Violence and HIV Risk Among Women
VHRW
HIV Risk Reduction for Women Reporting Intimate Partner Violence
2 other identifiers
interventional
120
1 country
1
Brief Summary
The purpose of the study is to test the feasibility, acceptability, and efficacy of an adapted intervention that is theoretically and empirically guided by the Information-Motivation-Behavioral skills model (IMB) and aims at reducing sexual risk behavior among women who have experienced Intimate Partner Violence (IPV), as well as such an intervention.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2012
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 20, 2012
CompletedStudy Start
First participant enrolled
September 1, 2012
CompletedFirst Posted
Study publicly available on registry
September 28, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2013
CompletedFebruary 19, 2014
February 1, 2014
1.1 years
July 20, 2012
February 17, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Change from Baseline in sexual risk behavior at 3 months
Sexual risk behavior is assessed by self-reported number sexual partners in the last three months and number of episodes of unprotected sex with each partner
at the completion of 3 months after the intervention
Secondary Outcomes (1)
Change from Baseline in experience of violence at 3 months
At the end 3-months after the end of the intervention
Study Arms (2)
community support group
ACTIVE COMPARATORsupporting positive and healthy relationships
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Women will be eligible to participate in the research study if they meet the following criteria:
- between ages 18 and 49;
- heterosexually active;
- have experienced intimate partner violence in the last three months;
- have engaged in risky sexual behavior in the past three months;
- not currently pregnant or trying to become pregnant; and
- physically and psychologically capable of providing informed consent. All subjects will be required to provide written informed consent prior to enrolling in the study.
You may not qualify if:
- Persons who meet one or more of the following criteria will be excluded from the study:
- men;
- women who have active psychosis or impaired mental status (confirmed with a Mini-Mental Status Exam);
- are unable to understand spoken English;
- are less than 18 years old or greater than 49 years old;
- are currently pregnant or trying to become pregnant
- women who are exclusively in same-sex relationships.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Rochester
Rochester, New York, 14642, United States
Study Officials
- PRINCIPAL INVESTIGATOR
Mona Mittal, PhD
University of Rochester
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 20, 2012
First Posted
September 28, 2012
Study Start
September 1, 2012
Primary Completion
October 1, 2013
Study Completion
October 1, 2013
Last Updated
February 19, 2014
Record last verified: 2014-02