Enhancing HIV Risk Reduction Among Indian Women With Risky Husbands
NCT01592994 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 220
Last updated 2014-12-04
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
Conditions
- Behavioral Risk for HIV
Interventions
- BEHAVIORAL
-
RHANI WIves
The RHANI Wives intervention included four household individual sessions and two small group community sessions delivered over 6-9 weeks. The intervention was based on Social Cognitive Theory (SCT)10 and the Theory of Gender and Power (TGP). SCT application supported focus on HIV/STI knowledge and condom skills building, as well as safer sex social norms and motivation. TGP guided the intervention focus on problem solving and skills building toward marital communication; embedded in this was gender equity counseling and support. The TGP approach allowed women to take a more active and assertive stance with husbands. Group sessions reinforced individual session knowledge and skills building and provided local social support.
Sponsors & Collaborators
-
National Institute of Mental Health (NIMH)
collaborator NIH -
Indian Council of Medical Research
collaborator OTHER_GOV -
Population Council
collaborator OTHER -
University of California, San Diego
lead OTHER
Principal Investigators
-
Anita Raj, PhD · UCSD Division of Global Public Health
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 40 Years
- Sex
- FEMALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2010-07-31
- Primary Completion
- 2011-10-31
- Completion
- 2011-12-31
Countries
- India
Study Locations
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