HIV/STI Risk Reduction for Incarcerated Women With Interpersonal Violence

Sexual Assault Clinical Trial

Official title: HIV/STI Risk Reduction for Incarcerated Women With Interpersonal Violence

Status Completed

Clinical Trial Summary

The pilot study aims to conduct a randomized pilot trial in a sample of 40 incarcerated women with lifetime interpersonal violence who are 6-10 weeks away from release to demonstrate the feasibility and acceptability of the proposed recruitment methods and research design, of the intervention training methods, of delivering the enhanced Women's Coop and nutrition control interventions. Per recent guidance from NIMH, the investigators will also examine 95% confidence intervals around differences between the proposed intervention and a dose-matched control condition (Nutrition Program), for the following outcomes through 8 months post prison release: reduced unprotected vaginal or anal sex occasions and fewer cases of vaginal trichomoniasis (primary); reduced interpersonal violence episodes, symptoms of PTSD and depression, and drug using/heavy drinking days (secondary); and increased affect management and social support (including effectiveness in obtaining substance use, mental health treatment and other resources) (tertiary).

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Physical Violence
• Sexual Abuse
• Sexual Assault
• Unsafe Sex

• NCT number: NCT01907126
• Study type: Interventional
• Source: Brown University
• Status: Completed
• Phase: Phase 2
• Start date: September 2011
• Completion date: October 2014