Information Visualizations to Facilitate HIV-related Patient-provider Communication (Info Viz: HIV)

Study Overview
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Brief Summary
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To complete the study aims, a mixed methods study that includes a single group pretest-posttest study design will be used to pilot test the infographic intervention. In-depth interviews will be completed with a selection of participants to explore participant perceptions of HIV-related communication using infographics. Data will be collected from participants through baseline (at enrollment) and follow up assessments (at 3-, 6-, and 9-month follow up visits). Follow up interviews will be conducted with the providers involved in the intervention to ascertain their perspectives on the clinical utility of infographics.

Detailed Description
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The Caribbean has among the highest HIV prevalence in the world. Regionally, the majority of HIV/AIDS cases are located on the island of Hispaniola, comprised of the Dominican Republic (DR) and Haiti. Due to a large international response and widespread availability of antiretroviral therapy (ART), in recent years the incidence of HIV in the DR has declined and prevalence hovers around 1% in the general population. The effective and long-term management of this condition depends on infected individuals being able to acquire ART and apply the learned information and self-management skills that lead to optimal adherence. HIV-related disparities exist in developing countries, such as the DR, where minority groups and/or those with low socioeconomic status experience higher disease burdens and worse health outcomes than those with higher socioeconomic status. These disparities may be exacerbated when individuals are unable to understand the health information, as low health literacy has been associated with worse health outcomes, less use of healthcare services, poorer knowledge of illness, and worse self-management. The effective management of HIV requires patients to acquire, comprehend, and use large amounts of complex information, including how to manage variations in health status, medications and their side effects, nutrition and exercise needs, and healthy coping. Health care providers can help patients understand pertinent health information by offering it in targeted, culturally-, language-, and literacy-appropriate ways. One such strategy is to use infographics to assist communication through visual representations of information. Participatory design of infographics supports presentation of information in a culturally appropriate and visually appealing format which can improve information understanding, health behaviors, attention span, and ability to recall information. It is critical to develop and test methods to improve the way health information is delivered to patients in these clinical contexts so patients, including those with low health literacy, can acquire and comprehend the information needed to improve self-management behavior and treatment outcomes. Preliminary studies showed many persons living with HIV (PLWH) attending Clínica de Familia La Romana do not fully comprehend and use the health information they receive through current modalities. In response, culturally relevant, evidence-based infographics to improve information delivery during clinical visits were developed with a participatory design methodology (manuscript under review). The next phase of this study is to rigorously assess if using these infographics is a feasible, acceptable, and efficacious method to enhance HIV-related clinician-patient communication and lead to improved patient outcomes. Additionally, a thorough exploration into the cultural factors of patient-provider communication in the Dominican Republic that can influence infographic use for clinician-patient communication in a clinical setting is warranted.

Official Title
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Information Visualizations to Facilitate Patient-provider Communication in HIV Care: Info Viz HIV

Conditions
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Health Communication

Intervention / Treatment
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* Other: Infographic intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult (≥) 18 years of age Spanish-speaking Living with HIV and have a detectable viral load Attend Clínica de Familia La Romana Plan to receive care at the same clinic for the next year Exclusion Criteria: Does not meet inclusion criteria Not able to understand study procedures or provide informed consent

Ages Eligible for Study
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Minimum Age: 18 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
Intervention Model: Single Group Assignment
Interventional Model Description: This study will use a single group pretest-posttest design to evaluate if using infographics during clinic visits can lead to improved patient outcomes.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Group<br>Participants in the intervention group will receive health education using infographics (Infographic Intervention) during their regularly scheduled clinic visits. | Other: Infographic intervention<br>* All study participants will receive health education using infographics during their regularly scheduled clinic appointments.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Association Between Mean CD4 Count at Baseline and 3-month Visit | Association between mean CD4 count at baseline and 3-month visits. | Baseline and 3-month visit | 
| Association Between Mean CD4 Count at Baseline and 6-month Visit | Association between mean CD4 count at baseline and 6-month visits. | Baseline and 6-month visit | 
| Association Between Mean CD4 Count at Baseline and 9-month Visit | Association between mean CD4 count at baseline and 9-month visits. | Baseline and 9-month visit | 
| Association Between Mean Viral Load at Baseline and at 3-month Visits | Test of association of mean viral load at baseline and at 3-month visits. | Baseline and 3-months | 
| Association Between Mean Viral Load at Baseline and at 6-month Visits | Test of association of mean viral load at baseline and at 6-month visits. | Baseline and 6-months | 
| Association Between Mean Viral Load at Baseline and at 9-month Visits | Test of association of mean viral load at baseline and at 9-month visits. | Baseline and 9-months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Satisfaction With Care Scale Score | 3 questions from the overall evaluation of the HIV clinic scale were administered for a total of 19 possible points on this scale. Range of possible scores is 1-19, with 19 being highest possible satisfaction with care. The breakdown of scoring by question is as follows: Question 1 is a 1-7 scale with 1 being completely unsatisfied and 7 being completely satisfied Question 2 is a 1-5 scale where 1 is definitely not and 5 is definitely yes Question 3 is a 1-7 scale where 1 is terrible and 7 is marvelous | Baseline, 3-, 6-, and 9-month visits | 
| Medication Adherence | 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 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). Therefore, participants are classified as either adherent or not adherent based on their answers to these questions. Any participant that didn't complete study visits or did not answer that question was considered missing. | Baseline, 3-, 6-, and 9-month visits | 
| Participant's Self-reported Health-related Quality of Life Score - Physical Functioning | Health-related quality of life will be measured with the Patient-Reported Outcomes Measurement Information System® (PROMIS)-29 measure, which measures 7 domains of health-related quality of life with 4 questions in each section pertaining to how that participant's health influences their life. In general, each question has five response options ranging in values from 1-5. To find the total raw score for this form with all the questions answered, the values from the responses of each question are summed. Raw scores are then translated into a T-score for each participant, which rescales the raw score into a standardized T-score with a mean of 50 and standard deviation (SD) of 10. Consequently, a person with a T-score of 40 would be one SD below the mean. | Up to 9 months from baseline | 
| Participants' Self-reported Health Status Over Past 4 Weeks. | General health status was assessed with one item where participants are asked to rank their health in the past four weeks as excellent, good, fair, poor, or very poor. Results are presented as the number of participants that self-rated their health in each of those categories. | Baseline, 3-months, 6-months, and 9-months | 
| Health Literacy | Health literacy will be assessed using the short assessment of health literacy- Spanish. Scores range from 0 - 18 and above a 15 indicates that participants are likely to have adequate health literacy. Participants are then categorized as health literate or not health literate. The final number of participants who are health literate are reported here. | Baseline visit only | 
| Percent of Participants Who Complete an In-depth Qualitative Interview | Participants will be invited to participate in an in-depth qualitative interview regarding their experiences. The number who participate will be reported as a percent of the total who are enrolled. | 9 months from baseline | 
| Participant's Self-reported Health-related Quality of Life Score - Anxiety | Health-related quality of life will be measured with the Patient-Reported Outcomes Measurement Information System® (PROMIS)-29 measure, which measures 7 domains of health-related quality of life with 4 questions in each section pertaining to how that participant's health influences their life. In general, each question has five response options ranging in values from 1-5. To find the total raw score for this form with all the questions answered, the values from the responses of each question are summed. Raw scores are then translated into a T-score for each participant, which rescales the raw score into a standardized T-score with a mean of 50 and standard deviation (SD) of 10. Consequently, a person with a T-score of 40 would be one SD below the mean. | Baseline, 3-, 6-, and 9-months | 
| Participant's Self-reported Health-related Quality of Life Score - Depression | Health-related quality of life will be measured with the Patient-Reported Outcomes Measurement Information System® (PROMIS)-29 measure, which measures 7 domains of health-related quality of life with 4 questions in each section pertaining to how that participant's health influences their life. In general, each question has five response options ranging in values from 1-5. To find the total raw score for this form with all the questions answered, the values from the responses of each question are summed. Raw scores are then translated into a T-score for each participant, which rescales the raw score into a standardized T-score with a mean of 50 and standard deviation (SD) of 10. Consequently, a person with a T-score of 40 would be one SD below the mean. | Baseline, 3-, 6-, and 9-months | 
| Participant's Self-reported Health-related Quality of Life Score - Fatigue | Health-related quality of life will be measured with the Patient-Reported Outcomes Measurement Information System® (PROMIS)-29 measure, which measures 7 domains of health-related quality of life with 4 questions in each section pertaining to how that participant's health influences their life. In general, each question has five response options ranging in values from 1-5. To find the total raw score for this form with all the questions answered, the values from the responses of each question are summed. Raw scores are then translated into a T-score for each participant, which rescales the raw score into a standardized T-score with a mean of 50 and standard deviation (SD) of 10. Consequently, a person with a T-score of 40 would be one SD below the mean. | Baseline, 3-, 6-, and 9-months | 
| Participant's Self-reported Health-related Quality of Life Score - Sleep Disturbance | Health-related quality of life will be measured with the Patient-Reported Outcomes Measurement Information System® (PROMIS)-29 measure, which measures 7 domains of health-related quality of life with 4 questions in each section pertaining to how that participant's health influences their life. In general, each question has five response options ranging in values from 1-5. To find the total raw score for this form with all the questions answered, the values from the responses of each question are summed. Raw scores are then translated into a T-score for each participant, which rescales the raw score into a standardized T-score with a mean of 50 and standard deviation (SD) of 10. Consequently, a person with a T-score of 40 would be one SD below the mean. | Baseline, 3-, 6-, and 9-months | 
| Participant's Self-reported Health-related Quality of Life Score - Social Activity Participation | Health-related quality of life will be measured with the Patient-Reported Outcomes Measurement Information System® (PROMIS)-29 measure, which measures 7 domains of health-related quality of life with 4 questions in each section pertaining to how that participant's health influences their life. In general, each question has five response options ranging in values from 1-5. To find the total raw score for this form with all the questions answered, the values from the responses of each question are summed. Raw scores are then translated into a T-score for each participant, which rescales the raw score into a standardized T-score with a mean of 50 and standard deviation (SD) of 10. Consequently, a person with a T-score of 40 would be one SD below the mean. | Baseline, 3-, 6-, and 9-months | 
| Participant's Self-reported Health-related Quality of Life Score - Pain Interference | Health-related quality of life will be measured with the Patient-Reported Outcomes Measurement Information System® (PROMIS)-29 measure, which measures 7 domains of health-related quality of life with 4 questions in each section pertaining to how that participant's health influences their life. In general, each question has five response options ranging in values from 1-5. To find the total raw score for this form with all the questions answered, the values from the responses of each question are summed. Raw scores are then translated into a T-score for each participant, which rescales the raw score into a standardized T-score with a mean of 50 and standard deviation (SD) of 10. Consequently, a person with a T-score of 40 would be one SD below the mean. | Baseline, 3-, 6-, and 9-months | 
| Satisfaction With Provider Scale Score at Each Time Point | 4 questions from the overall evaluation of the health care provider scale were administered for a total score of 29. The range of scores is 3-29, with 29 being the highest possible satisfaction with their health care provider. The scoring breakdown by each included question is as follows: Question 1 is 1- 7 points where 1 is completely dissatisfied and 7 is completely satisfied Question 2 is providing an integer value of trust in care provider on a scale from 1 to 10 Question 3 is 1- 7 points where 1 is terrible and 7 is marvelous Question 4 is 0- 5 points where 0 is definitely not and 5 is definitely yes | Baseline, 3-, 6-, and 9-month visits | 
| Association Between Mean HIV-related Knowledge Scores at Baseline and 3-month Visits. | 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 and 3-month visits | 
| Association Between Mean HIV-related Knowledge Scores at Baseline and 6-month Visits. | 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 and 6-month visits | 
| Association Between Mean HIV-related Knowledge Scores at Baseline and 9-month Visits. | 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 and 9-month visits | 
| Association of Engagement With Clinician Scale Score at Baseline and 3-months. | The Engagement with Health Care Providers scale is a 13 item scale through which clients rate how they feel about their interactions with their providers. Answers are recorded on a 4-point scale (1=always true and 4=never true). The range of scores is between 13 and 52. Lower scores (with 13 being the lowest score) indicate more provider engagement. | Baseline and 3-months | 
| Association of Engagement With Clinician Scale Score at Baseline and 6-months. | The Engagement with Health Care Providers scale is a 13 item scale through which clients rate how they feel about their interactions with their providers. Answers are recorded on a 4-point scale (1=always true and 4=never true). The range of scores is between 13 and 52. Lower scores (with 13 being the lowest score) indicate more provider engagement. | Baseline and 6-months | 
| Association of Engagement With Clinician Scale Score at Baseline and 9-months. | The Engagement with Health Care Providers scale is a 13 item scale through which clients rate how they feel about their interactions with their providers. Answers are recorded on a 4-point scale (1=always true and 4=never true). The range of scores is between 13 and 52. Lower scores (with 13 being the lowest score) indicate more provider engagement. | Baseline and 9-months | 
| Association Between SEMCD Scale Score at Baseline and 3-month Visits | Self-efficacy to manage chronic disease scale (SEMCD) will be used. This is a 6-item measure where 1 is not at all confident and 10 is completely confident. The total range of scores is 1-10. Final scores are calculated as the mean of the 6 questions, where higher scores indicate higher self-efficacy. | Baseline, 3-month visits | 
| Association Between SEMCD Scale Score at Baseline and 6-month Visits | Self-efficacy to manage chronic disease scale (SEMCD) will be used. This is a 6-item measure where 1 is not at all confident and 10 is completely confident. The total range of scores is 1-10. Final scores are calculated as the mean of the 6 questions, where higher scores indicate higher self-efficacy. | Baseline, 6-month visits | 
| Association Between SEMCD Scale Score at Baseline and 9-month Visits | Self-efficacy to manage chronic disease scale (SEMCD) will be used. This is a 6-item measure where 1 is not at all confident and 10 is completely confident. The total range of scores is 1-10. Final scores are calculated as the mean of the 6 questions, where higher scores indicate higher self-efficacy. | Baseline, 9-month visits | 
| Association Between Current Self-reported Health Status as Reported at Baseline and 3-months | Participants are asked to rank their current health status on a scale between 0 and 100 where 0 is death or the worst possible health (as bad or worse than being dead) and 100 is perfect health, or the best possible health (without HIV infection). | Baseline, 3-months | 
| Association Between Current Self-reported Health Status as Reported at Baseline and 6-months | Participants are asked to rank their current health status on a scale between 0 and 100 where 0 is death or the worst possible health (as bad or worse than being dead) and 100 is perfect health, or the best possible health (without HIV infection). | Baseline, 6-months | 
| Association Between Current Self-reported Health Status as Reported at Baseline and 9-months | Participants are asked to rank their current health status on a scale between 0 and 100 where 0 is death or the worst possible health (as bad or worse than being dead) and 100 is perfect health, or the best possible health (without HIV infection). | Baseline, 9-months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Information Visualization