Project ACCEPT: Engaging Newly Diagnosed HIV+ Youth in Care

This study is currently recruiting participants.
Verified March 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: March 19, 2014
Last verified: March 2014

December 14, 2012
March 19, 2014
January 2013
January 2016   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01751620 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
Project ACCEPT: Engaging Newly Diagnosed HIV+ Youth in Care
Project ACCEPT: Engaging Newly Diagnosed HIV+ Youth in Care

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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
HIV Positive Youth That Are Newly Engaged in Care.
  • 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
  • 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.
  • Experimental: Project ACCEPT
    Participants randomized to the intervention (Project ACCEPT) arm.
    Intervention: Behavioral: Project ACCEPT
  • Active Comparator: HEALTH
    Participants randomized to the comparison (HEALTH) arm.
    Intervention: Behavioral: HEALTH
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
240
January 2016
January 2016   (final data collection date for primary outcome measure)

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.
Both
16 Years to 24 Years
No
Contact: Sarah Thornton, BS (240) 453-5649 sarahthornton@westat.com
United States
 
NCT01751620
ATN 108
No
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • National Institute on Drug Abuse (NIDA)
  • National Institute of Mental Health (NIMH)
Study Chair: Sybil Hosek, PhD Adolescent Trials Network
Study Chair: Gary Harper, PhD Adolescent Trials Network
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP