Clinical trial NCT01592994: Enhancing HIV Risk Reduction Among Indian Women With Risky Husbands
Official title: Enhancing HIV Risk Reduction Among Indian Women With Risky Husbands
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Behavioral Risk for HIV
Keywords: HIV
condom use
India
women
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
name: Indian Council of Medical Research
name: Population Council
First posted: 2012-05-07
Enrollment: 220
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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


Eligibility 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

Primary outcomes:
measure: condom use
timeFrame: 4.5 months
Secondary outcomes:
Other outcomes:
Locations:
city: Bhandup
country: India
facility: Community
state: Mumbai
Study officials:
affiliation: UCSD Division of Global Public Health
name: Anita Raj, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.