NCT03400293

Real-world Insights of People With Human Immunodeficiency Virus (HIV) Infection

RISE: Real World Insights of People Living With HIV Shared Through Electronic Devices

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,184 (actual)
• Sponsor: ViiV Healthcare · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

This study is designed to identify the burden associated with HIV and its treatment, and assess their health-related quality of life (HRQoL) by measuring key HRQoL domains, including satisfaction with treatment and care, and internalised stigma (ISAT). The study will also explore data for various important subpopulations such as subjects who are virally suppressed; who we anticipate will be the majority of study subjects. The study design is an observational, cross sectional study employing subjects' own mobile phone devices for data entry.

Conditions

• HIV Infections

Interventions

Type	Name	Description
OTHER	Functional Assessment of HIV Infection	Functional Assessment of HIV Infection will be used to assess HRQoL of subjects. This will include 47 items.
OTHER	Patient Satisfaction Questionnaire	Patient Satisfaction Questionnaire will be used to assess burden and HRQoL in subjects. This will include 18 items.
OTHER	Symptom Distress Module	Symptom Distress Module will be used to assess burden and HRQoL in subjects. This will include 20 items.
OTHER	Patient Health Questionnaire	Patient Health Questionnaire will be used to assess burden and HRQoL in subjects. This will include 2 items.
OTHER	Internalized Stigma of AIDS Tool	Internalized Stigma of AIDS Tool will be used to assess burden and HRQoL in subjects. This will include 10 items.
OTHER	Medication adherence visual analogue scale	Medication adherence visual analogue scale will be used to assess burden and HRQoL in subjects. This will include 1 item.

Timeline

• Start date: 2018-01-18
• Primary completion: 2018-07-07
• Completion: 2018-07-07
• First posted: 2018-01-17
• Last updated: 2019-03-11

Locations

1 site across 1 country: United States