NCT02785302

Brief Summary

This is a multi-site, longitudinal study and it describes the transition process of behaviorally-infected HIV-positive youth as they move from pediatric- and adolescent-specific care to adult care. To achieve this goal, the transition process is characterized from the perspectives of HIV-positive youth, Adolescent Medicine Trials Unit (AMTU) clinic staff, and receiving adult clinic staff.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
136

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2015

Geographic Reach
1 country

14 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

August 1, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 19, 2015

Completed
7 months until next milestone

First Posted

Study publicly available on registry

May 27, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
Last Updated

February 28, 2017

Status Verified

December 1, 2016

Enrollment Period

1.3 years

First QC Date

October 19, 2015

Last Update Submit

February 27, 2017

Conditions

Keywords

PediatricHIVTransitionAdult Care

Outcome Measures

Primary Outcomes (6)

  • Transition Expectations and Experiences as assessed by the ACASI (comparison between pre- and post-transition)

    Baseline

  • Transition Expectations and Experiences as assessed by the ACASI (comparison between pre- and post-transition)

    39 weeks

  • Patterns of Transition as assessed by the ACASI, as well as medical and appointment records abstraction (comparison between pre- and post-transition)

    Baseline

  • Patterns of Transition as assessed by the ACASI, as well as medical and appointment records abstraction (comparison between pre- and post-transition)

    39 weeks

  • Patterns of Engagement in Care as assessed by the ACASI, as well as medical and appointment records abstraction (assessment over time from point of transition)

    Baseline

  • Patterns of Engagement in Care as assessed by the ACASI, as well as medical and appointment records abstraction (assessment over time from point of transition)

    39 weeks

Secondary Outcomes (3)

  • Transition Protocols at AMTUs and Adult Clinics

    1 day

  • Transition Processes at AMTUs and Adult Clinics

    1 day

  • Preparedness of Adult Clinics to Receive Behaviorally-Infected HIV-Positive Youth Transitioning from Adolescent Clinics

    1 day

Study Arms (2)

Adolescents and Young Adults:

Behaviorally-infected, HIV-positive, adolescents and young adults enrolled in ATN 125, aged 18 through 24, inclusive who are transition eligible. All subjects with available endpoint data will be included in the analysis.

AMTU and Adult Clinic Staff

Clinical staff at the Adolescent Medical Trials Units (AMTUs) and at adult clinics where the AMTUs refer their transitioning patients will be recruited to complete quantitative surveys and semi-structured interviews.

Eligibility Criteria

Age18 Years - 24 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Behaviorally-infected HIV-positive adolescents and young adults between the ages of 18 and 24 years, are recruited to complete computer assisted interviews to characterize the transition process and outcomes. AMTU staff and partner adult clinic staff are recruited to complete quantitative surveys and semi-structured interviews over the phone to explore transition processes and protocols. There are no minimum or maximum age criteria that staff must meet .

You may qualify if:

  • To be considered eligible to participate in 135, behaviorally-infected HIV-positive adolescents and young adults must be:
  • Enrolled in ATN 125
  • Be transition eligible. Transition eligible means that the youth are either (a) age 18 through 24 years old and planning to transition to adult medical care within six months after ATN 135 enrollment or (b) 24 years old and not actively planning to transition to adult medical care.
  • Willing and able to provide consent to participate.

You may not qualify if:

  • To be considered eligible for enrollment, an individual must not meet any of the criteria listed below.
  • Presence of serious psychiatric symptoms (e.g., active hallucinations, thought disorder) that would impair the individual's ability to provide true informed consent or participate in the baseline ACASI;
  • Visibly distraught (e.g., suicidal, homicidal, exhibiting violent behavior) at the time of consent or the baseline ACASI;
  • At the time of consent, intoxicated or under the influence of alcohol or other substances to such an extent that in the opinion of the study staff, the ability to give true informed consent is impaired; or
  • At the time of the baseline ACASI, intoxicated or under the influence of alcohol or other substances to such an extent that in the opinion of the study staff, the subject's ability to understand and answer the questions may be impaired and negatively impact the integrity of the research data.
  • AMTU and Partner Adult Clinic Staff
  • To be considered eligible to complete the AMTU and partner adult clinic surveys and semi-structured interviews, an individual must meet all of the criteria listed below.
  • Being a clinical staff (e.g., healthcare providers, social workers, case managers, transition person) at either an AMTU or AMTU-affiliated site or partner adult clinic;
  • Supporting (in any capacity) transition efforts for HIV-positive adolescents; and
  • Willing and able to provide verbal consent for surveys and semi-structured interviews.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Childrens Hospital of Los Angeles

Los Angeles, California, 90027, United States

Location

University of Colorado - The Children's Hospital of Denver

Aurora, Colorado, 80045, United States

Location

Children's Hosp Natinal Med Center

Washington D.C., District of Columbia, 20010, United States

Location

University of Miami

Miami, Florida, 33101, United States

Location

University of South Florida

Tampa, Florida, 33606, United States

Location

Stroger Hospital of Cook County

Chicago, Illinois, 60612, United States

Location

Tulane Medical Center

New Orleans, Louisiana, 70112, United States

Location

Johns Hopkins University

Baltimore, Maryland, 21287, United States

Location

Fenway Institute

Boston, Massachusetts, 02215, United States

Location

Wayne State University

Detroit, Michigan, 48201, United States

Location

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

Children's Hopsital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Related Links

Study Officials

  • Amanda E Tanner, PhD, MPH

    University of North Carolina, Greensboro

    STUDY CHAIR
  • J. Dennis Fortenberry, MD, MS

    Indiana University School of Medicine

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 19, 2015

First Posted

May 27, 2016

Study Start

August 1, 2015

Primary Completion

November 1, 2016

Study Completion

November 1, 2016

Last Updated

February 28, 2017

Record last verified: 2016-12

Locations