Boston University Medical Center
Boston, Massachusetts, 02118, United States
NCT Number: NCT00356291
This study will evaluate the effectiveness of motivational interviewing plus skill building in reducing HIV risk behavior in people with serious mental illnesses.
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Notify Me19 year and older
All sexes
Interventional
Phase 2
Boston, Massachusetts, 02118, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Time frame: Measured at Months 3 and 6
Time frame: Measured at Months 3 and 6
Time frame: Measured at Months 3 and 6
Time frame: Measured at Months 3 and 6
Time frame: Measured at Months 3 and 6
Time frame: Measured at Months 3 and 6
Boston Medical Center
Other
HIV Prevention for the Mentally Ill: Motivation-Skills
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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