An interventional study of Project ACCEPT and HEALTH in HIV Positive Youth That Are Newly Engaged in Care, sponsored by University of North Carolina, Chapel Hill. Completed at 4 sites in United States. Open to participants aged 16 Years to 24 Years. Per ClinicalTrials.gov, last updated 2017-02-28.
Sponsored by University of North Carolina, Chapel Hill · Not applicable, Interventional, and Supportive 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:
210 studies on the registry are indexed under HIV Seropositivity; 10 are open to participants now.
This study's enrollment of 167 is above the median of 89 across 140 interventional studies indexed under HIV Seropositivity.
Browse HIV Seropositivity studies →University of North Carolina, Chapel Hill is the lead sponsor of 1,340 studies on the registry; 133 are open to participants now.
Of its 155 completed or terminated interventional studies of FDA-regulated products, 136 (88%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants randomized to the intervention (Project ACCEPT) arm.
Behavioral: Project ACCEPT
Participants randomized to the comparison (HEALTH) arm.
Behavioral: HEALTH
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.
Also known as: Adolescents Coping, Connecting, Empowering and Protecting Together
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.
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.
Time frame: 3 years
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.
Time frame: 3 years
This study is completed, as verified in Oct 2016. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of North Carolina, Chapel Hill