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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01907126
• Other study ID #: R34MH094188
• Secondary ID: R34MH094188
• Status: Completed
• Phase: Phase 2
• First received: May 28, 2013
• Last updated: January 12, 2016
• Start date: September 2011
• Est. completion date: October 2014

Study information

• Verified date: January 2016
• Source: Brown University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Data and Safety Monitoring Board
• Study type: Interventional

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

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

Intervention

Behavioral:
• 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.
• 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.

Locations

Country	Name	City	State
United States	Adult Correctional Institution	Cranston	Rhode Island
United States	Massachusetts CorrectionalInstitution - Framingham	Framingham	Massachusetts
United States	South Middlesex CorrectionalCenter	Framingham	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Brown University	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Affect Management	Affect management is measured by the Distress Tolerance Scale (DTS). It is a 15-item self report measure that assesses perceived ability to tolerate emotional distress, including ability to regulate negative affect. The investigators will calculate effect sizes and 95% confidence intervals for improvement in affect modulation measured by the DTS. Exploratory tests for differences between conditions will use HLM with the baseline score as a covariate.	Slope over time: Baseline, Pre-release, 2 months after release, 5 months after release, 8 months after release	No
Other	Perceived Social Support	Multidimensional Scale of Perceived Social Support (MSPSS) will be used to measure general social support. The investigators will calculate effect sizes and 95% confidence intervals for improvement in social support measured by the MSPSS using HLM with baseline score as a covariate.	Slope over time: Baseline, Pre-release, 2 months after release, 5 months after release, 8 months after release	No
Other	Effectiveness in Obtaining Resources (EOR) and Treatment Received	The Effectiveness in Obtaining Resources Scale assesses respondents' effectiveness in obtaining resources in 13 areas: housing, material, goods and services, education, employment, health care for themselves and their children, child care, transportation, social support, legal assistance, financial issues, and other issues regarding themselves and their children. For this study, the investigators also ask questions assessing a woman's ability to access mental health treatment, substance use, and partner violence resources. The Treatment Services Review (TSR) assesses receipt of mental health and substance use services.; The investigators will also calculate effect sizes and 95% confidence intervals for effectiveness in obtaining resources measured by the EOR total score and for total days of treatment received measured by the TSR. Exploratory tests for differences between conditions will use HLM.	Slope over time: Baseline, Pre-release, 2 months after release, 5 months after release, 8 months after release	No
Primary	Number of Unprotected Sexual Occasions (USOs; Vaginal and Anal)	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).	Slope over time: Baseline, 2 months after release, 5 months after release, 8 months after release	No
Primary	Presence of Trichomoniasis	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.	Slope over time: Baseline, 2 months after release, 5 months after release, 8 months after release	No
Primary	Treatment Acceptability	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.	2 months post release	No
Primary	Treatment Feasibility	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	2 months post release	No
Secondary	Interpersonal violence (IPV) episodes	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.	Slope over time: Baseline, 2 months after release, 5 months after release, 8 months after release	No
Secondary	PTSD Symptom Severity	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.	Slope over time: Baseline, Pre-release, 2 months after release, 5 months after release, 8 months after release	No
Secondary	Depressive Symptom Severity	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.	Slope over time: Baseline, Pre-release, 2 months after release, 5 months after release, 8 months after release	No
Secondary	Post Release Drug Using/Heavy Drinking Days	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	Slope over time: 2 months after release, 5 months after release, 8 months after release	No