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

NCT03400293 | Completed

• 1 other identifier: 208141
• Study Type: observational
• Target: 1,184
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Human Immunodeficiency virus; Health Related Quality of Life; Functional Assessment of HIV Infection; Mobile app

Outcome Measures

Primary Outcomes (1)

• Percentage of virally suppressed PLHIV reporting different HRQoL scores

  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

  Up to 1 Week

Secondary Outcomes (4)

• Percentage of virally suppressed PLHIV reporting different satisfaction with care scores

  Up to 1 Week

• Percent difference in HRQoL scores among subject subgroups

  Up to 1 Week

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

  Up to 1 Week

• Percentage of subjects reporting diffferent HRQoL and medication adherence

  Up to 1 Week

Study Arms (1)

Subjects living with HIV

Subjects living with HIV will be recruited via digital advertising. These subjects will participate in completing various PRO instruments and targeted questions.

Other: Functional Assessment of HIV Infection; Other: Patient Satisfaction Questionnaire; Other: Symptom Distress Module; Other: Patient Health Questionnaire; Other: Internalized Stigma of AIDS Tool; Other: Medication adherence visual analogue scale

Interventions

Functional Assessment of HIV Infection OTHER

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

Subjects living with HIV

Patient Satisfaction Questionnaire OTHER

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

Subjects living with HIV

Symptom Distress Module OTHER

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

Subjects living with HIV

Patient Health Questionnaire OTHER

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

Subjects living with HIV

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.

Subjects living with HIV

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.

Subjects living with HIV

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

PLHIV will be recruited advertising in digital media. The study plan is to collect a complete set of data from 3000 PLHIV during a 90-180 day period in the US.

You may qualify if:

• \>= 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

You may not qualify if:

• Not Applicable

Sponsors & Collaborators

• ViiV Healthcare: lead
• Evidera: collaborator
• mProve: collaborator

Study Sites (1)

GSK Investigational Site

Arlington, Virginia, 22209, United States

Location

MeSH Terms

Conditions

HIV Infections; Acquired Immunodeficiency Syndrome

Interventions

Patient Health Questionnaire

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Surveys and Questionnaires; Data Collection; Epidemiologic Methods; Investigative Techniques; Psychological Tests; Behavioral Disciplines and Activities; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• GSK Clinical Trials

  ViiV Healthcare

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2018
• First Posted: January 17, 2018
• Study Start: January 18, 2018
• Primary Completion: July 7, 2018
• Study Completion: July 7, 2018
• Last Updated: March 11, 2019

Record last verified: 2019-03

Locations

US (1)