HIV/STI Risk Reduction for Incarcerated Women With Interpersonal Violence

Brown University

Status: Completed

Conditions: Physical Violence; Sexual Assault; Sexual Abuse; Unsafe Sex

Treatments: Behavioral: Nutrition Program (NP); Behavioral: Women's Prison CoOp (WPC)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01907126

R34MH094188 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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).

Enrollment: 42 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Exclusion criteria

• Cannot complete intake interview due to problems with reality testing, brain impairment, or language barrier

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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42 participants in 2 patient groups, including a placebo group

Women's Prison CoOp (WPC)

Experimental group

Description:

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.

Treatment:

Behavioral: Women's Prison CoOp (WPC)

Nutrition program (NP)

Placebo Comparator group

Description:

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

Treatment:

Behavioral: Nutrition Program (NP)