<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/NCT04429061</url>
  </required_header>
  <id_info>
    <org_study_id>IRB-300002251</org_study_id>
    <nct_id>NCT04429061</nct_id>
  </id_info>
  <brief_title>Reaching 90 90 90 in Adolescents in Zambia: Using All Our SKILLZ</brief_title>
  <acronym>SKILLZ</acronym>
  <official_title>Reaching 90 90 90 in Adolescents in Zambia: Using All Our SKILLZ</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Alabama at Birmingham</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of California, San Francisco</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Centre for Infectious Disease Research in Zambia</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Grassroot Soccer (GRS)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Washington University School of Medicine</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Alabama at Birmingham</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      &quot;SKILLZ,&quot; is a mixed methods evaluation of the Grassroots Soccer (GRS) SKILLZ Package based&#xD;
      in Lusaka, Zambia. The package is made up of three football-based programs: (1) SKILLZ-Girl -&#xD;
      implemented in schools as part of a 10-week program culminating in a tournament event; (2)&#xD;
      SKILLZ-Club - implemented as an ongoing extra-curricular activity after the completion of&#xD;
      SKILLZ-Girl; (3) SKILLZ-Plus - a clinic based football group targeted at girls that are&#xD;
      HIV-positive.&#xD;
&#xD;
      The programs work together to build a continued support system which encourages uptake of&#xD;
      Sexual Reproductive Health (SRH) and HIV services, while facilitating ART adherence (for&#xD;
      HV-positive participants) and continued engagement with health services over the long-term&#xD;
      (whether to contraceptive methods, HIV prevention services, HIV repeat testing, and/or HIV&#xD;
      treatment and care).&#xD;
&#xD;
      The study team has developed an enhanced SKILLZ-Girl offering, which will include a&#xD;
      comprehensive module on HIVST, contraceptives and PrEP, access to a nurse during the&#xD;
      implementation of sessions and the additional offering of HIVST and contraceptive services at&#xD;
      the event along with ongoing engagement through the SKILLZ-Club program (Enhanced Arm) , The&#xD;
      central hypothesis is that this enhanced curriculum will increase HIV testing and&#xD;
      contraceptive uptake compared to the standard SKILLZ curriculum &amp; standard event (SOC Arm).&#xD;
      The investigators further hypothesize that the intervention in the enhanced arm will&#xD;
      positively and directly affect a number of mediating factors including attendance at soccer&#xD;
      events where community-based SRH services are offered, SRH knowledge, empowerment,&#xD;
      self-confidence, and perceptions of gender balance, and (reduced) stigma.&#xD;
&#xD;
      For girls found to be HIV-positive, the follow-on SKILLZ intervention (SKILLZ-Plus) has been&#xD;
      designed to facilitate linkage to HIV care and treatment, reduce HIV-related stigma, increase&#xD;
      disclosure to family and partners, increase feelings of social support, empowerment,&#xD;
      self-efficacy, and ultimately adherence to ARVs, viral load suppression (VLS) and retention&#xD;
      in HIV care and treatment.&#xD;
&#xD;
      This study will be conducted in up to 32 secondary schools that GRS currently serves in the&#xD;
      Lusaka Urban District.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Research aim(s)/General Objective and Specific Objectives Aim 1: (a) Assess the impact of&#xD;
      SKILLZ over two years on HIV testing and (b) SRH-related prevention services uptake among&#xD;
      adolescent girls aged 16-19 in up to 23 intervention schools (with enhanced HIVST, PrEP, and&#xD;
      contraceptive method offerings) compared to up to 23 control schools using a&#xD;
      quasi-experimental difference-in-difference approach; and&#xD;
&#xD;
      Aim 1: (b) Describe linkage to care and treatment, and viral load suppression and retention&#xD;
      at 6, 12, and 18 months for girls who are identified to be HIV+ during the study, using&#xD;
      qualitative, programmatic, and administrative data.&#xD;
&#xD;
      This will be achieved by i) using a quasi-experimental difference-in-difference approach that&#xD;
      compares girls aged 16 and over in approximately 23 SKILLZ control schools compared to&#xD;
      approximately 23 schools where SKILLZ will be delivered with the enhanced HIVST and a variety&#xD;
      of contraceptive method offerings; and ii) through a cohort model using pre-existing&#xD;
      SmartCare data on HIV+ individuals in care to match to adolescent girls aged 16 and over from&#xD;
      the same district (Lusaka) who are identified to be HIV+ at any time during SKILLZ-Girl or&#xD;
      SKILLZ-Club participation.&#xD;
&#xD;
      Aim 2: Examine how the intervention works including lessons learned for future implementation&#xD;
      by&#xD;
&#xD;
        1. conducting a process evaluation to identify mediators, predictors, and barriers to&#xD;
           uptake of the SKILLZ-Girl, Club, and Plus curricula both quantitatively through&#xD;
           mediation and moderation analyses and qualitatively through a sequential explanatory&#xD;
           approach using focus groups discussions, interviews and observation with coaches and&#xD;
           girls; and by&#xD;
&#xD;
        2. monitoring fidelity&#xD;
&#xD;
      Aim 3: Estimate the short- and long-term cost-effectiveness and return on investment of the&#xD;
      SKILLZ Girl, Club, and Plus curricula for improving health outcomes for adolescent girls.&#xD;
&#xD;
      This is a mixed-methods evaluation of the SKILLZ intervention using the following approaches:&#xD;
&#xD;
      A quasi-experimental cohort of school-aged 16-year-old and over females to be followed for a&#xD;
      period of 18 month will be evaluated with a difference-in-difference (DID) approach to&#xD;
      estimate HIV testing uptake and sexual/reproductive health services use. Primary and&#xD;
      secondary outcomes will be measured at several timepoints longitudinally across up to 23&#xD;
      schools offering the SKILLZ-Girl and SKILLZ-Clubs program and up to 23 schools offering the&#xD;
      &quot;standard of care&quot; (SOC) and SOC Clubs. Recruitment is anticipated to take 6 months on a&#xD;
      rolling basis. The order in which schools will be selected will be random. Participants will&#xD;
      be clustered at the school-level; a random sample of girls will be enrolled from each&#xD;
      participating school, aged 16-years at the commencement of SKILLZ-Girl and who are in a grade&#xD;
      where GRS is offering the SKILLZ-Girl curriculum All enrolled girls will be followed over the&#xD;
      18 months' time period to assess SRH service uptake, including HIV testing. It is estimated&#xD;
      that the majority (~98%) of girls testing for HIV will likely be HIV-negative, based on&#xD;
      estimates from programmatic GRS data. While HIV-positive girls will continue to participate&#xD;
      in the school-based SKILLZ-Girl and Clubs activities and followed for SRH use, they will also&#xD;
      be offered contemporaneous enrolment into SKILLZ-Plus upon infection; retention in care and&#xD;
      Viral Load Suppression (VLS) at 6, 12, and 18 months will be measured for this subset.&#xD;
&#xD;
      Process evaluation: A process evaluation will be conducted to better understand the casual&#xD;
      pathways and effect mediators and moderators using mixed methods approaches, including&#xD;
      supplemental qualitative data collection. To investigate reasons why the program components&#xD;
      (SKILLZ-Girl, Club &amp; Plus) might fail or succeed in different schools or communities and&#xD;
      assess intervention effect mediators and moderators for HIV testing and contraceptive use&#xD;
      uptake we will use a mixed methods approach involving: (1) quantitative analyses of baseline&#xD;
      survey data for testing how variables can moderate the observed impact of the intervention,&#xD;
      and (2) qualitative data collected from a subset of SKILLZ participants in the evaluation&#xD;
      cohort and their coaches to further understand potential mediating pathways.&#xD;
&#xD;
      Fidelity monitoring: The study includes measures to monitor fidelity of the intervention&#xD;
      implementation, including receptivity to and understanding of the intervention amongst&#xD;
      participants, the perceived appropriateness and relevancy of the intervention for adolescent&#xD;
      girls in school, and the extent to which the intervention was delivered per protocol in&#xD;
      different communities and schools.&#xD;
&#xD;
      Economic evaluation: Time permitting (given the uncertainty of delays due to COVID), the&#xD;
      study will estimate the short- and long-term cost-effectiveness and return on investment of&#xD;
      SKILLZ for improving health outcomes for adolescent girls.&#xD;
&#xD;
      Data collection plan and tools SmartCare electronic data: All antiretroviral therapy services&#xD;
      offered as part of the study will be captured in the National EMR, SmartCare, which permits&#xD;
      measuring of utilization and clinical outcomes (i.e., Linkage to Care, VLS) at soccer events,&#xD;
      mobile clinics, and public clinics in Lusaka. VLS is defined as below detection, i.e., less&#xD;
      than 50 copies/ml. Retention in care will also be measured using SmartCare data on pharmacy&#xD;
      visits and defined as accessing pharmacy within a 90-day window of visits. Consent will be&#xD;
      requested from all participants as part of the consent process to access their SmartCare&#xD;
      records.&#xD;
&#xD;
      Youth-Friendly services electronic data: Depending on the location of the school, the girl's&#xD;
      residential address and/or her own personal preferences, participants will be referred to&#xD;
      either the PEPFAR Funded DREAMS houses or the M.A.C. funded youth-friendly spaces based in&#xD;
      local MOH clinics in order to access ongoing SRH services not provided by the coaches in&#xD;
      their CBD role (this will include accessing PrEP, STI testing and long-term contraceptive&#xD;
      methods). All interactions with the DREAMS houses or M.A.C centres (including meeting with&#xD;
      counsellors, referral and uptake of services) are captured in their respective electronic&#xD;
      databases. Consent will be requested from all participants as part of the consent process to&#xD;
      allow researchers to access either DREAMS or M.A.C data should they chose to access either of&#xD;
      these services.&#xD;
&#xD;
      Survey at baseline: A baseline survey will be administered to approximately 50 girls per&#xD;
      school randomly selected to participate in the evaluation to collect information on school&#xD;
      characteristics, sexual behaviour, age, HIV knowledge, maternal education, baseline HIV&#xD;
      status, and sexual/reproductive health uptake and retention. These variables will be used as&#xD;
      covariates and moderators for service uptake and retention. The target sample of&#xD;
      approximately 1380 girls will respond to a survey self-administered using ODk software upon&#xD;
      informed consent. The survey will be available in English, Nyanja and Bemba. Coaches and&#xD;
      study staff will on site be help girls navigate the survey. If during baseline, it appears&#xD;
      that there has been sufficient time to measure change, or the full SKILLZ-Girl curriculum was&#xD;
      not administered, the baseline survey may be re-administered to assist with validation of&#xD;
      responses (as opposed to implementing the follow-up survey provided below).&#xD;
&#xD;
      Survey post-SKILLZ-Girl event, 6-, 12-, and 18 months: A total of approximately 30 girls per&#xD;
      school (regardless of HIV status) will respond to a ODK survey to collect information on&#xD;
      sexual behaviour, HIV knowledge, maternal education, sexual/reproductive health uptake and&#xD;
      retention. Post-SKILLZ-Girl survey data will be used to assess the effect of SKILLS Girl and&#xD;
      SKILLZ-Club on the outcomes of interest. In schools selected to offer SKILLZ-Club, surveys&#xD;
      will be conducted during club attendance approximately 6 months after the SKILLZ-Girl&#xD;
      community soccer event. Surveys will be completed individually by the participant on a secure&#xD;
      tablet physically or via phone. Study staff will be available to assist participants to&#xD;
      navigate the survey if they request assistance. If a participant has opted to not attend the&#xD;
      clubs or has since left or changed schools, the coaches and study staff will attempt to trace&#xD;
      participants in the community in order to complete the follow-up survey.&#xD;
&#xD;
      Where a participant is contacted for follow-up and it is discovered that she has left Lusaka,&#xD;
      Chilanga, Chongwe and Kafue districts and it is not possible for study staff to arrange a&#xD;
      visit to meet with her, a personalized survey link will be sent to her via email or WhatsApp&#xD;
      (based on the participant's preference). She will then be invited to complete and submit the&#xD;
      survey online. Alternatively, if the participant prefers study staff will complete the survey&#xD;
      with the participant over the phone and enter their responses directly into ODK.&#xD;
&#xD;
      In the schools selected not to offer SKILLZ-Club, GRS will arrange for a 2-hour meeting&#xD;
      session with all participants still enrolled at that school, where all participants will&#xD;
      complete the surveys. If a participant opts to not attend the meeting or has since left or&#xD;
      changed schools, the coaches and study staff will attempt to trace participants in the&#xD;
      community in order to complete the follow-up survey.&#xD;
&#xD;
      Data management and storage&#xD;
&#xD;
      Quantitative:&#xD;
&#xD;
      Individual-level data will be collected on clinical, laboratory, and demographic&#xD;
      characteristics, including retention in care and VLS at 6, 12 and 24 months. Using case&#xD;
      reporting forms (CRFs), the team will collect study-specific data, including information&#xD;
      obtained directly from participants, routine programmatic data from GRS and abstract routine&#xD;
      clinical data from paper-based medical records, the SmartCare Electronic Management Records&#xD;
      (EMR), CIDRZ Laboratory Information Management System (LIMS) and DREAMS electronic management&#xD;
      system. Routinely collected individual-level clinical data are first written onto forms in&#xD;
      the paper medical record and then entered into the SmartCare EMR. SmartCare serves as a&#xD;
      repository of clinical data for HIV-infected individuals and includes such data fields as:&#xD;
      ART initiation date, ART regimen, visit dates, and laboratory data.&#xD;
&#xD;
      GRS will collect programmatic data through a combination of paper and electronic data entry&#xD;
      via tablets, with all data stored securely in RedCap. Where paper files are used for&#xD;
      programmatic management, data will be manually entered by study staff directly into the&#xD;
      RedCap database. De-identified data will made available to GRS co-investigators to enable&#xD;
      review of key fidelity and quality indicators in order to monitor implementation in real&#xD;
      time.&#xD;
&#xD;
      All paper study files will be stored in secured, locked cabinets located in locked rooms&#xD;
      available to study staff only. A secure server will be used to store encrypted study data,&#xD;
      including the study database. All personal identifiers will be removed prior to generating&#xD;
      the analytical dataset.&#xD;
&#xD;
      Qualitative:&#xD;
&#xD;
      All data will be obtained using digital audio recorders. Recorded data will be transferred on&#xD;
      to a lockable computer kept by the co-principal investigator leading the qualitative&#xD;
      research. Transcripts will go through a QA/QC process where researchers will cross check&#xD;
      randomly selected transcribed verbatim with the recordings.&#xD;
&#xD;
      Data analysis plan The primary outcome is the probability of testing for HIV at any time&#xD;
      during the period when SKILLZ is delivered through to 24 months after the final soccer event.&#xD;
      The primary analysis for Aim 1 will follow a difference-in-difference (DID) effect between&#xD;
      study arms. The outcome of interest will be regressed on an indicator of study arm assignment&#xD;
      interacted with a dichotomous variable POST which indicates the outcome after the&#xD;
      intervention is implemented; this differentiates baseline and end-line for each study arm,&#xD;
      controls for any time dependent variables that might confound the effect, as well as any&#xD;
      time-invariant observed or unobserved confounders that might differ between study arm&#xD;
      schools. Clustering by school will be accounted for by a generalized estimating equation&#xD;
      approach. Intention-to-treat (ITT) will be evaluated by including all girls in the evaluation&#xD;
      cohort assigned to each arm rather than all girls who actually participated in SKILLZ.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">February 1, 2020</start_date>
  <completion_date type="Anticipated">December 30, 2023</completion_date>
  <primary_completion_date type="Actual">December 31, 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>
    <intervention_model_description>Cluster randomised. Randomization at the school level defines a school as receiving arm one or arm two.</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of participants undergoing HIV testing within 12 months</measure>
    <time_frame>12 months</time_frame>
    <description>Number of participants, enrolled in the study, undergoing HIV testing (HIVST our Determine tests) over 1 year. Collected from facility testing registers and community testing registers.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of participants accessing SRH related prevention services within 12 months</measure>
    <time_frame>12 months</time_frame>
    <description>Number of participants, enrolled in the study, accessing contraception, PreP or PEP over 1 year. Determined through the electronic medical record and clinic registers.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The percentage of HIV infected participants being virally suppressed at 12 months</measure>
    <time_frame>12 months</time_frame>
    <description>The percentage of participants, testing HIV positive, who have an undetectable viral load (as defined by the laboratory doing the test) after one year on treatment. Collected from routine laboratory data.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The percentage of HIV infected participants retained in care at 3 months</measure>
    <time_frame>3 months</time_frame>
    <description>The percentage of participants, testing HIV positive, who are actively retained in care at 3 months ie are not more than 7 days late for a scheduled appointment. Determined using the electronic medical record.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The percentage of HIV infected participants retained in care at 6 months</measure>
    <time_frame>6 months</time_frame>
    <description>The percentage of participants, testing HIV positive, that have made their scheduled visit to the clinic within the first at 6 months of enrolment. (less than 7 days late), using the electronic medical record.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The percentage of HIV infected participants retained in care at 12 months</measure>
    <time_frame>12 months</time_frame>
    <description>The percentage of participants, testing HIV positive, who attend their scheduled visits within the first 12 months of enrolment (less than seven days late). determined through the electronic medical record.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Conduct a process evaluation to describe how the intervention worked</measure>
    <time_frame>12 months</time_frame>
    <description>FGD's, IDI's and routine program data ( attendance registers, process data and documented observations) will be used to identify mediators, predictors, and barriers to uptake of the SKILLZ package after implementation</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Average short-term costs for the program implementation based on net-costs for the intervention.</measure>
    <time_frame>Baseline through 12 months</time_frame>
    <description>Costs will include the personnel to manage the intervention, financial incentives and other related miscellaneous costs. These will be collected by the program manager and study team and will be based on actual costs.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Fidelity monitoring or adherence to the program as measured by the number of coaching sessions conducted per plan.</measure>
    <time_frame>Baseline through 12 months</time_frame>
    <description>Each session that is conducted will be documented including number of participants in attendance (assessed voia attendance registers and routine program data).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Identify barriers that prevent intervention participation</measure>
    <time_frame>Baseline through 12 months</time_frame>
    <description>Record and track key barriers through review of routine program data that prevent participants from engaging with the intervention. ie through review of the data collected by coaches from feedback from participants, FGD's and IDI's. During this COVID-19 period, we may be limited or may need to revise our anticipated collection of study results. The study record will reflect these changes as we navigate through the course of the study.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">1380</enrollment>
  <condition>HIV Infections</condition>
  <condition>Pregnancy Related</condition>
  <condition>STI</condition>
  <condition>Mental Health Wellness 1</condition>
  <arm_group>
    <arm_group_label>SOC Arm</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Standard of care (SOC): the sexual reproductive curriculum which is implemented by the schools as part of mandatory SRH education.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Enhanced Arm</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The SKILLZ-Girl Curriculum, plus the graduation event (including HIVST + access to family planning) and home based delivery of commodities with subsequent encouragement to be involved with SKILLZ-Clubs at their school</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>SKILLZ-Girl curriculum</intervention_name>
    <description>Participation in the SKILLZ-Girl curriculum and SKILLZ-Club</description>
    <arm_group_label>Enhanced Arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  The student is &gt;16 years of age prior to the first session of SKILLZ-Girl or the&#xD;
             student will turn 16 years of age before the last session of SKILLZ-Girl (ie prior to&#xD;
             the event)&#xD;
&#xD;
          -  Is enrolled in one of the SKILLZ STUDY schools&#xD;
&#xD;
          -  Is able to converse in and comprehend either Nyanja, English and/or Bemba&#xD;
&#xD;
          -  The Parent/Guardian of the participant has consented for the participant to take part&#xD;
             in the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  The student has a mental disability that would interfere with their ability to give&#xD;
             informed consent&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Carolyn Bolton, MPH, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>UAB/ CIDRZ</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Centre of Infectious Disease Research Zambia</name>
      <address>
        <city>Lusaka</city>
        <zip>10101</zip>
        <country>Zambia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Zambia</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>March 17, 2020</study_first_submitted>
  <study_first_submitted_qc>June 9, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <last_update_submitted>March 29, 2023</last_update_submitted>
  <last_update_submitted_qc>March 29, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 3, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Alabama at Birmingham</investigator_affiliation>
    <investigator_full_name>Carolyn Bolton</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Adolescents</keyword>
  <keyword>Zambia</keyword>
  <keyword>Football</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>HIV Infections</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>De-identified IPD will be shared via secure server to co-investigators</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_info_type>Analytic Code</ipd_info_type>
    <ipd_time_frame>Data will be shared with requisite co-investigators on a rolling basis in order to conduct interim analysis</ipd_time_frame>
    <ipd_access_criteria>Must be a co-investigator</ipd_access_criteria>
  </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>August 20, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/61/NCT04429061/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04429061
org study id: IRB-300002251
nct id: NCT04429061
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
"SKILLZ," is a mixed methods evaluation of the Grassroots Soccer (GRS) SKILLZ Package based
      in Lusaka, Zambia. The package is made up of three football-based programs: (1) SKILLZ-Girl -
      implemented in schools as part of a 10-week program culminating in a tournament event; (2)
      SKILLZ-Club - implemented as an ongoing extra-curricular activity after the completion of
      SKILLZ-Girl; (3) SKILLZ-Plus - a clinic based football group targeted at girls that are
      HIV-positive.

      The programs work together to build a continued support system which encourages uptake of
      Sexual Reproductive Health (SRH) and HIV services, while facilitating ART adherence (for
      HV-positive participants) and continued engagement with health services over the long-term
      (whether to contraceptive methods, HIV prevention services, HIV repeat testing, and/or HIV
      treatment and care).

      The study team has developed an enhanced SKILLZ-Girl offering, which will include a
      comprehensive module on HIVST, contraceptives and PrEP, access to a nurse during the
      implementation of sessions and the additional offering of HIVST and contraceptive services at
      the event along with ongoing engagement through the SKILLZ-Club program (Enhanced Arm) , The
      central hypothesis is that this enhanced curriculum will increase HIV testing and
      contraceptive uptake compared to the standard SKILLZ curriculum & standard event (SOC Arm).
      The investigators further hypothesize that the intervention in the enhanced arm will
      positively and directly affect a number of mediating factors including attendance at soccer
      events where community-based SRH services are offered, SRH knowledge, empowerment,
      self-confidence, and perceptions of gender balance, and (reduced) stigma.

      For girls found to be HIV-positive, the follow-on SKILLZ intervention (SKILLZ-Plus) has been
      designed to facilitate linkage to HIV care and treatment, reduce HIV-related stigma, increase
      disclosure to family and partners, increase feelings of social support, empowerment,
      self-efficacy, and ultimately adherence to ARVs, viral load suppression (VLS) and retention
      in HIV care and treatment.

      This study will be conducted in up to 32 secondary schools that GRS currently serves in the
      Lusaka Urban District.
Research aim(s)/General Objective and Specific Objectives Aim 1: (a) Assess the impact of
      SKILLZ over two years on HIV testing and (b) SRH-related prevention services uptake among
      adolescent girls aged 16-19 in up to 23 intervention schools (with enhanced HIVST, PrEP, and
      contraceptive method offerings) compared to up to 23 control schools using a
      quasi-experimental difference-in-difference approach; and

      Aim 1: (b) Describe linkage to care and treatment, and viral load suppression and retention
      at 6, 12, and 18 months for girls who are identified to be HIV+ during the study, using
      qualitative, programmatic, and administrative data.

      This will be achieved by i) using a quasi-experimental difference-in-difference approach that
      compares girls aged 16 and over in approximately 23 SKILLZ control schools compared to
      approximately 23 schools where SKILLZ will be delivered with the enhanced HIVST and a variety
      of contraceptive method offerings; and ii) through a cohort model using pre-existing
      SmartCare data on HIV+ individuals in care to match to adolescent girls aged 16 and over from
      the same district (Lusaka) who are identified to be HIV+ at any time during SKILLZ-Girl or
      SKILLZ-Club participation.

      Aim 2: Examine how the intervention works including lessons learned for future implementation
      by

        1. conducting a process evaluation to identify mediators, predictors, and barriers to
           uptake of the SKILLZ-Girl, Club, and Plus curricula both quantitatively through
           mediation and moderation analyses and qualitatively through a sequential explanatory
           approach using focus groups discussions, interviews and observation with coaches and
           girls; and by

        2. monitoring fidelity

      Aim 3: Estimate the short- and long-term cost-effectiveness and return on investment of the
      SKILLZ Girl, Club, and Plus curricula for improving health outcomes for adolescent girls.

      This is a mixed-methods evaluation of the SKILLZ intervention using the following approaches:

      A quasi-experimental cohort of school-aged 16-year-old and over females to be followed for a
      period of 18 month will be evaluated with a difference-in-difference (DID) approach to
      estimate HIV testing uptake and sexual/reproductive health services use. Primary and
      secondary outcomes will be measured at several timepoints longitudinally across up to 23
      schools offering the SKILLZ-Girl and SKILLZ-Clubs program and up to 23 schools offering the
      "standard of care" (SOC) and SOC Clubs. Recruitment is anticipated to take 6 months on a
      rolling basis. The order in which schools will be selected will be random. Participants will
      be clustered at the school-level; a random sample of girls will be enrolled from each
      participating school, aged 16-years at the commencement of SKILLZ-Girl and who are in a grade
      where GRS is offering the SKILLZ-Girl curriculum All enrolled girls will be followed over the
      18 months' time period to assess SRH service uptake, including HIV testing. It is estimated
      that the majority (~98%) of girls testing for HIV will likely be HIV-negative, based on
      estimates from programmatic GRS data. While HIV-positive girls will continue to participate
      in the school-based SKILLZ-Girl and Clubs activities and followed for SRH use, they will also
      be offered contemporaneous enrolment into SKILLZ-Plus upon infection; retention in care and
      Viral Load Suppression (VLS) at 6, 12, and 18 months will be measured for this subset.

      Process evaluation: A process evaluation will be conducted to better understand the casual
      pathways and effect mediators and moderators using mixed methods approaches, including
      supplemental qualitative data collection. To investigate reasons why the program components
      (SKILLZ-Girl, Club & Plus) might fail or succeed in different schools or communities and
      assess intervention effect mediators and moderators for HIV testing and contraceptive use
      uptake we will use a mixed methods approach involving: (1) quantitative analyses of baseline
      survey data for testing how variables can moderate the observed impact of the intervention,
      and (2) qualitative data collected from a subset of SKILLZ participants in the evaluation
      cohort and their coaches to further understand potential mediating pathways.

      Fidelity monitoring: The study includes measures to monitor fidelity of the intervention
      implementation, including receptivity to and understanding of the intervention amongst
      participants, the perceived appropriateness and relevancy of the intervention for adolescent
      girls in school, and the extent to which the intervention was delivered per protocol in
      different communities and schools.

      Economic evaluation: Time permitting (given the uncertainty of delays due to COVID), the
      study will estimate the short- and long-term cost-effectiveness and return on investment of
      SKILLZ for improving health outcomes for adolescent girls.

      Data collection plan and tools SmartCare electronic data: All antiretroviral therapy services
      offered as part of the study will be captured in the National EMR, SmartCare, which permits
      measuring of utilization and clinical outcomes (i.e., Linkage to Care, VLS) at soccer events,
      mobile clinics, and public clinics in Lusaka. VLS is defined as below detection, i.e., less
      than 50 copies/ml. Retention in care will also be measured using SmartCare data on pharmacy
      visits and defined as accessing pharmacy within a 90-day window of visits. Consent will be
      requested from all participants as part of the consent process to access their SmartCare
      records.

      Youth-Friendly services electronic data: Depending on the location of the school, the girl's
      residential address and/or her own personal preferences, participants will be referred to
      either the PEPFAR Funded DREAMS houses or the M.A.C. funded youth-friendly spaces based in
      local MOH clinics in order to access ongoing SRH services not provided by the coaches in
      their CBD role (this will include accessing PrEP, STI testing and long-term contraceptive
      methods). All interactions with the DREAMS houses or M.A.C centres (including meeting with
      counsellors, referral and uptake of services) are captured in their respective electronic
      databases. Consent will be requested from all participants as part of the consent process to
      allow researchers to access either DREAMS or M.A.C data should they chose to access either of
      these services.

      Survey at baseline: A baseline survey will be administered to approximately 50 girls per
      school randomly selected to participate in the evaluation to collect information on school
      characteristics, sexual behaviour, age, HIV knowledge, maternal education, baseline HIV
      status, and sexual/reproductive health uptake and retention. These variables will be used as
      covariates and moderators for service uptake and retention. The target sample of
      approximately 1380 girls will respond to a survey self-administered using ODk software upon
      informed consent. The survey will be available in English, Nyanja and Bemba. Coaches and
      study staff will on site be help girls navigate the survey. If during baseline, it appears
      that there has been sufficient time to measure change, or the full SKILLZ-Girl curriculum was
      not administered, the baseline survey may be re-administered to assist with validation of
      responses (as opposed to implementing the follow-up survey provided below).

      Survey post-SKILLZ-Girl event, 6-, 12-, and 18 months: A total of approximately 30 girls per
      school (regardless of HIV status) will respond to a ODK survey to collect information on
      sexual behaviour, HIV knowledge, maternal education, sexual/reproductive health uptake and
      retention. Post-SKILLZ-Girl survey data will be used to assess the effect of SKILLS Girl and
      SKILLZ-Club on the outcomes of interest. In schools selected to offer SKILLZ-Club, surveys
      will be conducted during club attendance approximately 6 months after the SKILLZ-Girl
      community soccer event. Surveys will be completed individually by the participant on a secure
      tablet physically or via phone. Study staff will be available to assist participants to
      navigate the survey if they request assistance. If a participant has opted to not attend the
      clubs or has since left or changed schools, the coaches and study staff will attempt to trace
      participants in the community in order to complete the follow-up survey.

      Where a participant is contacted for follow-up and it is discovered that she has left Lusaka,
      Chilanga, Chongwe and Kafue districts and it is not possible for study staff to arrange a
      visit to meet with her, a personalized survey link will be sent to her via email or WhatsApp
      (based on the participant's preference). She will then be invited to complete and submit the
      survey online. Alternatively, if the participant prefers study staff will complete the survey
      with the participant over the phone and enter their responses directly into ODK.

      In the schools selected not to offer SKILLZ-Club, GRS will arrange for a 2-hour meeting
      session with all participants still enrolled at that school, where all participants will
      complete the surveys. If a participant opts to not attend the meeting or has since left or
      changed schools, the coaches and study staff will attempt to trace participants in the
      community in order to complete the follow-up survey.

      Data management and storage

      Quantitative:

      Individual-level data will be collected on clinical, laboratory, and demographic
      characteristics, including retention in care and VLS at 6, 12 and 24 months. Using case
      reporting forms (CRFs), the team will collect study-specific data, including information
      obtained directly from participants, routine programmatic data from GRS and abstract routine
      clinical data from paper-based medical records, the SmartCare Electronic Management Records
      (EMR), CIDRZ Laboratory Information Management System (LIMS) and DREAMS electronic management
      system. Routinely collected individual-level clinical data are first written onto forms in
      the paper medical record and then entered into the SmartCare EMR. SmartCare serves as a
      repository of clinical data for HIV-infected individuals and includes such data fields as:
      ART initiation date, ART regimen, visit dates, and laboratory data.

      GRS will collect programmatic data through a combination of paper and electronic data entry
      via tablets, with all data stored securely in RedCap. Where paper files are used for
      programmatic management, data will be manually entered by study staff directly into the
      RedCap database. De-identified data will made available to GRS co-investigators to enable
      review of key fidelity and quality indicators in order to monitor implementation in real
      time.

      All paper study files will be stored in secured, locked cabinets located in locked rooms
      available to study staff only. A secure server will be used to store encrypted study data,
      including the study database. All personal identifiers will be removed prior to generating
      the analytical dataset.

      Qualitative:

      All data will be obtained using digital audio recorders. Recorded data will be transferred on
      to a lockable computer kept by the co-principal investigator leading the qualitative
      research. Transcripts will go through a QA/QC process where researchers will cross check
      randomly selected transcribed verbatim with the recordings.

      Data analysis plan The primary outcome is the probability of testing for HIV at any time
      during the period when SKILLZ is delivered through to 24 months after the final soccer event.
      The primary analysis for Aim 1 will follow a difference-in-difference (DID) effect between
      study arms. The outcome of interest will be regressed on an indicator of study arm assignment
      interacted with a dichotomous variable POST which indicates the outcome after the
      intervention is implemented; this differentiates baseline and end-line for each study arm,
      controls for any time dependent variables that might confound the effect, as well as any
      time-invariant observed or unobserved confounders that might differ between study arm
      schools. Clustering by school will be accounted for by a generalized estimating equation
      approach. Intention-to-treat (ITT) will be evaluated by including all girls in the evaluation
      cohort assigned to each arm rather than all girls who actually participated in SKILLZ.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Cluster randomised. Randomization at the school level defines a school as receiving arm one or arm two.
primary purpose: Supportive Care
masking: None (Open Label)
measure: Number of participants undergoing HIV testing within 12 months
time frame: 12 months
description: Number of participants, enrolled in the study, undergoing HIV testing (HIVST our Determine tests) over 1 year. Collected from facility testing registers and community testing registers.
measure: Number of participants accessing SRH related prevention services within 12 months
time frame: 12 months
description: Number of participants, enrolled in the study, accessing contraception, PreP or PEP over 1 year. Determined through the electronic medical record and clinic registers.
measure: The percentage of HIV infected participants being virally suppressed at 12 months
time frame: 12 months
description: The percentage of participants, testing HIV positive, who have an undetectable viral load (as defined by the laboratory doing the test) after one year on treatment. Collected from routine laboratory data.
measure: The percentage of HIV infected participants retained in care at 3 months
time frame: 3 months
description: The percentage of participants, testing HIV positive, who are actively retained in care at 3 months ie are not more than 7 days late for a scheduled appointment. Determined using the electronic medical record.
measure: The percentage of HIV infected participants retained in care at 6 months
time frame: 6 months
description: The percentage of participants, testing HIV positive, that have made their scheduled visit to the clinic within the first at 6 months of enrolment. (less than 7 days late), using the electronic medical record.
measure: The percentage of HIV infected participants retained in care at 12 months
time frame: 12 months
description: The percentage of participants, testing HIV positive, who attend their scheduled visits within the first 12 months of enrolment (less than seven days late). determined through the electronic medical record.
measure: Conduct a process evaluation to describe how the intervention worked
time frame: 12 months
description: FGD's, IDI's and routine program data ( attendance registers, process data and documented observations) will be used to identify mediators, predictors, and barriers to uptake of the SKILLZ package after implementation
measure: Average short-term costs for the program implementation based on net-costs for the intervention.
time frame: Baseline through 12 months
description: Costs will include the personnel to manage the intervention, financial incentives and other related miscellaneous costs. These will be collected by the program manager and study team and will be based on actual costs.
measure: Fidelity monitoring or adherence to the program as measured by the number of coaching sessions conducted per plan.
time frame: Baseline through 12 months
description: Each session that is conducted will be documented including number of participants in attendance (assessed voia attendance registers and routine program data).
measure: Identify barriers that prevent intervention participation
time frame: Baseline through 12 months
description: Record and track key barriers through review of routine program data that prevent participants from engaging with the intervention. ie through review of the data collected by coaches from feedback from participants, FGD's and IDI's. During this COVID-19 period, we may be limited or may need to revise our anticipated collection of study results. The study record will reflect these changes as we navigate through the course of the study.
arm group label: SOC Arm
arm group type: No Intervention
description: Standard of care (SOC): the sexual reproductive curriculum which is implemented by the schools as part of mandatory SRH education.
arm group label: Enhanced Arm
arm group type: Active Comparator
description: The SKILLZ-Girl Curriculum, plus the graduation event (including HIVST + access to family planning) and home based delivery of commodities with subsequent encouragement to be involved with SKILLZ-Clubs at their school
intervention type: Behavioral
intervention name: SKILLZ-Girl curriculum
description: Participation in the SKILLZ-Girl curriculum and SKILLZ-Club
arm group label: Enhanced Arm
criteria: 
gender: Female
minimum age: 16 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Carolyn Bolton, MPH, MD
role: Principal Investigator
affiliation: UAB/ CIDRZ
facility: 
country: Zambia
responsible party type: Principal Investigator
investigator affiliation: University of Alabama at Birmingham
investigator full name: Carolyn Bolton
investigator title: Principal Investigator
mesh term: HIV Infections
sharing ipd: Yes
ipd description: De-identified IPD will be shared via secure server to co-investigators
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd info type: Analytic Code
ipd time frame: Data will be shared with requisite co-investigators on a rolling basis in order to conduct interim analysis
ipd access criteria: Must be a co-investigator
provided document: 