NCT00510237

Brief Summary

This study will pilot test an HIV intervention for newly diagnosed youth (diagnosed for less than 15 months) to assess its acceptability and feasibility preliminary to and leading up to a full-scale, randomized trial. The general focus of the intervention is to aid in the psychosocial adjustment of adolescents who have recently been diagnosed with HIV.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at below P25 for not_applicable hiv

Timeline
Completed

Started Feb 2007

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2007

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 31, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 1, 2007

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed
Last Updated

March 6, 2017

Status Verified

August 1, 2016

Enrollment Period

1.3 years

First QC Date

July 31, 2007

Last Update Submit

March 2, 2017

Conditions

HIV

Keywords

HIVAdolescents newly diagnosed with HIV

Outcome Measures

Primary Outcomes (3)

  • The best procedures for a larger trial (e.g. timing, content etc. of ACASI administration)

    7 months

  • The appropriateness of specific instruments proposed.

    7 months

  • The perceived sensitivity of measures to change over time.

    7 months

Study Arms (2)

1

EXPERIMENTAL

5-7 females per group at each of the four sites.

Behavioral: "Adolescents Coping, Connecting, Empowering, and Protecting Together" (Project ACCEPT)

2

EXPERIMENTAL

5-7 males per group at each of the four sites.

Behavioral: "Adolescents Coping, Connecting, Empowering, and Protecting Together" (Project ACCEPT)

Interventions

"Adolescents Coping, Connecting, Empowering, and Protecting Together" (Project ACCEPT)BEHAVIORAL

The intervention will consist of a combination of individual and group-based sessions in which the youth will participate. This combination allows for more intensive individualized attention as well as supportive group sessions. Youth will first participate in two individual sessions, followed by nine group sessions, and end with one additional individual session.

12

Eligibility Criteria

Age16 Years - 24 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • To be considered eligible for enrollment in ATN 068, a participant must meet the criteria listed below:
  • Receive services at one of the 4 selected ATN sites or their community partners;
  • HIV-infected as documented by medical record review or verbal verification with referring professional;
  • Received HIV diagnosis less than 15 months ago as documented by medical record review or verbal verification with referring professional;
  • Fall between the ages of 16-24 (inclusive) at the time of informed consent/assent;
  • Must be willing to participate in the both the individual and group sessions;
  • Give informed consent/assent for study participation.

You may not qualify if:

  • Acquired HIV through perinatal infection;
  • Presence of serious psychiatric symptoms (active hallucinations, thought disorder);
  • Visibly distraught (suicidal, homicidal, exhibiting violent behavior);
  • Intoxicated or under the influence of alcohol or other substances at the time of study enrollment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

University of Miami School of Medicine

Miami, Florida, 33101, United States

Location

John Stroger Jr. Hospital of Cook County

Chicago, Illinois, 60612, United States

Location

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

Location

Related Links

Study Officials

  • Sybil Hosek, PhD

    John Stroger Jr. Hospital of Cook County

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 31, 2007

First Posted

August 1, 2007

Study Start

February 1, 2007

Primary Completion

June 1, 2008

Study Completion

January 1, 2009

Last Updated

March 6, 2017

Record last verified: 2016-08

Locations

US(4)