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NCT Number: NCT03400293

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

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.

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Key information

Conditions

HIV Infections Acquired Immunodeficiency Syndrome Blood-Borne Infections Communicable Diseases Genital Diseases Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

21 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

GSK Investigational Site

Arlington, Virginia, 22209, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • >= 21 years old
  • Language:Read and Understand English / Spanish
  • Positive diagnosis of HIV infection by a healthcare provider (self-reported)
  • Possesses a smartphone that has internet access

Exclusion criteria

  • Not Applicable

Treatment and study plan

Functional Assessment of HIV Infection

Other

Functional Assessment of HIV Infection will be used to assess HRQoL of subjects. This will include 47 items.

Patient satisfaction Questionnaire

Other

Patient Satisfaction Questionnaire will be used to assess burden and HRQoL in subjects. This will include 18 items.

Symptom Distress Module

Other

Symptom Distress Module will be used to assess burden and HRQoL in subjects. This will include 20 items.

Patient Health Questionnaire

Other

Patient Health Questionnaire will be used to assess burden and HRQoL in subjects. This will include 2 items.

Internalized Stigma of AIDS Tool

Other

Internalized Stigma of AIDS Tool will be used to assess burden and HRQoL in subjects. This will include 10 items.

Medication adherence visual analogue scale

Other

Medication adherence visual analogue scale will be used to assess burden and HRQoL in subjects. This will include 1 item.

Primary outcomes

  1. Percentage of virally suppressed PLHIV reporting different HRQoL scores

    Time frame: Up to 1 Week

    Evaluation of HRQoL will be conducted using scores achieved by Functional Assessment of HIV Infection (FAHI). QoL assessment will include physical well-being, social well-being, emotional well-being, functional and global well-being, and cognitive functioning

Secondary outcomes

  1. Percentage of virally suppressed PLHIV reporting different satisfaction with care scores

    Time frame: Up to 1 Week

    Evaluation of burden will include stigma, stigma, depression, and work productivity. The descriptive analysis will be assessed using Patient Satisfaction Questionnaire (PSQ)-18, Patient Health Questionnaire (PHQ)-2, and ISAT scores

  2. Percent difference in HRQoL scores among subject subgroups

    Time frame: Up to 1 Week

    Subject subgroups are defined in terms of the following socio-demographic, clinical, and biomedical factors: a. Age: older versus. younger (i.e., < 50 years old and over 50 years old) b. Gender (men / women / transgender) c. Race / ethnicity d. Sexual orientation (straight / gay / bisexual) e. Level of income f. Type of Insurance g. Apple (iPhone operating system) versus Android users h. Treatment regimen (e.g., number of pills per day, frequency of medication, single treatment regimen (STR) versus multiple treatment regimen (MTR) i. Diagnosis time / stage at which diagnosis was received (i.e. prompt vs. late diagnosis, time since diagnosis) j. Absence or presence (and number) of comorbidities k. Severity of symptoms (as assessed by the Symptom Distress Module patient reported outcome (PRO) instrument) l. Achievement of viral suppression.

  3. Percentage of subjects reporting different HRQoL scores and relationship with satisfaction with care

    Time frame: Up to 1 Week

    Statistical correlation of reported QoL scores (FAHI) and satisfaction with care scores (PHQ-18) will be analyzed.

  4. Percentage of subjects reporting diffferent HRQoL and medication adherence

    Time frame: Up to 1 Week

    Statistical correlation between QoL scores (FAHI) and adherence scores (adherence VAS) will be analyzed.

Sponsors and collaborators

Lead sponsor

ViiV Healthcare

Industry

Collaborators

  • Evidera
  • mProve

Registry information

Official study title

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

Acronym: RISE

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jan 17, 2018
Registry last updated
Mar 11, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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