Improving HIV Prevention Skills in People With Serious Mental Illnesses
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00356291|
Recruitment Status : Completed
First Posted : July 25, 2006
Last Update Posted : July 25, 2013
|Condition or disease||Intervention/treatment||Phase|
|HIV/AIDS||Behavioral: Skill-Building (SB) plus Motivational Interviewing Behavioral: Skill-Building (SB)||Phase 2|
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 (Clinical Trial)|
|Actual Enrollment :||53 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||HIV Prevention for the Mentally Ill: Motivation-Skills|
|Study Start Date :||April 2007|
|Primary Completion Date :||October 2008|
|Study Completion Date :||October 2008|
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.
- 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 ]
- Communication and negotiation skills [ 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 ]
- HIV knowledge (HIV/AIDS Knowledge Questionnaire - HIV-KQ) [ Time Frame: Measured at Months 3 and 6 ]
- Multidimensional Condom Attitude Scale (MCAS) [ Time Frame: Measured at Months 3 and 6 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00356291
|United States, Massachusetts|
|Boston University Medical Center|
|Boston, Massachusetts, United States, 02118|
|Principal Investigator:||Stephen M. Brady, PhD||Boston University|