HIVHandiVIHNCT02192658
Disability and HIV: Vulnerability of People With Disabilities to HIV Infection in Sub-Saharan Africa
An observational study of HIV and Reproductive Health, run by ANRS, Emerging Infectious Diseases at 1 site in Cameroon.
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. Read more about this study
- Who is it for?
- Ages 15 to 49 years
- Conditions the study is for
- HIV, Reproductive Health, Disability
- How many people
- 1,610 participants
- Where
- 1 siteCameroon
- Study dates
- Nov 2014to Jul 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 49 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- Age 15 to 49 years
- WG criteria: ≥ 1 major impairment or 2 minor difficulties with an activity
- Informed consent given
- 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.
Who cannot join
- 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):
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read more
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.
Read the detailed 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
- Conditions
- HIV, Reproductive Health, Disability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
HIV prevalence
HIV prevalence among People With Disability compared to Non-Disabled People. HIV serology will be assessed by rapid diagnostic tests.
Measured: 10 months
Secondary outcomes (1)
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.
Measured: 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2014 (estimated)
- Study startNov 2014
- Primary completionDec 2015
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by ANRS, Emerging Infectious DiseasesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Cross-sectional
- Enrolment
- 1,610 participants (actual)
Sponsor and investigators
- Lead sponsor
- ANRS, Emerging Infectious Diseases
- Sponsor type
- Other government
- Collaborators
- Handicap International, Institut de Recherche pour le Developpement, Institut de Formation et de Recherche Démographique, Forum Camerounais de Psychologie, Centre de Recherche Internationale pour la Santé de l'Université de Ouagadougou
- Responsible party
- Sponsor
- Investigators
- Pierre DE BEAUDRAP, MD, PhD, Study director, Institut de Recherche pour le Developpement (IRD)Gervais BENINGISSE, PhD, Study director, Institut de Formation et Recherche Demographique (IFORD)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02192658
- Sponsor's protocol ID
- ANRS 12302 - HandiVIH
- Acronym
- HandiVIH
- Status last verified
- Jul 2016
- First submitted
- 11 Jul 2014
- Last updated
- 12 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 26846895
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02192658
- Acronym / sponsor ID
- HandiVIH / ANRS 12302 - HandiVIH
- Conditions
- HIV, Reproductive Health, Disability
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,610 participants (actual)
- Lead sponsor
- ANRS, Emerging Infectious DiseasesOther government
- Collaborators
- Handicap International, Institut de Recherche pour le Developpement, Institut de Formation et de Recherche Démographique, Forum Camerounais de Psychologie, Centre de Recherche Internationale pour la Santé de l'Université de Ouagadougou
- Study start
- Nov 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 17 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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
Study design
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 15 to 49 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (8 listed)
- Age 15 to 49 years
- WG criteria: ≥ 1 major impairment or 2 minor difficulties with an activity
- Informed consent given
- Age 15 to 45 years in an interval of 5 years compared to the index PWD;
- Same sex as the index PWD;
Key exclusion criteria (6 listed)
- 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.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
HIV prevalence
Time frame: 10 months
HIV prevalence among People With Disability compared to Non-Disabled People. HIV serology will be assessed by rapid diagnostic tests.
1 secondary outcome
Risk factors
Time frame: 10 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2016.
- Derived from this study: PubMed 26846895De 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pierre DE BEAUDRAP, MD, PhD study director
Institut de Recherche pour le Developpement (IRD)
Gervais BENINGISSE, PhD study director
Institut de Formation et Recherche Demographique (IFORD)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV and Reproductive Health, run by ANRS, Emerging Infectious Diseases at 1 site in Cameroon.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Cameroon. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HIV prevalence (time frame: 10 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02192658, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2016.