Project ACCEPT: Engaging Newly Diagnosed HIV+ Youth in Care

Completed · Not applicable

Conditions studied: HIV Positive Youth That Are Newly Engaged in Care

In brief

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.

Key facts

Study ID

NCT01751620

Run by

University of North Carolina, Chapel Hill

People needed

167

Starts

2013-01-01

Expected to finish

2015-06-01

Last updated by the study team

2017-02-28

Who can join

Age: 16 and older, up to 24. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University of Miami School of Medicine — Miami, Florida, United States
• Stroger Hospital and the CORE Center — Chicago, Illinois, United States
• Wayne State University — Detroit, Michigan, United States
• St. Jude Childrens Research Hospital — Memphis, Tennessee, United States

Full record on ClinicalTrials.gov

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