PHASES: Provision of HIV Treatment at ATN Sites: An Evaluation for Stakeholders
Condition: HIV
Study type: Observational

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.
    

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.
      
Keywords: Continuum of care