NCT00242957

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Jun 2001

Typical duration for not_applicable hiv-infections

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2001

Completed
3.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2005

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

October 20, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 21, 2005

Completed
Last Updated

February 9, 2009

Status Verified

December 1, 2008

First QC Date

October 20, 2005

Last Update Submit

February 5, 2009

Conditions

Keywords

HIV/AIDSGender Based ViolenceStructural InterventionsSouth AfricaHIV Seronegativity

Outcome Measures

Primary Outcomes (4)

  • 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

Interventions

Eligibility Criteria

Age14 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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 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.

You may not qualify if:

  • Lack of informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Small Enterprise Foundation

Tzaneen, Limpopo, South Africa

Location

Related Publications (1)

  • 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.

Related Links

MeSH Terms

Conditions

HIV InfectionsAcquired Immunodeficiency Syndrome

Interventions

MethodsGender Equity

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesSlow Virus Diseases

Intervention Hierarchy (Ancestors)

Investigative TechniquesHealth InequitiesHealth StatusDemographyPopulation Characteristics

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 20, 2005

First Posted

October 21, 2005

Study Start

June 1, 2001

Study Completion

April 1, 2005

Last Updated

February 9, 2009

Record last verified: 2008-12

Locations