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Sponsored by: |
National Institute on Drug Abuse (NIDA) |
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Information provided by: | National Institute on Drug Abuse (NIDA) |
ClinicalTrials.gov Identifier: | NCT00447720 |
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.
Condition | Intervention | Phase |
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Mentally Ill Persons Substance Abuse HIV Infections |
Behavioral: case manager -delivered education about HIV |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study |
Official Title: | Translation of CDC and NIDA Programs to Prevent HIV/AIDS Among Persons With Serious Mental Illness |
Estimated Enrollment: | 300 |
Study Start Date: | June 2004 |
Estimated Study Completion Date: | June 2008 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Michael Blank, PhD | 215-349-8488 | mblank2@mail.med.upenn.edu |
Contact: Julie Tennille, MSW | 215-746-6716 | julie.tennille@gmail.com |
United States, Pennsylvania | |
Hall Mercer Community Mental Health Clinic | Recruiting |
Philadelphia, Pennsylvania, United States, 19104 |
Principal Investigator: | Michael Blank, PhD | Center for Mental Health Policy and Services Research |
Study ID Numbers: | 704260, 5-R01-DA015627-03 |
Study First Received: | March 13, 2007 |
Last Updated: | April 2, 2007 |
ClinicalTrials.gov Identifier: | NCT00447720 History of Changes |
Health Authority: | United States: Federal Government |
HIV prevention skills Seriously Mentally Ill (SMI) Substance abuse Philadelphia HIV seronegativity |
Virus Diseases Sexually Transmitted Diseases, Viral Mental Disorders HIV Infections Sexually Transmitted Diseases |
Acquired Immunodeficiency Syndrome Substance-Related Disorders Disorders of Environmental Origin Retroviridae Infections Immunologic Deficiency Syndromes |
RNA Virus Infections Sexually Transmitted Diseases, Viral Slow Virus Diseases Immune System Diseases Acquired Immunodeficiency Syndrome Disorders of Environmental Origin Infection Immunologic Deficiency Syndromes |
Virus Diseases Mental Disorders HIV Infections Sexually Transmitted Diseases Substance-Related Disorders Lentivirus Infections Retroviridae Infections |