The Intervention With Microfinance for AIDS and Gender Equity (IMAGE) Study
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|ClinicalTrials.gov Identifier: NCT00242957|
Recruitment Status : Completed
First Posted : October 21, 2005
Last Update Posted : February 9, 2009
|Condition or disease||Intervention/treatment||Phase|
|HIV Infections Gender Based Violence||Behavioral: Intervention with Microfinance for AIDS and Gender Equity||Not Applicable|
Background : While there is a high level of knowledge on HIV/AIDS 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 HIV/AIDS frequently co-exist, the impact of microfinance on vulnerability to HIV has not previously been explored.
Intervention Design : The IMAGE intervention combines two components:
- Microfinance: Implementation of a community-level, poverty-focused microfinance programme exclusively targeting women
- 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.
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 Type :||Interventional (Clinical Trial)|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Study Start Date :||June 2001|
|Study Completion Date :||April 2005|
- Cohort I: 12 month experience of intimate partner violence
- Cohort II: Condom use with last non-spousal partner
- Cohort III: Condom use with last non-spousal partner
- Cohort III: HIV incidence
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00242957
|Small Enterprise Foundation|
|Tzaneen, Limpopo Province, South Africa|
|Principal Investigator:||Paul M Pronyk, MD||London School of Hygiene and Tropical Medicine, UK & Rural AIDS and Development Action Research Programme, University of the Witwatersrand, South Africa|