Disability and HIV: Vulnerability of People With Disabilities to HIV Infection in Sub-Saharan Africa

HIV Clinical Trial

— HandiVIH  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02192658
• Other study ID #: ANRS 12302 - HandiVIH
• Status: Completed
• Phase: N/A
• First received: July 11, 2014
• Last updated: July 11, 2016
• Start date: November 2014
• Est. completion date: July 2016

Study information

• Verified date: July 2016
• Source: French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Cameroon: Division of Health Operations Research
• Study type: Observational

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1610
• Est. completion date: July 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years to 49 Years

Eligibility

For PWD:

Inclusion Criteria:

• Age 15 to 49 years

• WG criteria: = 1 major impairment or 2 minor difficulties with an activity

• Informed consent given

Exclusion Criteria:

• 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):

Inclusion criteria:

• 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.

Exclusion criteria:

• 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.

Study Design

Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• Disability
• HIV
• HIV Infections
• Reproductive Health

Locations

Country	Name	City	State
n/a

Sponsors (6)

Lead Sponsor	Collaborator
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)	Centre de Recherche Internationale pour la Santé de l’Université de Ouagadougou, Forum Camerounais de Psychologie, Handicap International, Institut de Formation et de Recherche Démographique, Institut de Recherche pour le Developpement

Country where clinical trial is conducted

Cameroon, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Access to care	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.	10 months	No
Primary	HIV prevalence	HIV prevalence among People With Disability compared to Non-Disabled People. HIV serology will be assessed by rapid diagnostic tests.	10 months	No
Secondary	Risk factors	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.	10 months	No