<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/NCT03808194</url>
  </required_header>
  <id_info>
    <org_study_id>STUDY00000036</org_study_id>
    <secondary_id>5R21MH110026</secondary_id>
    <nct_id>NCT03808194</nct_id>
  </id_info>
  <brief_title>Lotto to Link Study: A Prospective, Interventional, Randomized Study of Conditional Incentives</brief_title>
  <official_title>The Lotto to Link Study: A Prospective, Interventional, Randomized Study of Conditional Incentives to Engage HIV-positive Men in HIV Care in KwaZulu-Natal, South Africa</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Washington</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of Mental Health (NIMH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Washington</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>
      In this study the investigators will adapt and strengthen, test effectiveness, and explore&#xD;
      implementation of conditional lottery incentive linkage strategies to engage men in HIV care&#xD;
      and ART in KwaZulu-Natal, South Africa.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Of the 2.6 million South Africans on antiretroviral therapy (ART)1 only a third are men,&#xD;
      despite men making up 45% of HIV-positive persons.2 HIV-positive men are underrepresented&#xD;
      throughout the HIV prevention and care continuum, being less likely to test, link to care,&#xD;
      initiate ART, and more likely to be lost to follow-up. Few strategies have focused on men,&#xD;
      and when they have they have not been successful. Even with community-based HIV testing,&#xD;
      referral, text message reminders, and lay-counselor support (an optimized testing and linkage&#xD;
      to care package), doctors are only able to achieve 60% linkage to HIV care and ART among men.&#xD;
      HIV-positive men who are not in care are at risk for HIV-associated morbidity and mortality,&#xD;
      and their HIV-negative partners are at risk of HIV acquisition. Innovative strategies are&#xD;
      needed to motivate HIV-positive men to engage in care, and specifically to initiate and&#xD;
      adhere to ART.&#xD;
&#xD;
      Introducing a gamble, the chance of winning a lottery, into linkage to HIV care interventions&#xD;
      could make engagement in care more attractive to men. Men are often risk-takers and linking&#xD;
      to care successfully is a gamble: start ART vs. risk no ART. A lottery incentive strategy has&#xD;
      been successfully used to increase uptake of HIV prevention; in one recent example, lottery&#xD;
      incentives, conditioned on being STI (sexually transmitted infection) negative, decreased HIV&#xD;
      incidence by 60% among 'risk-loving' individuals in Lesotho, demonstrating one of the largest&#xD;
      effects to date of a behavioral intervention for HIV prevention. Given this prevention&#xD;
      success, the investigators hypothesize that lottery incentives have the potential to overcome&#xD;
      both structural and behavioral factors for linking HIV positive men to care, addressing&#xD;
      logistical challenges and risk preferences specific to men. For scale-up and implementation,&#xD;
      the investigators need to sculpt the content of lottery incentive strategies as well as the&#xD;
      approach to identify men not in care for whom lottery incentives are likely to work.&#xD;
&#xD;
      In this study the investigators will adapt and strengthen, test effectiveness, and explore&#xD;
      implementation of conditional lottery incentive linkage strategies to engage men in HIV care&#xD;
      and ART in KwaZulu-Natal, South Africa (the Lotto to Link Study). With the investigators&#xD;
      experienced, multi-disciplinary team, the investigators have drawn on their previous&#xD;
      successful community-based counseling and testing and linkage to prevention and care work to&#xD;
      strengthen linkage strategies for HIV-positive ART eligible men who are not in care.&#xD;
&#xD;
      The investigators will do 1) qualitative interviews to inform the study design, 2) conduct an&#xD;
      individual randomized study of conditional lottery incentives compared to an optimized&#xD;
      linkage package for HIV-positive men, and 3) finally, estimate the costs associated with&#xD;
      conditional incentives and retention in care.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 26, 2017</start_date>
  <completion_date type="Actual">January 31, 2019</completion_date>
  <primary_completion_date type="Actual">November 30, 2018</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>HIV-positive men who meet the study eligibility criteria will be randomized to one of two study arms: 1) Optimized ART linkage package, or 2) Optimized ART linkage package + conditional lottery incentive.</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of men virally suppressed after 6 months</measure>
    <time_frame>6 months</time_frame>
    <description>Conditional lottery incentives, above and beyond an optimized linkage package, will increase the uptake of clinic visits, ART initiation, and viral suppression among HIV-positive men not yet in care.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of men who have a positive alcohol or drug test</measure>
    <time_frame>6 months</time_frame>
    <description>Men who currently use drugs, consume more than the recommended amount of alcohol on an ongoing basis, or report depression and anxiety are less likely to link to care, stay retained in care, and achieve virologic suppression.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">132</enrollment>
  <condition>Incentives</condition>
  <condition>HIV Infections</condition>
  <condition>ART</condition>
  <arm_group>
    <arm_group_label>Optimized ART linkage package</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants in this arm will receive a clinic referral card and text messages to support linkage to ART.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Conditional lottery incentive</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants in this arm will receive a clinic referral card and text messages to support linkage to ART and will be entered into a lottery each time they meet the following conditions: visited the clinic by month 1, initiated treatment by month 3, and achieved viral suppression by month 6</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Conditional lottery incentive</intervention_name>
    <description>Participants in the lottery incentive arm must fulfill the following criteria to be entered into the lottery. Participants must visit the clinic by month 1, initiate ART by month 3 and achieve viral suppression by month 6. Participants in this arm will be eligible to win the lottery.</description>
    <arm_group_label>Conditional lottery incentive</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Optimized ART linkage package</intervention_name>
    <description>Optimized ART linkage package</description>
    <arm_group_label>Optimized ART linkage package</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Reside in the study community for the duration of follow-up&#xD;
&#xD;
          -  Must be 18 years or older&#xD;
&#xD;
          -  Able and willing to provide informed consent for study procedures&#xD;
&#xD;
          -  HIV-positive men must be eligible for ART by national guidelines and not on ART&#xD;
&#xD;
          -  Access to confidential text messaging&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        • There are no separate exclusion criteria&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ruanne V Barnabas, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Washington</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>HSRC Sweetwaters</name>
      <address>
        <city>Sweetwaters</city>
        <state>Kwa-Zulu Natal</state>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>South Africa</country>
  </location_countries>
  <verification_date>May 2019</verification_date>
  <study_first_submitted>January 3, 2019</study_first_submitted>
  <study_first_submitted_qc>January 16, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 17, 2019</study_first_posted>
  <last_update_submitted>May 28, 2019</last_update_submitted>
  <last_update_submitted_qc>May 28, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">May 30, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Washington</investigator_affiliation>
    <investigator_full_name>Ruanne Barnabas</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <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>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03808194
org study id: STUDY00000036
secondary id: 5R21MH110026
nct id: NCT03808194
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
In this study the investigators will adapt and strengthen, test effectiveness, and explore
      implementation of conditional lottery incentive linkage strategies to engage men in HIV care
      and ART in KwaZulu-Natal, South Africa.
Of the 2.6 million South Africans on antiretroviral therapy (ART)1 only a third are men,
      despite men making up 45% of HIV-positive persons.2 HIV-positive men are underrepresented
      throughout the HIV prevention and care continuum, being less likely to test, link to care,
      initiate ART, and more likely to be lost to follow-up. Few strategies have focused on men,
      and when they have they have not been successful. Even with community-based HIV testing,
      referral, text message reminders, and lay-counselor support (an optimized testing and linkage
      to care package), doctors are only able to achieve 60% linkage to HIV care and ART among men.
      HIV-positive men who are not in care are at risk for HIV-associated morbidity and mortality,
      and their HIV-negative partners are at risk of HIV acquisition. Innovative strategies are
      needed to motivate HIV-positive men to engage in care, and specifically to initiate and
      adhere to ART.

      Introducing a gamble, the chance of winning a lottery, into linkage to HIV care interventions
      could make engagement in care more attractive to men. Men are often risk-takers and linking
      to care successfully is a gamble: start ART vs. risk no ART. A lottery incentive strategy has
      been successfully used to increase uptake of HIV prevention; in one recent example, lottery
      incentives, conditioned on being STI (sexually transmitted infection) negative, decreased HIV
      incidence by 60% among 'risk-loving' individuals in Lesotho, demonstrating one of the largest
      effects to date of a behavioral intervention for HIV prevention. Given this prevention
      success, the investigators hypothesize that lottery incentives have the potential to overcome
      both structural and behavioral factors for linking HIV positive men to care, addressing
      logistical challenges and risk preferences specific to men. For scale-up and implementation,
      the investigators need to sculpt the content of lottery incentive strategies as well as the
      approach to identify men not in care for whom lottery incentives are likely to work.

      In this study the investigators will adapt and strengthen, test effectiveness, and explore
      implementation of conditional lottery incentive linkage strategies to engage men in HIV care
      and ART in KwaZulu-Natal, South Africa (the Lotto to Link Study). With the investigators
      experienced, multi-disciplinary team, the investigators have drawn on their previous
      successful community-based counseling and testing and linkage to prevention and care work to
      strengthen linkage strategies for HIV-positive ART eligible men who are not in care.

      The investigators will do 1) qualitative interviews to inform the study design, 2) conduct an
      individual randomized study of conditional lottery incentives compared to an optimized
      linkage package for HIV-positive men, and 3) finally, estimate the costs associated with
      conditional incentives and retention in care.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: HIV-positive men who meet the study eligibility criteria will be randomized to one of two study arms: 1) Optimized ART linkage package, or 2) Optimized ART linkage package + conditional lottery incentive.
primary purpose: Other
masking: Triple (Participant, Care Provider, Investigator)
measure: Number of men virally suppressed after 6 months
time frame: 6 months
description: Conditional lottery incentives, above and beyond an optimized linkage package, will increase the uptake of clinic visits, ART initiation, and viral suppression among HIV-positive men not yet in care.
measure: Number of men who have a positive alcohol or drug test
time frame: 6 months
description: Men who currently use drugs, consume more than the recommended amount of alcohol on an ongoing basis, or report depression and anxiety are less likely to link to care, stay retained in care, and achieve virologic suppression.
arm group label: Optimized ART linkage package
arm group type: Active Comparator
description: Participants in this arm will receive a clinic referral card and text messages to support linkage to ART.
arm group label: Conditional lottery incentive
arm group type: Experimental
description: Participants in this arm will receive a clinic referral card and text messages to support linkage to ART and will be entered into a lottery each time they meet the following conditions: visited the clinic by month 1, initiated treatment by month 3, and achieved viral suppression by month 6
intervention type: Other
intervention name: Conditional lottery incentive
description: Participants in the lottery incentive arm must fulfill the following criteria to be entered into the lottery. Participants must visit the clinic by month 1, initiate ART by month 3 and achieve viral suppression by month 6. Participants in this arm will be eligible to win the lottery.
arm group label: Conditional lottery incentive
intervention type: Other
intervention name: Optimized ART linkage package
description: Optimized ART linkage package
arm group label: Optimized ART linkage package
criteria: 
gender: Male
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Ruanne V Barnabas, MD
role: Principal Investigator
affiliation: University of Washington
facility: 
country: South Africa
responsible party type: Principal Investigator
investigator affiliation: University of Washington
investigator full name: Ruanne Barnabas
investigator title: Associate Professor
mesh term: HIV Infections
sharing ipd: No