Intervention for Newly Diagnosed Youth With HIV
This study has been completed.
Sponsor:
Collaborators:
Information provided by (Responsible Party):
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:
NCT00510237
First received: July 31, 2007
Last updated: December 14, 2012
Last verified: October 2012
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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 |
Resource links provided by NLM:
Further study details as provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
Primary Outcome Measures:
- 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.
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 16 Years to 24 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00510237
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 | |
Sponsors and Collaborators
Investigators
| 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 May 19, 2013