NCT01907126

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2011

Typical duration for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2011

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

May 28, 2013

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 24, 2013

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
Last Updated

March 20, 2025

Status Verified

March 1, 2025

Enrollment Period

3.1 years

First QC Date

May 28, 2013

Last Update Submit

March 18, 2025

Conditions

Unsafe SexPhysical ViolenceSexual AssaultSexual Abuse

Keywords

HIVSexually transmitted infectionsSexual abusePhysical abuseWomenPrison

Outcome Measures

Primary Outcomes (4)

  • 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

  • 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

  • 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

  • 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

Secondary Outcomes (4)

  • Interpersonal violence (IPV) episodes

    Slope over time: Baseline, 2 months after release, 5 months after release, 8 months after release

  • PTSD Symptom Severity

    Slope over time: Baseline, Pre-release, 2 months after release, 5 months after release, 8 months after release

  • Depressive Symptom Severity

    Slope over time: Baseline, Pre-release, 2 months after release, 5 months after release, 8 months after release

  • Post Release Drug Using/Heavy Drinking Days

    Slope over time: 2 months after release, 5 months after release, 8 months after release

Other Outcomes (3)

  • Affect Management

    Slope over time: Baseline, Pre-release, 2 months after release, 5 months after release, 8 months after release

  • Perceived Social Support

    Slope over time: Baseline, Pre-release, 2 months after release, 5 months after release, 8 months after release

  • Effectiveness in Obtaining Resources (EOR) and Treatment Received

    Slope over time: Baseline, Pre-release, 2 months after release, 5 months after release, 8 months after release

Study Arms (2)

Women's Prison CoOp (WPC)

EXPERIMENTAL

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)

Nutrition program (NP)

PLACEBO COMPARATOR

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

Behavioral: Nutrition Program (NP)

Interventions

Nutrition Program (NP)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.

Nutrition program (NP)
Women's Prison CoOp (WPC)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.

Women's Prison CoOp (WPC)

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Massachusetts CorrectionalInstitution - Framingham

Framingham, Massachusetts, 01702, United States

Location

South Middlesex CorrectionalCenter

Framingham, Massachusetts, 01702, United States

Location

Adult Correctional Institution

Cranston, Rhode Island, 02920, United States

Location

Related Publications (1)

  • Kuo CC, Rosen RK, Zlotnick C, Wechsberg WM, Peabody M, Johnson JE. Sexual health prevention for incarcerated women: eroticising safe sex during re-entry to the community. BMJ Sex Reprod Health. 2018 Jun 28:bmjsrh-2017-200024. doi: 10.1136/bmjsrh-2017-200024. Online ahead of print.

    PMID: 29954877DERIVED

MeSH Terms

Conditions

Unsafe SexSexually Transmitted Diseases

Interventions

Food Assistance

Condition Hierarchy (Ancestors)

Sexual BehaviorBehaviorCommunicable DiseasesInfectionsGenital DiseasesUrogenital DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Public AssistanceFinancing, GovernmentFinancing, OrganizedEconomicsHealth Care Economics and Organizations

Study Officials

  • Jennifer E Johnson, PhD

    Brown University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor (Research)

Study Record Dates

First Submitted

May 28, 2013

First Posted

July 24, 2013

Study Start

September 1, 2011

Primary Completion

October 1, 2014

Study Completion

October 1, 2014

Last Updated

March 20, 2025

Record last verified: 2025-03

Locations

US(3)