Skip to main content
Clinical Trials/NCT00356291
NCT00356291
Completed
Phase 2

HIV Prevention for the Mentally Ill: Motivation-Skills

Boston Medical Center1 site in 1 country53 target enrollmentApril 2007
ConditionsHIV/AIDS

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
HIV/AIDS
Sponsor
Boston Medical Center
Enrollment
53
Locations
1
Primary Endpoint
Communication and negotiation skills
Status
Completed
Last Updated
12 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 2007
End Date
October 2008
Last Updated
12 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Stephen Brady

Director, Mental Health Counseling & Behavioral Medicine Program Associate Professor of Psychiatry Boston University School of Medicine

Boston Medical Center

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

Outcomes

Primary Outcomes

Communication and negotiation skills

Time Frame: Measured at Months 3 and 6

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

Simulated demonstrations of use of male and female condoms, dental dams, and intravenous needle cleaning

Time Frame: Measured at Months 3 and 6

Access of HIV counseling and testing

Time Frame: Measured at Months 3 and 6

Secondary Outcomes

  • HIV knowledge (HIV/AIDS Knowledge Questionnaire - HIV-KQ)(Measured at Months 3 and 6)
  • Multidimensional Condom Attitude Scale (MCAS)(Measured at Months 3 and 6)

Study Sites (1)

Loading locations...

Similar Trials