Ignite Creation Date:
2024-05-05 @ 4:57 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00351026
Status:
COMPLETED
Last Update Posted:
2016-09-07
First Post:
2006-07-10
Brief Title:
Methadone Maintenance HIV Risk in Ukraine
Sponsor:
University of Pennsylvania
Organization:
University of Pennsylvania
Study Overview
Official Title:
Methadone Maintenance HIV Risk in Ukraine
Status:
COMPLETED
Status Verified Date:
2016-09
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:
Treatment of opioid dependence is an important way to reduce the spread of HIV and other infectious diseases particularly in Ukraine since intravenous opioid use is the major way these infections are being spread This proposal will be done at the Kiev City Narcology Hospital and the City AIDS Center with collaborators from the University of Alabama and the University of Colorado It will study the acceptability and impact of a 3-month course of methadone maintenance on 50 persons with opioid dependence 25 who are HIV and 25 HIV- The proposed work will build on a relationship that was established with the Ukrainian Co-Principal Investigator Sergiy Dvoryak MD during his Humphrey Fellowship at Johns Hopkins in 1999-2000 when he spent time with Dr Woody and Metzger at the Penn Addiction and Treatment and Research Center It will also extend studies of pharmacologic treatment for opioid dependence and risk reduction behavioral interventions that are being done by Drs Woody Schumacher and Booth in Russia and Ukraine Primary aims are to measure the acceptability and compliance with a 3-month course of methadone maintenance in HIV and HIV- patients measure the impact of a 3-month course of methadone in reducing opioid use in HIV and HIV- patients measure the impact of a 3-month course of methadone on reducing HIV risk behavior in HIV_and HIV- patients Secondary aims are to assess the degree to which a 3-month course of methadone maintenance reduces illegal activities and improves employment and psychiatric symptoms determine short-term outcome after completion of methadone treatment and obtain pilot data on the prevalence of hepatitis B and C among study patients This study will provide pilot data on the acceptability and efficacy of a short-term course of methadone maintenance on HIV and HIV- persons in a setting where this treatment has not been evaluated on the feasibility of conducting the kind of work that is proposed and will enhance research capabilities of Kiev investigators for future HIV prevention and treatment studies
Detailed Description:
Approximately 40 subjects have been enrolled in this study as of September 1 2009 Almost all have completed the 12 week study period and elected to transfer to the regular methadone program at the same location that was started in the last 2 years with support from the Global Fund A 1-year supplement has been awarded to pilot test an intervention developed by Dr Dvoryak to facilitate enrollment in methadone by persons who could benefit and an intervention called Life Steps developed by Safren and colleagues and aimed to facilitate adherence to antiretroviral therapy A site visit was completed in 509 in which we conducted two focus groups to determine local conditions that needed to be included in Life Steps so as to make it relevant to Ukrainian cultural conditions followed by modification and training in the slightly revised version of Life Steps We anticipate that the 25 additional HIV patients who will be enrolled to complete the supplement will start to be enrolled in 1009 when recruitment for the parent study has been completed
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 |
|---|---|---|---|
| R21DA021073 | NIH | None | httpsreporternihgovquickSearchR21DA021073 |