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

Completed

Conditions studied: HIV

In brief

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.

Key facts

Study ID

NCT02438592

Run by

University of North Carolina, Chapel Hill

People needed

924

Starts

2015-03-01

Expected to finish

2016-02-01

Last updated by the study team

2017-02-28

Who can join

Age: 13 and older, up to 24. Sex: any. Healthy volunteers: not accepted.

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;
• Discussion around HIV ART options;
• Primary and/or secondary HIV prevention education and counseling; or
• Diagnosis and treatment of complications of HIV, and of AIDS-defining conditions.

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*
• NOTE: If consent/assent is obtained prior to the enrollment date, assessment for these exclusion criteria must be performed again prior to administration of the baseline ACASI (Enrollment). If any are present, the subject cannot be enrolled; do not administer the ACASI. Reassessment of eligibility and enrollment may take place at a later date per the discretion of the treating clinician.

Where it is running

• University of Colorado/The Children's Hospital — Aurora, California, United States
• Children's Hopsital of Los Angeles — Los Angeles, California, United States
• Children's Hospital National Medical Center — Washington D.C., District of Columbia, United States
• University of Miami School of Medicine — Miami, Florida, United States
• University of South Florida — Tampa, Florida, United States
• Stroger Hospital of Cook County — Chicago, Illinois, United States
• Tulane University Health Sciences Center — New Orleans, Louisiana, United States
• Johns Hopkins University — Baltimore, Maryland, United States
• Fenway Institute — Boston, Massachusetts, United States
• Children's Hospital of Michigan — Detroit, Michigan, United States
• Montefiore Medical Center — The Bronx, New York, United States
• Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
• St. Jude Children's Research Hospital — Memphis, Tennessee, United States
• Baylor College of Medicine/Texas Children's Hospital — Houston, Texas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.