HIV/STI Risk Reduction for Incarcerated Women With Interpersonal Violence

This study is currently recruiting participants.
Verified July 2013 by Brown University
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Dr. Jennifer Johnson, Brown University
ClinicalTrials.gov Identifier:
NCT01907126
First received: May 28, 2013
Last updated: July 24, 2013
Last verified: July 2013
  Purpose

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).


Condition Intervention Phase
Unsafe Sex
Physical Violence
Sexual Assault
Sexual Abuse
Behavioral: Nutrition Program (NP)
Behavioral: Women's Prison CoOp (WPC)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: HIV/STI Risk Reduction for Incarcerated Women With Interpersonal Violence

Resource links provided by NLM:


Further study details as provided by Brown University:

Primary Outcome Measures:
  • Number of Unprotected Sexual Occasions (USOs; Vaginal and Anal) [ Time Frame: Slope over time: Baseline, 2 months after release, 5 months after release, 8 months after release ] [ Designated as safety issue: No ]
    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).

  • Presence of Trichomoniasis [ Time Frame: Slope over time: Baseline, 2 months after release, 5 months after release, 8 months after release ] [ Designated as safety issue: No ]
    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 Acceptability [ Time Frame: 2 months post release ] [ Designated as safety issue: No ]
    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.

  • Treatment Feasibility [ Time Frame: 2 months post release ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • Interpersonal violence (IPV) episodes [ Time Frame: Slope over time: Baseline, 2 months after release, 5 months after release, 8 months after release ] [ Designated as safety issue: No ]
    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.

  • PTSD Symptom Severity [ Time Frame: Slope over time: Baseline, Pre-release, 2 months after release, 5 months after release, 8 months after release ] [ Designated as safety issue: No ]
    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.

  • Depressive Symptom Severity [ Time Frame: Slope over time: Baseline, Pre-release, 2 months after release, 5 months after release, 8 months after release ] [ Designated as safety issue: No ]
    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.

  • Post Release Drug Using/Heavy Drinking Days [ Time Frame: Slope over time: 2 months after release, 5 months after release, 8 months after release ] [ Designated as safety issue: No ]
    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


Other Outcome Measures:
  • Affect Management [ Time Frame: Slope over time: Baseline, Pre-release, 2 months after release, 5 months after release, 8 months after release ] [ Designated as safety issue: No ]
    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.

  • Perceived Social Support [ Time Frame: Slope over time: Baseline, Pre-release, 2 months after release, 5 months after release, 8 months after release ] [ Designated as safety issue: No ]
    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.

  • Effectiveness in Obtaining Resources (EOR) and Treatment Received [ Time Frame: Slope over time: Baseline, Pre-release, 2 months after release, 5 months after release, 8 months after release ] [ Designated as safety issue: No ]

    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.



Estimated Enrollment: 40
Study Start Date: September 2011
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
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.
Placebo Comparator: Nutrition program (NP)
Participants in this condition will receive dose-matched nutrition education.
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01907126

Contacts
Contact: Marlanea Peabody, BPH 401-444-1934 marlanea_peabody@brown.edu

Locations
United States, Massachusetts
Massachusetts CorrectionalInstitution - Framingham Recruiting
Framingham, Massachusetts, United States, 01702
South Middlesex CorrectionalCenter Recruiting
Framingham, Massachusetts, United States, 01702
United States, Rhode Island
Adult Correctional Institution Recruiting
Cranston, Rhode Island, United States, 02920
Sponsors and Collaborators
Brown University
Investigators
Principal Investigator: Jennifer E Johnson, PhD Brown University
  More Information

No publications provided

Responsible Party: Dr. Jennifer Johnson, Associate Professor (Research), Brown University
ClinicalTrials.gov Identifier: NCT01907126     History of Changes
Other Study ID Numbers: R34 MH094188, R34MH094188
Study First Received: May 28, 2013
Last Updated: July 24, 2013
Health Authority: United States: Data and Safety Monitoring Board

Keywords provided by Brown University:
HIV
Sexually transmitted infections
Sexual abuse
Physical abuse
Women
Prison

ClinicalTrials.gov processed this record on April 20, 2014