Ignite Creation Date:
2024-05-06 @ 9:14 AM
Last Modification Date:
2024-10-26 @ 12:11 PM
Study NCT ID:
NCT02935296
Status:
COMPLETED
Last Update Posted:
2018-12-24
First Post:
2016-10-12
Brief Title:
Integrated Treatment and Prevention for People Who Inject Drugs
Sponsor:
HIV Prevention Trials Network
Organization:
HIV Prevention Trials Network
Study Overview
Official Title:
Integrated Treatment and Prevention for People Who Inject Drugs A Vanguard Study for a Network-based Randomized HIV Prevention Trial Comparing an Integrated Intervention Including Supported Antiretroviral Therapy to the Standard of Care
Status:
COMPLETED
Status Verified Date:
2018-12
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 determine the feasibility of a future trial that will assess whether an integrated intervention combining psychosocial counseling and supported referrals for antiretroviral therapy ART at any CD4 cell count and substance use treatment for HIV-infected people who inject drugs PWID will reduce HIV transmission to HIV-uninfected injection partners as compared to routine care dictated by national guidelines for HIV-infected PWID
Detailed Description:
This is a multi-site two-arm randomized vanguard study Network units will consist of an HIV-infected index participant and hisher HIV-uninfected network injection partners Network units will be randomized to the intervention or standard of care arms in a 13 ratio stratified by site To assess feasibility of the intervention additional interviews will be conducted with study staff systems navigators and counselors and clinic-based stakeholders at each study site
Approximately 500 Index participants and their partners will be enrolled
Approximately 500 Index participants and their partners will be enrolled
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 |
|---|---|---|---|
| UM1AI068619 | NIH | None | httpsreporternihgovquickSearchUM1AI068619 |