Project ACCEPT: Engaging Newly Diagnosed HIV+ Youth in Care
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01751620 |
Recruitment Status
:
Completed
First Posted
: December 18, 2012
Last Update Posted
: February 28, 2017
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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 |
Allocation: | Randomized |
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 |

Arm | Intervention/treatment |
---|---|
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.
|
- 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.

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, Learn About Clinical Studies.
Ages Eligible for Study: | 16 Years to 24 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

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 |
Additional Information:
Responsible Party: | University of North Carolina, Chapel Hill |
ClinicalTrials.gov Identifier: | NCT01751620 History of Changes |
Other Study ID Numbers: |
ATN 108 |
First Posted: | December 18, 2012 Key Record Dates |
Last Update Posted: | February 28, 2017 |
Last Verified: | October 2016 |
Additional relevant MeSH terms:
HIV Seropositivity HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections |
Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases |