- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03292913
Positive Health Check Evaluation Trial ((PHC))
August 1, 2022 updated by: RTI International
The purpose of the study is to evaluate the effect of Positive Health Check (PHC), an online intervention that delivers tailored, evidence-based prevention messages to HIV positive patients, on improving clinical outcomes and retention in care of people who are HIV positive and have unsuppressed viral loads.
The costs and processes of implementation will also be assessed to inform future dissemination.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The Positive Health Check (PHC) Evaluation Trial uses a randomized trial to test if a brief web-based counseling intervention can improve clinical outcomes among people living with human immunodeficiency virus (HIV).
The study will also assess implementation processes, collect data to determine cost effectiveness, and document the standard of care in each clinic.
The study will take place in four locations including Atlanta Veterans Affairs (VA) Medical Center (Atlanta, GA), Hillsborough County Health Department (Tampa, FL), Rutgers Infectious Disease Practice (Newark, NJ) and Crescent Care (New Orleans, LA).
The objectives of the PHC Evaluation Trial are four-fold: Objective 1) Implement a randomized trial to test if the PHC intervention improves clinical health outcomes, specifically viral load suppression and retention in care.
While Positive Health Check (PHC) is designed to improve antiretroviral therapy (ART) initiation, ART adherence and retention in care as well as reduce unprotected sex and promote safe injection practices, the primary outcome on which the trial is powered is viral suppression; Objective 2) Conduct an implementation evaluation to determine effective implementation strategies and integration of Positive Health Check (PHC) into human immunodeficiency virus (HIV) primary care clinics; Objective 3) Collect and document data on the cost of the PHC intervention implementation; Objective 4) Document the standard of care at each participating site.
Positive Health Check (PHC) is a web-based intervention that delivers tailored evidence-based prevention messages to human immunodeficiency virus (HIV) positive patients through a series of brief interactive videos designed to simulate a conversation with an human immunodeficiency virus (HIV) primary care provider.
Web-based interventions have been shown to be effective in improving adherence and reducing sexual risk.
Eligible patients, who use the intervention, are given a tablet with a privacy screen, a set of headphones, a unique login identification (ID) and will be prompted to create their own private password.
Once logged in, the intervention guides a patient through tailored messaging from a video doctor on patient-selected topics including treatment initiation or adherence, retention in care, sexual risk reduction, pregnancy, and intravenous drug use.
Throughout the intervention patients answer tailoring questions about themselves and based on their answers, are given tailored messages from their chosen video doctor.
Positive Health Check (PHC) is designed to facilitate patient-provider communication on these topics.
In the intervention, patients can select which questions they have for their doctor on the topics covered and which health promotion strategies they want to practice before their next visit.
The questions and chosen health promotion strategies ("tips") automatically populate to a handout which is given to the patient after logging off.
Patients also have access to another module that provides other information about human immunodeficiency virus (HIV) management, how to prevent transmission, and living a healthy lifestyle while being human immunodeficiency virus (HIV) positive.
The intervention will be considered implemented with fidelity if a patient completes the intervention in the clinic before or after seeing their primary care provider, or before or after a blood draw or ancillary appointment in advance of their appointment with their clinical provider.
A patient may also begin the intervention in the clinic and complete it after the appointment or at home within 21 days.
Evaluation of the intervention will include comparisons of the intervention and control arms on the primary outcome using data abstracted via electronic medical records, with the 12- month viral load value considered the primary outcome measure.
Study Type
Interventional
Enrollment (Actual)
799
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Florida
-
Tampa, Florida, United States, 33607
- Hillsborough County Health Department
-
-
Georgia
-
Atlanta, Georgia, United States, 30033
- Atlanta VA Medical Center
-
-
Louisiana
-
New Orleans, Louisiana, United States, 70119
- Crescent Care
-
-
New Jersey
-
Newark, New Jersey, United States, 07103
- Rutgers Infectious Disease Practice
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 18 years of age or older;
- Diagnosed with human immunodeficiency virus (HIV);
- English-speaking;
- Attending one of the four clinical sites;
- Meet at least one of the following: a) Most recent viral load lab result of ≥ 200 copies/mL, b) Attended an initial human immunodeficiency virus human immunodeficiency virus (HIV) appointment with a provider at one of the four sites within the past 12 months; c) Out of care (last attended appointment at the clinic was more than 12 months ago);
- Not involved in any other intervention that would bias outcome assessment,
- Deemed mentally competent and able to engage with the intervention.
Exclusion Criteria:
- Under 18 years of age;
- Human immunodeficiency virus (HIV) negative;
- Does not speak English;
- Does not attend one of the four clinical sites for (HIV) primary care;
- Meets all of the following: a) Most recent viral load lab result of < 200 copies/mL, b) Did not attend an initial human immunodeficiency virus (HIV) appointment with a provider at one of the four sites within the past 12 months, c) Last attended appointment at the clinic was less than 12 months ago)
- Involved in an intervention that would bias outcome assessment;
- Deemed mentally incompetent to engage with the intervention.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention Group
Receives the Positive Health Check intervention plus standard of care
|
Positive Health Check (PHC) is an online intervention that delivers tailored evidence-based prevention messages to human immunodeficiency virus (HIV) positive patients through a series of brief interactive videos designed to simulate a conversation with an human immunodeficiency virus (HIV) primary care provider.
|
Other: Control Group
Receives standard of care
|
Standard of care for patients with human immunodeficiency virus (HIV) (this includes standard of care practices around antiretroviral therapy (ART) initiation, adherence and retention)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With Viral Load Suppression
Time Frame: Targeted time frame is 12 months post-randomization with a possible range of 10-16 months to account for variable timing of clinic visits.
|
Viral load suppression was defined as having viral load < 200 copies/mL by the end of each participant's 12 months of follow-up assessment (with a window from start of 10 months through the end of 16 months post-randomization to accommodate timing of clinical visits).
|
Targeted time frame is 12 months post-randomization with a possible range of 10-16 months to account for variable timing of clinic visits.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants Retained in Care at 12-month Follow up
Time Frame: Up to 12 months post randomization
|
Retention in care is a patient defined as having at least one visit in each 6-month period within 12 months post-randomization separated by at least two months.
|
Up to 12 months post randomization
|
Retention in Care
Time Frame: 12 months of randomization
|
A 6-month visit gap was defined as having at least 189 days between two sequentially kept visits, post-randomization.
|
12 months of randomization
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Megan Lewis, PhD, RTI International
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 27, 2018
Primary Completion (Actual)
October 31, 2020
Study Completion (Actual)
October 31, 2020
Study Registration Dates
First Submitted
September 21, 2017
First Submitted That Met QC Criteria
September 21, 2017
First Posted (Actual)
September 26, 2017
Study Record Updates
Last Update Posted (Actual)
August 2, 2022
Last Update Submitted That Met QC Criteria
August 1, 2022
Last Verified
August 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immune System Diseases
- Slow Virus Diseases
- HIV Infections
- Acquired Immunodeficiency Syndrome
- HIV Seropositivity
- Immunologic Deficiency Syndromes
Other Study ID Numbers
- 1U18PS004967-01 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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