HIV Positive Youth That Are Newly Engaged in Care Clinical Trial
Official title:
Project ACCEPT: Engaging Newly Diagnosed HIV+ Youth in Care
| Verified date | October 2016 |
| Source | University of North Carolina, Chapel Hill |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 167 |
| Est. completion date | June 2015 |
| Est. primary completion date | June 2015 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 16 Years to 24 Years |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| 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 | University of Miami School of Medicine | Miami | Florida |
| Lead Sponsor | Collaborator |
|---|---|
| University of North Carolina, Chapel Hill | National Institute of Mental Health (NIMH), National Institute on Drug Abuse (NIDA) |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Examine the efficacy of Project ACCEPT compared with an attention-controlled health education comparison intervention | 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. | 3 years | |
| Secondary | Explore the relationship between HIV biomarkers and participant's level of engagement in care | Explore the relationship between HIV biomarkers (i.e., CD4 and viral load) and participant's level of engagement in care. | 3 years |