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| Name | Class |
|---|---|
| Centers for Disease Control and Prevention | FED |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Group | Experimental | Receives the Positive Health Check intervention plus standard of care |
|
| Control Group | Other | Receives standard of care |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Positive Health Check | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Targeted time frame is 12 months post-randomization with a possible range of 10-16 months to account for variable timing of clinic visits. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 12 months post randomization |
| Retention in Care |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Megan Lewis, PhD | RTI International | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hillsborough County Health Department | Tampa | Florida | 33607 | United States | ||
| Atlanta VA Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35972854 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 HIV positive patients through a series of brief interactive videos designed to simulate a conversation with an HIV primary care provider. |
| FG001 | Control Group | Receives standard of care Standard of Care: Standard of care for patients with HIV (this includes standard of care practices around ART initiation, adherence and retention) |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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One of the 397 participants in the Positive Health Check and Standard of Care group and one of the 402 participants in the Standard of Care group were missing data for age because it was not included in their patient charts.
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention Group | Positive Health Check and Standard of Care Participants with HIV diagnosis received Positive Health Check intervention and standard of care |
| BG001 | Control Group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | 2 participants, 1 from each group did not declare their age. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | All participants with a viral load measurement at baseline. | Posted | Count of Participants | Participants | Targeted time frame is 12 months post-randomization with a possible range of 10-16 months to account for variable timing of clinic visits. |
|
Baseline to 12 months post randomization
Each death was reviewed by the respective site's study Institutional Review Board (IRB) and deemed not related with the trial.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 HIV positive patients through a series of brief interactive videos designed to simulate a conversation with an HIV primary care provider. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Megan Lewis | RTI International Institute | 206-268-3613 | melewis@rti.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 24, 2022 | Mar 24, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 3, 2022 | Mar 3, 2022 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 22, 2020 | Aug 1, 2022 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D006679 | HIV Seropositivity |
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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|
| Standard of Care | Behavioral | Standard of care for patients with human immunodeficiency virus (HIV) (this includes standard of care practices around antiretroviral therapy (ART) initiation, adherence and retention) |
|
A 6-month visit gap was defined as having at least 189 days between two sequentially kept visits, post-randomization. |
| 12 months of randomization |
| Atlanta |
| Georgia |
| 30033 |
| United States |
| Crescent Care | New Orleans | Louisiana | 70119 | United States |
| Rutgers Infectious Disease Practice | Newark | New Jersey | 07103 | United States |
| Withdrawal by Subject |
|
| Clinic closed due to COVID |
|
Standard of care
Participants with HIV diagnosis received standard of care only
| BG002 | Total | Total of all reporting groups |
| Count of Participants |
| Participants |
|
| Age, Continuous | One of the 397 participants in the Positive Health Check and Standard of Care group and one of the 402 participants in the Standard of Care group were missing data for age because it was not included in their patient charts. | Mean | Standard Deviation | years |
|
| Sex: Female, Male | 1 participant did not declare gender/sex | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | All participants data were included in the trial data that was analyzed regardless of the missing demographics data. | Number | participants |
|
Standard of care only
|
|
|
| Secondary | 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. | All participants | Posted | Count of Participants | Participants | Up to 12 months post randomization |
|
|
|
|
| Secondary | Retention in Care | A 6-month visit gap was defined as having at least 189 days between two sequentially kept visits, post-randomization. | Posted | Count of Participants | Participants | 12 months of randomization |
|
|
|
|
| 9 |
| 397 |
| 0 |
| 397 |
| 0 |
| 397 |
| EG001 | Control Group | Receives standard of care Standard of Care: Standard of care for patients with HIV (this includes standard of care practices around ART initiation, adherence and retention) | 3 | 402 | 0 | 402 | 0 | 402 |
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| D015229 |
| Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D012897 | Slow Virus Diseases |
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|