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Sponsors and Collaborators: |
London School of Hygiene and Tropical Medicine University of Witwatersrand, South Africa Small Enterprise Foundation, Tzaneen, South Africa National Department of Health, South Africa Henry J.Kaiser Family Foundation, USA Ford Foundation Department for International Development, United Kingdom |
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Information provided by: | London School of Hygiene and Tropical Medicine |
ClinicalTrials.gov Identifier: | NCT00242957 |
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.
Condition | Intervention |
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HIV Infections Gender Based Violence |
Behavioral: Intervention with Microfinance for AIDS and Gender Equity |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study |
Study Start Date: | June 2001 |
Estimated Study Completion Date: | April 2005 |
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:
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
Ages Eligible for Study: | 14 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
South Africa, Limpopo Province | |
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 |
Study ID Numbers: | M991108; 598; SK/RN - 03PRT/24 |
Study First Received: | October 20, 2005 |
Last Updated: | February 5, 2009 |
ClinicalTrials.gov Identifier: | NCT00242957 History of Changes |
Health Authority: | South Africa: National Health Research Ethics Council |
HIV/AIDS Gender Based Violence Structural Interventions South Africa HIV Seronegativity |
Virus Diseases Sexually Transmitted Diseases, Viral HIV Infections Sexually Transmitted Diseases |
Acquired Immunodeficiency Syndrome Retroviridae Infections Immunologic Deficiency Syndromes |
Virus Diseases Sexually Transmitted Diseases, Viral RNA Virus Infections Slow Virus Diseases Immune System Diseases HIV Infections |
Sexually Transmitted Diseases Acquired Immunodeficiency Syndrome Lentivirus Infections Infection Retroviridae Infections Immunologic Deficiency Syndromes |