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HIV Prevention With the Mentally Ill

This study has been completed.
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Boston Medical Center
ClinicalTrials.gov Identifier:
NCT00643305
First received: March 20, 2008
Last updated: May 2, 2013
Last verified: March 2008
History of Changes
  Purpose

The purpose of this study is to determine whether motivational interviewing and skills building interventions reduce HIV risk behavior for adults with serious and persistent mental illness.


Condition Intervention Phase
HIV Infections
 Behavioral: Skills Building with Motivational Interviewing
Behavioral: Skills Building
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: HIV Prevention With the Mentally Ill: Motivation-Skills

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Boston Medical Center:

Primary Outcome Measures:
  • Self-reported reduction in HIV risk behavior for infection/re-infection of HIV, as measured by administration of the TimeLine Follow-Back. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Skillfulness in behaviors critical for efficacious use of HIV risk reduction strategies, measured by standardized role-plays and demonstrations [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • HIV-related knowledge, as measured by the HIV Knowledge Questionnaire (HIV-KQ) [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Accessing HIV counseling and testing, assessed by self-report [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Enrollment: 53
Study Start Date: February 2006
Study Completion Date: January 2009
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Skills Building with Motivational Interviewing (SB-MI)- combines education and general skills-building participants can use to reduce their at-risk behavior for HIV with increasing motivation to change HIV risk behaviors
 Behavioral: Skills Building with Motivational Interviewing
Based on the Stages of Change model, participants are provided with feedback related to their current HIV risk and Motivational Interviewing strategies are used to increase motivation to decrease HIV risk behaviors. Participants are also provided with information and training in skills critical for reducing HIV risk
Active Comparator: 2
Skills Building (SB) - provides education and general skills-building for reduction of HIV risk behaviors.
 Behavioral: Skills Building
Participants are provided with information and training in skills critical for reducing HIV risk.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age 19 and older
  • Able to provide consent
  • Able to understand and speak English
  • Willing and able to participate
  • Suffer from a serious and persistent mental illness (SMI)
  • Have had at least one HIV risk behavior (unprotected sexual activity, sharing injection drug needles without following Center for Disease Control guidelines for needle-cleaning, sexual activity while under the influence of drugs or alcohol) during the three-month period prior to the baseline evaluation

Exclusion Criteria:

  • Do not suffer from a serious mental illness
  • Have not engaged in an HIV risk behavior during the three-month period prior to the baseline evaluation.
  • Unable to provide consent
  • Unable to understand and speak English
  • Under the age of 19
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00643305

Locations
United States, Massachusetts
Boston Medical Center
Boston, Massachusetts, United States, 02118
Sponsors and Collaborators
Boston Medical Center
National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: Stephen Brady, Ph.D. The Trustees of Boston University, BUMS
  More Information

No publications provided

Responsible Party: Boston Medical Center
ClinicalTrials.gov Identifier: NCT00643305     History of Changes
Other Study ID Numbers: Project HELP, 5R34MH075644-02
Study First Received: March 20, 2008
Last Updated: May 2, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Boston Medical Center:
HIV
Motivational Interviewing
Skills
Prevention
 Mental illness
Risk reduction
HIV/AIDS
HIV Seronegativity

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
 Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on May 19, 2013