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

Completed

• Conditions: HIV Infections
• Interventions: 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

• Registration Number: NCT03400293
• Lead Sponsor: ViiV Healthcare

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-01-10
• Study First Submitted QC: 2018-01-10
• Study First Posted: 2018-01-17
• Study Start: 2018-01-18
• Primary Completion: 2018-07-07
• Study Completion: 2018-07-07
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-08
• Last Update Posted: 2019-03-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1184

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Subjects living with HIV	Functional Assessment of HIV Infection	Subjects living with HIV will be recruited via digital advertising. These subjects will participate in completing various PRO instruments and targeted questions.
Subjects living with HIV	Patient Satisfaction Questionnaire	Subjects living with HIV will be recruited via digital advertising. These subjects will participate in completing various PRO instruments and targeted questions.
Subjects living with HIV	Internalized Stigma of AIDS Tool	Subjects living with HIV will be recruited via digital advertising. These subjects will participate in completing various PRO instruments and targeted questions.
Subjects living with HIV	Symptom Distress Module	Subjects living with HIV will be recruited via digital advertising. These subjects will participate in completing various PRO instruments and targeted questions.
Subjects living with HIV	Patient Health Questionnaire	Subjects living with HIV will be recruited via digital advertising. These subjects will participate in completing various PRO instruments and targeted questions.
Subjects living with HIV	Medication adherence visual analogue scale	Subjects living with HIV will be recruited via digital advertising. These subjects will participate in completing various PRO instruments and targeted questions.

Primary Outcome Measures

Name	Time	Method
Percentage of virally suppressed PLHIV reporting different HRQoL scores	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 Outcome Measures

Name	Time	Method
Percent difference in HRQoL scores among subject subgroups	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.
Percentage of subjects reporting diffferent HRQoL and medication adherence	Up to 1 Week	Statistical correlation between QoL scores (FAHI) and adherence scores (adherence VAS) will be analyzed.
Percentage of virally suppressed PLHIV reporting different satisfaction with care scores	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
Percentage of subjects reporting different HRQoL scores and relationship with satisfaction with care	Up to 1 Week	Statistical correlation of reported QoL scores (FAHI) and satisfaction with care scores (PHQ-18) will be analyzed.

Trial Locations

Locations (1)

GSK Investigational Site; 🇺🇸 Arlington, Virginia, United States