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.

Study Overview

• Status: Completed
• Conditions: HIV/AIDS
• Intervention / Treatment: Behavioral: Skill-Building (SB) plus Motivational Interviewing; Behavioral: Skill-Building (SB)

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.

• Study Type: Interventional
• Enrollment (Actual): 53
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02118
      • Boston University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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)	Measured at Months 3 and 6
Communication and negotiation skills	Measured at Months 3 and 6
Simulated demonstrations of use of male and female condoms, dental dams, and intravenous needle cleaning	Measured at Months 3 and 6
Access of HIV counseling and testing	Measured at Months 3 and 6

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Boston Medical Center
• Collaborators: National Institute of Mental Health (NIMH)
• Investigators: Principal Investigator: Stephen M. Brady, PhD, Boston University

Study record dates

Study Major Dates

• Study Start: April 1, 2007
• Primary Completion (Actual): October 1, 2008
• Study Completion (Actual): October 1, 2008

Study Registration Dates

• First Submitted: July 21, 2006
• First Submitted That Met QC Criteria: July 21, 2006
• First Posted (Estimate): July 25, 2006

Study Record Updates

• Last Update Posted (Estimate): July 25, 2013
• Last Update Submitted That Met QC Criteria: July 23, 2013
• Last Verified: July 1, 2013

More Information

Terms related to this study

• Keywords: HIV; Prevention; Serious Mental Illness; AIDS
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases; HIV Infections; Mental Disorders; Acquired Immunodeficiency Syndrome
• Other Study ID Numbers: R34MH075644 (U.S. NIH Grant/Contract); DAHBR 9A-ASNM

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No