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NCT01907126 · ClinicalTrials.gov registry record · NA
HIV/STI Risk Reduction for Incarcerated Women With Interpersonal Violence
A NA study of Sexual Assault and Unsafe Sex, sponsored by Brown University.
- Completed
- Registry status
- NA
- Development phase
- 42
- Enrollment target
- 3
- Study locations
NCT01907126 is a NA study of Sexual Assault and Unsafe Sex that has completed, run by Brown University. The registered enrollment target is 42 participants, below the 747-participant average among 12 other Sexual Assault trials with a reported enrollment target (94% lower). The trial reports 3 study locations across 2 states.
The verdict
NCT01907126, a NA study of Sexual Assault and Unsafe Sex, has completed, sponsored by Brown University.
- COMPLETED
- Registry status
- NA
- Development phase
- 42 participants
- Enrollment target
- 3
- Study locations
Study 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).
Conditions Studied
Interventions
- BEHAVIORAL Nutrition Program (NP)
- BEHAVIORAL Women's Prison CoOp (WPC)
Study Locations (3)
Massachusetts
- Massachusetts CorrectionalInstitution - Framingham - Framingham
- South Middlesex CorrectionalCenter - Framingham
Rhode Island
- Adult Correctional Institution - Cranston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 42 participants |
| Start Date | 2011-09 |
| Est. Completion | 2014-10 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01907126
The ClinicalTrials.gov registry entry for NCT01907126 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 42 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 747-participant average among 12 other Sexual Assault trials with a reported enrollment target (94% lower). The listed sponsor is Brown University, which has 231 total studies on file at ClinicalTrials.gov.
The record links to 4 conditions, with Sexual Assault appearing as the primary indexed condition, and to 2 interventions - of which Nutrition Program (NP) is the first listed.
NCT01907126 reports 3 study locations spanning 2 distinct geographic areas - top geographies include Massachusetts, Rhode Island.
Frequently Asked Questions
What is clinical trial NCT01907126 about?
NCT01907126 is a clinical study titled "HIV/STI Risk Reduction for Incarcerated Women With Interpersonal Violence". 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 traini...
What is the current status of trial NCT01907126?
This trial is currently completed. It is a NA study. The enrollment target is 42 participants. The study started on 2011-09. Estimated completion is 2014-10.
What conditions does trial NCT01907126 study?
This clinical trial studies the following conditions: Sexual Assault, Unsafe Sex, Sexual Abuse, Physical Violence.
What interventions are being tested in trial NCT01907126?
The interventions under investigation include: Nutrition Program (NP) (BEHAVIORAL), Women's Prison CoOp (WPC) (BEHAVIORAL).
Who is sponsoring clinical trial NCT01907126?
This trial is sponsored by Brown University, which has 231 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01907126 being conducted?
This trial has 3 study locations across Massachusetts, Rhode Island. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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