Intervention for Newly Diagnosed Youth With HIV
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV |
Behavioral: "Adolescents Coping, Connecting, Empowering, and Protecting Together" (Project ACCEPT) |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Supportive Care |
| Official Title: | Intervention Development for Newly Diagnosed Youth With HIV |
- The best procedures for a larger trial (e.g. timing, content etc. of ACASI administration) [ Time Frame: 7 months ] [ Designated as safety issue: No ]
- The appropriateness of specific instruments proposed. [ Time Frame: 7 months ] [ Designated as safety issue: No ]
- The perceived sensitivity of measures to change over time. [ Time Frame: 7 months ] [ Designated as safety issue: No ]
| Enrollment: | 50 |
| Study Start Date: | February 2007 |
| Study Completion Date: | June 2008 |
| Primary Completion Date: | June 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
5-7 females per group at each of the four sites.
|
Behavioral: "Adolescents 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.
|
|
Experimental: 2
5-7 males per group at each of the four sites.
|
Behavioral: "Adolescents 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.
|
Hide Detailed DescriptionDetailed 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.
Eligibility| Ages Eligible for Study: | 16 Years to 24 Years |
| Genders Eligible for Study: | Both |
| Accepts 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 exclusion criteria listed below are considered ineligible:
- Acquired HIV through perinatal infection;
- Presence of serious psychiatric symptoms (active hallucinations, thought disorder);
- Visibly distraught (suicidal, homicidal, exhibiting violent behavior);
- Intoxicated or under the influence of alcohol or other substances at the time of study enrollment.
Contacts and Locations| United States, Florida | |
| University of Miami School of Medicine | |
| Miami, Florida, United States, 33101 | |
| United States, Illinois | |
| John Stroger Jr. Hospital of Cook County | |
| Chicago, Illinois, United States, 60612 | |
| United States, New York | |
| Montefiore Medical Center | |
| Bronx, New York, United States, 10467 | |
| United States, Tennessee | |
| St. Jude Children's Research Hospital | |
| Memphis, Tennessee, United States, 38105 | |
| Study Chair: | Sybil Hosek, PhD | John Stroger Jr. Hospital of Cook County |
More Information
Additional Information:
No publications provided
| Responsible Party: | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
| ClinicalTrials.gov Identifier: | NCT00510237 History of Changes |
| Other Study ID Numbers: | ATN 068 |
| Study First Received: | July 31, 2007 |
| Last Updated: | December 14, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
|
HIV Adolescents newly diagnosed with HIV |
ClinicalTrials.gov processed this record on June 18, 2013