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Clinical Trials/NCT01592994
NCT01592994
Completed
Phase 2

Enhancing HIV Risk Reduction Among Indian Women With Risky Husbands

University of California, San Diego1 site in 1 country220 target enrollmentJuly 2010

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Behavioral Risk for HIV
Sponsor
University of California, San Diego
Enrollment
220
Locations
1
Primary Endpoint
condom use
Status
Completed
Last Updated
11 years ago

Overview

Brief Summary

This grant involved the development, implementation, and assessment of the feasibility and acceptability of an HIV prevention intervention for at-risk wives in Mumbai, RHANI Wives (Raising HIV Awareness among Non-Infected Indian Wives). The RHANI Wives intervention was adapted from the HIV Intervention Program (HIV-IP), a community-based, multi-session HIV intervention with demonstrated effectiveness among Latinas whose primary risk for HIV was from their primary male partner (Raj et al. 2001).

Specific aims of this study are as follows:

  1. To adapt HIV-IP, a culture and gender-tailored HIV intervention for Latinas with demonstrated effectiveness in reducing risk for HIV, and to create RHANI Wives for use with at-risk Indian wives.
  2. To determine the feasibility and acceptability of RHANI Wives with at risk wives* in India. A two-group cluster randomized trial will involve random assignment of 12 neighborhood clusters (25 women/cluster) to receive the intervention (n=150) or a control condition (n=150). Intervention effects on the more proximal and likely safer sex mediating outcome of marital communication for this feasibility trial will be assessed via surveys at baseline and 3 month follow-up.

NOTE: Only 220 participants were able to be recruited into the study.

*At risk wives are defined as having a husband at higher risk for transactional sex based on wife's reports of his risky alcohol use (drunk in past 30 days, 3+ drinking days in past 7 days) or partner violence perpetration

Registry
clinicaltrials.gov
Start Date
July 2010
End Date
December 2011
Last Updated
11 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Anita Raj

Professor

University of California, San Diego

Eligibility Criteria

Inclusion Criteria

  • married female aged 18-40 years
  • fluency in Hindi or Marathi
  • residence with husband in the area of study for a period of 2 months or greater
  • reports that husband engaged in either heavy drinking- past 30 day drunken behavior, or frequent drinking- 3 drinking days in past 7 days, or lifetime spousal violence perpetration
  • no plans to relocate from the area in the next year.

Exclusion Criteria

  • cognitive impairment indicated at recruitment

Outcomes

Primary Outcomes

condom use

Time Frame: 4.5 months

condom protected sex in marital relationships

Study Sites (1)

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