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HIV Prevention Among Substance Abusing SMI

Primary Purpose

Mentally Ill Persons, Substance Abuse, HIV Infections

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
PATH
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Mentally Ill Persons focused on measuring HIV prevention skills, Seriously Mentally Ill (SMI), Substance abuse, Philadelphia, HIV seronegativity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • May not be HIV+

Sites / Locations

  • Hall Mercer Community Mental Health Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

PATH counseling

Treatment as Usual

Arm Description

These participants received the PATH intervention

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

Outcomes

Primary Outcome Measures

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.
Condom skills
Behavioral skills

Secondary Outcome Measures

Behavioral risk self report
HIV risk reduction
Self-report

Full Information

First Posted
March 13, 2007
Last Updated
December 1, 2015
Sponsor
University of Pennsylvania
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT00447720
Brief Title
HIV Prevention Among Substance Abusing SMI
Official Title
Translation of CDC and NIDA Programs to Prevent HIV/AIDS Among Persons With Serious Mental Illness
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
June 2004 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
June 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pennsylvania
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
Persons with serious mental illness (SMI) are at increased risk for HIV/AIDS. The relative risk of HIV/AIDS is at least five times greater in SMI as the general Medicaid population in Philadelphia and over seven times for those also treated for substance abuse. We will implement a prevention program for persons with SMI who also abuse substances over five years at a local Community Mental Health Center. Preventing AIDS Through Health (PATH) is a translation of two HIV prevention programs proven effective in the general population and among substance users. Both are highly structured, manualized interventions. PATH uses mental health case managers to draw on features of both interventions depending on individual consumer risk profiles. These case managers have special expertise in providing services to this population and we believe that this expertise, prior relationships with these persons, and an ability to regularly reinforce the intervention will result in significantly reduced risk. There are two sets of research participants - the persons with SMI as well as the case managers themselves. Informed consent will be obtained from both sets of participants. It is estimated that approximately 300 individuals with mental illnesses will participate; with 150 assigned to the control group and 150 assigned to the treatment group. There will be approximately 32 participating case managers whose caseloads will be randomized to treatment. Blood testing will identify those who are HIV positive at baseline. Breathalyzer and urine testing will supplement clinical interviews and other measures to identify substance abuse co-morbidity. Using a longitudinal experimental and control group design, we will randomly assign case managers to deliver the intervention to consenting participants in their caseloads who meet inclusion criteria. Independent interviews will be conducted with case managers before the intervention, and again at 3,6,and 12-months post intervention and focus on changes in risk behaviors, fidelity of translation of the intervention, cost and outcomes. Breathalyzer and urine tests at 12-months will supplement self-reports of use of alcohol, cocaine, marijuana, benzodiazepines, and opiates. This is minimal risk research. The potential exists for great benefits to the mental health system at large. Potential risks are quite reasonable given the safeguards proposed and the valuable information to be yielded on the development of responsive interventions and practices to improve care for urban SMI who are at risk for HIV infection. The potential risks for participants in the study are not expected to be greater than those obtained during the performance of routine psychological or physical examinations or tests. All instruments used in primary data collection are those that are frequently used in similar research with similar populations and have not been associated with any adverse events. The questions that will be asked of the research participant pose no more risk than those they would respond to in the course of treatment. That is, the questions are similar to those that mental health professionals ask in the course of treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mentally Ill Persons, Substance Abuse, HIV Infections
Keywords
HIV prevention skills, Seriously Mentally Ill (SMI), Substance abuse, Philadelphia, HIV seronegativity

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
238 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PATH counseling
Arm Type
Experimental
Arm Description
These participants received the PATH intervention
Arm Title
Treatment as Usual
Arm Type
Active Comparator
Arm Description
These individuals receive treatment as they normally would receive in the community
Intervention Type
Behavioral
Intervention Name(s)
PATH
Intervention Description
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.
Primary Outcome Measure Information:
Title
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.
Time Frame
24 months
Title
Condom skills
Description
Behavioral skills
Time Frame
baseline, 6,12
Secondary Outcome Measure Information:
Title
Behavioral risk self report
Time Frame
baseline, 6, 12, and 24 months
Title
HIV risk reduction
Description
Self-report
Time Frame
baseline, 6, 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: May not be HIV+
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Blank, PhD
Organizational Affiliation
Center for Mental Health Policy and Services Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hall Mercer Community Mental Health Clinic
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

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HIV Prevention Among Substance Abusing SMI

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