The main aim of this study is to determine the impact of digital health technology, such as Alexa Skill, used to support the initiation of home-based subcutaneous immunoglobulin (SCIG) treatment, treatment management, and overall participant experience.

This is a non-interventional, observational study to identify relevant concepts of SCIG treatment experience, as well as satisfaction regarding Alexa skill-assisted SCIG initiation, infusion, and disease/therapy management.

The study will enroll approximately 36 participants (26 patients/caregivers and 10 healthcare professionals [HCPs]). Participants will be enrolled into following observational Cohorts:

• Adult patients with primary immunodeficiency (PID)
• Caregivers of patients with a self-reported diagnosis of PID
• HCPs who prescribe SCIG for patients with PID

Interviews will be conducted by a trained qualitative research interviewer with patients, caregivers, and HCPs, and self-reported data will be collected.

This trial will be conducted in the United States. The overall duration of the study will be approximately 4 months.

Inclusion Criteria:

Patients and caregivers:

• Adult patient (aged 18 years or older) with PID who recently initiated (within 4 months) or will soon initiate (within 30 days) HyQvia or Cuvitru at home or caregiver (aged 18 years or older) supporting participants (any age) with PID who recently initiated (within 4 months) or will soon initiate (within 30 days) HyQvia or Cuvitru at home.
• Patient has a self-reported physician diagnosis of PID.
• Resides in the US or US territories.
• Can speak and read English fluently.
• Able to participate in an interview(s).
• Must have a wireless network (Wi-Fi) at home (cannot be a wireless hotspot).
• Must have an existing Amazon account.
• Must be willing to receive an Amazon Echo Show device and connect the device to Wi-Fi.
• Must have a smartphone and be willing to download and use the Alexa application to access the Alexa Skill test.

Additional criteria for patients and caregivers completing qualitative debriefing interviews:

• Must have at least 2 SCIG infusions (HyQvia or Cuvitru) at a residential home or residential assisted living facility within 6 to12 weeks.
• Must attest to use of Alexa Skill to support at-home SCIG infusions.

For HCPs:

• Resides in the US or US territories.
• Must be an immunologist or registered nurse/nurse practitioner.
• Licensed to practice in the US.
• Can speak and read English fluently.
• Able to participate in a debriefing interview.
• Willing to provide informed consent.
• Must have a wireless network (Wi-Fi).
• Must have an existing Amazon account.
• Must be willing to receive an Amazon Echo Show device and connect the device to Wi-Fi.
• Must have a smartphone and be willing to download and use the Alexa application to access the Alexa Skill test.
• Must attest to exploration of Alexa Skill as a support tool for patients and caregivers administering SCIG infusions at home.

Exclusion Criteria

• Patients who were previously on SCIG and transitioned to either HyQvia or Cuvitru SCIG product will be excluded.

The study population will include adult patients and/or caregivers supporting patients with PID and HCPs involved in treating patients with PID who reside in the United States (US).

Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.