HIV/AIDS, Severe Mental Illness and Homelessness
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ClinicalTrials.gov Identifier: NCT01172704 |
Recruitment Status
:
Completed
First Posted
: July 30, 2010
Last Update Posted
: April 1, 2016
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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:
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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
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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
Condition or disease | Intervention/treatment | Phase |
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HIV AIDS | Behavioral: Skills Building - Motivational Interviewing | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 240 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
Official Title: | HIV/AIDS, Severe Mental Illness and Homelessness |
Study Start Date : | October 2010 |
Actual Primary Completion Date : | April 2015 |
Actual Study Completion Date : | January 2016 |
Arm | Intervention/treatment |
---|---|
Active Comparator: Care as Usual
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.
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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.
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Experimental: Skills Building - Motivational Interviewing
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
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.
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- Frequency of Risk Taking Behavior [ Time Frame: One year ]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.
- HIV Counseling & Testing [ Time Frame: One year ]Participants in SB-MI will demonstrate higher rates of accessing HIV counseling and testing at 6 month follow-up, as compared to participants in CAU.

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Ages Eligible for Study: | 19 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01172704
United States, Massachusetts | |
Boston Medical Center | |
Boston, Massachusetts, United States, 02118 |
Principal Investigator: | Stephen Brady, PhD | Boston University | |
Study Director: | Jori Berger-Greenstein, PhD | Boston University |
Responsible Party: | Stephen Brady, Director, Mental Health Counseling & Behavioral Medicine Program Associate Professor of Psychiatry Boston University School of Medicine, Boston Medical Center |
ClinicalTrials.gov Identifier: | NCT01172704 History of Changes |
Other Study ID Numbers: |
BMC HIV Prevention |
First Posted: | July 30, 2010 Key Record Dates |
Last Update Posted: | April 1, 2016 |
Last Verified: | March 2016 |
Keywords provided by Stephen Brady, Boston Medical Center:
Motivational Interviewing Serious Mental Illness HIV/AIDS HIV Testing |
Additional relevant MeSH terms:
Mental Disorders |