HIV Infections Clinical Trial
Official title:
Translation of CDC and NIDA Programs to Prevent HIV/AIDS Among Persons With Serious Mental Illness
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.
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.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
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