Positive Health Check Evaluation Trial

The PHC Evaluation Trial uses a randomized trial to test if a brief web-based counseling
intervention can improve clinical outcomes among people living with 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 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 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 PHC into 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. PHC is a web-based
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. 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 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. 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 HIV management, how to prevent transmission, and
living a healthy lifestyle while being HIV positive. The intervention will be considered
implemented with fidelity if a patient completes the intervention in the clinic before 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 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.

Inclusion Criteria:

1. 18 years of age or older;

2. Diagnosed with HIV;

3. English-speaking;

4. Attending one of the four clinical sites;

5. Meet at least one of the following: a) Most recent viral load lab result of ≥ 200
copies/mL, b) Attended an initial 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);

6. Not involved in any other intervention that would bias outcome assessment,

7. Deemed mentally competent and able to engage with the intervention.

Exclusion Criteria:

1. Under 18 years of age;

2. HIV negative;

3. Does not speak English;

4. Does not attend one of the four clinical sites for HIV primary care;

5. Meets all of the following: a) Most recent viral load lab result of < 200 copies/mL,
b) Did not attend an initial 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)

6. Involved in an intervention that would bias outcome assessment;

7. Deemed mentally incompetent to engage with the intervention.