Effect of a Micro-finance-based Intervention for the Prevention of Intimate-partner Violence and HIV

HIV Clinical Trial

Official title:

Effect of a Micro-finance-based Intervention for the Prevention of Intimate-partner Violence and HIV: a Multi-centric Randomized Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02606344
• Other study ID #: nmp/22186
• Status: Completed
• Phase: N/A
• First received: November 13, 2015
• Last updated: November 13, 2015
• Start date: September 2014
• Est. completion date: November 2015

Study information

• Verified date: November 2015
• Source: NMP Medical Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 561
• Est. completion date: November 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• AIDS
• Domestic Violence
• HIV

Intervention

Other:
• Mico-finance based intervention

Locations

Country	Name	City	State
India	NMP Medical Research Institute	Deharadun	Uttarakhand
India	Vinita Nursing Home	Hindaun	Rajasthan
India	Sonal Foundation	Mahesana	Gujarat

Sponsors (4)

Lead Sponsor	Collaborator
NMP Medical Research Institute	Macmillan Research Group UK, Sonal Foundation, India, Vinita Nursing Home, India

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of New Sexually Transmitted Infections		12 months	No
Secondary	Proportion of women Reporting Physical, Sexual, or Psychological Partner Violence		12 Months	No
Secondary	Proportion of unprotected sexual acts with partner		12 month	No