HIV Prevention Among Substance Abusing SMI

HIV Infections Clinical Trial

Official title:

Translation of CDC and NIDA Programs to Prevent HIV/AIDS Among Persons With Serious Mental Illness

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00447720
• Other study ID #: 704260
• Secondary ID: 5R01DA015627-03
• Status: Completed
• Phase: Phase 3
• First received: March 13, 2007
• Last updated: December 1, 2015
• Start date: June 2004
• Est. completion date: June 2008

Study information

• Verified date: December 2015
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 238
• Est. completion date: June 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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+

Study Design

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

Related Conditions & MeSH terms

• HIV Infections
• Mentally Ill Persons
• Substance Abuse

Intervention

Behavioral:
• PATH
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.

Locations

Country	Name	City	State
United States	Hall Mercer Community Mental Health Clinic	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pennsylvania	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	Condom skills	Behavioral skills	baseline, 6,12	No
Secondary	Behavioral risk self report		baseline, 6, 12, and 24 months	No
Secondary	HIV risk reduction	Self-report	baseline, 6, 12 months	No