Information Visualizations to Enhance HIV-related Communication

Study Overview
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Brief Summary
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HIV disproportionately affects Latinos who have more infections, faster disease progression, more HIV-related deaths, and slower diagnosis and treatment than their white/majority counterparts. This is a concern across the United States (US) and in developing countries, such as the Dominican Republic (DR). The HIV-related health disparities experienced by Latinos are made worse when those living with HIV have low health literacy and difficulty understanding the information they need to manage their health. The PI developed a set of images to assist clinicians in providing information to Latino people living with HIV (PLWH). These images have been put into a mobile health app so clinicians can easily access them during clinic visits. The PI has tested her with PLWH in the DR and in New York City. So, the next steps in this research are to ensure the images are relevant and useful to Latinos across the United States (US) and to further assess if, and to what extent, the images can improve health outcomes among PLWH in the US and in the DR. We will therefore, adapt images to Latinos of Mexican origin/descent and then test them to determine if these images help clinicians provide information to patients by conducting a study at clinical sites in the US and in the DR.

Official Title
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Information Visualizations to Facilitate Clinician-patient Communication in HIV Care (Info Viz: HIV)

Conditions
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HIV, Communication Research

Intervention / Treatment
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* Other: Info Viz for Health


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - Participants must self-identify as Latino, be English or Spanish-speaking, living with HIV with a detectable viral load (>200 copies/mL) at any point in the past year or have an indication of adherence risk, and planning to receive care at the study site for the next year. Exclusion Criteria: Not meeting inclusion criteria or not having the mental capacity to understand the study or provide informed consent.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: There is a treatment and a control group at each site.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>The treatment group will be exposed to the infographic intervention when they present for clinic/study visits. During their visit with the provider, the provider offer health education while using infographics. | Other: Info Viz for Health<br>* During the intervention, health care providers provide HIV-related health education using a mobile app that contains a bilingual database of relevant infographics.<br>|
| No Intervention: Control<br>The control groups will receive standard health education. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in CD4 count over time | Change in Cluster of Differentiation 4 (CD4) count measured at 3-month intervals following baseline visit | Baseline, 3-month, 6-month, 9-month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in viral load over time | Change in viral load count measured at 3-month intervals following baseline | Baseline, 3-month, 6-month, 9-month | 
| HIV-related knowledge assessment | 14 questions pertaining to HIV-related knowledge were developed according to the information that will be included in the intervention. Participants will receive one point for each correct answer and then the scores for each question will be summed to obtain a final score. Therefore, the minimum score will be 0 and maximum score will be 14 where the scores closer to 14 indicate patients have more HIV-related knowledge | Baseline, 3-month, 6-month, 9-month | 
| Satisfaction with Care Scale Score | 11 questions on patients' satisfaction with health care provider and the health care center adapted from previously validated instruments are included. Each question response has a different scale: Question 1: High Score 7 Question 2: High Score 10 Question 3: High Score 7 Question 4: High Score 5 Question 5: High Score 5 Question 6: High Score 6 Question 7: High Score 7 Question 8: High Score 7 Question 9: High Score 5 Question 10: High Score 5 Question 11: High Score 10 | Baseline, 3-month, 6-month, 9-month | 
| SEMCD Scale Score | The Self#Efficacy for Managing Chronic Disease (SEMCD) scale is a 6#item questionnaire that measures confidence in one's ability to manage fatigue, pain, emotional distress, and other symptoms using self#management techniques. Each item is scored from a minimum value of 1 which indicates not at all confident to a maximum score of 10, which indicates completely confident. Final scores are calculated as the mean of the 6 questions ranging from 1(minimum) to 10 (maximum), where higher scores indicate higher self-efficacy (better outcome). | Baseline, 3-month, 6-month, 9-month | 
| Medication Adherence Score | Adherence will be measured with the validated simplified medication adherence questionnaire (SMAQ)-6 scale, a 6- item questionnaire. A person is considered non-adherent if there is a yes answer for any of items 1,2,3, and 5. Additionally, if they answer that they have missed more than two doses of their medication in the past week (item 4) or if they have gone more than two days without taking their medication in the past 3 months (item 6), they are also considered non-adherent. | Baseline, 3-month, 6-month, 9-month | 
| Health Status Average Score | Health status will be assessed with the Health Status Assessment which includes two quality of life measures. The first, a general health item scored on a five-point scale where 1 is excellent and 5 is poor and the second, a health assessment scale from 0 - 100 where 0=death or worst possible health and 100=perfect or best possible health. | Baseline, 3-month, 6-month, 9-month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Health literacy, HIV, Infographic, Information-visualization, Clinician-patient communication, Health education