Project ACCEPT: Engaging Newly Diagnosed HIV+ Youth in Care

Not Applicable

Completed

• Conditions: HIV Positive Youth That Are Newly Engaged in Care
• Interventions: Behavioral: Project ACCEPT; Behavioral: HEALTH

• Registration Number: NCT01751620
• Lead Sponsor: University of North Carolina, Chapel Hill

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-12-14
• Study First Submitted QC: 2012-12-14
• Study First Posted: 2012-12-18
• Study Start: 2013-01
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Status Verified: 2016-10
• Last Update Submitted: 2017-02-27
• Last Update Posted: 2017-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 167

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Project ACCEPT	Project ACCEPT	Participants randomized to the intervention (Project ACCEPT) arm.
HEALTH	HEALTH	Participants randomized to the comparison (HEALTH) arm.

Primary Outcome Measures

Name	Time	Method
Examine the efficacy of Project ACCEPT compared with an attention-controlled health education comparison intervention	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.

Secondary Outcome Measures

Name	Time	Method
Explore the relationship between HIV biomarkers and participant's level of engagement in care	3 years	Explore the relationship between HIV biomarkers (i.e., CD4 and viral load) and participant's level of engagement in care.

Trial Locations

Locations (4)

University of Miami School of Medicine; 🇺🇸 Miami, Florida, United States

Stroger Hospital and the CORE Center; 🇺🇸 Chicago, Illinois, United States

Wayne State University; 🇺🇸 Detroit, Michigan, United States

St. Jude Childrens Research Hospital; 🇺🇸 Memphis, Tennessee, United States