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NCT01172704 · ClinicalTrials.gov registry record · Phase 2

HIV/AIDS, Severe Mental Illness and Homelessness

A Phase 2 study, sponsored by Boston Medical Center.

Completed
Registry status
Phase 2
Development phase
240
Enrollment target

NCT01172704 is a Phase 2 study that has completed, run by Boston Medical Center. The registered enrollment target is 240 participants.

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The verdict

NCT01172704, a Phase 2 study, has completed, sponsored by Boston Medical Center.

COMPLETED
Registry status
Phase 2
Development phase
240 participants
Enrollment target

Study Summary

This is a two-arm randomized controlled trial (RCT) for 308 seriously mentally ill adults (SMI) engaging in risky sexual and/or drug use behavior, comparing a brief HIV primary and secondary prevention intervention \[Skills building and Motivational Interviewing (SB-MI) to Care as Usual (CAU)\]. The study setting is a large urban safety net Medical Center and outcomes will be measured at 3, 6, and 12 months. The SB-MI intervention (3 sessions + booster) was initially developed as the experimental condition in an R34 pilot project which demonstrated its feasibility and promise. For the proposed project, the investigators will recruit a larger sample which includes men and women with and without HIV, from various ethnic and racial groups, sexual orientations and housing arrangements, as well as a range of psychiatric disorders and functional capacities. In this way the investigators can more rigorously demonstrate the promise of SB-MI with SMI. The investigators will also conduct a sub-study after the 6 month follow-up to examine the impact at 12 months of an additional booster session for SB-MI participants. The investigators specific aims are: 1. To examine the effectiveness of a brief, tailored primary and secondary risk reduction strategy to CAU for people with serious mental illness. The desired outcomes include: * Decreased frequency of risk behaviors (number of partners, number of encounters) * Increased use of barrier precautions and IV needle cleaning * Positive changes in information and motivation, as well as risk behaviors * Increased HIV Counseling and Testing for those who do not know their HIV status 2. To examine the effectiveness of a 2nd booster session after the 6 month follow-up for ½ of participants randomized to SB-MI. The primary outcome will be: * Decreased frequency of risk behaviors and increased use of barrier precautions at the 12 month follow-up

Interventions

  • BEHAVIORAL Skills Building - Motivational Interviewing

Trial Details

FieldValue
Enrollment Target 240 participants
Start Date 2010-10
Est. Completion 2016-01
Phase Phase 2

Sponsor

Boston Medical Center

253 total trials

What the Registry Record Tells You About NCT01172704

The ClinicalTrials.gov registry entry for NCT01172704 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 240 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boston Medical Center, which has 253 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which Skills Building - Motivational Interviewing is the first listed.

NCT01172704 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01172704 about?

NCT01172704 is a clinical study titled "HIV/AIDS, Severe Mental Illness and Homelessness". This is a two-arm randomized controlled trial (RCT) for 308 seriously mentally ill adults (SMI) engaging in risky sexual and/or drug use behavior, comparing a brief HIV primary and secondary prevention intervention \[Skills building and Motivational Interviewing (SB-MI) to Care as Usual (CAU)\]. The...

What is the current status of trial NCT01172704?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 240 participants. The study started on 2010-10. Estimated completion is 2016-01.

What interventions are being tested in trial NCT01172704?

The interventions under investigation include: Skills Building - Motivational Interviewing (BEHAVIORAL).

Who is sponsoring clinical trial NCT01172704?

This trial is sponsored by Boston Medical Center, which has 253 total clinical trials registered on ClinicalTrials.gov.

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

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.