Improving HIV Prevention Skills in People With Serious Mental Illnesses

NCT00356291 | Completed Phase 2

• 2 other identifiers: R34MH075644DAHBR 9A-ASNM
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

Brief Summary

This study will evaluate the effectiveness of motivational interviewing plus skill building in reducing HIV risk behavior in people with serious mental illnesses.

Conditions

HIV/AIDS

Keywords

HIV; AIDS; Prevention; Serious Mental Illness

Outcome Measures

Primary Outcomes (4)

• Timeline Followback (TLFB) measures of HIV risk behaviors and use of HIV risk prevention strategies (including use of male and female condoms, dental dams, and recommended intravenous needle-cleaning)

  Measured at Months 3 and 6

• Communication and negotiation skills

  Measured at Months 3 and 6

• Simulated demonstrations of use of male and female condoms, dental dams, and intravenous needle cleaning

  Measured at Months 3 and 6

• Access of HIV counseling and testing

  Measured at Months 3 and 6

Secondary Outcomes (2)

• HIV knowledge (HIV/AIDS Knowledge Questionnaire - HIV-KQ)

  Measured at Months 3 and 6

• Multidimensional Condom Attitude Scale (MCAS)

  Measured at Months 3 and 6

Study Arms (2)

1

EXPERIMENTAL

Participants will receive Skill-Building and Motivational Interviewing.

Behavioral: Skill-Building (SB) plus Motivational Interviewing

2

ACTIVE COMPARATOR

Participants will receive Skill-Building.

Behavioral: Skill-Building (SB)

Interventions

Skill-Building (SB) plus Motivational Interviewing BEHAVIORAL

SB is a 4 to 5 session individually-based psychoeducational intervention. Participants meet weekly with an interventionist for 3 to 4 weeks and then receive a booster session 3 months after baseline. The traditional Skill-Building intervention will be augmented with Motivational Interviewing techniques.

1

Skill-Building (SB) BEHAVIORAL

SB is a 4-session individually-based psychoeducational HIV risk reduction intervention. Participants meet weekly with an interventionist for 3 weeks and then receive a booster session 3 months after baseline.

2

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Meets criteria for a serious and persistent mental illness (as defined by the Massachusetts Department of Mental Health)
• English-speaking
• Engagement in HIV risk behavior within 3 months prior to study entry
• Ability to keep study-related appointments

You may not qualify if:

• Unstable mental status

Sponsors & Collaborators

• Boston Medical Center: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Boston University Medical Center

Boston, Massachusetts, 02118, United States

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Stephen M. Brady, PhD

  Boston University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Mental Health Counseling & Behavioral Medicine Program Associate Professor of Psychiatry Boston University School of Medicine

Study Record Dates

• First Submitted: July 21, 2006
• First Posted: July 25, 2006
• Study Start: April 1, 2007
• Primary Completion: October 1, 2008
• Study Completion: October 1, 2008
• Last Updated: July 25, 2013

Record last verified: 2013-07

Locations

US (1)