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

July 21, 2006
July 23, 2013
April 2007
October 2008   (final data collection date for primary outcome measure)
  • 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 ]
  • Communication and Negotiation Skills
  • Global Assessment of Function Ratings
  • Structured Clinical Interview I
  • Structured Clinical Interview II
  • Timeline Followback (TLFB)
  • Condom Use (all measured at Months 3 and 6)
  • Mini Mental Status Exam
Complete list of historical versions of study NCT00356291 on ClinicalTrials.gov Archive Site
  • 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 ]
Not Provided
Not Provided
Not Provided
 
Improving HIV Prevention Skills in People With Serious Mental Illnesses
HIV Prevention for the Mentally Ill: Motivation-Skills

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

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
HIV/AIDS
  • 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.
  • 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.
  • Experimental: 1
    Participants will receive Skill-Building and Motivational Interviewing.
    Intervention: Behavioral: Skill-Building (SB) plus Motivational Interviewing
  • Active Comparator: 2
    Participants will receive Skill-Building.
    Intervention: Behavioral: Skill-Building (SB)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
53
October 2008
October 2008   (final data collection date for primary outcome measure)

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
Both
19 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00356291
R34 MH75644, R34MH075644, DAHBR 9A-ASNM
Not Provided
Stephen Brady, Boston Medical Center
Boston Medical Center
National Institute of Mental Health (NIMH)
Principal Investigator: Stephen M. Brady, PhD Boston University
Boston Medical Center
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP