Project ACCEPT: Engaging Newly Diagnosed HIV+ Youth in Care
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|ClinicalTrials.gov Identifier: NCT01751620|
Recruitment Status : Completed
First Posted : December 18, 2012
Last Update Posted : February 28, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|HIV Positive Youth That Are Newly Engaged in Care||Behavioral: Project ACCEPT Behavioral: HEALTH||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||167 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Project ACCEPT: Engaging Newly Diagnosed HIV+ Youth in Care|
|Study Start Date :||January 2013|
|Actual Primary Completion Date :||June 2015|
|Actual Study Completion Date :||June 2015|
Experimental: Project ACCEPT
Participants randomized to the intervention (Project ACCEPT) arm.
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
Active Comparator: HEALTH
Participants randomized to the comparison (HEALTH) arm.
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 [ Time Frame: 3 years ]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.
- Explore the relationship between HIV biomarkers and participant's level of engagement in care [ Time Frame: 3 years ]Explore the relationship between HIV biomarkers (i.e., CD4 and viral load) and participant's level of engagement in care.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01751620
|United States, Florida|
|University of Miami School of Medicine|
|Miami, Florida, United States, 33101|
|United States, Illinois|
|Stroger Hospital and the CORE Center|
|Chicago, Illinois, United States, 60612|
|United States, Michigan|
|Wayne State University|
|Detroit, Michigan, United States, 48201|
|United States, Tennessee|
|St. Jude Childrens Research Hospital|
|Memphis, Tennessee, United States, 38105|
|Study Chair:||Sybil Hosek, PhD||Adolescent Trials Network|
|Study Chair:||Gary Harper, PhD||Adolescent Trials Network|