Enhancing HIV Risk Reduction Among Indian Women With Risky Husbands

NCT01592994 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 220

Last updated 2014-12-04

No results posted yet for this study

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01592994 on ClinicalTrials.gov