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

NCT ID: NCT03400293

Last Updated: 2019-03-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

1184 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-01-18

Study Completion Date

2018-07-07

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

HIV Infections

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Functional Assessment of HIV Infection

Intervention Type OTHER

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

Patient Satisfaction Questionnaire

Intervention Type OTHER

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

Symptom Distress Module

Intervention Type OTHER

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

Patient Health Questionnaire

Intervention Type OTHER

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

Internalized Stigma of AIDS Tool

Intervention Type 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

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Functional Assessment of HIV Infection

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

Intervention Type OTHER

Patient Satisfaction Questionnaire

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

Intervention Type OTHER

Symptom Distress Module

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

Intervention Type OTHER

Patient Health Questionnaire

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

Intervention Type 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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Evidera

INDUSTRY

Sponsor Role collaborator

mProve

UNKNOWN

Sponsor Role collaborator

ViiV Healthcare

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

GSK Clinical Trials

Role: STUDY_DIRECTOR

ViiV Healthcare

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

GSK Investigational Site

Arlington, Virginia, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

208141

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.