NCT00643305

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
53

participants targeted

Target at P25-P50 for phase_2 hiv-infections

Timeline
Completed

Started Feb 2006

Typical duration for phase_2 hiv-infections

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2006

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

March 20, 2008

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 26, 2008

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed
Last Updated

May 3, 2013

Status Verified

March 1, 2008

Enrollment Period

2.7 years

First QC Date

March 20, 2008

Last Update Submit

May 2, 2013

Conditions

HIV Infections

Keywords

HIVMotivational InterviewingSkillsPreventionMental illnessRisk reductionHIV/AIDSHIV Seronegativity

Outcome Measures

Primary Outcomes (4)

  • Self-reported reduction in HIV risk behavior for infection/re-infection of HIV, as measured by administration of the TimeLine Follow-Back.

    6 months

  • Skillfulness in behaviors critical for efficacious use of HIV risk reduction strategies, measured by standardized role-plays and demonstrations

    6 months

  • HIV-related knowledge, as measured by the HIV Knowledge Questionnaire (HIV-KQ)

    6 months

  • Accessing HIV counseling and testing, assessed by self-report

    6 months

Study Arms (2)

1

EXPERIMENTAL

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

2

ACTIVE COMPARATOR

Skills Building (SB) - provides education and general skills-building for reduction of HIV risk behaviors.

Behavioral: Skills Building

Interventions

Skills Building with Motivational InterviewingBEHAVIORAL

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

1
Skills BuildingBEHAVIORAL

Participants are provided with information and training in skills critical for reducing HIV risk.

2

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

MeSH Terms

Conditions

HIV InfectionsMental DisordersRisk Reduction BehaviorAcquired Immunodeficiency Syndrome

Interventions

Motivational Interviewing

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesBehaviorSlow Virus Diseases

Intervention Hierarchy (Ancestors)

Directive CounselingCounselingMental Health ServicesBehavioral Disciplines and ActivitiesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Stephen Brady, Ph.D.

    The Trustees of Boston University, BUMS

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 20, 2008

First Posted

March 26, 2008

Study Start

February 1, 2006

Primary Completion

October 1, 2008

Study Completion

January 1, 2009

Last Updated

May 3, 2013

Record last verified: 2008-03

Locations

US(1)