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| Tracking Information | |||||
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| First Received Date ICMJE | October 20, 2005 | ||||
| Last Updated Date | February 5, 2009 | ||||
| Start Date ICMJE | June 2001 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00242957 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | The Intervention With Microfinance for AIDS and Gender Equity (IMAGE) Study | ||||
| Official Title ICMJE | |||||
| 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. |
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| Detailed Description | 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 |
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| Study Phase | |||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Prevention, Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study | ||||
| Condition ICMJE |
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| Intervention ICMJE | Behavioral: Intervention with Microfinance for AIDS and Gender Equity | ||||
| Study Arms / Comparison Groups | |||||
| Publications * | Pronyk PM, Hargreaves JR, Kim JC, Morison LA, Phetla G, Watts C, Busza J, Porter JD. Effect of a structural intervention for the prevention of intimate-partner violence and HIV in rural South Africa: a cluster randomised trial. Lancet. 2006 Dec 2;368(9551):1973-83. | ||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | |||||
| Completion Date | April 2005 | ||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 14 Years and older | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | South Africa | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00242957 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | M991108; 598; SK/RN - 03PRT/24 | ||||
| Study Sponsor ICMJE | London School of Hygiene and Tropical Medicine | ||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| Information Provided By | London School of Hygiene and Tropical Medicine | ||||
| Verification Date | December 2008 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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