HIV/AIDS, Severe Mental Illness and Homelessness

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

Conditions

• HIV
• AIDS

Interventions

BEHAVIORAL

Skills Building - Motivational Interviewing

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.

Sponsors & Collaborators

• Boston Medical Center

  lead OTHER

Principal Investigators

• Stephen Brady, PhD · Boston University

• Jori Berger-Greenstein, PhD · Boston University

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

19 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2010-10-31

Primary Completion

2015-04-30

Completion

2016-01-31

Countries

• United States

Study Locations