Clinical trial NCT01907126: HIV/STI Risk Reduction for Incarcerated Women With Interpersonal Violence
Official title: HIV/STI Risk Reduction for Incarcerated Women With Interpersonal Violence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Unsafe Sex
Physical Violence
Sexual Assault
Sexual Abuse
Keywords: HIV
Sexually transmitted infections
Sexual abuse
Physical abuse
Women
Prison
Lead sponsor: Brown University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2013-07-24
Enrollment: 42
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility 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

Primary outcomes:
measure: Number of Unprotected Sexual Occasions (USOs; Vaginal and Anal)
timeFrame: Slope over time: Baseline, 2 months after release, 5 months after release, 8 months after release
measure: Presence of Trichomoniasis
timeFrame: Slope over time: Baseline, 2 months after release, 5 months after release, 8 months after release
measure: Treatment Acceptability
timeFrame: 2 months post release
measure: Treatment Feasibility
timeFrame: 2 months post release
Secondary outcomes:
measure: Interpersonal violence (IPV) episodes
timeFrame: Slope over time: Baseline, 2 months after release, 5 months after release, 8 months after release
measure: PTSD Symptom Severity
timeFrame: Slope over time: Baseline, Pre-release, 2 months after release, 5 months after release, 8 months after release
measure: Depressive Symptom Severity
timeFrame: Slope over time: Baseline, Pre-release, 2 months after release, 5 months after release, 8 months after release
measure: Post Release Drug Using/Heavy Drinking Days
timeFrame: Slope over time: 2 months after release, 5 months after release, 8 months after release
Other outcomes:
measure: Affect Management
timeFrame: Slope over time: Baseline, Pre-release, 2 months after release, 5 months after release, 8 months after release
measure: Perceived Social Support
timeFrame: Slope over time: Baseline, Pre-release, 2 months after release, 5 months after release, 8 months after release
measure: Effectiveness in Obtaining Resources (EOR) and Treatment Received
timeFrame: Slope over time: Baseline, Pre-release, 2 months after release, 5 months after release, 8 months after release
Locations:
city: Framingham
country: United States
facility: Massachusetts CorrectionalInstitution - Framingham
state: Massachusetts
city: Framingham
country: United States
facility: South Middlesex CorrectionalCenter
state: Massachusetts
city: Cranston
country: United States
facility: Adult Correctional Institution
state: Rhode Island
Study officials:
affiliation: Brown University
name: Jennifer E Johnson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.