Ignite Creation Date:
2024-05-05 @ 6:38 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00510237
Status:
COMPLETED
Last Update Posted:
2017-03-06
First Post:
2007-07-31
Brief Title:
Intervention for Newly Diagnosed Youth With HIV
Sponsor:
University of North Carolina Chapel Hill
Organization:
University of North Carolina Chapel Hill
Study Overview
Official Title:
Intervention Development for Newly Diagnosed Youth With HIV
Status:
COMPLETED
Status Verified Date:
2016-08
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 will pilot test an HIV intervention for newly diagnosed youth diagnosed for less than 15 months to assess its acceptability and feasibility preliminary to and leading up to a full-scale randomized trial The general focus of the intervention is to aid in the psychosocial adjustment of adolescents who have recently been diagnosed with HIV
Detailed Description:
The intervention will consist of a combination of individual and group-based sessions in which the youth will participate This combination allows for more intensive individualized attention as well as supportive group sessions Youth will first participate in two individual sessions followed by nine group sessions and end with one additional individual session
Individual Session I Orientation I
Part A - meet with interventionist for ecological assessment rapport building and preparation for meeting with medical provider Part B - meet with medical provider to answer HIV specific medical questions ie transmission information viral loadt-cells opportunistic infectionsetc The interventionist will be present in Part B as well
Individual Session II Orientation II
Part A - meet with interventionist for continued debriefing questionanswer preparation for group participation
Part B - meet with peer facilitator to discuss individual experiences living with HIV rapport building peer-specific questions The interventionist will be present in Part B as well
Individual session III Wrap-up and Action Planning to take place after group sessions are complete
Part A - action plan with linkage to identified agencies via facilitated referrals Part B - optional support building - participants may bring parents partner friend or other potential source of support for questionanswer session with interventionist
Session I Developing Group Cohesion
- Icebreaker team building group rules facilitation of group ownership by participants
Session II Disclosure Stigma Relationships
Disclosure to family friends peers and co-workers as well as dealing with stigma associated with HIVAIDS
Concerns about current or future romantic andor sexual relationships including discussion of safer sex condom use sero-discordant couples
Session III Preparing for Medical Intervention
- Working with medical providers an overview of clinic appointments and expectations surrounding attendance a preliminary discussion of medications side effects and medical management as well as strategies for adherence
Session IV Healthy Living
Issues related to drugs and alcohol
Leisure activities such as sports and entertainment
Self-care including nutrition and exercise
The importance of school and work
Session V Stress ReductionRelaxation Spirituality
Techniques including deep breathing progressive muscle relaxation visualization meditation and self-hypnosis
Self-care including complimentary therapies such as massage and acupuncture
Spirituality
Planning social outings and activities
Session VI Gender Specific
Males issues surrounding sexuality and sexual orientation male role of caring for self loved ones and the community
Females issues surrounding sexuality pregnancy and parenting female role of caring for self loved ones and the community
Session VII Self-EsteemSelf-Worth
- Strategies to improve self-esteem and self-worth
Session VIII Legal IssuesAdvocacy
Legal rights and advocacy
Linkage to community advocacy groups
Preparing to become a speakeradvocate
Health insurancelife insurance
Session IX Future Planning
- Planning for the future including issues related to work and school eg job application process applying for financial aid job training and career choices
Individual Session I Orientation I
Part A - meet with interventionist for ecological assessment rapport building and preparation for meeting with medical provider Part B - meet with medical provider to answer HIV specific medical questions ie transmission information viral loadt-cells opportunistic infectionsetc The interventionist will be present in Part B as well
Individual Session II Orientation II
Part A - meet with interventionist for continued debriefing questionanswer preparation for group participation
Part B - meet with peer facilitator to discuss individual experiences living with HIV rapport building peer-specific questions The interventionist will be present in Part B as well
Individual session III Wrap-up and Action Planning to take place after group sessions are complete
Part A - action plan with linkage to identified agencies via facilitated referrals Part B - optional support building - participants may bring parents partner friend or other potential source of support for questionanswer session with interventionist
Session I Developing Group Cohesion
- Icebreaker team building group rules facilitation of group ownership by participants
Session II Disclosure Stigma Relationships
Disclosure to family friends peers and co-workers as well as dealing with stigma associated with HIVAIDS
Concerns about current or future romantic andor sexual relationships including discussion of safer sex condom use sero-discordant couples
Session III Preparing for Medical Intervention
- Working with medical providers an overview of clinic appointments and expectations surrounding attendance a preliminary discussion of medications side effects and medical management as well as strategies for adherence
Session IV Healthy Living
Issues related to drugs and alcohol
Leisure activities such as sports and entertainment
Self-care including nutrition and exercise
The importance of school and work
Session V Stress ReductionRelaxation Spirituality
Techniques including deep breathing progressive muscle relaxation visualization meditation and self-hypnosis
Self-care including complimentary therapies such as massage and acupuncture
Spirituality
Planning social outings and activities
Session VI Gender Specific
Males issues surrounding sexuality and sexual orientation male role of caring for self loved ones and the community
Females issues surrounding sexuality pregnancy and parenting female role of caring for self loved ones and the community
Session VII Self-EsteemSelf-Worth
- Strategies to improve self-esteem and self-worth
Session VIII Legal IssuesAdvocacy
Legal rights and advocacy
Linkage to community advocacy groups
Preparing to become a speakeradvocate
Health insurancelife insurance
Session IX Future Planning
- Planning for the future including issues related to work and school eg job application process applying for financial aid job training and career choices
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