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

HIV Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02438592
• Other study ID #: ATN 125
• Status: Completed
• Phase: N/A
• First received: April 2, 2015
• Last updated: February 27, 2017
• Start date: March 2015
• Est. completion date: February 2016

Study information

• Verified date: March 2016
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 924
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 24 Years

Eligibility

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.

Related Conditions & MeSH terms

• HIV

Locations

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

Sponsors (3)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	National Institute of Mental Health (NIMH), National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The proportion of subjects engaged in care at Baseline, per subject year, as defined by the HRSA HAB measure		Baseline
Primary	The proportion of subjects engaged in care at Week 26, per subject year, as defined by the HRSA HAB measure		Week 26
Primary	The proportion of subjects engaged in care at Week 52, per subject year, as defined by the HRSA HAB measure		Week 52
Primary	The proportion of subjects engaged in care at Week 78, per subject year, as defined by the HRSA HAB measure		Week 78
Primary	The proportion of subjects engaged in care at Baseline, per subject year, as defined by the DHHS measure		Baseline
Primary	The proportion of subjects engaged in care at Week 26, per subject year, as defined by the DHHS measure		Week 26
Primary	The proportion of subjects engaged in care at Week 52, per subject year, as defined by the DHHS measure		Week 52
Primary	The proportion of subjects engaged in care at Week 78, per subject year, as defined by the DHHS measure		Week 78
Primary	The proportion of subjects prescribed antiretroviral therapy at Baseline per subject year		Baseline
Primary	The proportion of subjects prescribed antiretroviral therapy at Week 26 per subject year		Week 26
Primary	The proportion of subjects prescribed antiretroviral therapy at Week 52 per subject year		Week 52
Primary	The proportion of subjects prescribed antiretroviral therapy at Week 78 per subject year		Week 78
Primary	The proportion of subjects that have achieved viral suppression at Baseline per subject year		Baseline
Primary	The proportion of subjects that have achieved viral suppression at Week 26 per subject year		Week 26
Primary	The proportion of subjects that have achieved viral suppression at Week 52 per subject year		Week 52
Primary	The proportion of subjects that have achieved viral suppression at Week 78 per subject year		Week 78
Secondary	The proportion of subjects with advanced HIV disease at time of first clinical visit defined as a CD4 count < 200 cells/mm3		Baseline
Secondary	The incidence of STIs in the study population as an indicator of transmission risk at Baseline		Baseline
Secondary	The incidence of STIs in the study population as an indicator of transmission risk at Week 26		Week 26
Secondary	The incidence of STIs in the study population as an indicator of transmission risk at Week 52		Week 52
Secondary	The incidence of STIs in the study population as an indicator of transmission risk at Week 78		Week 78
Secondary	Number of subjects with mental health issues at Baseline		Baseline
Secondary	Number of subjects engaging in substance use at Baseline		Baseline
Secondary	Number of subjects engaging in sexual risk behaviors at Baseline		Baseline
Secondary	ART adherence rate at Baseline		Baseline
Secondary	Frequency of missed clinic visits at Baseline		Baseline
Secondary	Frequency of missed clinic visits at Week 26		Week 26
Secondary	Frequency of missed clinic visits at Week 52		Week 52
Secondary	Frequency of missed clinic visits at Week 78		Week 78
Secondary	Types of services available at each AMTU at Baseline		Baseline
Secondary	Types of services available at each AMTU at 48 weeks after Baseline		Week 48
Secondary	Types of services available at each AMTU at 96 weeks after Baseline		Week 96
Secondary	Proportion of subjects notifying their sexual partners after learning their HIV status		Baseline
Secondary	Timing of subjects notifying their partners after learning about their HIV status		Baseline
Secondary	Proportion of subjects with whom partner notification was discussed		Baseline

External Links

•   ATN website