Skip to content

Enhancing HIV Risk Reduction Among Indian Women With Risky Husbands

Enhancing HIV Risk Reduction Among Indian Women With Risky Husbands

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01592994
Acronym
RHANI Wives
Enrollment
220
Registered
2012-05-07
Start date
2010-07-31
Completion date
2011-12-31
Last updated
2014-12-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Behavioral Risk for HIV

Keywords

HIV, condom use, India, women

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

Interventions

BEHAVIORALRHANI 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

National Institute of Mental Health (NIMH)
CollaboratorNIH
Indian Council of Medical Research
CollaboratorOTHER_GOV
Population Council
CollaboratorOTHER
University of California, San Diego
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes

Inclusion criteria

1. married female aged 18-40 years 2. fluency in Hindi or Marathi 3. residence with husband in the area of study for a period of 2 months or greater 4. 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 5. no plans to relocate from the area in the next year.

Exclusion criteria

* cognitive impairment indicated at recruitment

Design outcomes

Primary

MeasureTime frameDescription
condom use4.5 monthscondom protected sex in marital relationships

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 8, 2026