<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/NCT03795415</url>
  </required_header>
  <id_info>
    <org_study_id>ANRS12373</org_study_id>
    <nct_id>NCT03795415</nct_id>
  </id_info>
  <brief_title>ANRS12373 GUNDO SO - Evaluation of an Empowerment Program for WLHIV in Mali</brief_title>
  <official_title>Evaluation of the Short- and Mid-term Effects of an Empowerment Program Focused on Serostatus Disclosure Management for Women Living With HIV in Mali</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>ANRS, Emerging Infectious Diseases</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Fondation de France</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Aix Marseille Université</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Université du Québec a Montréal</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Centre Population et Développement (CEPED), Paris, France</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>ARCAD-SIDA MALI</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Groupe de Recherche en Psychologie Sociale (GRePS), Bron, France</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Coalition Plus, France</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>ANRS, Emerging Infectious Diseases</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>
      The objective of this research is to measure the short- and mid-term effects of an&#xD;
      empowerment program focused on serostatus disclosure management for women living with HIV&#xD;
      (WLHIV) in Mali on the &quot;burden of secrecy&quot;.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Serostatus disclosure is a critical issue for persons living with HIV (PLHIV). Studies&#xD;
      identified numerous benefits associated with disclosure, but various negative consequences&#xD;
      have also been documented. Gender inequality must be taken into account regarding the&#xD;
      disclosure issue, in particular in Mali, where women are economically dependent and have a&#xD;
      low decision-making power. Moreover, in Mali, since 2006, PLHIV have a legal obligation to&#xD;
      disclose their serostatus to their spouse and sexual partner(s) &quot; as soon as possible, or&#xD;
      within 6 weeks &quot; after the diagnosis. Although this law is not enforced, it highlights the&#xD;
      sensitive nature of the serostatus disclosure issue and raise concerns among PLHIV and other&#xD;
      stakeholders.&#xD;
&#xD;
      To support women living with HIV (WLHIV), an empowerment program (Gundo-So) was implemented&#xD;
      by ARCAD-SIDA in Mali, in collaboration with several partners. This program aims to empower&#xD;
      WLHIV, so that they can make informed decision about disclosing or keeping their serostatus&#xD;
      secret in their various life contexts, and that they can identify strategies to disclose or&#xD;
      to keep the secret, as well as to manage potential negative reactions. Gundo-So (&quot;The room of&#xD;
      confidences&quot;) was adapted from a program established in quebec and has been implemented in&#xD;
      Mali.&#xD;
&#xD;
      The objective of this research is to measure the short- and mid-term effects of an&#xD;
      empowerment program focused on serostatus disclosure management for women living with HIV&#xD;
      (WLHIV) in Mali on the &quot;burden of secrecy&quot;.&#xD;
&#xD;
      The evaluation of the effects of the Gundo-So program will be helpful to assess the relevance&#xD;
      of a national or subregional extension of the program, or even an adaptation to other target&#xD;
      populations (e.g. heterosexual men and men who have sex with men living with HIV).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">May 27, 2019</start_date>
  <completion_date type="Anticipated">May 2021</completion_date>
  <primary_completion_date type="Anticipated">February 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Short term evaluation of the burden associated with the disclosure issue using questionnaires</measure>
    <time_frame>The short term effect will be measured at the end of the intervention and compared between Group 1 and 2. Up to 6 months from the beginning of the randomization to the end of the intervention</time_frame>
    <description>Improvement of the management of the sharing of the serological status. Empowerment in sharing the HIV status (questionnaire)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Short term evaluation of the burden associated with the secrecy issue using questionnaires</measure>
    <time_frame>The short term effect will be measured at the end of the intervention and compared between Group 1 and 2. Up to 6 months from the beginning of the randomization to the end of the intervention</time_frame>
    <description>Improvement of the management of the secret of the serological status. Empowerment in keeping secret the HIV status (questionnaire)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mid term evaluation of the burden associated with the disclosure issue using questionnaires</measure>
    <time_frame>The mid term effect will be measured 9 months after the intervention : up to 9 months after the intervention</time_frame>
    <description>Improvement of the management of the sharing of the serological status. Empowerment in sharing the HIV status (questionnaire)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mid term evaluation of the burden associated with the secrecy issue using questionnaires</measure>
    <time_frame>The mid term effect will be measured 9 months after the intervention : up to 9 months after the intervention</time_frame>
    <description>Improvement of the management of the secret of the serological status. Empowerment in keeping secret the HIV status (questionnaire)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes in quality of life of WLHIV: questionnaire</measure>
    <time_frame>Measured at the randomization and then immediately after the intervention</time_frame>
    <description>Assess the changes in quality of life (questionnaire)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evolution of sexual practices and use of risk reduction strategies</measure>
    <time_frame>Measured at the randomization and then immediately after the intervention</time_frame>
    <description>Assess changes of sexual practices and risk reductions strategies (questionnaire)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Reported compliance (questionnaire)</measure>
    <time_frame>Measured at the randomization and then immediately after the intervention</time_frame>
    <description>Assess changes of reported compliance throught HIV antiretroviral treatments (questionnaire)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Biological data : HIV viral load</measure>
    <time_frame>From 6 months before the intervention until the last follow up (total 2 years)</time_frame>
    <description>Access changes in HIV viral load due to the intervention (via the medical file)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Biological data : cluster of differentiation 4 levels</measure>
    <time_frame>From 6 months before the intervention until the last follow up (total 2 years)</time_frame>
    <description>Access changes in cluster of differentiation 4 levels due to the intervention (via the medical file)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Satisfaction of the intervention: questionnaire</measure>
    <time_frame>Measured immediately after the intervention</time_frame>
    <description>Assess the satisfaction of the intervention using questionnaire</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">224</enrollment>
  <condition>HIV Seropositivity</condition>
  <condition>Disclosure</condition>
  <condition>Empowerment</condition>
  <condition>HIV/AIDS</condition>
  <arm_group>
    <arm_group_label>Immediate Arm (G1)</arm_group_label>
    <description>3 months after enrollment, each big groups of 16 will be split in two groups. Women in G1 will receive the intervention Gundo-So immediately. (From month 3 to month 6).&#xD;
112 women will be in immediate arm in 14 groups of 8 women.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Delayed Arm (G2)</arm_group_label>
    <description>3 months after enrollment, each big groups of 16 will be split in two groups. Women in G2 will receive the intervention Gundo-So 3 months after. (From month 6 to month 9).&#xD;
112 women will be in delayed arm in 14 groups of 8 women.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Gundo So</intervention_name>
    <description>Gundo-So was adapted from a program established in quebec. It has been implemented in Mali following 3 phases: 1) cultural adaptation; 2) validation using a pre-post intervention evaluation; 3) scale-up&#xD;
The programm consists on 9 group meetings group spread over 9 weeks (for 8 WLHIV + 2 trained community-based leaders). Each meeting has some particular thematics with adapted tools.</description>
    <arm_group_label>Delayed Arm (G2)</arm_group_label>
    <arm_group_label>Immediate Arm (G1)</arm_group_label>
    <other_name>Gundo So - The room of confidences</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The programm Gundo So has been adapted for groups of malian women living with HIV (WLHIV).&#xD;
        The study population is described with the inclusion criteria. Moreover, in order to&#xD;
        participate at this research, women have to answer &quot;Yes&quot; at at least one of those 2&#xD;
        questions :&#xD;
&#xD;
          -  (1) is it difficult for you to share your HIV serostatus ; and (1.1) is it&#xD;
             inconvenient for you?&#xD;
&#xD;
          -  (2) is it difficult for you to keep your HIV serostatus secret; and (2.1) is it&#xD;
             inconvenient for you?&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  women living with HIV&#xD;
&#xD;
          -  living in Bamako area (Mali)&#xD;
&#xD;
          -  over 18 years old&#xD;
&#xD;
          -  knowing their serological status for more than 6 months and less than 5 years&#xD;
&#xD;
          -  being available to participate in the 9 weekly sessions lasting about 2 hours each.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  having already participated in Gundo-So&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Marie Préau, Pr</last_name>
    <role>Principal Investigator</role>
    <affiliation>GRePS</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Lucas Riegel</last_name>
    <phone>+33 1 77 93 97 63</phone>
    <email>lriegel@coalitionplus.org</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Marie Préau, Pr</last_name>
    <phone>+33 4 78 77 31 63</phone>
    <email>marie.preau@univ-lyon2.fr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>CESAC de BAMAKO</name>
      <address>
        <city>Bamako</city>
        <country>Mali</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Djénébou Traoré, Dr</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Usac Cnam</name>
      <address>
        <city>Bamako</city>
        <country>Mali</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Djénébou Traore, Dr</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>USAC commune IV</name>
      <address>
        <city>Bamako</city>
        <country>Mali</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Djénébou Traoré, Dr</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>USAC commune I</name>
      <address>
        <city>Bamako</city>
        <country>Mali</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Djénébou Traore, Dr</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>USAC commune VI</name>
      <address>
        <city>Bamako</city>
        <country>Mali</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Djénébou Traore, Dr</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>USAC commune V</name>
      <address>
        <city>Bamako</city>
        <country>Mali</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Djénébou Traore, Dr</last_name>
    </contact>
  </location>
  <location_countries>
    <country>Mali</country>
  </location_countries>
  <reference>
    <citation>Bernier A, Yattassaye A, Beaulieu-Prevost D, Otis J, Henry E, Flores-Aranda J, Massie L, Preau M, Keita BD. Empowering Malian women living with HIV regarding serostatus disclosure management: Short-term effects of a community-based intervention. Patient Educ Couns. 2018 Feb;101(2):248-255. doi: 10.1016/j.pec.2017.07.030. Epub 2017 Jul 26.</citation>
    <PMID>28789863</PMID>
  </reference>
  <verification_date>July 2019</verification_date>
  <study_first_submitted>June 15, 2018</study_first_submitted>
  <study_first_submitted_qc>January 3, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 7, 2019</study_first_posted>
  <last_update_submitted>July 2, 2019</last_update_submitted>
  <last_update_submitted_qc>July 2, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 5, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>WLHIV</keyword>
  <keyword>empowerment</keyword>
  <keyword>disclosure</keyword>
  <keyword>Mali</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>HIV Seropositivity</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03795415
org study id: ANRS12373
nct id: NCT03795415
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The objective of this research is to measure the short- and mid-term effects of an
      empowerment program focused on serostatus disclosure management for women living with HIV
      (WLHIV) in Mali on the "burden of secrecy".
Serostatus disclosure is a critical issue for persons living with HIV (PLHIV). Studies
      identified numerous benefits associated with disclosure, but various negative consequences
      have also been documented. Gender inequality must be taken into account regarding the
      disclosure issue, in particular in Mali, where women are economically dependent and have a
      low decision-making power. Moreover, in Mali, since 2006, PLHIV have a legal obligation to
      disclose their serostatus to their spouse and sexual partner(s) " as soon as possible, or
      within 6 weeks " after the diagnosis. Although this law is not enforced, it highlights the
      sensitive nature of the serostatus disclosure issue and raise concerns among PLHIV and other
      stakeholders.

      To support women living with HIV (WLHIV), an empowerment program (Gundo-So) was implemented
      by ARCAD-SIDA in Mali, in collaboration with several partners. This program aims to empower
      WLHIV, so that they can make informed decision about disclosing or keeping their serostatus
      secret in their various life contexts, and that they can identify strategies to disclose or
      to keep the secret, as well as to manage potential negative reactions. Gundo-So ("The room of
      confidences") was adapted from a program established in quebec and has been implemented in
      Mali.

      The objective of this research is to measure the short- and mid-term effects of an
      empowerment program focused on serostatus disclosure management for women living with HIV
      (WLHIV) in Mali on the "burden of secrecy".

      The evaluation of the effects of the Gundo-So program will be helpful to assess the relevance
      of a national or subregional extension of the program, or even an adaptation to other target
      populations (e.g. heterosexual men and men who have sex with men living with HIV).
observational model: Case-Control
time perspective: Prospective
measure: Short term evaluation of the burden associated with the disclosure issue using questionnaires
time frame: The short term effect will be measured at the end of the intervention and compared between Group 1 and 2. Up to 6 months from the beginning of the randomization to the end of the intervention
description: Improvement of the management of the sharing of the serological status. Empowerment in sharing the HIV status (questionnaire)
measure: Short term evaluation of the burden associated with the secrecy issue using questionnaires
time frame: The short term effect will be measured at the end of the intervention and compared between Group 1 and 2. Up to 6 months from the beginning of the randomization to the end of the intervention
description: Improvement of the management of the secret of the serological status. Empowerment in keeping secret the HIV status (questionnaire)
measure: Mid term evaluation of the burden associated with the disclosure issue using questionnaires
time frame: The mid term effect will be measured 9 months after the intervention : up to 9 months after the intervention
description: Improvement of the management of the sharing of the serological status. Empowerment in sharing the HIV status (questionnaire)
measure: Mid term evaluation of the burden associated with the secrecy issue using questionnaires
time frame: The mid term effect will be measured 9 months after the intervention : up to 9 months after the intervention
description: Improvement of the management of the secret of the serological status. Empowerment in keeping secret the HIV status (questionnaire)
measure: Changes in quality of life of WLHIV: questionnaire
time frame: Measured at the randomization and then immediately after the intervention
description: Assess the changes in quality of life (questionnaire)
measure: Evolution of sexual practices and use of risk reduction strategies
time frame: Measured at the randomization and then immediately after the intervention
description: Assess changes of sexual practices and risk reductions strategies (questionnaire)
measure: Reported compliance (questionnaire)
time frame: Measured at the randomization and then immediately after the intervention
description: Assess changes of reported compliance throught HIV antiretroviral treatments (questionnaire)
measure: Biological data : HIV viral load
time frame: From 6 months before the intervention until the last follow up (total 2 years)
description: Access changes in HIV viral load due to the intervention (via the medical file)
measure: Biological data : cluster of differentiation 4 levels
time frame: From 6 months before the intervention until the last follow up (total 2 years)
description: Access changes in cluster of differentiation 4 levels due to the intervention (via the medical file)
measure: Satisfaction of the intervention: questionnaire
time frame: Measured immediately after the intervention
description: Assess the satisfaction of the intervention using questionnaire
arm group label: Immediate Arm (G1)
description: 3 months after enrollment, each big groups of 16 will be split in two groups. Women in G1 will receive the intervention Gundo-So immediately. (From month 3 to month 6).
112 women will be in immediate arm in 14 groups of 8 women.
arm group label: Delayed Arm (G2)
description: 3 months after enrollment, each big groups of 16 will be split in two groups. Women in G2 will receive the intervention Gundo-So 3 months after. (From month 6 to month 9).
112 women will be in delayed arm in 14 groups of 8 women.
intervention type: Behavioral
intervention name: Gundo So
description: Gundo-So was adapted from a program established in quebec. It has been implemented in Mali following 3 phases: 1) cultural adaptation; 2) validation using a pre-post intervention evaluation; 3) scale-up
The programm consists on 9 group meetings group spread over 9 weeks (for 8 WLHIV + 2 trained community-based leaders). Each meeting has some particular thematics with adapted tools.
arm group label: Delayed Arm (G2)
arm group label: Immediate Arm (G1)
other name: Gundo So - The room of confidences
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Marie Préau, Pr
role: Principal Investigator
affiliation: GRePS
last name: Lucas Riegel
phone: +33 1 77 93 97 63
email: lriegel@coalitionplus.org
last name: Marie Préau, Pr
phone: +33 4 78 77 31 63
email: marie.preau@univ-lyon2.fr
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: Mali
citation: Bernier A, Yattassaye A, Beaulieu-Prevost D, Otis J, Henry E, Flores-Aranda J, Massie L, Preau M, Keita BD. Empowering Malian women living with HIV regarding serostatus disclosure management: Short-term effects of a community-based intervention. Patient Educ Couns. 2018 Feb;101(2):248-255. doi: 10.1016/j.pec.2017.07.030. Epub 2017 Jul 26.
PMID: 28789863
responsible party type: Sponsor
mesh term: HIV Seropositivity
sharing ipd: Undecided