Project ACCEPT: Engaging Newly Diagnosed HIV+ Youth in Care

NCT01751620 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 167

Last updated 2017-02-28

No results posted yet for this study

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.

Conditions

  • HIV Positive Youth That Are Newly Engaged in Care

Interventions

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.

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.

Sponsors & Collaborators

  • National Institute on Drug Abuse (NIDA)

    collaborator NIH
  • National Institute of Mental Health (NIMH)

    collaborator NIH
  • University of North Carolina, Chapel Hill

    lead OTHER

Principal Investigators

  • Sybil Hosek, PhD · Adolescent Trials Network

  • Gary Harper, PhD · Adolescent Trials Network

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
24 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-01-31
Primary Completion
2015-06-30
Completion
2015-06-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01751620 on ClinicalTrials.gov