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Human Immunodeficiency Virus (HIV) Positive(PHC)NCT03292913

Positive Health Check Evaluation Trial

A study testing Positive Health Check in people with Human Immunodeficiency Virus (HIV) Positive, run by RTI International at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Positive Health Check
Could I receive a placebo?
No, everyone receives an active treatment
How many people
799 participants
Where
4 sitesUnited States
Study dates
27 Feb 2018to 31 Oct 2020
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

4 sites in 1 country.

United States4 sites
  • Atlanta VA Medical Center

    Atlanta, Georgia, 30033

  • Crescent Care

    New Orleans, Louisiana, 70119

  • Rutgers Infectious Disease Practice

    Newark, New Jersey, 07103

  • Hillsborough County Health Department

    Tampa, Florida, 33607

Other trials in United States

About this study

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.

Read the 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.

Being tested
Positive Health Check, Standard of Care
Keywords
Human Immunodeficiency Virus (HIV)
Medical subject headings
HIV Seropositivity, Acquired Immunodeficiency Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Positive Health CheckBehavioural

    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.

  • Standard of CareBehavioural

    Standard of care for patients with human immunodeficiency virus (HIV) (this includes standard of care practices around antiretroviral therapy (ART) initiation, adherence and retention)

Study groups in NCT03292913
Study groupRoleWhat they receive
Intervention GroupExperimentalReceives the Positive Health Check intervention plus standard of care
Receives: Behavioral: Positive Health Check
Control GroupOtherReceives standard of care
Receives: Behavioral: Standard of Care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With Viral Load Suppression

    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).

    Measured: 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 outcomes (2)
  1. Number of Participants Retained in Care at 12-month Follow up

    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.

    Measured: Up to 12 months post randomization

  2. Retention in Care

    A 6-month visit gap was defined as having at least 189 days between two sequentially kept visits, post-randomization.

    Measured: 12 months of randomization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Sep 2017
  2. Study start27 Feb 2018
  3. Primary completion31 Oct 2020
  4. Study completion31 Oct 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
799 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03292913
Sponsor's protocol ID
1U18PS004967-01
Acronym
(PHC)
Status last verified
Aug 2022
First submitted
21 Sep 2017
Last updated
2 Aug 2022
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Lewis MA, Harshbarger C, Bann C, Marconi VC, Somboonwit C, Piazza MD, Swaminathan S, Burrus O, Galindo C, Borkowf CB, Marks G, Karns S, Zulkiewicz B, Ortiz A, Abdallah I, Garner BR, Courtenay-Quirk C; Positive Health Check Study Team. Effectiveness of an Interactive, Highly Tailored "Video Doctor" Intervention to Suppress Viral Load and Retain Patients With HIV in Clinical Care: A Randomized Clinical Trial. J Acquir Immune Defic Syndr. 2022 Sep 1;91(1):58-67. doi: 10.1097/QAI.0000000000003045. Epub 2022 Jun 27.

    PubMed 35972854

Questions about this trial

What is this clinical trial studying?

A study testing Positive Health Check in people with Human Immunodeficiency Virus (HIV) Positive, run by RTI International at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Aug 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03292913, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2022.

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