Clinical trial NCT01751620: Project ACCEPT: Engaging Newly Diagnosed HIV+ Youth in Care
Official title: Project ACCEPT: Engaging Newly Diagnosed HIV+ Youth in Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Positive Youth That Are Newly Engaged in Care
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
name: National Institute of Mental Health (NIMH)
First posted: 2012-12-18
Enrollment: 167
Sex: ALL
Minimum age (years): 16
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility 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.

Primary outcomes:
measure: Examine the efficacy of Project ACCEPT compared with an attention-controlled health education comparison intervention
timeFrame: 3 years
Secondary outcomes:
measure: Explore the relationship between HIV biomarkers and participant's level of engagement in care
timeFrame: 3 years
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami School of Medicine
state: Florida
city: Chicago
country: United States
facility: Stroger Hospital and the CORE Center
state: Illinois
city: Detroit
country: United States
facility: Wayne State University
state: Michigan
city: Memphis
country: United States
facility: St. Jude Childrens Research Hospital
state: Tennessee
Study officials:
affiliation: Adolescent Trials Network
name: Sybil Hosek, PhD
role: STUDY_CHAIR
affiliation: Adolescent Trials Network
name: Gary Harper, PhD
role: STUDY_CHAIR
References: