search
Back to results

Project ACCEPT: Engaging Newly Diagnosed HIV+ Youth in Care

Primary Purpose

HIV Positive Youth That Are Newly Engaged in Care

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Project ACCEPT
HEALTH
Sponsored by
University of North Carolina, Chapel Hill
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for HIV Positive Youth That Are Newly Engaged in Care

Eligibility Criteria

16 Years - 24 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Miami School of Medicine
  • Stroger Hospital and the CORE Center
  • Wayne State University
  • St. Jude Childrens Research Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Project ACCEPT

HEALTH

Arm Description

Participants randomized to the intervention (Project ACCEPT) arm.

Participants randomized to the comparison (HEALTH) arm.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
December 14, 2012
Last Updated
February 27, 2017
Sponsor
University of North Carolina, Chapel Hill
Collaborators
National Institute on Drug Abuse (NIDA), National Institute of Mental Health (NIMH)
search

1. Study Identification

Unique Protocol Identification Number
NCT01751620
Brief Title
Project ACCEPT: Engaging Newly Diagnosed HIV+ Youth in Care
Official Title
Project ACCEPT: Engaging Newly Diagnosed HIV+ Youth in Care
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of North Carolina, Chapel Hill
Collaborators
National Institute on Drug Abuse (NIDA), National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Positive Youth That Are Newly Engaged in Care

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
167 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Project ACCEPT
Arm Type
Experimental
Arm Description
Participants randomized to the intervention (Project ACCEPT) arm.
Arm Title
HEALTH
Arm Type
Active Comparator
Arm Description
Participants randomized to the comparison (HEALTH) arm.
Intervention Type
Behavioral
Intervention Name(s)
Project ACCEPT
Other Intervention Name(s)
Adolescents Coping, Connecting, Empowering and Protecting Together
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
HEALTH
Intervention Description
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.
Primary Outcome Measure Information:
Title
Examine the efficacy of Project ACCEPT compared with an attention-controlled health education comparison intervention
Description
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
Secondary Outcome Measure Information:
Title
Explore the relationship between HIV biomarkers and participant's level of engagement in care
Description
Explore the relationship between HIV biomarkers (i.e., CD4 and viral load) and participant's level of engagement in care.
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
24 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sybil Hosek, PhD
Organizational Affiliation
Adolescent Trials Network
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Gary Harper, PhD
Organizational Affiliation
Adolescent Trials Network
Official's Role
Study Chair
Facility Information:
Facility Name
University of Miami School of Medicine
City
Miami
State/Province
Florida
ZIP/Postal Code
33101
Country
United States
Facility Name
Stroger Hospital and the CORE Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Wayne State University
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
St. Jude Childrens Research Hospital
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38105
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Project ACCEPT: Engaging Newly Diagnosed HIV+ Youth in Care

We'll reach out to this number within 24 hrs