NCT02192658

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,610

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 11, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 17, 2014

Completed
4 months until next milestone

Study Start

First participant enrolled

November 1, 2014

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

July 12, 2016

Status Verified

July 1, 2016

Enrollment Period

1.1 years

First QC Date

July 11, 2014

Last Update Submit

July 11, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • HIV prevalence

    HIV prevalence among People With Disability compared to Non-Disabled People. HIV serology will be assessed by rapid diagnostic tests.

    10 months

Secondary Outcomes (1)

  • Risk factors

    10 months

Other Outcomes (1)

  • Access to care

    10 months

Study Arms (2)

People with Disability (PWD) (N= 850)

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.

Non-Disabled People (control group) (N= 850)

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.

Eligibility Criteria

Age15 Years - 49 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

Community sample: \- PWD are 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 is used in Yaounde. The city has been divided in enumeration areas (EAs). First step : EAs are drawn randomly with probability proportional to their size in number of households. Second step: in each EA, 30 households are randomly drawn and each person living in these households is screened for disability with the WG tool, according to the inclusion and exclusion criteria. \- For each PWD, 1 non-disabled control person is randomly chosen from the census list of the same enumeration area. Controls are matched on age and sex.

You may qualify if:

  • Age 15 to 49 years
  • WG criteria: ≥ 1 major impairment or 2 minor difficulties with an activity
  • Informed consent given

You may not qualify if:

  • Any severe disease that, according to the investigator, precludes the participation of the subject to ANY aspect of the study
  • Temporary impairment (\>1 year) which is likely to be cured quickly
  • Subject consenting to none of the aspects of the study.
  • For Non-Disabled People (control group):
  • Age 15 to 45 years in an interval of 5 years compared to the index PWD;
  • Same sex as the index PWD;
  • Not answering to the WG criteria for disability;
  • Living in the same enumeration area as the Index PWD;
  • Informed consent given.
  • Any conditions, that - according to the interviewer - don't permit to participate at any part of the study;
  • Subject consenting to none of the aspects of the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Yaoundé, Cameroon

Location

Related Publications (1)

  • De Beaudrap P, Pasquier E, Tchoumkeu A, Touko A, Essomba F, Brus A, Desgrees du Lou A, Aderemi TJ, Hanass-Hancock J, Eide AH, Mont D, Mac-Seing M, Beninguisse G. HandiVIH--A population-based survey to understand the vulnerability of people with disabilities to HIV and other sexual and reproductive health problems in Cameroon: protocol and methodological considerations. BMJ Open. 2016 Feb 4;6(2):e008934. doi: 10.1136/bmjopen-2015-008934.

Study Officials

  • Pierre DE BEAUDRAP, MD, PhD

    Institut de Recherche pour le Developpement (IRD)

    STUDY DIRECTOR
  • Gervais BENINGISSE, PhD

    Institut de Formation et Recherche Demographique (IFORD)

    STUDY DIRECTOR

Study Design

Study Type
observational
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 11, 2014

First Posted

July 17, 2014

Study Start

November 1, 2014

Primary Completion

December 1, 2015

Study Completion

July 1, 2016

Last Updated

July 12, 2016

Record last verified: 2016-07

Locations