Ignite Creation Date:
2024-05-05 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00130819
Status:
COMPLETED
Last Update Posted:
2015-04-15
First Post:
2005-08-15
Brief Title:
Comparison of HIV Clinic-based Treatment With Buprenorphine Versus Referred Care in Heroin-dependent Participants
Sponsor:
Johns Hopkins University
Organization:
Johns Hopkins University
Study Overview
Official Title:
Buprenorphine Effectiveness Evaluation in HIV Enhancement BEEHIVE A Randomized Trial of HIV Clinic-based BuprenorphineNaloxone vs Case Management and Referral in Opioid-dependent Individuals
Status:
COMPLETED
Status Verified Date:
2009-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to compare the effectiveness of two approaches to treating HIV-infected patients who are addicted to opioid drugs eg heroin in an inner-city HIV clinic The two approaches are
Case management and referral - participants are managed by a case manager and referred to a specialized drug treatment center where they receive counseling and medications for opioid-dependence eg methadone or buprenorphine or
Clinic-based treatment - participants receive counseling and treatment with buprenorphine at the HIV clinic
Case management and referral - participants are managed by a case manager and referred to a specialized drug treatment center where they receive counseling and medications for opioid-dependence eg methadone or buprenorphine or
Clinic-based treatment - participants receive counseling and treatment with buprenorphine at the HIV clinic
Detailed Description:
We the investigators at Johns Hopkins University propose to enroll and randomize 120 opioid-dependent HIV-infected participants who receive care in the Johns Hopkins HIV Clinic to either
clinic-based care with buprenorphine clinic-based BPNNX arm or
case management and referral to an opioid treatment program for opioid agonist-based therapy case management and referral arm
The study interventions and follow-up will last 12 months Participants will be enrolled over a 3-year period Participants who are assigned to the clinic-based BPNNX arm will receive BPNNX Suboxone individual counseling from a nurse interventionist and group therapy sessions Participants who are assigned to the case management and referral arm will be enrolled in an established case management and adherence program in the Johns Hopkins HIV Clinic Project LINK LINK provides intensive case management education and support by a team that includes a social worker a nurse a pharmacist educator and peer advocates In addition to providing counseling and linkage to needed services LINK will expedite intake at licensed opioid treatment programs that provide agonist-based therapy for opioid dependence The clinic-based BPN intervention is a new strategy that was developed in a pilot project over the past 6 months The case-management and referral arm represents standard-of-care in our clinic which has been enhanced and codified for this trial Study outcome visits will be performed at baseline 1 month 3 months 6 months 9 months and 12 months
Comparisons
Retention to substance abuse treatment
Urine drug screens
Adherence to HIV primary care provider visits
Use of and adherence to highly active antiretroviral therapy HAART
HIV RNA levels and CD4 cell counts
HIV transmission risk behaviors eg injection sharing of drug paraphernalia sexual behaviors
Costs and resource utilization
clinic-based care with buprenorphine clinic-based BPNNX arm or
case management and referral to an opioid treatment program for opioid agonist-based therapy case management and referral arm
The study interventions and follow-up will last 12 months Participants will be enrolled over a 3-year period Participants who are assigned to the clinic-based BPNNX arm will receive BPNNX Suboxone individual counseling from a nurse interventionist and group therapy sessions Participants who are assigned to the case management and referral arm will be enrolled in an established case management and adherence program in the Johns Hopkins HIV Clinic Project LINK LINK provides intensive case management education and support by a team that includes a social worker a nurse a pharmacist educator and peer advocates In addition to providing counseling and linkage to needed services LINK will expedite intake at licensed opioid treatment programs that provide agonist-based therapy for opioid dependence The clinic-based BPN intervention is a new strategy that was developed in a pilot project over the past 6 months The case-management and referral arm represents standard-of-care in our clinic which has been enhanced and codified for this trial Study outcome visits will be performed at baseline 1 month 3 months 6 months 9 months and 12 months
Comparisons
Retention to substance abuse treatment
Urine drug screens
Adherence to HIV primary care provider visits
Use of and adherence to highly active antiretroviral therapy HAART
HIV RNA levels and CD4 cell counts
HIV transmission risk behaviors eg injection sharing of drug paraphernalia sexual behaviors
Costs and resource utilization
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| HRSA-04-078 | None | None | None |