HIV Prevention Among Substance Abusing SMI

NCT00447720 | Completed Phase 3 DMC

• 2 other identifiers: 7042605R01DA015627-03
• Study Type: interventional
• Target: 238
• Locations: 1 country
• Sites: 1

Brief Summary

This study seeks to examine the effectiveness of translating two proven interventions, RESPECT, and the NIDA Community Based Outreach Model, into one program of education, PATH, to be delivered by case managers to their seriously mentally ill, substance abusing clients. The objective is to teach case managers to assess the specific risk profiles of their clients, and then create a plan of intervention aimed at reducing high risk sexual and substance abusing behaviors.

Conditions

Mentally Ill Persons; Substance Abuse; HIV Infections

Keywords

HIV prevention skills; Seriously Mentally Ill (SMI); Substance abuse; Philadelphia; HIV seronegativity

Outcome Measures

Primary Outcomes (2)

• Outcome measures used for calculating effectiveness will be reduction in sexual and substance-use-related risk behaviors. Other outcomes include improved condom use as well as increase in knowledge of HIV.

  24 months

• Condom skills

  Behavioral skills

  baseline, 6,12

Secondary Outcomes (2)

• Behavioral risk self report

  baseline, 6, 12, and 24 months

• HIV risk reduction

  baseline, 6, 12 months

Study Arms (2)

PATH counseling

EXPERIMENTAL

These participants received the PATH intervention

Behavioral: PATH

Treatment as Usual

ACTIVE COMPARATOR

These individuals receive treatment as they normally would receive in the community

Behavioral: PATH

Interventions

PATH BEHAVIORAL

We have chosen to translate two proven prevention programs for delivery to the SMI populations by their case managers. These interventions are the Brief Counseling intervention from the Project Respect program and the Community-Based Outreach Program (CBOM). Together we will translate them into ongoing case management for SMI persons who also abuse substances in the Preventing AIDS through Health Project (PATH). Consistent with other findings regarding HIV infections among the SMI, in our preliminary studies we found that these individuals are at much higher risk within the population of persons being served in Philadelphia.

PATH counseling; Treatment as Usual

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Recipient of case management at Hall Mercer Community Health Center
• Use of substance or history of using substances
• Sexual activity or interest in a sexual relationship sometime in the future

You may not qualify if:

• May not be HIV+

Sponsors & Collaborators

• University of Pennsylvania: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Hall Mercer Community Mental Health Clinic

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Substance-Related Disorders; HIV Infections

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Michael Blank, PhD

  Center for Mental Health Policy and Services Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 13, 2007
• First Posted: March 15, 2007
• Study Start: June 1, 2004
• Primary Completion: June 1, 2008
• Study Completion: June 1, 2008
• Last Updated: December 3, 2015

Record last verified: 2015-12

Locations

US (1)