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Improving HIV Prevention Skills in People With Serious Mental Illnesses

Boston Medical Center (BMC) logo

Boston Medical Center (BMC)

Status and phase

Completed
Phase 2

Conditions

HIV/AIDS

Treatments

Behavioral: Skill-Building (SB)
Behavioral: Skill-Building (SB) plus Motivational Interviewing

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT00356291
DAHBR 9A-ASNM
R34MH075644 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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

Full 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.

Enrollment

53 patients

Sex

All

Ages

19+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

53 participants in 2 patient groups

1
Experimental group
Description:
Participants will receive Skill-Building and Motivational Interviewing.
Treatment:
Behavioral: Skill-Building (SB) plus Motivational Interviewing
2
Active Comparator group
Description:
Participants will receive Skill-Building.
Treatment:
Behavioral: Skill-Building (SB)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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