Viewing Study NCT02935296



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

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