Clinical trial NCT02438592: PHASES: Provision of HIV Treatment at ATN Sites: An Evaluation for Stakeholders
Official title: PHASES: Provision of HIV Treatment at ATN Sites: An Evaluation for Stakeholders
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV
Keywords: Continuum of care
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
name: National Institute of Mental Health (NIMH)
First posted: 2015-05-08
Enrollment: 924
Sex: ALL
Minimum age (years): 13
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
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.

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.

Detailed description: This is an observational study involving retrospective and prospective medical record review covering a total maximum of 104 weeks (24 months) per subject. Behavioral data will be collected via ACASI at study entry to assess demographic and psychosocial variables of study subjects. All other data (biomedical, ART, healthcare utilization) at subsequent study visits will be collected via medical record abstraction. Information about missed visits as well as other healthcare utilization data can be abstracted from electronic appointment systems or other electronic systems at the clinical sites. Subject data will be abstracted from medical records for up to a maximum 26 weeks prior to the baseline study visit, as well as up to a maximum 78 weeks after the baseline study visit or through January 31, 2017, whichever occurs first, for a total maximum of 104 weeks or two years per subject. Data will also be collected from each Adolescent Medicine Trials Unit to assess clinic level variables at baseline (within 30 days of protocol registration) and 48 and 96 weeks after baseline. 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: The proportion of subjects engaged in care at Baseline, per subject year, as defined by the HRSA HAB measure
timeFrame: Baseline
measure: The proportion of subjects engaged in care at Week 26, per subject year, as defined by the HRSA HAB measure
timeFrame: Week 26
measure: The proportion of subjects engaged in care at Week 52, per subject year, as defined by the HRSA HAB measure
timeFrame: Week 52
measure: The proportion of subjects engaged in care at Week 78, per subject year, as defined by the HRSA HAB measure
timeFrame: Week 78
measure: The proportion of subjects engaged in care at Baseline, per subject year, as defined by the DHHS measure
timeFrame: Baseline
measure: The proportion of subjects engaged in care at Week 26, per subject year, as defined by the DHHS measure
timeFrame: Week 26
measure: The proportion of subjects engaged in care at Week 52, per subject year, as defined by the DHHS measure
timeFrame: Week 52
measure: The proportion of subjects engaged in care at Week 78, per subject year, as defined by the DHHS measure
timeFrame: Week 78
measure: The proportion of subjects prescribed antiretroviral therapy at Baseline per subject year
timeFrame: Baseline
measure: The proportion of subjects prescribed antiretroviral therapy at Week 26 per subject year
timeFrame: Week 26
measure: The proportion of subjects prescribed antiretroviral therapy at Week 52 per subject year
timeFrame: Week 52
measure: The proportion of subjects prescribed antiretroviral therapy at Week 78 per subject year
timeFrame: Week 78
measure: The proportion of subjects that have achieved viral suppression at Baseline per subject year
timeFrame: Baseline
measure: The proportion of subjects that have achieved viral suppression at Week 26 per subject year
timeFrame: Week 26
measure: The proportion of subjects that have achieved viral suppression at Week 52 per subject year
timeFrame: Week 52
measure: The proportion of subjects that have achieved viral suppression at Week 78 per subject year
timeFrame: Week 78
Secondary outcomes:
measure: The proportion of subjects with advanced HIV disease at time of first clinical visit defined as a CD4 count < 200 cells/mm3
timeFrame: Baseline
measure: The incidence of STIs in the study population as an indicator of transmission risk at Baseline
timeFrame: Baseline
measure: The incidence of STIs in the study population as an indicator of transmission risk at Week 26
timeFrame: Week 26
measure: The incidence of STIs in the study population as an indicator of transmission risk at Week 52
timeFrame: Week 52
measure: The incidence of STIs in the study population as an indicator of transmission risk at Week 78
timeFrame: Week 78
measure: Number of subjects with mental health issues at Baseline
timeFrame: Baseline
measure: Number of subjects engaging in substance use at Baseline
timeFrame: Baseline
measure: Number of subjects engaging in sexual risk behaviors at Baseline
timeFrame: Baseline
measure: ART adherence rate at Baseline
timeFrame: Baseline
measure: Frequency of missed clinic visits at Baseline
timeFrame: Baseline
measure: Frequency of missed clinic visits at Week 26
timeFrame: Week 26
measure: Frequency of missed clinic visits at Week 52
timeFrame: Week 52
measure: Frequency of missed clinic visits at Week 78
timeFrame: Week 78
measure: Types of services available at each AMTU at Baseline
timeFrame: Baseline
measure: Types of services available at each AMTU at 48 weeks after Baseline
timeFrame: Week 48
measure: Types of services available at each AMTU at 96 weeks after Baseline
timeFrame: Week 96
measure: Proportion of subjects notifying their sexual partners after learning their HIV status
timeFrame: Baseline
measure: Timing of subjects notifying their partners after learning about their HIV status
timeFrame: Baseline
measure: Proportion of subjects with whom partner notification was discussed
timeFrame: Baseline
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado/The Children's Hospital
state: California
city: Los Angeles
country: United States
facility: Children's Hopsital of Los Angeles
state: California
city: Washington
country: United States
facility: Children's Hospital National Medical Center
state: District of Columbia
city: Miami
country: United States
facility: University of Miami School of Medicine
state: Florida
city: Tampa
country: United States
facility: University of South Florida
state: Florida
city: Chicago
country: United States
facility: Stroger Hospital of Cook County
state: Illinois
city: New Orleans
country: United States
facility: Tulane University Health Sciences Center
state: Louisiana
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: Boston
country: United States
facility: Fenway Institute
state: Massachusetts
city: Detroit
country: United States
facility: Children's Hospital of Michigan
state: Michigan
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
city: Memphis
country: United States
facility: St. Jude Children's Research Hospital
state: Tennessee
city: Houston
country: United States
facility: Baylor College of Medicine/Texas Children's Hospital
state: Texas
Study officials:
affiliation: NYU Langone Health
name: Bret Rudy, MD
role: PRINCIPAL_INVESTIGATOR
References: