PHASES: Provision of HIV Treatment at ATN Sites: An Evaluation for Stakeholders

NCT02438592 | Completed

• 1 other identifier: ATN 125
• Study Type: observational
• Target: 924
• Locations: 1 country
• Sites: 14

Brief Summary

This is an observational study involving retrospective and prospective medical record review covering a total maximum of 104 weeks (24 months) per subject. An Audio Computer- Assisted Self-Interview (ACASI) at study entry will assess demographic and psychosocial variables of study subjects. Data will also be collected to assess clinic level variables. Definitions of engagement, prescription of antiretroviral therapy (ART), and viral suppression in the Continuum of Care (CoC) will utilize common definitions including those by U.S. Department of Health and Human Services (DHHS) and Health Resources and Services Administration (HRSA) HIV/AIDS Bureau (HAB). Data will be collected in a large, simple trial design manner to provide all elements for both the primary and secondary outcomes.

Conditions

HIV

Keywords

Continuum of care

Outcome Measures

Primary Outcomes (16)

• The proportion of subjects engaged in care at Baseline, per subject year, as defined by the HRSA HAB measure

  Baseline

• The proportion of subjects engaged in care at Week 26, per subject year, as defined by the HRSA HAB measure

  Week 26

• The proportion of subjects engaged in care at Week 52, per subject year, as defined by the HRSA HAB measure

  Week 52

• The proportion of subjects engaged in care at Week 78, per subject year, as defined by the HRSA HAB measure

  Week 78

• The proportion of subjects engaged in care at Baseline, per subject year, as defined by the DHHS measure

  Baseline

• The proportion of subjects engaged in care at Week 26, per subject year, as defined by the DHHS measure

  Week 26

• The proportion of subjects engaged in care at Week 52, per subject year, as defined by the DHHS measure

  Week 52

• The proportion of subjects engaged in care at Week 78, per subject year, as defined by the DHHS measure

  Week 78

• The proportion of subjects prescribed antiretroviral therapy at Baseline per subject year

  Baseline

• The proportion of subjects prescribed antiretroviral therapy at Week 26 per subject year

  Week 26

• The proportion of subjects prescribed antiretroviral therapy at Week 52 per subject year

  Week 52

• The proportion of subjects prescribed antiretroviral therapy at Week 78 per subject year

  Week 78

• The proportion of subjects that have achieved viral suppression at Baseline per subject year

  Baseline

• The proportion of subjects that have achieved viral suppression at Week 26 per subject year

  Week 26

• The proportion of subjects that have achieved viral suppression at Week 52 per subject year

  Week 52

• The proportion of subjects that have achieved viral suppression at Week 78 per subject year

  Week 78

Secondary Outcomes (19)

• The proportion of subjects with advanced HIV disease at time of first clinical visit defined as a CD4 count < 200 cells/mm3

  Baseline

• The incidence of STIs in the study population as an indicator of transmission risk at Baseline

  Baseline

• The incidence of STIs in the study population as an indicator of transmission risk at Week 26

  Week 26

• The incidence of STIs in the study population as an indicator of transmission risk at Week 52

  Week 52

• The incidence of STIs in the study population as an indicator of transmission risk at Week 78

  Week 78

Eligibility Criteria

• Age: 13 Years - 24 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

1. Behaviorally-infected, HIV-positive adolescents and young adults who are currently receiving or plan to receive their medical care at any clinical site that is part of the AMTU; 2. Ages 13 through 24, inclusive, at the Baseline visit; 3. Males and females; 4. Ability to understand spoken English; and 5. Ability for the AMTU staff to access the subject's medical records for a maximum of 78 weeks after enrollment or through February 2017, whichever occurs first.

You may qualify if:

• Laboratory evidence of HIV-1 infection per Centers for Disease Control and Prevention (CDC) Surveillance Case Definition for HIV Infection, 2014 (Section 1.1) http://www.cdc.gov/mmwr/preview/mmwrhtml/rr6303a1.htm;
• Behaviorally-acquired HIV after age 9 years;
• Age 13 through 24 years, inclusive, at the baseline visit (Enrollment);
• Planning to receive HIV medical care at an AMTU or at any clinical site that is part of the AMTU for the duration of study follow-up
• If transition to an adult health care provider must occur during the course of study participation, continued AMTU staff accessibility to medical and appointment records;
• Ability for the AMTU staff to access medical and appointment records for a maximum of 78 weeks after enrollment or through February 2017, whichever occurs first;
• Ability to understand spoken English;
• Willing and able to provide signed informed consent or assent;
• NOTE: If consent/assent is obtained \> 4 weeks prior to the enrollment date, reaffirmation of consent must be obtained prior to starting the Baseline visit.
• Parent or Legal Guardian permission, if applicable; and
• In addition to all the criteria listed above, to be considered eligible for enrollment after August 31, 2015, an individual must also meet the following criterion.
• Must be considered either: (a) newly engaged in HIV medical care defined as no previous initial comprehensive HIV medical care visit with consent occurring before, at the time of, or within four weeks following that initial comprehensive visit; or (b) newly re-engaged in HIV medical care defined as attending the last medical appointment more than 52 weeks ago.
• \*NOTE: The initial HIV medical care appointment is defined as a routine HIV medical appointment where the adolescent attends with a medical provider authorized to prescribe medication.
• This HIV medical appointment must be a non-emergency, routine condition-focused exam AND one or more of the following:
• CD4, VL lab draw and/or review of these lab results;

You may not qualify if:

• 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\*; or
• Intoxicated or under the influence of alcohol or other substances at the time of consent or the baseline ACASI\*

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• National Institute on Drug Abuse (NIDA): collaborator
• National Institute of Mental Health (NIMH): collaborator

Study Sites (14)

University of Colorado/The Children's Hospital

Aurora, California, 80045, United States

Location

Children's Hopsital of Los Angeles

Los Angeles, California, 90027, United States

Location

Children's Hospital National Medical Center

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

Location

University of Miami School of Medicine

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 University Health Sciences 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

Children's Hospital of Michigan

Detroit, Michigan, 48201, United States

Location

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

Location

Baylor College of Medicine/Texas Children's Hospital

Houston, Texas, 77030, United States

Location

Related Links

• ATN website

Study Officials

• Bret Rudy, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: April 2, 2015
• First Posted: May 8, 2015
• Study Start: March 1, 2015
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: February 28, 2017

Record last verified: 2016-03

Locations

US (14)