Trial record 14 of 680 for:    adolescent health | Open Studies

Project ACCEPT: Engaging Newly Diagnosed HIV+ Youth in Care

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Sponsor:
Collaborators:
Information provided by (Responsible Party):
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:
NCT01751620
First received: December 14, 2012
Last updated: May 8, 2014
Last verified: May 2014
  Purpose

The proposed study is a two-group randomized repeated measures design that will examine the efficacy of Project ACCEPT (Adolescents Coping, Connecting, Empowering and Protecting Together) to improve engagement in care among youth newly diagnosed with HIV at five AMTU sites across the United States. Youth will be randomized into one of two study arms; Project ACCEPT, the intervention, or HEALTH, the health education attention-controlled comparison condition. Both arms consist of two individual sessions followed by six group sessions and a final individual session which is expected to take approximately nine weeks after which youth will have four follow-up visits at the following time points:

  • post intervention (immediately after the last session);
  • 3 months post the last session;
  • 6 months post the last session; and
  • 12 months post the last session. The trial will be repeated in up to three waves.

Condition Intervention
HIV Positive Youth That Are Newly Engaged in Care.
Behavioral: Project ACCEPT
Behavioral: HEALTH

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Project ACCEPT: Engaging Newly Diagnosed HIV+ Youth in Care

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:
  • Examine the efficacy of Project ACCEPT compared with an attention-controlled health education comparison intervention [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    Conduct a randomized controlled trial to examine the efficacy of Project ACCEPT compared with an attention-controlled health education comparison intervention (HEALTH). The goals of the intervention are to improve engagement in care, decrease psychosocial barriers to care, and decrease sexual risk for youth newly diagnosed with HIV.


Secondary Outcome Measures:
  • Explore the relationship between HIV biomarkers and participant's level of engagement in care [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    Explore the relationship between HIV biomarkers (i.e., CD4 and viral load) and participant's level of engagement in care.


Estimated Enrollment: 240
Study Start Date: January 2013
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Project ACCEPT
Participants randomized to the intervention (Project ACCEPT) arm.
Behavioral: Project ACCEPT
The intervention, Project ACCEPT, combines weekly individual and group sessions that address a range of issues that impact engagement in care for youth living with HIV, including stigma, disclosure, health relationships, substance use, and future life plans.
Other Name: Adolescents Coping, Connecting, Empowering and Protecting Together
Active Comparator: HEALTH
Participants randomized to the comparison (HEALTH) arm.
Behavioral: HEALTH
The comparison condition, HEALTH, matches Project ACCEPT in number of sessions and duration. The weekly sessions will cover information on alcohol, drugs, HIV and other sexually transmitted diseases (STDs) to meet the ethical responsibility to provide risk reduction information to youth assigned.

  Eligibility

Ages Eligible for Study:   16 Years to 24 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • HIV-infected and aware of his/her status as documented by medical record review or verbal verification by provider (i.e., medical or mental health care provider, case manager, social worker, etc.);
  • Received HIV diagnosis within the past 12 months (+ 3 months) at the time of consent/assent as documented by medical record review or verbal verification with referring professional (i.e., medical or mental health care provider, case manager, social worker, etc.);
  • Between the ages of 16-24 (inclusive) at the time of informed consent/assent;
  • Receives services at one of the selected AMTUs or one of their community partners;
  • Willing to participate in both the individual and group sessions;
  • Ability to speak and understand spoken English;
  • Able to understand and willing to provide signed informed consent/assent in English or Spanish; and
  • Willingness to provide signed informed consent or assent with parental/legal guardian permission as applicable.

Exclusion Criteria:

  • Participated in a previous wave, if enrolling into Wave 2 or 3;
  • Intoxicated or under the influence of alcohol or other substances at the time of consent/assent;
  • Visibly distraught and/or visibly emotionally unstable (i.e., exhibiting suicidal, homicidal, or violent behavior) in the opinion of the site personnel would interfere with the ability to give true informed consent; and
  • Any concurrent participation in other behavioral studies. Permission from the protocol team may be provided for uncertain cases.
  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: NCT01751620

Contacts
Contact: Sarah Thornton, BS (240) 453-5649 sarahthornton@westat.com

Locations
United States, Florida
University of Miami School of Medicine Recruiting
Miami, Florida, United States, 33101
Contact: Donna Maturo, MSN    305-243-3442    dmaturo@med.miami.edu   
Principal Investigator: Larry Friedman, MD         
United States, Illinois
Stroger Hospital and the CORE Center Recruiting
Chicago, Illinois, United States, 60612
Contact: Kelly Bojan, DNP    312-572-4571    kbojan@sbcglobal.net   
Principal Investigator: Jaime Martinez, MD         
United States, Michigan
Wayne State University Recruiting
Detroit, Michigan, United States, 48201
Contact: Monique L Green-Jones, MPH    313-966-9763    mogreen@med.wayne.edu   
Contact: Charnell Cromer, MSN    313-966-0622    ccromer@med.wayne.edu   
Principal Investigator: Elizabeth Secord, MD         
United States, Tennessee
St. Jude Childrens Research Hospital Recruiting
Memphis, Tennessee, United States, 38105
Contact: Mary Dillard, BSN    901-595-4083    mary.dillard@stjude.org   
Principal Investigator: Aditya Gaur, MD         
Sponsors and Collaborators
Investigators
Study Chair: Sybil Hosek, PhD Adolescent Trials Network
Study Chair: Gary Harper, PhD Adolescent Trials Network
  More Information

Additional Information:
No publications provided

Responsible Party: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier: NCT01751620     History of Changes
Other Study ID Numbers: ATN 108
Study First Received: December 14, 2012
Last Updated: May 8, 2014
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
HIV Seropositivity
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases

ClinicalTrials.gov processed this record on October 19, 2014