An interventional study of Positive Health Check and Standard of Care in Human Immunodeficiency Virus (HIV) Positive, sponsored by RTI International. Completed at 4 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-08-02.
Sponsored by RTI International · Not applicable, Interventional, and Supportive care
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.
Exclusion Criteria:
Receives the Positive Health Check intervention plus standard of care
Behavioral: Positive Health Check
Receives standard of care
Behavioral: 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.
Standard of care for patients with human immunodeficiency virus (HIV) (this includes standard of care practices around antiretroviral therapy (ART) initiation, adherence and retention)
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).
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.
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.
Time frame: Up to 12 months post randomization
Retention in Care
A 6-month visit gap was defined as having at least 189 days between two sequentially kept visits, post-randomization.
Time frame: 12 months of randomization
| Milestone | Intervention Group | Control Group |
|---|---|---|
| Started | 397 | 402 |
| Completed | 315 | 314 |
| Not completed | 82 | 88 |
| Withdrew: Death | 9 | 3 |
| Withdrew: Lost to follow-up | 49 | 49 |
| Withdrew: Withdrawal by subject | 2 | 0 |
| Withdrew: Clinic closed due to covid | 22 | 36 |
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).
| Participants | Intervention Group | Control Group |
|---|---|---|
| Number of Participants With Viral Load Suppression | 210 | 213 |
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.
| Participants | Intervention Group | Control Group |
|---|---|---|
| Number of Participants Retained in Care at 12-month Follow up | 257 | 247 |
A 6-month visit gap was defined as having at least 189 days between two sequentially kept visits, post-randomization.
| Participants | Intervention Group | Control Group |
|---|---|---|
| Retention in Care | 113 | 164 |
Collected over Baseline to 12 months post randomization. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Intervention Group | 9/397 (2.3%) | 0/397 (0%) | 0/397 (0%) |
| Control Group | 3/402 (0.7%) | 0/402 (0%) | 0/402 (0%) |
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.
| Age, Categorical(Participants) | Intervention Group | Control Group | Total |
|---|---|---|---|
| Participants — <=18 years | 0 | 0 | 0 |
| Participants — Between 18 and 65 years | 376 | 383 | 759 |
| Participants — >=65 years | 20 | 18 | 38 |
| Age, Continuous(years) | Intervention Group | Control Group | Total |
|---|---|---|---|
| Mean | 45.4 ± 13.0 | 44.5 ± 12.6 | 44.9 ± 12.8 |
| Sex: Female, Male(Participants) | Intervention Group | Control Group | Total |
|---|---|---|---|
| Participants — Female | 303 | 306 | 609 |
| Participants — Male | 94 | 95 | 189 |
| Ethnicity (NIH/OMB)(Participants) | Intervention Group | Control Group | Total |
|---|---|---|---|
| Hispanic or Latino | 31 | 32 | 63 |
| Not Hispanic or Latino | 359 | 365 | 724 |
| Unknown or Not Reported | 7 | 5 | 12 |
| Race (NIH/OMB)(Participants) | Intervention Group | Control Group | Total |
|---|---|---|---|
| American Indian or Alaska Native | 1 | 0 | 1 |
| Asian | 1 | 1 | 2 |
| Native Hawaiian or Other Pacific Islander | 0 | 1 | 1 |
| Black or African American | 299 | 301 | 600 |
| White | 85 | 88 | 173 |
| More than one race | 4 | 2 | 6 |
| Unknown or Not Reported | 7 | 9 | 16 |
| Region of Enrollment(participants) | Intervention Group | Control Group | Total |
|---|---|---|---|
| United States | 397 | 402 | 799 |
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Acquired Immunodeficiency Syndrome→
RTI International