<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/NCT02192658</url>
  </required_header>
  <id_info>
    <org_study_id>ANRS 12302 - HandiVIH</org_study_id>
    <nct_id>NCT02192658</nct_id>
  </id_info>
  <brief_title>Disability and HIV: Vulnerability of People With Disabilities to HIV Infection in Sub-Saharan Africa</brief_title>
  <acronym>HandiVIH</acronym>
  <official_title>Disability and HIV: an Appraisal of the Vulnerability of People With Disabilities to HIV Infection in Two Main Cities of Sub-Saharan Africa</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>ANRS, Emerging Infectious Diseases</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Handicap International</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Institut de Recherche pour le Developpement</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Institut de Formation et de Recherche Démographique</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Forum Camerounais de Psychologie</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Centre de Recherche Internationale pour la Santé de l'Université de Ouagadougou</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>ANRS, Emerging Infectious Diseases</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      According to the recent World Report on Disability, around 15% of the world population lives&#xD;
      with a disability and 80% of people with disabilities (PWD) live in developing countries.&#xD;
      More and more evidence show that PWD are more likely to be poor, vulnerable to physical and&#xD;
      sexual violence, and to have less access to education. Therefore, PWD are likely to have an&#xD;
      increased risk for HIV infection, potentially being a key population in regard to this&#xD;
      epidemic.&#xD;
&#xD;
      The vulnerability of PWD was recognized in 2007 by the United Nations Convention on the&#xD;
      Rights of Persons with Disabilities. However, data on the extent how PWD are affected by HIV&#xD;
      is still very limited. As a result, PWD are usually overlooked by National AIDS Control&#xD;
      Programmes and few projects specifically targeting them have been developed.&#xD;
&#xD;
      Recognizing the need for appropriate and reliable data to help protect the rights of PWD and&#xD;
      achieve a better inclusion of disability in National AIDS Control Programmes, the Institute&#xD;
      of Research for Development (IRD), the Institut de Formation et Recherche Demographique&#xD;
      (IFORD) and Handicap International (HI) propose this study that aims to provide quantitative&#xD;
      and qualitative data on the vulnerability of PWD to HIV infection in Cameroon and Burkina&#xD;
      Faso, in order to define if this vulnerable population is also a Key Population in relation&#xD;
      to the HIV epidemic. This study adopts a multidisciplinary approach (quantitative and&#xD;
      qualitative methods). Quantitative data are collected only in Cameroon.&#xD;
&#xD;
      Only the quantitative study is described here.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      OBJECTIVES:&#xD;
&#xD;
      The general objective of this study is to provide information on the vulnerability of PWD to&#xD;
      HIV infection.&#xD;
&#xD;
      The objectives of the quantitative component of this study are:&#xD;
&#xD;
      Estimation of the HIV burden among PWD:&#xD;
&#xD;
        -  To estimate the prevalence of HIV in PWD comprehensively and for each of the following&#xD;
           disabilities 1) hearing 2) visual 3) mobility 4) cognitive (intellectual)&#xD;
&#xD;
        -  To compare the HIV prevalence between PWD and non-disabled matched controls&#xD;
&#xD;
        -  To assess the association between PWD's social network characteristics and the risk for&#xD;
           HIV&#xD;
&#xD;
      Assessment of the knowledge, behaviour and practice toward HIV infection and sexual and&#xD;
      reproductive health (including contraception) overall and for each of the impairment groups&#xD;
      mentioned above:&#xD;
&#xD;
        -  To describe and analyze the knowledge, attitude and behaviours related to HIV infection&#xD;
&#xD;
        -  To compare the knowledge, attitude and behaviours between PWD and non-disabled matched&#xD;
           controls&#xD;
&#xD;
        -  To describe sexual and reproductive activities of PWD&#xD;
&#xD;
        -  To describe and analyze the access and actual use of family planning methods in PWD&#xD;
&#xD;
      Access to HIV prevention and health careglobally and for each of the impairment groups&#xD;
      mentioned above:&#xD;
&#xD;
        -  To describe and analyze the determinants of and barriers to access to prevention and&#xD;
           testing services&#xD;
&#xD;
        -  To describe and analyze the determinants of and barriers to access to care&#xD;
&#xD;
        -  To compare the access to services between PWD and non-disabled matched controls&#xD;
&#xD;
      Specific objectives related to disability:&#xD;
&#xD;
        -  To describe the population of PWD in Yaoundé&#xD;
&#xD;
        -  To describe and analyze the characteristics of the social networks of PWD&#xD;
&#xD;
      METHODOLOGY&#xD;
&#xD;
      Study design:&#xD;
&#xD;
      This is a cross sectionnal study assessing HIV prevalence, HIV risk factors and sexual &amp;&#xD;
      reproductive health of PWD compared to a control group of Non-Disabled People. PWD are&#xD;
      sampled from the general population using a two-step sampling method. Eligible subjects are&#xD;
      proposed an HIV test and to respond to a questionnaire on their Knowledge, Attitudes and&#xD;
      Practices (KAP) in relation to HIV and SRH, on their social network and on their access to&#xD;
      prevention and care services. The life-grid interview method is used to collect data on&#xD;
      subject's history of social participation, employment, resources, sexual partnership and&#xD;
      reproductive life. Controls are selected from the PWD's neighborhood.&#xD;
&#xD;
      Sample size:&#xD;
&#xD;
      850 disabled subjects and 850 non-disabled controls&#xD;
&#xD;
      Study location: Yaounde, Cameroon&#xD;
&#xD;
      Estimated planning or Study timetable :&#xD;
&#xD;
      Study start date: April 2014 (exploratory work) Total trial/study duration: 24 months&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2014</start_date>
  <completion_date type="Actual">July 2016</completion_date>
  <primary_completion_date type="Actual">December 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>HIV prevalence</measure>
    <time_frame>10 months</time_frame>
    <description>HIV prevalence among People With Disability compared to Non-Disabled People. HIV serology will be assessed by rapid diagnostic tests.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Risk factors</measure>
    <time_frame>10 months</time_frame>
    <description>Risk factors to HIV and reproductive health behaviours among People with Disability compared to Non-Disabled People. Different risk factors (Knowledges - Attitudes - Practices) for HIV and reproductive health behaviours will be assessed in both groups, the people with disability group and the control non-disabled people group, through a questionnaire.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Access to care</measure>
    <time_frame>10 months</time_frame>
    <description>Access to services among People with Disability compared to Non-Disabled People. Access to reproductive health and HIV services will be assessed in both groups, through a questionnaire.</description>
  </other_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">1610</enrollment>
  <condition>HIV</condition>
  <condition>Reproductive Health</condition>
  <condition>Disability</condition>
  <arm_group>
    <arm_group_label>People with Disability (PWD) (N= 850)</arm_group_label>
    <description>PWD will be identified thanks to the disability screening tool developped by the Washington Group (WG). This tool is based on the WHO International Classification of Functionning (ICF).&#xD;
A stratified cluster sampling in 2 steps will be used in both, Yaounde and Ouagadougou. Each city will be divided in enumeration areas (EAs). First step : EAs will be drawn randomly with probability proportional to their size in number of households. Second step: in each EA, 30 households will be randomly drawn and each person living in these households will be screened for disability with the WG tool, according to the inclusion and exclusion criteria.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Non-Disabled People (control group) (N= 850)</arm_group_label>
    <description>For each PWD, 1 non-disabled control person will be randomly chosen from the census list of the same enumeration area. Control will also be matched on age and sex.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Community sample:&#xD;
&#xD;
        - PWD are identified thanks to the disability screening tool developped by the Washington&#xD;
        Group (WG). This tool is based on the WHO International Classification of Functionning&#xD;
        (ICF).&#xD;
&#xD;
        A stratified cluster sampling in 2 steps is used in Yaounde. The city has been divided in&#xD;
        enumeration areas (EAs). First step : EAs are drawn randomly with probability proportional&#xD;
        to their size in number of households. Second step: in each EA, 30 households are randomly&#xD;
        drawn and each person living in these households is screened for disability with the WG&#xD;
        tool, according to the inclusion and exclusion criteria.&#xD;
&#xD;
        - For each PWD, 1 non-disabled control person is randomly chosen from the census list of&#xD;
        the same enumeration area. Controls are matched on age and sex.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        For PWD:&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 15 to 49 years&#xD;
&#xD;
          -  WG criteria: ≥ 1 major impairment or 2 minor difficulties with an activity&#xD;
&#xD;
          -  Informed consent given&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any severe disease that, according to the investigator, precludes the participation of&#xD;
             the subject to ANY aspect of the study&#xD;
&#xD;
          -  Temporary impairment (&gt;1 year) which is likely to be cured quickly&#xD;
&#xD;
          -  Subject consenting to none of the aspects of the study.&#xD;
&#xD;
        For Non-Disabled People (control group):&#xD;
&#xD;
        Inclusion criteria:&#xD;
&#xD;
          -  Age 15 to 45 years in an interval of 5 years compared to the index PWD;&#xD;
&#xD;
          -  Same sex as the index PWD;&#xD;
&#xD;
          -  Not answering to the WG criteria for disability;&#xD;
&#xD;
          -  Living in the same enumeration area as the Index PWD;&#xD;
&#xD;
          -  Informed consent given.&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  Any conditions, that - according to the interviewer - don't permit to participate at&#xD;
             any part of the study;&#xD;
&#xD;
          -  Subject consenting to none of the aspects of the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>15 Years</minimum_age>
    <maximum_age>49 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Pierre DE BEAUDRAP, MD, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Institut de Recherche pour le Developpement (IRD)</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Gervais BENINGISSE, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Institut de Formation et Recherche Demographique (IFORD)</affiliation>
  </overall_official>
  <location>
    <facility>
      <address>
        <city>Yaounde</city>
        <country>Cameroon</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Cameroon</country>
  </location_countries>
  <removed_countries>
    <country>Burkina Faso</country>
  </removed_countries>
  <verification_date>July 2016</verification_date>
  <study_first_submitted>July 11, 2014</study_first_submitted>
  <study_first_submitted_qc>July 16, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 17, 2014</study_first_posted>
  <last_update_submitted>July 11, 2016</last_update_submitted>
  <last_update_submitted_qc>July 11, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 12, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>HIV Infections</mesh_term>
  </condition_browse>
  <pending_results>
    <submitted>July 2, 2019</submitted>
    <returned>August 13, 2019</returned>
  </pending_results>
  <!-- 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/NCT02192658
org study id: ANRS 12302 - HandiVIH
nct id: NCT02192658
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
According to the recent World Report on Disability, around 15% of the world population lives
      with a disability and 80% of people with disabilities (PWD) live in developing countries.
      More and more evidence show that PWD are more likely to be poor, vulnerable to physical and
      sexual violence, and to have less access to education. Therefore, PWD are likely to have an
      increased risk for HIV infection, potentially being a key population in regard to this
      epidemic.

      The vulnerability of PWD was recognized in 2007 by the United Nations Convention on the
      Rights of Persons with Disabilities. However, data on the extent how PWD are affected by HIV
      is still very limited. As a result, PWD are usually overlooked by National AIDS Control
      Programmes and few projects specifically targeting them have been developed.

      Recognizing the need for appropriate and reliable data to help protect the rights of PWD and
      achieve a better inclusion of disability in National AIDS Control Programmes, the Institute
      of Research for Development (IRD), the Institut de Formation et Recherche Demographique
      (IFORD) and Handicap International (HI) propose this study that aims to provide quantitative
      and qualitative data on the vulnerability of PWD to HIV infection in Cameroon and Burkina
      Faso, in order to define if this vulnerable population is also a Key Population in relation
      to the HIV epidemic. This study adopts a multidisciplinary approach (quantitative and
      qualitative methods). Quantitative data are collected only in Cameroon.

      Only the quantitative study is described here.
OBJECTIVES:

      The general objective of this study is to provide information on the vulnerability of PWD to
      HIV infection.

      The objectives of the quantitative component of this study are:

      Estimation of the HIV burden among PWD:

        -  To estimate the prevalence of HIV in PWD comprehensively and for each of the following
           disabilities 1) hearing 2) visual 3) mobility 4) cognitive (intellectual)

        -  To compare the HIV prevalence between PWD and non-disabled matched controls

        -  To assess the association between PWD's social network characteristics and the risk for
           HIV

      Assessment of the knowledge, behaviour and practice toward HIV infection and sexual and
      reproductive health (including contraception) overall and for each of the impairment groups
      mentioned above:

        -  To describe and analyze the knowledge, attitude and behaviours related to HIV infection

        -  To compare the knowledge, attitude and behaviours between PWD and non-disabled matched
           controls

        -  To describe sexual and reproductive activities of PWD

        -  To describe and analyze the access and actual use of family planning methods in PWD

      Access to HIV prevention and health careglobally and for each of the impairment groups
      mentioned above:

        -  To describe and analyze the determinants of and barriers to access to prevention and
           testing services

        -  To describe and analyze the determinants of and barriers to access to care

        -  To compare the access to services between PWD and non-disabled matched controls

      Specific objectives related to disability:

        -  To describe the population of PWD in Yaoundé

        -  To describe and analyze the characteristics of the social networks of PWD

      METHODOLOGY

      Study design:

      This is a cross sectionnal study assessing HIV prevalence, HIV risk factors and sexual &
      reproductive health of PWD compared to a control group of Non-Disabled People. PWD are
      sampled from the general population using a two-step sampling method. Eligible subjects are
      proposed an HIV test and to respond to a questionnaire on their Knowledge, Attitudes and
      Practices (KAP) in relation to HIV and SRH, on their social network and on their access to
      prevention and care services. The life-grid interview method is used to collect data on
      subject's history of social participation, employment, resources, sexual partnership and
      reproductive life. Controls are selected from the PWD's neighborhood.

      Sample size:

      850 disabled subjects and 850 non-disabled controls

      Study location: Yaounde, Cameroon

      Estimated planning or Study timetable :

      Study start date: April 2014 (exploratory work) Total trial/study duration: 24 months
time perspective: Cross-Sectional
measure: HIV prevalence
time frame: 10 months
description: HIV prevalence among People With Disability compared to Non-Disabled People. HIV serology will be assessed by rapid diagnostic tests.
measure: Risk factors
time frame: 10 months
description: Risk factors to HIV and reproductive health behaviours among People with Disability compared to Non-Disabled People. Different risk factors (Knowledges - Attitudes - Practices) for HIV and reproductive health behaviours will be assessed in both groups, the people with disability group and the control non-disabled people group, through a questionnaire.
measure: Access to care
time frame: 10 months
description: Access to services among People with Disability compared to Non-Disabled People. Access to reproductive health and HIV services will be assessed in both groups, through a questionnaire.
arm group label: People with Disability (PWD) (N= 850)
description: PWD will be identified thanks to the disability screening tool developped by the Washington Group (WG). This tool is based on the WHO International Classification of Functionning (ICF).
A stratified cluster sampling in 2 steps will be used in both, Yaounde and Ouagadougou. Each city will be divided in enumeration areas (EAs). First step : EAs will be drawn randomly with probability proportional to their size in number of households. Second step: in each EA, 30 households will be randomly drawn and each person living in these households will be screened for disability with the WG tool, according to the inclusion and exclusion criteria.
arm group label: Non-Disabled People (control group) (N= 850)
description: For each PWD, 1 non-disabled control person will be randomly chosen from the census list of the same enumeration area. Control will also be matched on age and sex.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 15 Years
maximum age: 49 Years
healthy volunteers: No
last name: Pierre DE BEAUDRAP, MD, PhD
role: Study Director
affiliation: Institut de Recherche pour le Developpement (IRD)
last name: Gervais BENINGISSE, PhD
role: Study Director
affiliation: Institut de Formation et Recherche Demographique (IFORD)
facility: 
country: Cameroon
country: Burkina Faso
responsible party type: Sponsor
mesh term: HIV Infections
submitted: July 2, 2019
returned: August 13, 2019