HIV/AIDS, Severe Mental Illness and Homelessness

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by Boston Medical Center
Sponsor:
Information provided by (Responsible Party):
Boston Medical Center
ClinicalTrials.gov Identifier:
NCT01172704
First received: June 9, 2010
Last updated: July 24, 2013
Last verified: July 2013
  Purpose

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

Condition Intervention Phase
HIV
AIDS
Behavioral: Skills Building - Motivational Interviewing
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: HIV/AIDS, Severe Mental Illness and Homelessness

Resource links provided by NLM:


Further study details as provided by Boston Medical Center:

Primary Outcome Measures:
  • Frequency of Risk Taking Behavior [ Time Frame: One year ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • HIV Counseling & Testing [ Time Frame: One year ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 308
Study Start Date: October 2010
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.
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.

Detailed Description:

Our long-term objective is to reduce the incidence of HIV risk behavior for SMI by developing an intervention that can be easily translated and adapted to "real world" settings. Our proposed project is designed to augment previously-developed research on HIV risk reduction interventions for SMI. The innovations the investigators have developed include: 1) SB-MI intervention design that can be utilized with diverse participants with SM in contrast to other research which has focused on either primary or secondary prevention with a fairly discrete population, such as women of color, patients in a drug recovery program etc. The investigators will examine treatment response as a function of diverse participant characteristics; 2) SB-MI intervention is delivered in an individual format to provides a flexible structure for tailoring strategies and techniques for each participant's complex cognitive and psychosexual functioning, as well as his/her needs and values in contrast to research on HIV prevention in SMI which generally occurs in group and does not allow for individualized tailoring. In addition, our experience with group interventions is they do not easily allow for discussions of risk related to complex sexual and physical abuse histories, sex trading and other stigmatized activities characteristic of SMI. Our individualized approach affords maximum flexibility and privacy in selecting topics of intervention, which the investigators also believe to be essential to the spirit of Motivational Interviewing; 3) Previous interventions have typically been either very brief (e.g. one half-hour session) or time-intensive. In contrast, our intervention (3 sessions + 1 or 2 Booster(s)) is long enough to allow participants to form a working alliance with providers, but not so lengthy as to be burdensome or non-translatable for the real-world settings in which patients routinely seek care such as urban safety net Medical Center's; 4) a review of the literature suggests that many health behavior changes fade within a fairly short period of time; our inclusion of booster session and a sub-study examining the effect of a 2nd booster after the 6 month follow-up is a novel way of strengthening the effects of our intervention. The investigators will also be extending our follow-up period to 12 months, to allow us to further assess long-term change; and 5) No study to date has examined HIV counseling and testing as an outcome for this population (Senn & Carey, 2009). The investigators believe this represents a significant deficit in attending to the needs of SMI, given that testing and access to life-extending treatment should be an essential component to prevention interventions for SMI. Both our SB-MI and CAU conditions will include referrals for HIV testing where indicated, although the SB-MI intervention systematically supports motivation for participants seeking HIV counseling and testing services, whereas CAU provides information and general support for testing. The investigators hope to see that the attention paid to this issue in SB-MI yields greater access to HIV testing services.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01172704

Contacts
Contact: Cathryn H Rollason-Reese, MSEd 617-414-2369

Locations
United States, Massachusetts
Boston Medical Center Recruiting
Boston, Massachusetts, United States, 02118
Contact: Cathryn Rollason-Reese, MSEd    617-414-2369      
Principal Investigator: Stephen Brady, PhD         
Sub-Investigator: Jori Berger-Greenstein, PhD         
Sponsors and Collaborators
Boston Medical Center
Investigators
Principal Investigator: Stephen Brady, PhD Boston University
Study Director: Jori Berger-Greenstein, PhD Boston University
  More Information

No publications provided

Responsible Party: Boston Medical Center
ClinicalTrials.gov Identifier: NCT01172704     History of Changes
Other Study ID Numbers: BMC HIV Prevention
Study First Received: June 9, 2010
Last Updated: July 24, 2013
Health Authority: United States: Federal Government

Keywords provided by Boston Medical Center:
Motivational Interviewing
Serious Mental Illness
HIV/AIDS
HIV Testing

Additional relevant MeSH terms:
Mental Disorders
Acquired Immunodeficiency Syndrome
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immunologic Deficiency Syndromes
Immune System Diseases

ClinicalTrials.gov processed this record on July 29, 2014