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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03400293
Other study ID # 208141
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 18, 2018
Est. completion date July 7, 2018

Study information

Verified date March 2019
Source ViiV Healthcare
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 1184
Est. completion date July 7, 2018
Est. primary completion date July 7, 2018
Accepts healthy volunteers No
Gender All
Age group 21 Years and older
Eligibility 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:

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Functional Assessment of HIV Infection
Functional Assessment of HIV Infection will be used to assess HRQoL of subjects. This will include 47 items.
Patient Satisfaction Questionnaire
Patient Satisfaction Questionnaire will be used to assess burden and HRQoL in subjects. This will include 18 items.
Symptom Distress Module
Symptom Distress Module will be used to assess burden and HRQoL in subjects. This will include 20 items.
Patient Health Questionnaire
Patient Health Questionnaire will be used to assess burden and HRQoL in subjects. This will include 2 items.
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.
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.

Locations

Country Name City State
United States GSK Investigational Site Arlington Virginia

Sponsors (3)

Lead Sponsor Collaborator
ViiV Healthcare Evidera, mProve

Country where clinical trial is conducted

United States, 

Outcome

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