Improving HIV Prevention Skills in People With Serious Mental Illnesses

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Stephen Brady, Boston Medical Center
ClinicalTrials.gov Identifier:
NCT00356291
First received: July 21, 2006
Last updated: July 23, 2013
Last verified: July 2013
  Purpose

This study will evaluate the effectiveness of motivational interviewing plus skill building in reducing HIV risk behavior in people with serious mental illnesses.


Condition Intervention Phase
HIV/AIDS
Behavioral: Skill-Building (SB) plus Motivational Interviewing
Behavioral: Skill-Building (SB)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: HIV Prevention for the Mentally Ill: Motivation-Skills

Resource links provided by NLM:


Further study details as provided by Boston Medical Center:

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) [ Time Frame: Measured at Months 3 and 6 ] [ Designated as safety issue: No ]
  • Communication and negotiation skills [ Time Frame: Measured at Months 3 and 6 ] [ Designated as safety issue: No ]
  • Simulated demonstrations of use of male and female condoms, dental dams, and intravenous needle cleaning [ Time Frame: Measured at Months 3 and 6 ] [ Designated as safety issue: No ]
  • Access of HIV counseling and testing [ Time Frame: Measured at Months 3 and 6 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • HIV knowledge (HIV/AIDS Knowledge Questionnaire - HIV-KQ) [ Time Frame: Measured at Months 3 and 6 ] [ Designated as safety issue: No ]
  • Multidimensional Condom Attitude Scale (MCAS) [ Time Frame: Measured at Months 3 and 6 ] [ Designated as safety issue: No ]

Enrollment: 53
Study Start Date: April 2007
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Participants will receive Skill-Building and Motivational Interviewing.
Behavioral: Skill-Building (SB) plus Motivational Interviewing
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.
Active Comparator: 2
Participants will receive Skill-Building.
Behavioral: Skill-Building (SB)
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.

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.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  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: NCT00356291

Locations
United States, Massachusetts
Boston University Medical Center
Boston, Massachusetts, United States, 02118
Sponsors and Collaborators
Boston Medical Center
Investigators
Principal Investigator: Stephen M. Brady, PhD Boston University
  More Information

No publications provided

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: NCT00356291     History of Changes
Other Study ID Numbers: R34 MH75644, R34MH075644, DAHBR 9A-ASNM
Study First Received: July 21, 2006
Last Updated: July 23, 2013
Health Authority: United States: Federal Government

Keywords provided by Boston Medical Center:
HIV
AIDS
Prevention
Serious Mental Illness

ClinicalTrials.gov processed this record on September 16, 2014