Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2025-12-26 @ 1:43 AM
Study NCT ID:
NCT01592994
Status:
COMPLETED
Last Update Posted:
2014-12-04
First Post:
2012-05-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Enhancing HIV Risk Reduction Among Indian Women With Risky Husbands
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 220}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-12', 'completionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-12-03', 'studyFirstSubmitDate': '2012-05-03', 'studyFirstSubmitQcDate': '2012-05-04', 'lastUpdatePostDateStruct': {'date': '2014-12-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-05-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'condom use', 'timeFrame': '4.5 months', 'description': 'condom protected sex in marital relationships'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['HIV', 'condom use', 'India', 'women'], 'conditions': ['Behavioral Risk for HIV']}, 'referencesModule': {'references': [{'pmid': '32608505', 'type': 'DERIVED', '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."}, {'pmid': '24795094', 'type': 'DERIVED', '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.'}]}, 'descriptionModule': {'briefSummary': "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).\n\nSpecific aims of this study are as follows:\n\n1. 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.\n2. 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.\n\nNOTE: Only 220 participants were able to be recruited into the study.\n\n\\*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"}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. married female aged 18-40 years\n2. fluency in Hindi or Marathi\n3. residence with husband in the area of study for a period of 2 months or greater\n4. 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\n5. no plans to relocate from the area in the next year.\n\nExclusion Criteria:\n\n* cognitive impairment indicated at recruitment'}, 'identificationModule': {'nctId': 'NCT01592994', 'acronym': 'RHANI Wives', 'briefTitle': 'Enhancing HIV Risk Reduction Among Indian Women With Risky Husbands', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Diego'}, 'officialTitle': 'Enhancing HIV Risk Reduction Among Indian Women With Risky Husbands', 'orgStudyIdInfo': {'id': 'R21MH085312', 'link': 'https://reporter.nih.gov/quickSearch/R21MH085312', 'type': 'NIH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'control', 'description': '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.'}, {'type': 'EXPERIMENTAL', 'label': 'RHANI Wives Intervention', 'description': '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.', 'interventionNames': ['Behavioral: RHANI WIves']}], 'interventions': [{'name': 'RHANI WIves', 'type': 'BEHAVIORAL', 'description': '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.', 'armGroupLabels': ['RHANI Wives Intervention']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bhāndup', 'state': 'Mumbai', 'country': 'India', 'facility': 'Community', 'geoPoint': {'lat': 19.15, 'lon': 72.93333}}], 'overallOfficials': [{'name': 'Anita Raj, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UCSD Division of Global Public Health'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Diego', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Mental Health (NIMH)', 'class': 'NIH'}, {'name': 'Indian Council of Medical Research', 'class': 'OTHER_GOV'}, {'name': 'Population Council', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Anita Raj', 'investigatorAffiliation': 'University of California, San Diego'}}}}