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

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ClinicalTrials.gov Identifier: NCT01592994
Recruitment Status : Completed
First Posted : May 7, 2012
Last Update Posted : December 4, 2014
Sponsor:
Collaborators:
National Institute of Mental Health (NIMH)
Indian Council of Medical Research
Population Council
Information provided by (Responsible Party):
Anita Raj, University of California, San Diego

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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


Condition or disease Intervention/treatment Phase
Behavioral Risk for HIV Behavioral: RHANI WIves Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 220 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Enhancing HIV Risk Reduction Among Indian Women With Risky Husbands
Study Start Date : July 2010
Actual Primary Completion Date : October 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
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.
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.


Outcome Measures
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Primary Outcome Measures :
  1. condom use [ Time Frame: 4.5 months ]
    condom protected sex in marital relationships


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes 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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01592994


Locations
India
Community
Bhandup, Mumbai, India
Sponsors and Collaborators
University of California, San Diego
National Institute of Mental Health (NIMH)
Indian Council of Medical Research
Population Council
Investigators
Principal Investigator: Anita Raj, PhD UCSD Division of Global Public Health
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 ( U.S. NIH Grant/Contract )
First Posted: May 7, 2012    Key Record Dates
Last Update Posted: December 4, 2014
Last Verified: December 2014

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