<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/NCT04468724</url>
  </required_header>
  <id_info>
    <org_study_id>ANRS 14056</org_study_id>
    <nct_id>NCT04468724</nct_id>
  </id_info>
  <brief_title>MAKASI Intervention for African and Caribbean Migrants' Empowerment in Sexual Health in Paris Greater Area</brief_title>
  <acronym>MAKASI</acronym>
  <official_title>MAKASI. An Intervention for African and Caribbean Migrants' Empowerment in Sexual Health in Order to Reduce Their Social and Health Vulnerabilities in Paris Greater Area</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>French National Agency for Research on AIDS and Viral Hepatitis</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Agence Regionale de Sante d'Ile de 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>
      Background. Immigrants from Sub-Saharan Africa are the second group most affected by HIV in&#xD;
      France. Part of these HIV infections occurred after arrival in France, in relation to social&#xD;
      hardships. Immigrants coming from the non-French Caribbean islands face similar difficulties.&#xD;
      Many actors strive for an easier access to healthcare services for immigrants; however the&#xD;
      mere supply of knowledge and medicalised solutions is not enough to make persons adopt&#xD;
      prevention behaviours. It seems necessary to act upon empowerment to bring resources to&#xD;
      individuals and communities in order to improve their autonomy and action capacity. Civil&#xD;
      Society Organisations and researchers join forces in the MAKASI interventional research which&#xD;
      aims at reinforcing immigrants' empowerment in sexual health in order to reduce their&#xD;
      exposure to sexual risks.&#xD;
&#xD;
      Objectives : The MAKASI intervention consists in a unique Empowerment interview based on the&#xD;
      principles of motivational interviewing, using an Active Referral system to social or&#xD;
      sanitary services relevant to the person's needs. Our hypothesis is that this intervention is&#xD;
      going to reinforce four dimensions of empowerment in sexual health among immigrants: the&#xD;
      capacity to express their needs, competencies in sexual, self-esteem, awareness of exposure&#xD;
      to HIV and STIs. The proposed research aims at measuring the efficacy of the intervention on&#xD;
      these four dimensions, and at evaluating its processes and efficiency (cost-efficacy).&#xD;
&#xD;
      Methods: The intervention is delivered within the mobile units of Afrique Avenir in the&#xD;
      public spaces where African and Caribbean populations live and work. The evaluation uses&#xD;
      integrated mixed-method approach, combining a quantitative evaluation of impact and a&#xD;
      qualitative research on processes. The measure of impact will be done by comparing indicators&#xD;
      on the four dimensions of empowerment in sexual health and indicators of exposure to sexual&#xD;
      risks, between an arm where the intervention is immediate and an arm where the intervention&#xD;
      is differed by 3 months (control arm). The qualitative evaluation of the intervention&#xD;
      processes will be based upon an ethnographic approach of the intervention and the&#xD;
      participants' experience.&#xD;
&#xD;
      Perspectives: This project will demonstrate the efficacy and the efficiency of an innovative&#xD;
      intervention aiming at reducing Sub-Saharan and Caribbean immigrants' exposure to risks in&#xD;
      sexual health.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Migrants from Sub-Saharan Africa are the second group most affected by HIV epidemic in&#xD;
      France. Previous study established that part of HIV infections among Sub-Saharan migrants&#xD;
      occurred after arrival in France, and that the exposure to sexual risks was linked both to&#xD;
      social hardships and structural difficulties experienced during the settlement period in&#xD;
      France. Many actors strive for an easier access to healthcare services for migrants, however&#xD;
      the mere supply of knowledge and medicalised solutions is not enough to make persons adopt&#xD;
      protection or healthcare practices. It seems necessary to work for the individual and&#xD;
      community empowerment in order to bring resources to individuals and communities so they can&#xD;
      more easily take action in the new and complex context of a host country.&#xD;
&#xD;
      To improve the prevention of sexual risks in this population coming from Sub-Saharan Africa,&#xD;
      local charities and researchers join forces in order to propose an interventional research&#xD;
      which aims at enabling Sub-Saharan migrants to appropriate prevention and healthcare means,&#xD;
      especially in the area of sexual health, to reinforce their autonomy, their capacity and&#xD;
      power to take action and to protect their health against the disruption caused by migration&#xD;
      and the difficulty in accessing rights and fundamental needs.&#xD;
&#xD;
      The pilot phase of this research has made it possible to build an empowerment intervention&#xD;
      which consists of a single individual interview based on the principles of motivational&#xD;
      maintenance, articulated with an active orientation towards adequate social or health&#xD;
      services, possibly accompanied when necessary. Our hypothesis is that this intervention will&#xD;
      strengthen four dimensions of empowerment in sexual health among immigrants:&#xD;
&#xD;
        -  Ability to express needs: Ability to talk about sexuality or sexual health to peers or&#xD;
           professionals&#xD;
&#xD;
        -  sexual health skills: know the different tools of combined prevention, know where to go&#xD;
           for screening, gynaecology or sexual health consultation&#xD;
&#xD;
        -  self-esteem: knowing your rights, having the material means (housing, administrative&#xD;
           situation, financial resources) to refuse a situation of sexual constraint and avoid&#xD;
           being exposed to violence, feeling that you can act on your own situation (sense of&#xD;
           personal effectiveness)&#xD;
&#xD;
        -  awareness of HIV exposure and its determinants: being informed about the epidemiology of&#xD;
           HIV, the fact that it is possible to be infected in France, and risk factors&#xD;
&#xD;
      Objectives&#xD;
&#xD;
      To strengthen the sexual health empowerment of immigrants from sub-Saharan Africa and the&#xD;
      Caribbean, we propose to act on the four dimensions of sexual empowerment with the following&#xD;
      specific objectives:&#xD;
&#xD;
      Ability to express needs:&#xD;
&#xD;
        -  Speaking up&#xD;
&#xD;
        -  Reduce social isolation&#xD;
&#xD;
      Sexual Health Skills:&#xD;
&#xD;
        -  Improve knowledge of health and social resources&#xD;
&#xD;
        -  Improve access to screening&#xD;
&#xD;
        -  Improve access to sexual health services (Contraception, condoms, Prep)&#xD;
&#xD;
        -  Improve ownership of combined prevention&#xD;
&#xD;
      Self-esteem:&#xD;
&#xD;
        -  Improve people's autonomy in social processes (housing, paper)&#xD;
&#xD;
        -  Improving Mental Health: Reducing Psychological Distress and Suffering&#xD;
&#xD;
        -  Improve personal efficiency&#xD;
&#xD;
      Awareness of HIV and STI exposure&#xD;
&#xD;
      • Improve perception of HIV and STI exposure, effectiveness of antiretroviral treatment and&#xD;
      preventive strategies.&#xD;
&#xD;
      The research aims to measure the effectiveness of the intervention against all of these&#xD;
      indicators, as well as to conduct an evaluation of the processes and efficiency&#xD;
      (cost-effectiveness).&#xD;
&#xD;
      Methods:&#xD;
&#xD;
      The intervention is part of the action already carried out by the mobile team of Afrique&#xD;
      Avenir, which offers in strategic places of passage (markets, squares, RER stations, etc.) an&#xD;
      awareness of sexual health through cultural mediation and a TROD offer. The MAKASI&#xD;
      intervention involves identifying immigrants in precarious situations and exposed to HIV in&#xD;
      these awareness-raising places, offering them a personalized interview with a health mediator&#xD;
      to help them prioritize their needs, and guide them through the health and welfare system.&#xD;
&#xD;
      To assess this complex intervention, we will use an integrated mixed-method approach. A&#xD;
      quantitative impact assessment and a qualitative assessment of the processes will be&#xD;
      conducted in parallel to establish, by integrating these data, the causal attribution of the&#xD;
      effects of the intervention.&#xD;
&#xD;
      Quantitative assessment of impact:&#xD;
&#xD;
      To measure the impact of the intervention, we propose a two-arm diagram: an intervention arm&#xD;
      and a control arm. However, for ethical reasons, in order to offer help to all identified&#xD;
      people with social or health needs, we will compare an arm where the intervention is&#xD;
      immediate, and an arm where it is delayed by 3 months (control arm). The comparison of what&#xD;
      happens in the first three months will measure the short-term effect of the intervention, and&#xD;
      establish a causal link between the intervention and the observed changes. All people, in&#xD;
      both arms, will be followed six months to observe the evolution of the indicators in the&#xD;
      medium term. The impact assessment of the intervention will be made possible both by&#xD;
      comparison between the immediate intervention arm and the control arms in the first three&#xD;
      months, and by comparison before/after the intervention in both arms). Individuals will be&#xD;
      randomly allocated to the immediate or delayed intervention arm after an initial interview to&#xD;
      identify social and health needs. The goal is to include 1200 people (600 in each arm).&#xD;
&#xD;
      Qualitative assessment of processes and effects:&#xD;
&#xD;
      The qualitative analysis of the processes aims to highlight and analyse the successes,&#xD;
      failures and limitations of the intervention, with particular regard to the implementation&#xD;
      and its effects. It will also be necessary to produce knowledge on the conditions of&#xD;
      reproduction or the extension of the intervention. This analysis will be based on an&#xD;
      ethnographic approach to the intervention and the participants' journey, with a work of&#xD;
      observation of the different stages and in-depth and repeated semi-directive interviews.&#xD;
&#xD;
      Cost collection will measure the efficiency of the response.&#xD;
&#xD;
      Expected results :&#xD;
&#xD;
      This project will demonstrate the effectiveness and efficiency of an innovative intervention&#xD;
      to reduce exposure to sexual health risks among immigrants from sub-Saharan Africa and the&#xD;
      Caribbean, and will highlight the conditions of its reproduction or extension. It is closely&#xD;
      linked to the initiative towards Paris without AIDS, which develops the collective dimensions&#xD;
      of empowerment through different approaches in the communities concerned.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">February 1, 2019</start_date>
  <completion_date type="Anticipated">January 31, 2021</completion_date>
  <primary_completion_date type="Anticipated">January 31, 2021</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>In order to measure the impact of the intervention, we propose a two-arm essay: an intervention arm and a control arm. However, for ethical reasons, it was impossible not to offer help to all the screened persons who were in need of help for social or health reasons. That is why we will compare an arm where the intervention is immediate with an arm where the intervention is differed by three months (control arm). The comparison about what happens in the three first months will allow us to measure the impact of the intervention at three months. All participants will have a follow up of six months after the intervention.&#xD;
The participants will be randomly allocated to the immediate arm or the differed arm (please see below).</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change of unprotected sex</measure>
    <time_frame>0, 3 months, 6 months after inclusion</time_frame>
    <description>Declare unprotected sex at least once during the last three months (percent)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change of transactional sex</measure>
    <time_frame>0, 3 months, 6 months after inclusion</time_frame>
    <description>Declare Transactional sex at least once during the last three months (percent)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change of Forced sex</measure>
    <time_frame>0, 3 months, 6 months after inclusion</time_frame>
    <description>Declare having forced to have sex at least once during the last three months (percent)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Empowerment - Social Isolation</measure>
    <time_frame>0, 3 months, 6 months after inclusion</time_frame>
    <description>Feeling to be alone (percent)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Empowerment - Ability to talk</measure>
    <time_frame>0, 3 months, 6 months after inclusion</time_frame>
    <description>Empowerment - Perception of ability to talk about one's situation with a professional (percent)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Empowerment - Health insurance</measure>
    <time_frame>0, 3 months, 6 months after inclusion</time_frame>
    <description>Empowerment - having a health insurance (percent)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Empowerment - HIV test</measure>
    <time_frame>0, 3 months, 6 months after inclusion</time_frame>
    <description>Empowerment - Has been HIV tested</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Empowerment - TASP knowledge</measure>
    <time_frame>0, 3 months, 6 months after inclusion</time_frame>
    <description>Empowerment - Knowledge that HIV treatment prevents from transmitting HIV</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Empowerment - mental health score</measure>
    <time_frame>0, 3 months, 6 months after inclusion</time_frame>
    <description>Empowerment - PHQ 9 (Patient Health Questionnaire in 9 items) score : from 0 (good mental health) to 9 (very bad mental health)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Empowerment - self-efficacy</measure>
    <time_frame>0, 3 months, 6 months after inclusion</time_frame>
    <description>Empowerment - feeling of control over the decisions that affect its life (percent)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Empowerment - HIV risk awareness</measure>
    <time_frame>0, 3 months, 6 months after inclusion</time_frame>
    <description>Empowerment - knowing that the risk of being HIV infected concerns everyone (percent)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Empowerment - access to healthcare structure</measure>
    <time_frame>0, 3 months, 6 months after inclusion</time_frame>
    <description>Empowerment - having had access to a health structure when needed, in the last 3 months (percent)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">1200</enrollment>
  <condition>HIV/AIDS</condition>
  <condition>STI</condition>
  <arm_group>
    <arm_group_label>IMMEDIATE</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>People who are included in the Immediate Arm receive the Makasi intervention right away or in a six-week time if they are not available on the spot</description>
  </arm_group>
  <arm_group>
    <arm_group_label>DIFFERED</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>People who are included in the Differed Arm receive the Makasi intervention three months after inclusion</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>MAKASI</intervention_name>
    <description>The Makasi intervention consists in a unique Empowerment interview, based on motivational interviewing techniques. Is is made of three components:&#xD;
Listening and building trust&#xD;
Active referral to structures that answers sanitary and social needs&#xD;
Sexual Health Prevention&#xD;
Materials used are: referral letters, bilingual health guides, adapted maps of the the neighborhoods with useful addresses.&#xD;
The Makasi intervention is proposed and delivered in an outreach setting: health mediators propose information on general health and rapid HIV and HCV testing. They screen the people attending and propose Makasi to eligible persons.</description>
    <arm_group_label>DIFFERED</arm_group_label>
    <arm_group_label>IMMEDIATE</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Be aged at least 18&#xD;
&#xD;
          -  HIV negative&#xD;
&#xD;
          -  Born in sub-Saharan Africa or the non-French Carribean&#xD;
&#xD;
          -  At least one of the eight vulnerability criteria: no stable house, no job, food&#xD;
             deprivation, no papers, feeling isolated, not knowing where to go to to the doctor, no&#xD;
             health insurance, experiencing violence&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Does not speak French or English&#xD;
&#xD;
          -  Persons whose rapid HIV or HCV test is reactive&#xD;
&#xD;
          -  Persons who are not able to give an informed consent: bad mental health, persons who&#xD;
             are on drugs&#xD;
      </textblock>
    </criteria>
    <gender>All</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>Annabel Desgrées du Loû, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>French Institute for Sustainable Developement (IRD)</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Annabel Desgrées du Loû, PhD</last_name>
    <phone>+33 1 76 53 34 53</phone>
    <email>annabel.desgrees@ird.fr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Anne Gosselin, PhD</last_name>
    <email>anne.gosselin@icmigrations.fr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Afrique Avenir Mobile Unit</name>
      <address>
        <city>Paris</city>
        <zip>75003</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Romain Mbiribindi</last_name>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <reference>
    <citation>Gosselin A, Carillon S, Coulibaly K, Ridde V, Taeron C, Kohou V, Zoumenou I, Mbiribindi R, Derche N, Desgrees du Lou A; MAKASI Study Group. Participatory development and pilot testing of the Makasi intervention: a community-based outreach intervention to improve sub-Saharan and Caribbean immigrants' empowerment in sexual health. BMC Public Health. 2019 Dec 5;19(1):1646. doi: 10.1186/s12889-019-7943-2.</citation>
    <PMID>31805909</PMID>
  </reference>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>June 26, 2020</study_first_submitted>
  <study_first_submitted_qc>July 8, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 13, 2020</study_first_posted>
  <last_update_submitted>July 8, 2020</last_update_submitted>
  <last_update_submitted_qc>July 8, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 13, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Migrants</keyword>
  <keyword>Sexual Health</keyword>
  <keyword>Empowerment</keyword>
  <keyword>community-based intervention</keyword>
  <keyword>HIV prevention</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acquired Immunodeficiency Syndrome</mesh_term>
    <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/NCT04468724
org study id: ANRS 14056
nct id: NCT04468724
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Background. Immigrants from Sub-Saharan Africa are the second group most affected by HIV in
      France. Part of these HIV infections occurred after arrival in France, in relation to social
      hardships. Immigrants coming from the non-French Caribbean islands face similar difficulties.
      Many actors strive for an easier access to healthcare services for immigrants; however the
      mere supply of knowledge and medicalised solutions is not enough to make persons adopt
      prevention behaviours. It seems necessary to act upon empowerment to bring resources to
      individuals and communities in order to improve their autonomy and action capacity. Civil
      Society Organisations and researchers join forces in the MAKASI interventional research which
      aims at reinforcing immigrants' empowerment in sexual health in order to reduce their
      exposure to sexual risks.

      Objectives : The MAKASI intervention consists in a unique Empowerment interview based on the
      principles of motivational interviewing, using an Active Referral system to social or
      sanitary services relevant to the person's needs. Our hypothesis is that this intervention is
      going to reinforce four dimensions of empowerment in sexual health among immigrants: the
      capacity to express their needs, competencies in sexual, self-esteem, awareness of exposure
      to HIV and STIs. The proposed research aims at measuring the efficacy of the intervention on
      these four dimensions, and at evaluating its processes and efficiency (cost-efficacy).

      Methods: The intervention is delivered within the mobile units of Afrique Avenir in the
      public spaces where African and Caribbean populations live and work. The evaluation uses
      integrated mixed-method approach, combining a quantitative evaluation of impact and a
      qualitative research on processes. The measure of impact will be done by comparing indicators
      on the four dimensions of empowerment in sexual health and indicators of exposure to sexual
      risks, between an arm where the intervention is immediate and an arm where the intervention
      is differed by 3 months (control arm). The qualitative evaluation of the intervention
      processes will be based upon an ethnographic approach of the intervention and the
      participants' experience.

      Perspectives: This project will demonstrate the efficacy and the efficiency of an innovative
      intervention aiming at reducing Sub-Saharan and Caribbean immigrants' exposure to risks in
      sexual health.
Migrants from Sub-Saharan Africa are the second group most affected by HIV epidemic in
      France. Previous study established that part of HIV infections among Sub-Saharan migrants
      occurred after arrival in France, and that the exposure to sexual risks was linked both to
      social hardships and structural difficulties experienced during the settlement period in
      France. Many actors strive for an easier access to healthcare services for migrants, however
      the mere supply of knowledge and medicalised solutions is not enough to make persons adopt
      protection or healthcare practices. It seems necessary to work for the individual and
      community empowerment in order to bring resources to individuals and communities so they can
      more easily take action in the new and complex context of a host country.

      To improve the prevention of sexual risks in this population coming from Sub-Saharan Africa,
      local charities and researchers join forces in order to propose an interventional research
      which aims at enabling Sub-Saharan migrants to appropriate prevention and healthcare means,
      especially in the area of sexual health, to reinforce their autonomy, their capacity and
      power to take action and to protect their health against the disruption caused by migration
      and the difficulty in accessing rights and fundamental needs.

      The pilot phase of this research has made it possible to build an empowerment intervention
      which consists of a single individual interview based on the principles of motivational
      maintenance, articulated with an active orientation towards adequate social or health
      services, possibly accompanied when necessary. Our hypothesis is that this intervention will
      strengthen four dimensions of empowerment in sexual health among immigrants:

        -  Ability to express needs: Ability to talk about sexuality or sexual health to peers or
           professionals

        -  sexual health skills: know the different tools of combined prevention, know where to go
           for screening, gynaecology or sexual health consultation

        -  self-esteem: knowing your rights, having the material means (housing, administrative
           situation, financial resources) to refuse a situation of sexual constraint and avoid
           being exposed to violence, feeling that you can act on your own situation (sense of
           personal effectiveness)

        -  awareness of HIV exposure and its determinants: being informed about the epidemiology of
           HIV, the fact that it is possible to be infected in France, and risk factors

      Objectives

      To strengthen the sexual health empowerment of immigrants from sub-Saharan Africa and the
      Caribbean, we propose to act on the four dimensions of sexual empowerment with the following
      specific objectives:

      Ability to express needs:

        -  Speaking up

        -  Reduce social isolation

      Sexual Health Skills:

        -  Improve knowledge of health and social resources

        -  Improve access to screening

        -  Improve access to sexual health services (Contraception, condoms, Prep)

        -  Improve ownership of combined prevention

      Self-esteem:

        -  Improve people's autonomy in social processes (housing, paper)

        -  Improving Mental Health: Reducing Psychological Distress and Suffering

        -  Improve personal efficiency

      Awareness of HIV and STI exposure

      • Improve perception of HIV and STI exposure, effectiveness of antiretroviral treatment and
      preventive strategies.

      The research aims to measure the effectiveness of the intervention against all of these
      indicators, as well as to conduct an evaluation of the processes and efficiency
      (cost-effectiveness).

      Methods:

      The intervention is part of the action already carried out by the mobile team of Afrique
      Avenir, which offers in strategic places of passage (markets, squares, RER stations, etc.) an
      awareness of sexual health through cultural mediation and a TROD offer. The MAKASI
      intervention involves identifying immigrants in precarious situations and exposed to HIV in
      these awareness-raising places, offering them a personalized interview with a health mediator
      to help them prioritize their needs, and guide them through the health and welfare system.

      To assess this complex intervention, we will use an integrated mixed-method approach. A
      quantitative impact assessment and a qualitative assessment of the processes will be
      conducted in parallel to establish, by integrating these data, the causal attribution of the
      effects of the intervention.

      Quantitative assessment of impact:

      To measure the impact of the intervention, we propose a two-arm diagram: an intervention arm
      and a control arm. However, for ethical reasons, in order to offer help to all identified
      people with social or health needs, we will compare an arm where the intervention is
      immediate, and an arm where it is delayed by 3 months (control arm). The comparison of what
      happens in the first three months will measure the short-term effect of the intervention, and
      establish a causal link between the intervention and the observed changes. All people, in
      both arms, will be followed six months to observe the evolution of the indicators in the
      medium term. The impact assessment of the intervention will be made possible both by
      comparison between the immediate intervention arm and the control arms in the first three
      months, and by comparison before/after the intervention in both arms). Individuals will be
      randomly allocated to the immediate or delayed intervention arm after an initial interview to
      identify social and health needs. The goal is to include 1200 people (600 in each arm).

      Qualitative assessment of processes and effects:

      The qualitative analysis of the processes aims to highlight and analyse the successes,
      failures and limitations of the intervention, with particular regard to the implementation
      and its effects. It will also be necessary to produce knowledge on the conditions of
      reproduction or the extension of the intervention. This analysis will be based on an
      ethnographic approach to the intervention and the participants' journey, with a work of
      observation of the different stages and in-depth and repeated semi-directive interviews.

      Cost collection will measure the efficiency of the response.

      Expected results :

      This project will demonstrate the effectiveness and efficiency of an innovative intervention
      to reduce exposure to sexual health risks among immigrants from sub-Saharan Africa and the
      Caribbean, and will highlight the conditions of its reproduction or extension. It is closely
      linked to the initiative towards Paris without AIDS, which develops the collective dimensions
      of empowerment through different approaches in the communities concerned.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: In order to measure the impact of the intervention, we propose a two-arm essay: an intervention arm and a control arm. However, for ethical reasons, it was impossible not to offer help to all the screened persons who were in need of help for social or health reasons. That is why we will compare an arm where the intervention is immediate with an arm where the intervention is differed by three months (control arm). The comparison about what happens in the three first months will allow us to measure the impact of the intervention at three months. All participants will have a follow up of six months after the intervention.
The participants will be randomly allocated to the immediate arm or the differed arm (please see below).
primary purpose: Prevention
masking: None (Open Label)
measure: Change of unprotected sex
time frame: 0, 3 months, 6 months after inclusion
description: Declare unprotected sex at least once during the last three months (percent)
measure: Change of transactional sex
time frame: 0, 3 months, 6 months after inclusion
description: Declare Transactional sex at least once during the last three months (percent)
measure: Change of Forced sex
time frame: 0, 3 months, 6 months after inclusion
description: Declare having forced to have sex at least once during the last three months (percent)
measure: Empowerment - Social Isolation
time frame: 0, 3 months, 6 months after inclusion
description: Feeling to be alone (percent)
measure: Empowerment - Ability to talk
time frame: 0, 3 months, 6 months after inclusion
description: Empowerment - Perception of ability to talk about one's situation with a professional (percent)
measure: Empowerment - Health insurance
time frame: 0, 3 months, 6 months after inclusion
description: Empowerment - having a health insurance (percent)
measure: Empowerment - HIV test
time frame: 0, 3 months, 6 months after inclusion
description: Empowerment - Has been HIV tested
measure: Empowerment - TASP knowledge
time frame: 0, 3 months, 6 months after inclusion
description: Empowerment - Knowledge that HIV treatment prevents from transmitting HIV
measure: Empowerment - mental health score
time frame: 0, 3 months, 6 months after inclusion
description: Empowerment - PHQ 9 (Patient Health Questionnaire in 9 items) score : from 0 (good mental health) to 9 (very bad mental health)
measure: Empowerment - self-efficacy
time frame: 0, 3 months, 6 months after inclusion
description: Empowerment - feeling of control over the decisions that affect its life (percent)
measure: Empowerment - HIV risk awareness
time frame: 0, 3 months, 6 months after inclusion
description: Empowerment - knowing that the risk of being HIV infected concerns everyone (percent)
measure: Empowerment - access to healthcare structure
time frame: 0, 3 months, 6 months after inclusion
description: Empowerment - having had access to a health structure when needed, in the last 3 months (percent)
arm group label: IMMEDIATE
arm group type: Experimental
description: People who are included in the Immediate Arm receive the Makasi intervention right away or in a six-week time if they are not available on the spot
arm group label: DIFFERED
arm group type: Other
description: People who are included in the Differed Arm receive the Makasi intervention three months after inclusion
intervention type: Behavioral
intervention name: MAKASI
description: The Makasi intervention consists in a unique Empowerment interview, based on motivational interviewing techniques. Is is made of three components:
Listening and building trust
Active referral to structures that answers sanitary and social needs
Sexual Health Prevention
Materials used are: referral letters, bilingual health guides, adapted maps of the the neighborhoods with useful addresses.
The Makasi intervention is proposed and delivered in an outreach setting: health mediators propose information on general health and rapid HIV and HCV testing. They screen the people attending and propose Makasi to eligible persons.
arm group label: DIFFERED
arm group label: IMMEDIATE
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Annabel Desgrées du Loû, PhD
role: Principal Investigator
affiliation: French Institute for Sustainable Developement (IRD)
last name: Annabel Desgrées du Loû, PhD
phone: +33 1 76 53 34 53
email: annabel.desgrees@ird.fr
last name: Anne Gosselin, PhD
email: anne.gosselin@icmigrations.fr
facility: 
status: Recruiting
contact: 
country: France
citation: Gosselin A, Carillon S, Coulibaly K, Ridde V, Taeron C, Kohou V, Zoumenou I, Mbiribindi R, Derche N, Desgrees du Lou A; MAKASI Study Group. Participatory development and pilot testing of the Makasi intervention: a community-based outreach intervention to improve sub-Saharan and Caribbean immigrants' empowerment in sexual health. BMC Public Health. 2019 Dec 5;19(1):1646. doi: 10.1186/s12889-019-7943-2.
PMID: 31805909
responsible party type: Sponsor
mesh term: Acquired Immunodeficiency Syndrome
mesh term: HIV Infections
sharing ipd: No