Improving HIV Prevention Skills in People With Serious Mental Illnesses

HIV/AIDS Clinical Trial

Official title:

HIV Prevention for the Mentally Ill: Motivation-Skills

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00356291
• Other study ID #: R34MH075644
• Secondary ID: R34MH075644DAHBR
• Status: Completed
• Phase: Phase 2
• First received: July 21, 2006
• Last updated: July 23, 2013
• Start date: April 2007
• Est. completion date: October 2008

Study information

• Verified date: July 2013
• Source: Boston Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

This study will evaluate the effectiveness of motivational interviewing plus skill building in reducing HIV risk behavior in people with serious mental illnesses.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: October 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• HIV/AIDS

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Boston University Medical Center	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Boston Medical Center	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	Communication and negotiation skills		Measured at Months 3 and 6	No
Primary	Simulated demonstrations of use of male and female condoms, dental dams, and intravenous needle cleaning		Measured at Months 3 and 6	No
Primary	Access of HIV counseling and testing		Measured at Months 3 and 6	No
Secondary	HIV knowledge (HIV/AIDS Knowledge Questionnaire - HIV-KQ)		Measured at Months 3 and 6	No
Secondary	Multidimensional Condom Attitude Scale (MCAS)		Measured at Months 3 and 6	No