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The Intervention With Microfinance for AIDS and Gender Equity (IMAGE) Study

Primary Purpose

HIV Infections, Gender Based Violence

Status
Completed
Phase
Not Applicable
Locations
South Africa
Study Type
Interventional
Intervention
Intervention with Microfinance for AIDS and Gender Equity
Sponsored by
London School of Hygiene and Tropical Medicine
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for HIV Infections focused on measuring HIV/AIDS, Gender Based Violence, Structural Interventions, South Africa, HIV Seronegativity

Eligibility Criteria

14 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Cohort I (Intervention community) : Joining the IMAGE programme Cohort I (Comparison community) : Female, Eligible to receive microfinance loan and residing in an IMAGE Comparison community, matched on community pair and age group (18-25, 26-35, 36-45, 46-55, 56+) to the index IMAGE participant. Cohort II (Intervention community) : 14-35 years old at time of interview. Current residence in the household of a woman who joins the IMAGE programme. Cohort II (Comparison community) : 14-35 years old at time of interview. Current residence in the household of the non-IMAGE participant selected for inclusion in Cohort I. Cohort III (Intervention community) : 14-35 years old at time of interview, Household member in a community where IMAGE is operating. Cohort III (Comparison community) : 14-35 years old at time of interview. Household member in an IMAGE study community where IMAGE is not operating. Exclusion Criteria: Lack of informed consent

Sites / Locations

  • Small Enterprise Foundation

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
October 20, 2005
Last Updated
February 5, 2009
Sponsor
London School of Hygiene and Tropical Medicine
Collaborators
University of Witwatersrand, South Africa, Small Enterprise Foundation, Tzaneen, South Africa, National Department of Health, South Africa, The Henry J. Kaiser Family Foundation, Ford Foundation, Department for International Development, United Kingdom
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1. Study Identification

Unique Protocol Identification Number
NCT00242957
Brief Title
The Intervention With Microfinance for AIDS and Gender Equity (IMAGE) Study
Study Type
Interventional

2. Study Status

Record Verification Date
December 2008
Overall Recruitment Status
Completed
Study Start Date
June 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2005 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
London School of Hygiene and Tropical Medicine
Collaborators
University of Witwatersrand, South Africa, Small Enterprise Foundation, Tzaneen, South Africa, National Department of Health, South Africa, The Henry J. Kaiser Family Foundation, Ford Foundation, Department for International Development, United Kingdom

4. Oversight

5. Study Description

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 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. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections, Gender Based Violence
Keywords
HIV/AIDS, Gender Based Violence, Structural Interventions, South Africa, HIV Seronegativity

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
Intervention with Microfinance for AIDS and Gender Equity
Primary Outcome Measure Information:
Title
Cohort I: 12 month experience of intimate partner violence
Title
Cohort II: Condom use with last non-spousal partner
Title
Cohort III: Condom use with last non-spousal partner
Title
Cohort III: HIV incidence

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Cohort I (Intervention community) : Joining the IMAGE programme Cohort I (Comparison community) : Female, Eligible to receive microfinance loan and residing in an IMAGE Comparison community, matched on community pair and age group (18-25, 26-35, 36-45, 46-55, 56+) to the index IMAGE participant. Cohort II (Intervention community) : 14-35 years old at time of interview. Current residence in the household of a woman who joins the IMAGE programme. Cohort II (Comparison community) : 14-35 years old at time of interview. Current residence in the household of the non-IMAGE participant selected for inclusion in Cohort I. Cohort III (Intervention community) : 14-35 years old at time of interview, Household member in a community where IMAGE is operating. Cohort III (Comparison community) : 14-35 years old at time of interview. Household member in an IMAGE study community where IMAGE is not operating. Exclusion Criteria: Lack of informed consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul M Pronyk, MD
Organizational Affiliation
London School of Hygiene and Tropical Medicine, UK & Rural AIDS and Development Action Research Programme, University of the Witwatersrand, South Africa
Official's Role
Principal Investigator
Facility Information:
Facility Name
Small Enterprise Foundation
City
Tzaneen
State/Province
Limpopo Province
Country
South Africa

12. IPD Sharing Statement

Citations:
PubMed Identifier
17141704
Citation
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. doi: 10.1016/S0140-6736(06)69744-4.
Results Reference
derived
Links:
URL
http://www.sef.co.za/
Description
Small Enterprise Foundation

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The Intervention With Microfinance for AIDS and Gender Equity (IMAGE) Study

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