- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00061100
HIV Counseling Intervention for Methadone-Maintained Patients - 2
April 22, 2019 updated by: Frances R Levin, New York State Psychiatric Institute
HIV Counseling Intervention for Methadone-Maintained Patients
The purpose of this study is to evaluate HIV counseling intervention for Methadone-Maintained Patients.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The purpose of this proposal is to evaluate, in methadone-maintained patients the association between an ADHD diagnosis and high-risk HIV/Hepatitis behavior.
In addition, the investigators would like to determine whether a new manually-guided HIV intervention; RISE: Reduce high risk Intravenous drug use and unsafe Sexual Encounters is superior to standard HIV/Hepatitis psycho-education.
Study Type
Interventional
Enrollment (Actual)
50
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New York
-
New York, New York, United States, 10032
- Research Foundation for Mental Hygiene, Inc.
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Must meet DSM-IV criteria for opiate dependence and currently in methadone maintenance treatment
- Able to give informed consent and capable of complying with study procedures
- Women who are of childbearing age and/or pregnant may be included
- Individuals who are HIV-positive or have Acquired Immunodeficiency Syndrome may be included
- Patients who demonstrate moderate to high HIV risk behaviors will be included
- Patients with low to no HIV risk behaviors will be excluded
- Patients receiving a stable dose of methadone for three weeks will be included
Exclusion Criteria:
- Currently meets DSM-IV criteria for current Axis I psychiatric disorders (other than ADHD or substance abuse) which requires medical intervention, i.e., active suicide ideation, active psychosis, anxiety disorders, depression requiring hospitalization
- Patients who have exhibited suicidal or homicidal behavior within the past two years
- HIV positive patients must have knowledge of their status for a minimum of three weeks
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: RISE intervention
Targeted RISE intervention- Behavior therapy Rise
|
manually-guided HIV intervention RISE: Reduce high risk Intravenous drug use and unsafe Sexual Encounter
|
Active Comparator: Standard Education
Education intervention.
Standard prevention education
|
standard psychosocial Education for HIV/hepatitis prevention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
AIDS risk behavior based on the Risk Behavior Assessment
Time Frame: assessed monthly during 2 months of study or length of participation
|
assessed monthly during 2 months of study or length of participation
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 1999
Primary Completion (Actual)
October 1, 2003
Study Completion (Actual)
October 1, 2003
Study Registration Dates
First Submitted
May 21, 2003
First Submitted That Met QC Criteria
May 21, 2003
First Posted (Estimate)
May 22, 2003
Study Record Updates
Last Update Posted (Actual)
April 23, 2019
Last Update Submitted That Met QC Criteria
April 22, 2019
Last Verified
April 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- #3884
- R01DA011444 (U.S. NIH Grant/Contract)
- 3884 (NYSPI IRB)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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