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

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

Study Overview

• Status: Completed
• Conditions: Behavioral Risk for HIV
• Intervention / Treatment: Behavioral: RHANI WIves

• Study Type: Interventional
• Enrollment (Actual): 220
• Phase: Phase 2

Contacts and Locations

Study Locations

• India
  • Mumbai
    • Bhandup, Mumbai, India
      • Community

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
condom use	condom protected sex in marital relationships	4.5 months

Collaborators and Investigators

• Sponsor: University of California, San Diego
• Collaborators: 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

Publications and helpful links

General Publications

• Hameed M, O'Doherty L, Gilchrist G, Tirado-Munoz J, Taft A, Chondros P, Feder G, Tan M, Hegarty K. Psychological therapies for women who experience intimate partner violence. Cochrane Database Syst Rev. 2020 Jul 1;7(7):CD013017. doi: 10.1002/14651858.CD013017.pub2.
• Saggurti N, Nair S, Silverman JG, Naik DD, Battala M, Dasgupta A, Balaiah D, Raj A. Impact of the RHANI Wives intervention on marital conflict and sexual coercion. Int J Gynaecol Obstet. 2014 Jul;126(1):18-22. doi: 10.1016/j.ijgo.2014.01.015. Epub 2014 Apr 3.

Study record dates

Study Major Dates

• Study Start: July 1, 2010
• Primary Completion (Actual): October 1, 2011
• Study Completion (Actual): December 1, 2011

Study Registration Dates

• First Submitted: May 3, 2012
• First Submitted That Met QC Criteria: May 4, 2012
• First Posted (Estimate): May 7, 2012

Study Record Updates

• Last Update Posted (Estimate): December 4, 2014
• Last Update Submitted That Met QC Criteria: December 3, 2014
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Keywords: HIV; women; India; condom use
• Other Study ID Numbers: R21MH085312 (U.S. NIH Grant/Contract)