Clinical trial NCT00356291: Improving HIV Prevention Skills in People With Serious Mental Illnesses
Official title: HIV Prevention for the Mentally Ill: Motivation-Skills
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: HIV/AIDS
Keywords: HIV
AIDS
Prevention
Serious Mental Illness
Lead sponsor: Boston Medical Center
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2006-07-25
Enrollment: 53
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
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)
timeFrame: Measured at Months 3 and 6
measure: Communication and negotiation skills
timeFrame: Measured at Months 3 and 6
measure: Simulated demonstrations of use of male and female condoms, dental dams, and intravenous needle cleaning
timeFrame: Measured at Months 3 and 6
measure: Access of HIV counseling and testing
timeFrame: Measured at Months 3 and 6
Secondary outcomes:
measure: HIV knowledge (HIV/AIDS Knowledge Questionnaire - HIV-KQ)
timeFrame: Measured at Months 3 and 6
measure: Multidimensional Condom Attitude Scale (MCAS)
timeFrame: Measured at Months 3 and 6
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston University Medical Center
state: Massachusetts
Study officials:
affiliation: Boston University
name: Stephen M. Brady, PhD
role: PRINCIPAL_INVESTIGATOR
References: