Ignite Creation Date:
2025-12-24 @ 3:56 PM
Ignite Modification Date:
2026-01-04 @ 8:34 AM
Study NCT ID:
NCT02438592
Status:
COMPLETED
Last Update Posted:
2017-02-28
First Post:
2015-04-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PHASES: Provision of HIV Treatment at ATN Sites: An Evaluation for Stakeholders
Sponsor:
University of North Carolina, Chapel Hill
Organization:
Study Overview
Official Title:
PHASES: Provision of HIV Treatment at ATN Sites: An Evaluation for Stakeholders
Status:
COMPLETED
Status Verified Date:
2016-03
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:
This is an observational study involving retrospective and prospective medical record review covering a total maximum of 104 weeks (24 months) per subject. An Audio Computer- Assisted Self-Interview (ACASI) at study entry will assess demographic and psychosocial variables of study subjects. Data will also be collected to assess clinic level variables. Definitions of engagement, prescription of antiretroviral therapy (ART), and viral suppression in the Continuum of Care (CoC) will utilize common definitions including those by U.S. Department of Health and Human Services (DHHS) and Health Resources and Services Administration (HRSA) HIV/AIDS Bureau (HAB). Data will be collected in a large, simple trial design manner to provide all elements for both the primary and secondary outcomes.
Detailed Description:
This is an observational study involving retrospective and prospective medical record review covering a total maximum of 104 weeks (24 months) per subject. Behavioral data will be collected via ACASI at study entry to assess demographic and psychosocial variables of study subjects. All other data (biomedical, ART, healthcare utilization) at subsequent study visits will be collected via medical record abstraction. Information about missed visits as well as other healthcare utilization data can be abstracted from electronic appointment systems or other electronic systems at the clinical sites. Subject data will be abstracted from medical records for up to a maximum 26 weeks prior to the baseline study visit, as well as up to a maximum 78 weeks after the baseline study visit or through January 31, 2017, whichever occurs first, for a total maximum of 104 weeks or two years per subject. Data will also be collected from each Adolescent Medicine Trials Unit to assess clinic level variables at baseline (within 30 days of protocol registration) and 48 and 96 weeks after baseline. Definitions of engagement, prescription of antiretroviral therapy (ART), and viral suppression in the Continuum of Care (CoC) will utilize common definitions including those by U.S. Department of Health and Human Services (DHHS) and Health Resources and Services Administration (HRSA) HIV/AIDS Bureau (HAB). Data will be collected in a large, simple trial design manner to provide all elements for both the primary and secondary outcomes.
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?: