- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02606344
Effect of a Micro-finance-based Intervention for the Prevention of Intimate-partner Violence and HIV
November 13, 2015 updated by: NMP Medical Research Institute
Effect of a Micro-finance-based Intervention for the Prevention of Intimate-partner Violence and HIV: a Multi-centric Randomized Trial
The high rates of HIV infection in women have brought into sharp focus the problem of violence against women.
There is a growing recognition that women and girls' risk of and vulnerability to HIV infection is shaped by deep-rooted and pervasive gender inequalities violence against them in particular.
The links between intimate partner violence and HIV/AIDS are explained by biological as well as sociocultural and economic factors.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
561
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Gujarat
-
Mahesana, Gujarat, India, 384001
- Sonal Foundation
-
-
Rajasthan
-
Hindaun, Rajasthan, India
- Vinita Nursing Home
-
-
Uttarakhand
-
Deharadun, Uttarakhand, India
- NMP Medical Research Institute
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- at least 18 years old;
- Must plan to reside in study areas for the next 12 months
- Must visit camp at least 1 time per week
- Must provide contact information of friend or family member
Exclusion Criteria:
- Unwilling to provide local information
- Psychological disturbance, cognitive impairment or threatening behavior
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention Group (IG)
Loans were provided to poor women who enrolled in the intervention group.
A participatory learning and action curriculum was integrated into loan meetings, which took place every 2 weeks.
|
|
No Intervention: Control Group (CG)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Incidence of New Sexually Transmitted Infections
Time Frame: 12 months
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Proportion of women Reporting Physical, Sexual, or Psychological Partner Violence
Time Frame: 12 Months
|
12 Months
|
Proportion of unprotected sexual acts with partner
Time Frame: 12 month
|
12 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Neha Sharma, PhD, Macmillan Research Group UK
- Principal Investigator: Kalvinder Kour, MBA, NMP Medical Research Institute, India
- Principal Investigator: Vinita Makkad, MD, Vinita Nursing Home, India
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2014
Primary Completion (Actual)
October 1, 2015
Study Completion (Actual)
November 1, 2015
Study Registration Dates
First Submitted
November 13, 2015
First Submitted That Met QC Criteria
November 13, 2015
First Posted (Estimate)
November 17, 2015
Study Record Updates
Last Update Posted (Estimate)
November 17, 2015
Last Update Submitted That Met QC Criteria
November 13, 2015
Last Verified
November 1, 2015
More Information
Terms related to this study
Other Study ID Numbers
- nmp/22186
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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