xml: <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/NCT05967208</url>
    </required_header>
    <id_info>
      <org_study_id>Pro00120208</org_study_id>
      <nct_id>NCT05967208</nct_id>
    </id_info>
    <brief_title>Confidential Social Network Referrals for HIV Testing</brief_title>
    <acronym>CONSORT</acronym>
    <official_title>Confidential Social Network Referrals for HIV Testing</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of South Carolina</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Duke University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Kilimanjaro Christian Medical Centre, Tanzania</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>University of South Carolina</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>
        Despite worldwide efforts to promote HIV testing, rates of testing remain low. The purpose of&#xD;
        this study is to evaluate the acceptability, efficacy, and cost-effectiveness of confidential&#xD;
        SMS-based social network referrals for HIV testing as a means of reaching high-risk&#xD;
        individuals and prompting them to test for HIV. To accomplish this purpose, the study has 5&#xD;
        specific aims:&#xD;
  &#xD;
        Aim 1 will conduct qualitative, formative work to identify desirable provider- and&#xD;
        client-side characteristics of a confidential SMS-based HIV testing referral system.&#xD;
  &#xD;
        Aim 2 will adapt an existing mHealth system (mParis) to add CONSORT functionality.&#xD;
  &#xD;
        Aim 3 will pilot-test the CONSORT system to collect preliminary data on the system's&#xD;
        acceptability, performance, and potential efficacy.&#xD;
  &#xD;
        Aim 4 will evaluate the acceptability and efficacy of CONSORT in a randomized controlled&#xD;
        trial.&#xD;
  &#xD;
        Aim 5 will evaluate the incremental cost-effectiveness of CONSORT vs. other referral options.&#xD;
  &#xD;
        If CONSORT is shown to be acceptable, effective, and cost-effective, such mobile-phone&#xD;
        supported, chain-referral methods could greatly improve the cost-effectiveness of HIV testing&#xD;
        efforts.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        No additional detail available&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">May 1, 2025</start_date>
    <completion_date type="Anticipated">April 1, 2027</completion_date>
    <primary_completion_date type="Anticipated">October 1, 2026</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Health Services Research</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Uptake of HIV testing</measure>
      <time_frame>Within 30 days of the time of the testing offer</time_frame>
      <description>The number of referred clients presenting for HIV testing at participating study sites within 30 days of the testing offer, per 100 index clients.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">600</enrollment>
    <condition>HIV</condition>
    <arm_group>
      <arm_group_label>CONSORT referrals + Card referrals</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Intervention arm</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Card referrals alone</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Control arm</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>CONSORT referrals</intervention_name>
      <description>Participants will be offered SMS-based confidential social network referrals for HIV testing (&quot;CONSORT referrals&quot;) to extend to any of their social and sexual network contacts.</description>
      <arm_group_label>CONSORT referrals + Card referrals</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Card referrals</intervention_name>
      <description>Participants will be offered physical invitation cards (&quot;card referrals&quot;) to extend to any of their social and sexual network contacts.</description>
      <arm_group_label>CONSORT referrals + Card referrals</arm_group_label>
      <arm_group_label>Card referrals alone</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion criteria:&#xD;
  &#xD;
            -  at least 18 years old&#xD;
  &#xD;
            -  live, work, or regularly receive care in Moshi, Tanzania&#xD;
  &#xD;
            -  literate&#xD;
  &#xD;
          Exclusion criteria:&#xD;
  &#xD;
            -  under age 18 years&#xD;
  &#xD;
            -  does not live, work, or regularly receive care in Moshi, Tanzania&#xD;
  &#xD;
            -  illiterate&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Jan Ostermann, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of South Carolina</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Nathan Thielman, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Duke University</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Bernard Njau, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Kilimanjaro Christian Medical Centre, Tanzania</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Jan Ostermann, PhD</last_name>
      <phone>+1-803-777-8747</phone>
      <email>jano@mailbox.sc.edu</email>
    </overall_contact>
    <reference>
      <citation>Ostermann J, Njau B, Masaki M, Mtuy T, Itemba D, Hobbie A, Yelverton V, Moore S, Yamanis T, Thielman NM. Feasibility, Acceptability, and Potential Cost-Effectiveness of a Novel Mobile Phone Intervention to Promote Human Immunodeficiency Virus Testing Within Social Networks in Tanzania. Sex Transm Dis. 2022 Nov 1;49(11):778-781. doi: 10.1097/OLQ.0000000000001611. Epub 2022 Jan 29.</citation>
      <PMID>35093981</PMID>
    </reference>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>January 26, 2023</study_first_submitted>
    <study_first_submitted_qc>July 25, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>July 25, 2023</last_update_submitted>
    <last_update_submitted_qc>July 25, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of South Carolina</investigator_affiliation>
      <investigator_full_name>Jan Ostermann</investigator_full_name>
      <investigator_title>Associate Professor</investigator_title>
    </responsible_party>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>All investigators are committed to managing and distributing original data and results to enable subsequent availability to the scientific community, policy makers, and other stakeholders. Final research data including metadata and descriptors may be made available after publication of study findings through a CONSORT data repository. Researchers may access data by request to the Principal Investigators. Access will be provided subject to Tanzanian and US rules, laws, regulations and policies and consistent with institutional review board approvals and consent documents. If conditions prevent making some data elements available (e.g., third party data), relevant publications and presentations will be provided.</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_info_type>Analytic Code</ipd_info_type>
      <ipd_time_frame>After publication of study findings</ipd_time_frame>
      <ipd_access_criteria>Access will be provided subject to Tanzanian and US rules, laws, regulations and policies and consistent with institutional review board approvals and consent documents. If conditions prevent making some data elements available (e.g., third party data), relevant publications and presentations will be provided.</ipd_access_criteria>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05967208
  org study id: Pro00120208
  nct id: NCT05967208
  lead sponsor: 
  collaborator: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Despite worldwide efforts to promote HIV testing, rates of testing remain low. The purpose of
        this study is to evaluate the acceptability, efficacy, and cost-effectiveness of confidential
        SMS-based social network referrals for HIV testing as a means of reaching high-risk
        individuals and prompting them to test for HIV. To accomplish this purpose, the study has 5
        specific aims:
  
        Aim 1 will conduct qualitative, formative work to identify desirable provider- and
        client-side characteristics of a confidential SMS-based HIV testing referral system.
  
        Aim 2 will adapt an existing mHealth system (mParis) to add CONSORT functionality.
  
        Aim 3 will pilot-test the CONSORT system to collect preliminary data on the system's
        acceptability, performance, and potential efficacy.
  
        Aim 4 will evaluate the acceptability and efficacy of CONSORT in a randomized controlled
        trial.
  
        Aim 5 will evaluate the incremental cost-effectiveness of CONSORT vs. other referral options.
  
        If CONSORT is shown to be acceptable, effective, and cost-effective, such mobile-phone
        supported, chain-referral methods could greatly improve the cost-effectiveness of HIV testing
        efforts.
  No additional detail available
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Health Services Research
  masking: None (Open Label)
  measure: Uptake of HIV testing
  time frame: Within 30 days of the time of the testing offer
  description: The number of referred clients presenting for HIV testing at participating study sites within 30 days of the testing offer, per 100 index clients.
  arm group label: CONSORT referrals + Card referrals
  arm group type: Experimental
  description: Intervention arm
  arm group label: Card referrals alone
  arm group type: Active Comparator
  description: Control arm
  intervention type: Behavioral
  intervention name: CONSORT referrals
  description: Participants will be offered SMS-based confidential social network referrals for HIV testing ("CONSORT referrals") to extend to any of their social and sexual network contacts.
  arm group label: CONSORT referrals + Card referrals
  intervention type: Behavioral
  intervention name: Card referrals
  description: Participants will be offered physical invitation cards ("card referrals") to extend to any of their social and sexual network contacts.
  arm group label: CONSORT referrals + Card referrals
  arm group label: Card referrals alone
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Jan Ostermann, PhD
  role: Principal Investigator
  affiliation: University of South Carolina
  last name: Nathan Thielman, MD
  role: Principal Investigator
  affiliation: Duke University
  last name: Bernard Njau, PhD
  role: Principal Investigator
  affiliation: Kilimanjaro Christian Medical Centre, Tanzania
  last name: Jan Ostermann, PhD
  phone: +1-803-777-8747
  email: jano@mailbox.sc.edu
  citation: Ostermann J, Njau B, Masaki M, Mtuy T, Itemba D, Hobbie A, Yelverton V, Moore S, Yamanis T, Thielman NM. Feasibility, Acceptability, and Potential Cost-Effectiveness of a Novel Mobile Phone Intervention to Promote Human Immunodeficiency Virus Testing Within Social Networks in Tanzania. Sex Transm Dis. 2022 Nov 1;49(11):778-781. doi: 10.1097/OLQ.0000000000001611. Epub 2022 Jan 29.
  PMID: 35093981
  responsible party type: Principal Investigator
  investigator affiliation: University of South Carolina
  investigator full name: Jan Ostermann
  investigator title: Associate Professor
  sharing ipd: Yes
  ipd description: All investigators are committed to managing and distributing original data and results to enable subsequent availability to the scientific community, policy makers, and other stakeholders. Final research data including metadata and descriptors may be made available after publication of study findings through a CONSORT data repository. Researchers may access data by request to the Principal Investigators. Access will be provided subject to Tanzanian and US rules, laws, regulations and policies and consistent with institutional review board approvals and consent documents. If conditions prevent making some data elements available (e.g., third party data), relevant publications and presentations will be provided.
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd info type: Analytic Code
  ipd time frame: After publication of study findings
  ipd access criteria: Access will be provided subject to Tanzanian and US rules, laws, regulations and policies and consistent with institutional review board approvals and consent documents. If conditions prevent making some data elements available (e.g., third party data), relevant publications and presentations will be provided.