Ignite Creation Date:
2025-12-25 @ 4:12 AM
Ignite Modification Date:
2026-03-04 @ 11:53 AM
Study NCT ID:
NCT01751620
Status:
COMPLETED
Last Update Posted:
2017-02-28
First Post:
2012-12-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Project ACCEPT: Engaging Newly Diagnosed HIV+ Youth in Care
Sponsor:
University of North Carolina, Chapel Hill
Organization:
Study Overview
Official Title:
Project ACCEPT: Engaging Newly Diagnosed HIV+ Youth in Care
Status:
COMPLETED
Status Verified Date:
2016-10
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 proposed study is a two-group randomized repeated measures design that will examine the efficacy of Project ACCEPT (Adolescents Coping, Connecting, Empowering and Protecting Together) to improve engagement in care among youth newly diagnosed with HIV at five AMTU sites across the United States. Youth will be randomized into one of two study arms; Project ACCEPT, the intervention, or HEALTH, the health education attention-controlled comparison condition. Both arms consist of two individual sessions followed by six group sessions and a final individual session which is expected to take approximately nine weeks after which youth will have four follow-up visits at the following time points:
* post intervention (immediately after the last session);
* 3 months post the last session;
* 6 months post the last session; and
* 12 months post the last session. The trial will be repeated in up to three waves.
* post intervention (immediately after the last session);
* 3 months post the last session;
* 6 months post the last session; and
* 12 months post the last session. The trial will be repeated in up to three waves.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?: