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HIV/AIDS, Severe Mental Illness and Homelessness

Primary Purpose

HIV, AIDS

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Skills Building - Motivational Interviewing
Sponsored by
Boston Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for HIV focused on measuring Motivational Interviewing, Serious Mental Illness, HIV/AIDS, HIV Testing

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Boston Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Care as Usual

Skills Building - Motivational Interviewing

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

HIV Counseling & Testing
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.

Full Information

First Posted
June 9, 2010
Last Updated
March 30, 2016
Sponsor
Boston Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01172704
Brief Title
HIV/AIDS, Severe Mental Illness and Homelessness
Official Title
HIV/AIDS, Severe Mental Illness and Homelessness
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
January 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Boston Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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: 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 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV, AIDS
Keywords
Motivational Interviewing, Serious Mental Illness, HIV/AIDS, HIV Testing

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
240 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Care as Usual
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Skills Building - Motivational Interviewing
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Skills Building - Motivational Interviewing
Intervention Description
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.
Primary Outcome Measure Information:
Title
Frequency of Risk Taking Behavior
Description
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.
Time Frame
One year
Secondary Outcome Measure Information:
Title
HIV Counseling & Testing
Description
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.
Time Frame
One year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen Brady, PhD
Organizational Affiliation
Boston University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jori Berger-Greenstein, PhD
Organizational Affiliation
Boston University
Official's Role
Study Director
Facility Information:
Facility Name
Boston Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States

12. IPD Sharing Statement

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HIV/AIDS, Severe Mental Illness and Homelessness

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