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: May 15, 2014
Last verified: May 2014
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: May 15, 2014
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 July 28, 2014