HIV/AIDS, Severe Mental Illness and Homelessness

NCT01172704 | Completed Phase 2 DMC

• 1 other identifier: BMC HIV Prevention
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief 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:

• 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
• 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

Conditions

HIV; AIDS

Keywords

Motivational Interviewing; Serious Mental Illness; HIV/AIDS; HIV Testing

Outcome Measures

Primary Outcomes (1)

• Frequency of Risk Taking Behavior

  Mean Changes from baseline to follow-ups at 6 and 12 months for constructs of the IMB (Information Motivation Behavior) Model will be larger for participants randomized to the SB-MI condition compared to CAU.

  One year

Secondary Outcomes (1)

• HIV Counseling & Testing

  One year

Study Arms (2)

Care as Usual

ACTIVE COMPARATOR

Participants randomized to CAU receive the standard care given to patients of the Boston Medical Center who are interested in learning more about HIV/AIDS. Included in this care would be referrals for HIV counseling and testing.

Behavioral: Skills Building - Motivational Interviewing

Skills Building - Motivational Interviewing

EXPERIMENTAL

Participants randomized to SB-MI will receive three individual sessions and a booster. Content of the sessions are as follows; Session 1: Risk Behavior Feedback \& Building Motivation; Session 2: Building Motivation \& Skill Selection and Practice; Session 3: Developing Change Plan \& Skill Practice and Booster Session(s): Review Change Plan Implementation, Maintaining Motivation \& Skill Practice.

Behavioral: Skills Building - Motivational Interviewing

Interventions

Skills Building - Motivational Interviewing BEHAVIORAL

SB-MI incorporates Motivational Interviewing strategies into a psycho-educational HIV risk reduction protocol to help participants identify high-risk behaviors, reduce ambivalence about these behaviors, increase motivation to change behaviors, and develop a specific plan of action for risk reduction. Consistent with MI, information gathered at baseline regarding HIV risk behaviors is systematically reviewed in a personalized way with each participant at the outset of the intervention. This is designed to engage participants in becoming active agents in the change process and to assist participants in recognizing discrepancies between their current risk behaviors and goals and values, which typically do not include HIV infection or transmitting HIV to others. Also consistent with the principles of MI, participants are empowered to choose those educational and skills-based modules which "fit" their personal risk profile and values.

Care as Usual; Skills Building - Motivational Interviewing

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Meet criteria for a serious mental illness (SMI)
• Engaged in HIV risk behavior during the previous 3 months
• Able to attend assessment and intervention appointments
• Have receptive and expressive English language skills sufficient for meaningful participation
• Are 19 years of age or older.
• Capable of providing informed consent.

You may not qualify if:

• Unable to comprehend the assessment and/or intervention materials.
• Unable to provide independent consent and/or under a full guardianship.
• Do not meet criteria for a serious mental illness (SMI)
• Have not engaged in HIV risk behavior during the previous 3 months

Sponsors & Collaborators

• Boston Medical Center: lead

Study Sites (1)

Boston 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 Brady, PhD

  Boston University

  PRINCIPAL INVESTIGATOR

• Jori Berger-Greenstein, PhD

  Boston University

  STUDY DIRECTOR

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: June 9, 2010
• First Posted: July 30, 2010
• Study Start: October 1, 2010
• Primary Completion: April 1, 2015
• Study Completion: January 1, 2016
• Last Updated: April 1, 2016

Record last verified: 2016-03

Locations

US (1)