HIV/STI Risk Reduction for Incarcerated Women With Interpersonal Violence

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2014-10-31

Brief Summary

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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).

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Detailed Description

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Conditions

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Unsafe Sex Physical Violence Sexual Assault Sexual Abuse

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Women's Prison CoOp (WPC)

Will receive 5 group psychoeducation sessions plus individual pre-release and post-release goal planning sessions. Psychoeducation sessions will cover HIV risk and violence prevention, interpersonal violence-specific sexual safety skills, empowerment through knowledge and treatment, and skills for increasing affect regulation and social support.

Group Type EXPERIMENTAL

Women's Prison CoOp (WPC)

Intervention Type BEHAVIORAL

Weekly as 60-minute sessions, 3 group and two individual sessions during incarceration as close to prison discharge as possible. Session 1 focuses on understanding and reviewing HIV risks, including interpersonal violence. Session 2 addresses gender, power, violence, and affect management to counter the emotional effects of violence. Session 3 addresses IV-specific sexual safety skills, including affect management skills. Session 4 helps women begin to develop a personalized safety plan, which may include increasing social support and access to resources. Session 5 helps her finalize and practice the plan, and Session 6 problem-solves any difficulties that have arisen in executing the plan.

Nutrition program (NP)

Participants in this condition will receive dose-matched nutrition education.

Group Type PLACEBO_COMPARATOR

Nutrition Program (NP)

Intervention Type BEHAVIORAL

Nutrition Program (NP) participants will receive the same number, format, and schedule of group and individual 60-minute sessions, which will focus on low-cost strategies for improving nutrition.

Interventions

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Nutrition Program (NP)

Nutrition Program (NP) participants will receive the same number, format, and schedule of group and individual 60-minute sessions, which will focus on low-cost strategies for improving nutrition.

Intervention Type BEHAVIORAL

Women's Prison CoOp (WPC)

Weekly as 60-minute sessions, 3 group and two individual sessions during incarceration as close to prison discharge as possible. Session 1 focuses on understanding and reviewing HIV risks, including interpersonal violence. Session 2 addresses gender, power, violence, and affect management to counter the emotional effects of violence. Session 3 addresses IV-specific sexual safety skills, including affect management skills. Session 4 helps women begin to develop a personalized safety plan, which may include increasing social support and access to resources. Session 5 helps her finalize and practice the plan, and Session 6 problem-solves any difficulties that have arisen in executing the plan.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Females in prison
* Experienced lifetime interpersonal violence (includes physical or sexual assault or abuse)
* At least one unprotected sexual occasion with a male partner within the 90 days prior to incarceration
* Approximately 6-10 weeks before release
* Expect to be released to locations within RI or MA