Ignite Creation Date:
2025-12-24 @ 3:44 PM
Ignite Modification Date:
2026-01-04 @ 1:30 PM
Study NCT ID:
NCT00255892
Status:
COMPLETED
Last Update Posted:
2017-02-28
First Post:
2005-11-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intervention Development for Newly Diagnosed Youth With HIV
Sponsor:
University of North Carolina, Chapel Hill
Organization:
Study Overview
Official Title:
Intervention Development for Newly Diagnosed Youth With HIV
Status:
COMPLETED
Status Verified Date:
2016-02
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 study is an exploratory qualitative investigation of the challenges, strengths, and needed areas of support associated with receiving an HIV diagnosis among youth living with HIV. Qualitative interviews will be conducted with health care providers who work with adolescents living with HIV and focus groups will be conducted with adolescents who are living with HIV (ages 16-24). One third of the focus groups will be conducted in Spanish. Findings from this study will be used to create an outline and development plan for a culturally-sensitive and developmentally appropriate intervention (or set of interventions) for youth recently diagnosed with HIV.
Detailed Description:
Providers will participate in one interview of approximately one-hour duration; these interviews are expected to occur over a 2 month period. Following the completion of the provider interviews, participants will participate in one 2-hour focus group. A total of 6 focus groups (2 at each of the 3 study sites) are anticipated to occur over a 6-8 week period. The complete study duration is expected to take 12 months.
Part A - Provider interviews - 15 clinical providers, 15 mental health providers, 15 case managers (1 provider from each category per ATN site resulting in a total of 45 interviews).
Part B - Focus groups - 36-48 youth living with HIV. It is estimated there will be 6-8 participants per group and we will conduct two groups at each of three different sites (one male specific group and one female specific group) for a total of six focus groups. One third of the focus groups will be conducted in Spanish.
The provider interviews will be comprised of participants who are clinical providers, mental health providers, and case managers with at least 1 year of experience working with HIV+ youth; one from each category will be interviewed from all 15 ATN sites.
The focus groups will be comprised of participants who are between the ages of 16 and 24, diagnosed HIV+ and aware of their HIV diagnosis for between 12-24 months, and receive services at three selected ATN sites or their community partner.
Focus group participants will be balanced to reflect the diversity (i.e., age, pregnant and parenting women, MSM, mono-lingual Spanish-speaking, etc.) of the clinic populations.
Part A - Provider interviews - 15 clinical providers, 15 mental health providers, 15 case managers (1 provider from each category per ATN site resulting in a total of 45 interviews).
Part B - Focus groups - 36-48 youth living with HIV. It is estimated there will be 6-8 participants per group and we will conduct two groups at each of three different sites (one male specific group and one female specific group) for a total of six focus groups. One third of the focus groups will be conducted in Spanish.
The provider interviews will be comprised of participants who are clinical providers, mental health providers, and case managers with at least 1 year of experience working with HIV+ youth; one from each category will be interviewed from all 15 ATN sites.
The focus groups will be comprised of participants who are between the ages of 16 and 24, diagnosed HIV+ and aware of their HIV diagnosis for between 12-24 months, and receive services at three selected ATN sites or their community partner.
Focus group participants will be balanced to reflect the diversity (i.e., age, pregnant and parenting women, MSM, mono-lingual Spanish-speaking, etc.) of the clinic populations.
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?: