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Improving HIV Prevention Skills in People With Serious Mental Illnesses

Primary Purpose

HIV/AIDS

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

About this trial

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

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Meets criteria for a serious and persistent mental illness (as defined by the Massachusetts Department of Mental Health) English-speaking Engagement in HIV risk behavior within 3 months prior to study entry Ability to keep study-related appointments Exclusion Criteria: Unstable mental status

Sites / Locations

  • Boston University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

Participants will receive Skill-Building and Motivational Interviewing.

Participants will receive Skill-Building.

Outcomes

Primary Outcome Measures

Timeline Followback (TLFB) measures of HIV risk behaviors and use of HIV risk prevention strategies (including use of male and female condoms, dental dams, and recommended intravenous needle-cleaning)
Communication and negotiation skills
Simulated demonstrations of use of male and female condoms, dental dams, and intravenous needle cleaning
Access of HIV counseling and testing

Secondary Outcome Measures

HIV knowledge (HIV/AIDS Knowledge Questionnaire - HIV-KQ)
Multidimensional Condom Attitude Scale (MCAS)

Full Information

First Posted
July 21, 2006
Last Updated
July 23, 2013
Sponsor
Boston Medical Center
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT00356291
Brief Title
Improving HIV Prevention Skills in People With Serious Mental Illnesses
Official Title
HIV Prevention for the Mentally Ill: Motivation-Skills
Study Type
Interventional

2. Study Status

Record Verification Date
July 2013
Overall Recruitment Status
Completed
Study Start Date
April 2007 (undefined)
Primary Completion Date
October 2008 (Actual)
Study Completion Date
October 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Boston Medical Center
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

5. Study Description

Brief Summary
This study will evaluate the effectiveness of motivational interviewing plus skill building in reducing HIV risk behavior in people with serious mental illnesses.
Detailed Description
People with serious mental illness (SMI) are at higher risk for contracting HIV than the general population. Although fewer people with SMI are sexually active, as compared to the healthy population, those with SMI who are sexually active tend to engage in sexual behaviors that put them at increased risk for HIV and other STDs. The onset of SMI, which often interferes with normal psychosocial development, may cause these behaviors. Additionally, SMI is frequently associated with poor judgment, affective instability, and impulsiveness. Interventions designed to reduce the risk for contracting HIV in people with SMI exist, but they have had little success. New approaches to treating this population are essential. This study will evaluate the effectiveness of motivational interviewing (MI) plus skill building (SB) exercises in reducing HIV risk behavior in people with SMI. Participants in this 6-month, open-label study are randomly assigned to partake in SB training either alone or combined with MI. The skill building program focuses on behavioral skills training, with an emphasis on negotiating and communicating with prospective partners. Training includes information about HIV risk, including mechanisms of transmission, abstinence, and safer sex and drug use behaviors; HIV risk reduction strategies, including condom use, abstinence/safer sex negotiation skills, and reduced/safer drug use; and an opportunity to be tested for HIV if the participant has not already done so. The SB plus MI intervention (SB-MI) includes components of the SB intervention, as well as elements of MI. MI includes identifying high risk sexual and drug use behaviors related to HIV; reducing the ambivalence about making high risk behavior changes; increasing motivation to change high risk behaviors; and developing a plan to implement these changes. HIV testing may be included. Participants in both interventions report to the study site on six to seven occasions over the course of the study. The visits last between 1 and 2 hours and include both treatment and evaluation. Participants attend two follow-up visits, one 3 months after randomization, and one 6 months after randomization.

6. Conditions and Keywords

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

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Participants will receive Skill-Building and Motivational Interviewing.
Arm Title
2
Arm Type
Active Comparator
Arm Description
Participants will receive Skill-Building.
Intervention Type
Behavioral
Intervention Name(s)
Skill-Building (SB) plus Motivational Interviewing
Intervention Description
SB is a 4 to 5 session individually-based psychoeducational intervention. Participants meet weekly with an interventionist for 3 to 4 weeks and then receive a booster session 3 months after baseline. The traditional Skill-Building intervention will be augmented with Motivational Interviewing techniques.
Intervention Type
Behavioral
Intervention Name(s)
Skill-Building (SB)
Intervention Description
SB is a 4-session individually-based psychoeducational HIV risk reduction intervention. Participants meet weekly with an interventionist for 3 weeks and then receive a booster session 3 months after baseline.
Primary Outcome Measure Information:
Title
Timeline Followback (TLFB) measures of HIV risk behaviors and use of HIV risk prevention strategies (including use of male and female condoms, dental dams, and recommended intravenous needle-cleaning)
Time Frame
Measured at Months 3 and 6
Title
Communication and negotiation skills
Time Frame
Measured at Months 3 and 6
Title
Simulated demonstrations of use of male and female condoms, dental dams, and intravenous needle cleaning
Time Frame
Measured at Months 3 and 6
Title
Access of HIV counseling and testing
Time Frame
Measured at Months 3 and 6
Secondary Outcome Measure Information:
Title
HIV knowledge (HIV/AIDS Knowledge Questionnaire - HIV-KQ)
Time Frame
Measured at Months 3 and 6
Title
Multidimensional Condom Attitude Scale (MCAS)
Time Frame
Measured at Months 3 and 6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Meets criteria for a serious and persistent mental illness (as defined by the Massachusetts Department of Mental Health) English-speaking Engagement in HIV risk behavior within 3 months prior to study entry Ability to keep study-related appointments Exclusion Criteria: Unstable mental status
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen M. Brady, PhD
Organizational Affiliation
Boston University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Boston University Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States

12. IPD Sharing Statement

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Improving HIV Prevention Skills in People With Serious Mental Illnesses

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