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COMPLETED NA

HIV/STI Risk Reduction for Incarcerated Women With Interpersonal Violence

NCT01907126 · View on ClinicalTrials.gov ↗

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).

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

FieldValue
Enrollment Target 42 participants
Start Date 2011-09
Est. Completion 2014-10
Phase NA

Sponsor

Brown University

268 total trials

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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. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 42 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Brown University, which has 268 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT01907126 reports 3 study locations spanning 2 distinct geographic areas — top geographies include Massachusetts, Rhode Island. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT01907126?

The interventions under investigation include: Nutrition Program (NP) (BEHAVIORAL), Women's Prison CoOp (WPC) (BEHAVIORAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01907126?

This trial is sponsored by Brown University, which has 268 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial