Improving HIV Prevention Skills in People With Serious Mental Illnesses
Recruitment status was Active, not recruiting
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Purpose
This study will evaluate the effectiveness of motivational interviewing plus skill building in reducing HIV risk behavior in people with serious mental illnesses.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV/AIDS |
Behavioral: Skill-Building (SB) plus Motivational Interviewing Behavioral: Skill-Building (SB) |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | HIV Prevention for the Mentally Ill: Motivation-Skills |
- 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 ] [ Designated as safety issue: No ]
- Communication and negotiation skills [ Time Frame: Measured at Months 3 and 6 ] [ Designated as safety issue: No ]
- Simulated demonstrations of use of male and female condoms, dental dams, and intravenous needle cleaning [ Time Frame: Measured at Months 3 and 6 ] [ Designated as safety issue: No ]
- Access of HIV counseling and testing [ Time Frame: Measured at Months 3 and 6 ] [ Designated as safety issue: No ]
- HIV knowledge (HIV/AIDS Knowledge Questionnaire - HIV-KQ) [ Time Frame: Measured at Months 3 and 6 ] [ Designated as safety issue: No ]
- Multidimensional Condom Attitude Scale (MCAS) [ Time Frame: Measured at Months 3 and 6 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 60 |
| Study Start Date: | April 2007 |
| Estimated Study Completion Date: | October 2008 |
| Estimated Primary Completion Date: | October 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
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| Ages Eligible for Study: | 19 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
More Information
No publications provided
| Responsible Party: | Stephen M. Brady, PhD, Boston University School of Medicine |
| ClinicalTrials.gov Identifier: | NCT00356291 History of Changes |
| Other Study ID Numbers: | R34 MH75644, DAHBR 9A-ASNM |
| Study First Received: | July 21, 2006 |
| Last Updated: | August 26, 2008 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Institute of Mental Health (NIMH):
|
HIV AIDS Prevention Serious Mental Illness |
Additional relevant MeSH terms:
|
Acquired Immunodeficiency Syndrome Mental Disorders HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections |
Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Slow Virus Diseases Immunologic Deficiency Syndromes Immune System Diseases |
ClinicalTrials.gov processed this record on June 18, 2013