <measure>
          <title>Healthcare Utilization</title>
          <description>Healthcare utilization will be measured. Healthcare utilization will be measured as a composite of attendance at HIV care visits, laboratory services, and use of other specialist services at study sites and use of health services at non-study sites such as hospitalizations or visits to other medical specialists.</description>
          <population>Data not collected.</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_list>

    <reported_events>
      <time_frame>12 months</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Standard-of-care</title>
          <description>Adolescents randomized to the standard arm will receive monthly HIV care in the GHESKIO Adolescent Clinic. Clinical care is provided in an individual exam room by a nurse. The patient is sequentially referred to the laboratory, social worker, and pharmacy for medication refills. A typical visit, including wait time, lasts 3 hours.</description>
        </group>
        <group group_id="E2">
          <title>FANMI - Cohort Care</title>
          <description>Adolescents randomized to FANMI will receive all monthly HIV care in the community room of the Prince Albert School in Village of God. Adolescents will be grouped in cohorts of 5-10 peers. The entire visit will take ~ 2 hours.&#xD;
FANMI - Cohort Care: FANMI includes receiving integrated clinical care, group counseling, and social activities in a single session by the same provider to simplify care and strengthen relationships between peers and providers. FANMI groups consist of 5-10 adolescents meeting once per month.</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="60"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="60"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="60"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="60"/>
              </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. Daniel Fitzgerald</name_or_title>
      <organization>Weill Cornell Medicine</organization>
      <phone>646-962-8140</phone>
      <email>dwf2001@med.cornell.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/NCT03286504
org study id: 1504016098
secondary id: R01HD091935
nct id: NCT03286504
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The investigators will conduct a randomized controlled trial of Group Care in the GHESKIO
      Community Center versus Individual Care in the GHESKIO Adolescent Clinic for 160 HIV-infected
      adolescent girls age 16-23 years in Haiti (80 adolescents per arm). Group Care includes
      receiving integrated clinical and social support services in groups of 5-8 adolescents at a
      monthly visit. The primary outcome is retention in HIV care at 12 months after randomization.
The investigators will conduct a randomized controlled trial of Group Care in the GHESKIO
      Community Center versus Individual Care in the GHESKIO Adolescent Clinic for 160 HIV-infected
      adolescent girls age 16-23 years in Haiti (80 per arm). Adolescents randomized to Group Care
      will receive HIV services including integrated clinical and social support care in groups of
      5-10. Adolescents randomized to Individual Care will continue to receive individual care at
      the GHESKIO Adolescent Clinic, which is the current standard of care (described below). If a
      subject declines to participate in the study they will continue to receive standard HIV care.
      Participants will be randomized to either Group Care or Individual Care in a 1:1 ratio using
      a computer generated random assignment.

      Individual Care (standard of care): Adolescents randomized to Individual Care will receive
      care in the GHESKIO Adolescent Clinic which cares for both males and females age 13-23 years.
      The Adolescent Clinic waiting room has a television showing educational videos. After seeing
      a triage peer counselor and having their vital signs taken, participants see a nurse
      practitioner (NP) one-on-one in a private room for a 10-15 minute clinic visit. The NP may
      also provide family support counseling including family visits per clinical judgment. Each NP
      sees approximately 20 HIV-infected adolescents per day. The adolescent then returns to the
      HIV positive peer counselor, who provides one-on-one counseling for 30 minutes on topics
      chosen by the adolescent and the counselor. Each counselor sees ~10 adolescents per day.

      Group Care (intervention): Adolescent girls randomized to Group Care will join a group within
      one week of study enrollment and receive care in the GHESKIO Community Center. The
      investigators estimate that it will take 4-6 weeks to constitute a full group of 5-10. During
      this enrollment phase, groups will meet weekly, adding new participants each week. The
      participants will then meet monthly with an NP and a HIV positive peer counselor. Each
      monthly group session will last ~2 hours. This is comparable to the time it takes for a
      patient to pass through the Adolescent HIV Clinic. It will start with a 30 minute
      unstructured discussion. This time is intentionally unstructured and responds to our previous
      research finding that adolescents want to talk about topics of their choosing with their
      peers. This will be followed by a 45 minute group counseling session following a structured
      curriculum, addressing topics such as social isolation, stigma, family support, sexual risk
      behavior, life goals, medication adherence, job skills, and transitions. This is followed by
      a 30 minute social activity led by two rotating group leaders who are elected by their peers.
      Social activities include crafts, playing cards, and charades. Participants will be seen one
      by one by the NP for ~10-15 minutes in a screened in clinical area during the unstructured
      discussion and the social activity. All HIV clinical services, including provision of
      antiretroviral therapy (ART) medications, CD4 T cell monitoring, screening for symptoms and
      OI, medication adherence monitoring, family planning, and general primary care will be
      provided by the NP. Girls who become eligible for ART will be provided with individual
      counseling and promptly initiated on ART by the NP. The primary hypothesis is that Group Care
      will improve retention at 12 months compared with standard Individual Care. The study has >
      90% power to detect a difference in retention from 60% to 85%. Participants in both study
      arms will complete a questionnaire with a research nurse at enrollment, 6, and 12 months
      collecting data on HIV knowledge, HIV-related stigma, HIV disclosure, social and family
      support, depression and alcohol use, problem solving skills, and food insecurity.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: 12 Month Retention
time frame: 12 months
description: Retention in care at 12 months will be measured. 12 month retention is defined as being alive at 12 months and having a care visit between 9 and 15 months after enrollment.
measure: 12 Month Viral Suppression
time frame: 12 months
description: Viral suppression at 12 months will be measured. Suppressed viral load will be defined as a binary outcome based upon the WHO definition of viral suppression as a plasma HIV-1 RNA level <1000 copies/µl.
measure: Time to Antiretroviral Therapy (ART) Initiation
time frame: 12 months
description: Time to ART initiation is the number of calendar days from date of HIV diagnosis to date of ART initiation.
measure: Optimal Antiretroviral Therapy (ART) Adherence
time frame: 12 months
description: ART adherence will be measured by self-report using two questions: 1) number of pills missed in the past 4 days and 2) forgot to take pills last weekend. A response of no missed pills in the past 4 days and did not forget to take pills last weekend is defined as 'optimal' adherence. All other responses are defined as 'sub-optimal' adherence.
measure: Sexual Risk Behavior
time frame: 12 months
description: Sexual risk behavior will be measured by regular condom use among those who are sexually active. Regular condom use is defined as a response of 'often' or 'always' when asked about condom use during sexual intercourse.
measure: Number of Sexually Transmitted Infections
time frame: 12 months
description: Sexually Transmitted Infections will include syphilis, diagnosed using a serum RPR (HUMAN) followed by a treponemal test if positive (Bioline Standard Diagnostics), chlamydia and gonorrhea, diagnosed by the urine GeneXpert GT/NG assay.
measure: Acceptability
time frame: 12 months
description: FANMI Acceptability will be assessed using qualitative interviews conducted at 6 and 12 months after study enrollment with a subset of 30 FANMI participants and clinic providers (nurses and peer educators). A trained qualitative research assistant will interview adolescents to explore attitudes about the FANMI intervention, specifically as it relates to social isolation, stigma, and family rejection, self-esteem and clinic-level factors.
measure: Healthcare Utilization
time frame: 12 months
description: Healthcare utilization will be measured. Healthcare utilization will be measured as a composite of attendance at HIV care visits, laboratory services, and use of other specialist services at study sites and use of health services at non-study sites such as hospitalizations or visits to other medical specialists.
arm group label: Standard-of-care
arm group type: No Intervention
description: Adolescents randomized to the standard arm will receive monthly HIV care in the GHESKIO Adolescent Clinic. Clinical care is provided in an individual exam room by a nurse. The patient is sequentially referred to the laboratory, social worker, and pharmacy for medication refills. A typical visit, including wait time, lasts 3 hours.
arm group label: FANMI - Cohort Care
arm group type: Experimental
description: Adolescents randomized to FANMI will receive all monthly HIV care in the community room of the Prince Albert School in Village of God. Adolescents will be grouped in cohorts of 5-10 peers. The entire visit will take ~ 2 hours.
intervention type: Behavioral
intervention name: FANMI - Cohort Care
description: FANMI includes receiving integrated clinical care, group counseling, and social activities in a single session by the same provider to simplify care and strengthen relationships between peers and providers. FANMI groups consist of 5-10 adolescents meeting once per month.
arm group label: FANMI - Cohort Care
criteria: 
gender: Female
gender based: Yes
gender description: The HIV epidemic in Haiti disproportionally affects adolescent girls age 16-23. Our study involves recruitment and enrollment of adolescent girls to determine if our intervention is effective in retaining HIV-infected adolescent girls in Haiti.
minimum age: 16 Years
maximum age: 23 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Daniel Fitzgerald, MD
role: Principal Investigator
affiliation: Weill Medical College of Cornell University
facility: 
country: Haiti
responsible party type: Sponsor
sharing ipd: Yes
ipd description: Data will be shared once the trial is complete
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 