Clinical trial NCT00447720: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Mentally Ill Persons
Substance Abuse
HIV Infections
Keywords: HIV prevention skills
Seriously Mentally Ill (SMI)
Substance abuse
Philadelphia
HIV seronegativity
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2007-03-15
Enrollment: 238
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

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+

Primary outcomes:
measure: 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.
timeFrame: 24 months
measure: Condom skills
timeFrame: baseline, 6,12
Secondary outcomes:
measure: Behavioral risk self report
timeFrame: baseline, 6, 12, and 24 months
measure: HIV risk reduction
timeFrame: baseline, 6, 12 months
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Hall Mercer Community Mental Health Clinic
state: Pennsylvania
Study officials:
affiliation: Center for Mental Health Policy and Services Research
name: Michael Blank, PhD
role: PRINCIPAL_INVESTIGATOR
References: