HIV Counseling Intervention for Methadone-Maintained Patients - 2
3 other identifiers
interventional
50
1 country
1
Brief Summary
The purpose of this study is to evaluate HIV counseling intervention for Methadone-Maintained Patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Oct 1999
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 1999
CompletedFirst Submitted
Initial submission to the registry
May 21, 2003
CompletedFirst Posted
Study publicly available on registry
May 22, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2003
CompletedApril 23, 2019
April 1, 2019
4 years
May 21, 2003
April 22, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
AIDS risk behavior based on the Risk Behavior Assessment
assessed monthly during 2 months of study or length of participation
Study Arms (2)
RISE intervention
EXPERIMENTALTargeted RISE intervention- Behavior therapy Rise
Standard Education
ACTIVE COMPARATOREducation intervention. Standard prevention education
Interventions
manually-guided HIV intervention RISE: Reduce high risk Intravenous drug use and unsafe Sexual Encounter
standard psychosocial Education for HIV/hepatitis prevention
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Research Foundation for Mental Hygiene, Inc.
New York, New York, 10032, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Frances R Levin, M.D.
Research Foundation for Mental Hygiene, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of Substance Use Disorder
Study Record Dates
First Submitted
May 21, 2003
First Posted
May 22, 2003
Study Start
October 1, 1999
Primary Completion
October 1, 2003
Study Completion
October 1, 2003
Last Updated
April 23, 2019
Record last verified: 2019-04