HIV/STI Risk Reduction for Incarcerated Women With Interpersonal Violence
- Conditions
- Physical ViolenceUnsafe SexSexual AbuseSexual Assault
- Interventions
- Behavioral: Nutrition Program (NP)Behavioral: Women's Prison CoOp (WPC)
- Registration Number
- NCT01907126
- Lead Sponsor
- Brown University
- Brief 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 42
- 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
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Nutrition program (NP) Nutrition Program (NP) Participants in this condition will receive dose-matched nutrition education. Women's Prison CoOp (WPC) 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.
- Primary Outcome Measures
Name Time Method Presence of Trichomoniasis Slope over time: Baseline, 2 months after release, 5 months after release, 8 months after release The investigators will calculate odds ratios and 95% confidence intervals for any positive trichomoniasis test during follow-up using logistic regression, with baseline trichomoniasis status as a covariate. The presence of Trichomoniasis is measured by rapid test.
Treatment Feasibility 2 months post release One of the primary goals of a treatment development study is to demonstrate the feasibility of the proposed treatment and of the study and recruitment methods. As a result, the investigators will assess the feasibility of the research procedures by examining study recruitment and refusal rates, participants' willingness to be randomized, follow-up rates, reliability and range of responses to study questionnaires, and success of the interventionist training program
Number of Unprotected Sexual Occasions (USOs; Vaginal and Anal) Slope over time: Baseline, 2 months after release, 5 months after release, 8 months after release The investigators will calculate effect sizes and confidence intervals for number of USOs. The number of USOs will be measured by the Timeline Follow Back (TLFB).
Treatment Acceptability 2 months post release The investigators will assess the feasibility and acceptability of WPC and NP by examining rates of treatment attendance, rates of treatment completion (attending at least 5 of the 6 scheduled individual sessions) and drop-out, and scores on the End of Treatment Questionnaire. Additionally, they will examine reasons for termination for consistent patterns. Acceptability of both WPC and NP using data from Client Satisfaction Questionnaire and detailed exit interviews will be examined.
- Secondary Outcome Measures
Name Time Method PTSD Symptom Severity Slope over time: Baseline, Pre-release, 2 months after release, 5 months after release, 8 months after release PTSD Symptom Severity as measured by the Davidson Trauma Scale (DTS). The investigators will calculate effect sizes and 95% confidence intervals for reduction in PTSD symptoms using the DTS total scores. Exploratory tests for differences between conditions will use HLM with baseline scores as covariates.
Interpersonal violence (IPV) episodes Slope over time: Baseline, 2 months after release, 5 months after release, 8 months after release Episodes of interpersonal violence (physical or sexual abuse or assault) as measured by the Trauma History Questionnaire (THQ) and the Conflict Tactic Scale (CTS2). The investigators will calculate the effect size and 95% confidence intervals for number of interpersonal violence episodes during the follow-up period using Trauma History Q data. For women who have been in at least one romantic relationship during the follow-up period, the investigators will also explore differences in IPV severity using CTS2 scores. Exploratory tests for differences between conditions will use hierarchical linear modeling (HLM), with baseline scores as covariates.
Post Release Drug Using/Heavy Drinking Days Slope over time: 2 months after release, 5 months after release, 8 months after release Total number of days that women used drugs or had 4+ drinks as measured by the Timeline Followback (TLFB). Self-report data will be compared to significant other report, urine drug screens, and breath alcohol tests. The investigators will calculate effect sizes and 95% confidence intervals for number of drug using/heavy drinking days using TLFB data. Exploratory tests for differences bet-ween conditions will use HLM with using/heavy drinking days in the 90 prior to incarceration as a covariate
Depressive Symptom Severity Slope over time: Baseline, Pre-release, 2 months after release, 5 months after release, 8 months after release Depressive Symptom Severity as measured by the Quick Inventory of Depressive Symptomatology Self Report (QIDS-SR). The investigators will calculate effect sizes and 95% confidence intervals for reduction in depressive symptoms using the QIDS-SR total scores. Exploratory tests for differences between conditions will use HLM with baseline scores as covariates.
Trial Locations
- Locations (3)
Massachusetts CorrectionalInstitution - Framingham
🇺🇸Framingham, Massachusetts, United States
South Middlesex CorrectionalCenter
🇺🇸Framingham, Massachusetts, United States
Adult Correctional Institution
🇺🇸Cranston, Rhode Island, United States