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Project ACCEPT: Engaging Newly Diagnosed HIV+ Youth in Care

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ClinicalTrials.gov Identifier: NCT01751620
Recruitment Status : Completed
First Posted : December 18, 2012
Last Update Posted : February 28, 2017
Sponsor:
Collaborators:
National Institute on Drug Abuse (NIDA)
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:

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 or disease Intervention/treatment Phase
HIV Positive Youth That Are Newly Engaged in Care Behavioral: Project ACCEPT Behavioral: HEALTH Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 167 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Project ACCEPT: Engaging Newly Diagnosed HIV+ Youth in Care
Study Start Date : January 2013
Actual Primary Completion Date : June 2015
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. Examine the efficacy of Project ACCEPT compared with an attention-controlled health education comparison intervention [ Time Frame: 3 years ]
    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 :
  1. Explore the relationship between HIV biomarkers and participant's level of engagement in care [ Time Frame: 3 years ]
    Explore the relationship between HIV biomarkers (i.e., CD4 and viral load) and participant's level of engagement in care.


Eligibility Criteria
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Ages Eligible for Study:   16 Years to 24 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01751620


Locations
United States, Florida
University of Miami School of Medicine
Miami, Florida, United States, 33101
United States, Illinois
Stroger Hospital and the CORE Center
Chicago, Illinois, United States, 60612
United States, Michigan
Wayne State University
Detroit, Michigan, United States, 48201
United States, Tennessee
St. Jude Childrens Research Hospital
Memphis, Tennessee, United States, 38105
Sponsors and Collaborators
University of North Carolina, Chapel Hill
National Institute on Drug Abuse (NIDA)
National Institute of Mental Health (NIMH)
Investigators
Study Chair: Sybil Hosek, PhD Adolescent Trials Network
Study Chair: Gary Harper, PhD Adolescent Trials Network
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:
ATN website  This link exits the ClinicalTrials.gov site

Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT01751620     History of Changes
Other Study ID Numbers: ATN 108
First Posted: December 18, 2012    Key Record Dates
Last Update Posted: February 28, 2017
Last Verified: October 2016

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