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Intervention for Newly Diagnosed Youth With HIV

Intervention Development for Newly Diagnosed Youth With HIV

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00510237
Enrollment
50
Registered
2007-08-01
Start date
2007-02-28
Completion date
2009-01-31
Last updated
2017-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV

Keywords

HIV, Adolescents newly diagnosed with HIV

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 (i.e., transmission information, viral load/t-cells, opportunistic infections,etc.). The interventionist will be present in Part B as well. Individual Session II: Orientation II Part A - meet with interventionist for continued debriefing, question/answer, 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 question/answer 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 HIV/AIDS; * Concerns about current or future romantic and/or 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 Reduction/Relaxation & 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-Esteem/Self-Worth \- Strategies to improve self-esteem and self-worth; Session VIII: Legal Issues/Advocacy * Legal rights and advocacy; * Linkage to community advocacy groups; * Preparing to become a speaker/advocate; * Health insurance/life insurance. Session IX: Future Planning \- Planning for the future including issues related to work and school (e.g., job application process, applying for financial aid), job training and career choices.

Interventions

BEHAVIORALAdolescents Coping, Connecting, Empowering, and Protecting Together (Project ACCEPT)

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.

Sponsors

National Institute on Drug Abuse (NIDA)
CollaboratorNIH
National Institute of Mental Health (NIMH)
CollaboratorNIH
University of North Carolina, Chapel Hill
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
16 Years to 24 Years
Healthy volunteers
No

Inclusion criteria

To be considered eligible for enrollment in ATN 068, a participant must meet the criteria listed below: * Receive services at one of the 4 selected ATN sites or their community partners; * HIV-infected as documented by medical record review or verbal verification with referring professional; * Received HIV diagnosis less than 15 months ago as documented by medical record review or verbal verification with referring professional; * Fall between the ages of 16-24 (inclusive) at the time of informed consent/assent; * Must be willing to participate in the both the individual and group sessions; * Give informed consent/assent for study participation.

Exclusion criteria

Participants who meet any of the

Design outcomes

Primary

MeasureTime frame
The best procedures for a larger trial (e.g. timing, content etc. of ACASI administration)7 months
The appropriateness of specific instruments proposed.7 months
The perceived sensitivity of measures to change over time.7 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026