Trial record 10 of 16 for:    " April 18, 2012":" May 18, 2012"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]

Enhancing HIV Risk Reduction Among Indian Women With Risky Husbands (RHANI Wives)

This study has been completed.
Sponsor:
Collaborators:
Indian Council of Medical Research
Population Council
Information provided by (Responsible Party):
Anita Raj, University of California, San Diego
ClinicalTrials.gov Identifier:
NCT01592994
First received: May 3, 2012
Last updated: May 4, 2012
Last verified: May 2012
  Purpose

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


Condition Intervention Phase
Behavioral Risk for HIV
Behavioral: RHANI WIves
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Enhancing HIV Risk Reduction Among Indian Women With Risky Husbands

Resource links provided by NLM:


Further study details as provided by University of California, San Diego:

Primary Outcome Measures:
  • condom use [ Time Frame: 4.5 months ] [ Designated as safety issue: No ]
    condom protected sex in marital relationships


Enrollment: 220
Study Start Date: July 2010
Study Completion Date: December 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: control
control participants received basic messages on the utility of condoms in protecting from HIV and other STIs, and they were informed about local HIV/STI counseling and testing services.
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.
Experimental: RHANI Wives Intervention
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) 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.
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.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01592994

Locations
India
Community
Bhandup, Mumbai, India
Sponsors and Collaborators
University of California, San Diego
Indian Council of Medical Research
Population Council
Investigators
Principal Investigator: Anita Raj, PhD UCSD Division of Global Public Health
  More Information

No publications provided by University of California, San Diego

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Anita Raj, Professor, University of California, San Diego
ClinicalTrials.gov Identifier: NCT01592994     History of Changes
Other Study ID Numbers: R21MH085312
Study First Received: May 3, 2012
Last Updated: May 4, 2012
Health Authority: United States: Institutional Review Board
India: Indian Council on Medical Research

Keywords provided by University of California, San Diego:
HIV
condom use
India
women

ClinicalTrials.gov processed this record on August 26, 2014