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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
| National Institute of Mental Health (NIMH) | NIH |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Project ACCEPT | Experimental | Participants randomized to the intervention (Project ACCEPT) arm. |
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| HEALTH | Active Comparator | Participants randomized to the comparison (HEALTH) arm. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Project ACCEPT | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sybil Hosek, PhD | Adolescent Trials Network | Study Chair |
| Gary Harper, PhD | Adolescent Trials Network | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami School of Medicine | Miami | Florida | 33101 | United States | ||
| Stroger Hospital and the CORE Center |
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| Label | URL |
|---|---|
| ATN website | View source |
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| ID | Term |
|---|---|
| D006262 | Health |
| ID | Term |
|---|---|
| D011154 | Population Characteristics |
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| HEALTH | Behavioral | 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. |
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| Chicago |
| Illinois |
| 60612 |
| United States |
| Wayne State University | Detroit | Michigan | 48201 | United States |
| St. Jude Childrens Research Hospital | Memphis | Tennessee | 38105 | United States |