Ignite Creation Date:
2024-05-05 @ 12:07 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00242957
Status:
COMPLETED
Last Update Posted:
2009-02-09
First Post:
2005-10-20
Brief Title:
The Intervention With Microfinance for AIDS and Gender Equity IMAGE Study
Sponsor:
London School of Hygiene and Tropical Medicine
Organization:
London School of Hygiene and Tropical Medicine
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2008-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The IMAGE Study is a cluster randomised trial of a structural intervention for the prevention of HIV and gender based violence being conducted in South Africa
Detailed Description:
Background While there is a high level of knowledge on HIVAIDS in rural South Africa structural factors including poverty and gender inequalities have critically impeded prevention efforts based on modifying individual risk Attempts to rigorously evaluate structural interventions for the prevention of HIV infection in sub-Saharan Africa remain under-developed
Microfinance is a well-established development tool with nearly 100 million clients world wide Loans to poor households particularly to women facilitate business development opportunities Prior research has demonstrated significant economic and social benefits Health benefits have also been documented and include improvements in immunization coverage better nutrition and contraceptive use While poverty and HIVAIDS frequently co-exist the impact of microfinance on vulnerability to HIV has not previously been explored
Intervention Design The IMAGE intervention combines two components
1 Microfinance Implementation of a community-level poverty-focused microfinance programme exclusively targeting women
2 Gender and HIV training A two phase participatory learning and action curriculum has been integrated into bi-weekly microfinance meetings The first phase consists of 10 structured sessions facilitated by trainers while the second phase facilitates community mobilsation activities from within the microfinance centre
Study Design
The IMAGE Study randomised four pairs of communities that were matched on size and accessibility The intervention communities received the IMAGE intervention from late 2001 Comparison communities will receive the intervention strategy approximately three years later
The study enrols individuals into three pairs of cohorts intervention and comparison Data is collected on the major health-related endpoints as detailed below Qualitative and quantitative data are also collected to document processes of change and potential pathways of impact Data analysis will be appropriate to the cluster-randomised study design
Cohort I Women recruited to IMAGE intervention and Randomly selected women eligible to join IMAGE from control villages Sample size per arm - 450 Length of follow up - 2 years Primary outcomes 12 month experience of intimate partner violence
Cohort II Young people aged 14-35 living in the households of women in cohort I Intervention and Comparison Project sample size per arm - 750 Duration of follow up - 2 years Primary outcomes - Condom use with last non-spousal partner
Cohort III Randomly selected young people aged 14-35 living in Intervention communities and Comparison communities Project sample size per arm - 1500 Duration of follow up - 3 years Primary outcomes - Condom use with last non-spousal partner HIV incidence
Microfinance is a well-established development tool with nearly 100 million clients world wide Loans to poor households particularly to women facilitate business development opportunities Prior research has demonstrated significant economic and social benefits Health benefits have also been documented and include improvements in immunization coverage better nutrition and contraceptive use While poverty and HIVAIDS frequently co-exist the impact of microfinance on vulnerability to HIV has not previously been explored
Intervention Design The IMAGE intervention combines two components
1 Microfinance Implementation of a community-level poverty-focused microfinance programme exclusively targeting women
2 Gender and HIV training A two phase participatory learning and action curriculum has been integrated into bi-weekly microfinance meetings The first phase consists of 10 structured sessions facilitated by trainers while the second phase facilitates community mobilsation activities from within the microfinance centre
Study Design
The IMAGE Study randomised four pairs of communities that were matched on size and accessibility The intervention communities received the IMAGE intervention from late 2001 Comparison communities will receive the intervention strategy approximately three years later
The study enrols individuals into three pairs of cohorts intervention and comparison Data is collected on the major health-related endpoints as detailed below Qualitative and quantitative data are also collected to document processes of change and potential pathways of impact Data analysis will be appropriate to the cluster-randomised study design
Cohort I Women recruited to IMAGE intervention and Randomly selected women eligible to join IMAGE from control villages Sample size per arm - 450 Length of follow up - 2 years Primary outcomes 12 month experience of intimate partner violence
Cohort II Young people aged 14-35 living in the households of women in cohort I Intervention and Comparison Project sample size per arm - 750 Duration of follow up - 2 years Primary outcomes - Condom use with last non-spousal partner
Cohort III Randomly selected young people aged 14-35 living in Intervention communities and Comparison communities Project sample size per arm - 1500 Duration of follow up - 3 years Primary outcomes - Condom use with last non-spousal partner HIV incidence
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None