Project ACCEPT: Engaging Newly Diagnosed HIV+ Youth in Care
This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Information provided by (Responsible Party):
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:
NCT01751620
First received: December 14, 2012
Last updated: February 12, 2015
Last verified: December 2014
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Purpose
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 | Intervention |
|---|---|
|
HIV Positive Youth That Are Newly Engaged in Care. |
Behavioral: Project ACCEPT Behavioral: HEALTH |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Supportive Care |
| Official Title: | Project ACCEPT: Engaging Newly Diagnosed HIV+ Youth in Care |
Resource links provided by NLM:
Further study details as provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
Primary Outcome Measures:
- Examine the efficacy of Project ACCEPT compared with an attention-controlled health education comparison intervention [ Time Frame: 3 years ] [ Designated as safety issue: No ]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.
Secondary Outcome Measures:
- Explore the relationship between HIV biomarkers and participant's level of engagement in care [ Time Frame: 3 years ] [ Designated as safety issue: No ]Explore the relationship between HIV biomarkers (i.e., CD4 and viral load) and participant's level of engagement in care.
| Estimated Enrollment: | 240 |
| Study Start Date: | January 2013 |
| Estimated Study Completion Date: | January 2016 |
| Estimated Primary Completion Date: | January 2016 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
Behavioral: HEALTH
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.
|
Eligibility| Ages Eligible for Study: | 16 Years to 24 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01751620
Please refer to this study by its ClinicalTrials.gov identifier: NCT01751620
Locations
| 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 | |
Sponsors and Collaborators
Investigators
| Study Chair: | Sybil Hosek, PhD | Adolescent Trials Network | |
| Study Chair: | Gary Harper, PhD | Adolescent Trials Network |
More Information
Additional Information:
No publications provided
| Responsible Party: | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
| ClinicalTrials.gov Identifier: | NCT01751620 History of Changes |
| Other Study ID Numbers: | ATN 108 |
| Study First Received: | December 14, 2012 |
| Last Updated: | February 12, 2015 |
| Health Authority: | United States: Federal Government |
ClinicalTrials.gov processed this record on March 01, 2015