Enhancing HIV Risk Reduction Among Indian Women With Risky Husbands (RHANI Wives)
This study has been completed.
Sponsor:
University of California, San Diego
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
ClinicalTrials.gov Identifier:
NCT01592994
First received: May 3, 2012
Last updated: December 3, 2014
Last verified: December 2014
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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:
- 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.
- 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.
|
|
|
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 (Adult) |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- married female aged 18-40 years
- fluency in Hindi or Marathi
- residence with husband in the area of study for a period of 2 months or greater
- 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
- 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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Please refer to this study by its ClinicalTrials.gov identifier: NCT01592994
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
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
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: | December 3, 2014 |
| 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 September 30, 2016