Skip to content

Information Visualizations to Facilitate HIV-related Patient-provider Communication in New York City (Info Viz: HIV-NYC)

Information Visualizations to Facilitate HIV-related Patient-provider Communication in New York City (Info Viz: HIV-NYC)

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04102540
Enrollment
32
Registered
2019-09-25
Start date
2019-10-07
Completion date
2020-07-29
Last updated
2021-09-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Communication

Keywords

Information Visualization

Brief summary

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- and 6-month follow up visits). Follow up interviews will be conducted with members of the clinical team to ascertain their perspectives on the clinical utility of infographics.

Detailed description

Latinos are the largest and fastest growing minority group in the US, and they are disproportionately affected by HIV. In 2014, almost 25% of new cases of HIV infections were among Latinos although they only represent 17% of the US population. Additionally, Latinos have a faster rate of progression from HIV to AIDS, higher rates of HIV-related deaths, and marked delay in the diagnosis of infections. Approximately 42% of HIV diagnoses among Latinos in the US are in persons born abroad. In absolute numbers, new HIV diagnoses among foreign-born individuals in the US were the highest among Caribbean-born persons, which may partially be attributed to high rates of bidirectional travel. It is, therefore, critical that HIV prevention and treatment activities incorporate factors associated with Latino immigrant and transnational groups. In Washington Heights, New York City, understanding these factors related with bi-directional travel to the Dominican Republic (DR) is warranted, as the Latino population of Washington Heights is largely comprised of Dominicans. Many factors contribute to the health disparities experienced by Latinos, of which low health literacy and literacy in general are potential contributors. Health literacy, or the degree to which individuals have the capacity to obtain, process, and understand basic health information and services needed to make appropriate health decisions, is an established concern affecting vulnerable communities globally. Not surprisingly, Spanish-speaking, less educated, and/or foreign-born Latinos have lower health literacy than those born in the US. Low health literacy can lead to worse health outcomes, less use of services, and poorer knowledge of illness. Also, patients with limited health literacy are likely to have low numeracy which affects interpretations of medication quantities, time between doses, and time between appointments, among other quantitative knowledge relating to effective management of HIV. Infographics are emerging technologies to help teach complex health concepts to patients with low health literacy. When effectively designed, infographics (information visualizations) contain a depth and breadth of information and lead to improved understanding of concepts. By carefully selecting the design and included content, simple images can convey large amounts of information in a visually appealing and comprehensible way. Methodically constructed infographics have been shown to improve communication about health behaviors and health risks and minimize comprehension differences between individuals with high and low health literacy. They can also help improve information exchange amidst culture and language differences by using images familiar to patients to explain complicated processes as well as augment attention span and recall of learned material. Furthermore, rigorously designed and evaluated infographics can help mitigate health disparities by helping clinicians provide the information that people need for effective health management in an understandable way. During preliminary studies, the investigators developed a set of infographics designed to facilitate HIV-related clinician-patient communication during clinic visits. Initial infographics were designed by persons living with HIV (PLWH) in the Dominican Republic and are now being tested for feasibility and usability among a cohort in the DR. In this study, the investigators propose to assess the feasibility of using the infographic intervention in a clinic that specializes in HIV care in Washington Heights to improve clinical communication and subsequently, patient outcomes. Additionally, the investigators will collect information about acculturation and bi-directional travel to more thoroughly assess how these factors relate to HIV infection among Hispanic/Latino populations living in the US.

Interventions

Information visualizations (infographics) will be used to teach participants about HIV during study visits immediately following their normal clinic visits.

Sponsors

National Institute of Nursing Research (NINR)
CollaboratorNIH
Columbia University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Intervention model description

This study will use a single pretest-posttest design to evaluate if using infographics for patient education can lead to improved patient outcomes.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Adult ≥ 18 years of age * Living with HIV and has a detectable viral load * Self-identifies as Hispanic/Latino * Plan to receive care at the same clinic for the next 6 months

Exclusion criteria

* Does not meet inclusion criteria * Not able to understand study procedures or provide informed consent

Design outcomes

Primary

MeasureTime frameDescription
Mean CD4 CountBaseline, 3-, and 6-monthsMean Cluster of Differentiation 4 (CD4) count at each time point.
Mean Viral LoadBaseline, 3-, and 6-monthsMean viral load at each time point

Secondary

MeasureTime frameDescription
Mean Score on the SEMCD ScaleBaseline, 3-, and 6-monthsThe 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).
Number of Participants Who Are Adherent to Their MedicationsBaseline, 3-, and 6-monthsAdherence 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.
Number of Participants Who Reported Each of the 5 General Health CategoriesBaseline, 3-, and 6-monthsParticipants rated their general health as excellent, very good, good, more or less, or bad.
Mean Score on Current Health StatusBaseline, 3-, and 6-monthsCurrent health status will be assessed with one question from the Health Status Assessment which asks participants to rate their current health by providing a number on a scale from 0 - 100 where 0=death or worst possible health and 100=perfect or best possible health.
Mean Score on HIV-related Knowledge AssessmentBaseline, 3-, and 6-months14 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.
Number of Participants With Likely Limited, Possibly Limited, or Adequate Health Literacy According to NVS MeasurementBaseline visit onlyA second measure of health literacy, the Newest Vital Sign (NVS) will also be administered. Scores on this scale range from 0-6 where a score of 0-1 suggests high likelihood of limited literacy, a score of 2-3 indicates the possibility of limited literacy, and a score of 4-6 almost always indicates adequate literacy.
Number of Participants in Each Acculturation Category Presented in the Brief ARSMABaseline visit onlyThe Brief Acculturation Rating Scale for Mexican Americans-II (Brief ARSMA)12 item instrument that assesses level of acculturation that has been used in Mexican Americans as well as other Latino subgroups, including Dominicans. Scores are calculated by summing the scores and dividing by 12 to get a mean acculturation. Higher scores indicate greater acculturation.
Percent of Participants Who Complete an In-depth Qualitative Interview6 months after baselineParticipants 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.
Number of Participants With Likely Low vs. Adequate Health Literacy According to SAHL-S&E MeasurementBaseline visit onlyHealth literacy will be assessed using the short assessment of health literacy- Spanish. Scores range from 0 - 18 and a score above a 15 indicates that participants are likely to have adequate health literacy.
Mean Score on Satisfaction With Care ScaleBaseline, 3-, and 6-months7 questions on patients' satisfaction with health care provider and the health care center adapted from previously validated instruments were included. Each question response from included questions has a different score range: Question 1: 1 - 7 Question 2: 1 - 10 Question 3: 1 - 7 Question 4: 1 - 5 Question 5: 1 - 7 Question 6: 1 - 7 Question 7: 1 - 5 Total scores range from 7 - 48, which is calculated from the lowest and highest possible scores on each of the included questions. Higher scores indicating more satisfaction with care.

Countries

United States

Participant flow

Participants by arm

ArmCount
Intervention Group
Participants in the intervention group will receive health education using infographics (Infographic Intervention) during a study visit scheduled immediately following their regularly scheduled clinic visits. Infographic intervention: Information visualizations (infographics) will be used to teach participants about HIV during study visits immediately following their normal clinic visits.
30
Total30

Withdrawals & dropouts

PeriodReasonFG000
Overall StudyLost to Follow-up6
Overall StudyWithdrawn by PI2

Baseline characteristics

CharacteristicIntervention Group
Age, Continuous52.4 years
STANDARD_DEVIATION 14.19
Country of birth
Dominican Republic
15 Participants
Country of birth
Other
6 Participants
Country of birth
United States
9 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
30 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
0 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
Highest level of education completed
0-5 years of school
4 Participants
Highest level of education completed
6-8 years of school
6 Participants
Highest level of education completed
9-11 years of school
6 Participants
Highest level of education completed
Finished HS/ has GED
10 Participants
Highest level of education completed
University or other education past HS
4 Participants
Married or in a serious relationship
Married or in a serious relationship
7 Participants
Married or in a serious relationship
NOT married or in a serious relationship
23 Participants
New Patient
Established patient
26 Participants
New Patient
New patient
4 Participants
Preferred language of participation
English-speaking
12 Participants
Preferred language of participation
Spanish-speaking
18 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
Race (NIH/OMB)
Asian
0 Participants
Race (NIH/OMB)
Black or African American
4 Participants
Race (NIH/OMB)
More than one race
12 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Unknown or Not Reported
10 Participants
Race (NIH/OMB)
White
4 Participants
Region of Enrollment
United States
30 Participants
Sex/Gender, Customized
Female
11 Participants
Sex/Gender, Customized
Male
18 Participants
Sex/Gender, Customized
Other
1 Participants
Years attending the clinic10.04 Years
STANDARD_DEVIATION 9.41
Years living with HIV16.28 Years
STANDARD_DEVIATION 9.7

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 30
other
Total, other adverse events
0 / 30
serious
Total, serious adverse events
0 / 30

Outcome results

Primary

Mean CD4 Count

Mean Cluster of Differentiation 4 (CD4) count at each time point.

Time frame: Baseline, 3-, and 6-months

Population: 2 participants were withdrawn by the PI and were not included in analyses.

ArmMeasureGroupValue (MEAN)Dispersion
Infographic Intervention GroupMean CD4 CountCD4 Count at Baseline321.5 Cells/mm^3Standard Deviation 1038
Infographic Intervention GroupMean CD4 CountCD4 Count after second exposure to intervention418 Cells/mm^3Standard Deviation 944
Infographic Intervention GroupMean CD4 CountCD4 Count after third exposure to intervention390.5 Cells/mm^3Standard Deviation 834
Comparison: Statistical analysis of CD4 count between baseline/exposure 1 and exposure 2 to the intervention.p-value: 0.28395% CI: [-48.9, 163.7]Quantile Regression
Comparison: Statistical analysis of CD4 count between baseline/exposure 1 and exposure 3 to the intervention.p-value: 0.182395% CI: [-29.5, 151.2]Quantile regression
Primary

Mean Viral Load

Mean viral load at each time point

Time frame: Baseline, 3-, and 6-months

Population: 2 participants were withdrawn from the study by the PI, therefore, 30 subjects were included in the analysis.

ArmMeasureGroupValue (MEAN)
Infographic Intervention GroupMean Viral LoadBaseline/exposure 197,266 copies/mL
Infographic Intervention GroupMean Viral LoadExposure 293,242 copies/mL
Infographic Intervention GroupMean Viral LoadExposure 321,116 copies/mL
Comparison: Statistical analysis of viral load between baseline/exposure 1 and exposure 2 to the intervention.p-value: 0.779595% CI: [-339.8, 255.8]Quantile Regression
Comparison: Statistical analysis of viral load between baseline/exposure 1 and exposure 3 to the intervention.p-value: 0.597195% CI: [-296.1, 170.1]Quantile Regression
Secondary

Mean Score on Current Health Status

Current health status will be assessed with one question from the Health Status Assessment which asks participants to rate their current health by providing a number on a scale from 0 - 100 where 0=death or worst possible health and 100=perfect or best possible health.

Time frame: Baseline, 3-, and 6-months

Population: 2 participants were withdrawn from the study by the PI, therefore, 30 subjects were included in the analysis.

ArmMeasureGroupValue (MEAN)Dispersion
Infographic Intervention GroupMean Score on Current Health StatusBaseline/exposure 168 score on a scaleStandard Deviation 20.66
Infographic Intervention GroupMean Score on Current Health StatusExposure 275.45 score on a scaleStandard Deviation 17.03
Infographic Intervention GroupMean Score on Current Health StatusExposure 382.29 score on a scaleStandard Deviation 16.8
Comparison: Statistical analysis of current health status between baseline/exposure 1 and exposure 2 to the intervention.p-value: 0.057295% CI: [-0.3, 18.6]Quantile Regression
Comparison: Statistical analysis of self-efficacy to manage HIV scale score between baseline/exposure 1 and exposure 3 to the intervention.p-value: 0.033295% CI: [1.1, 25.1]Quantile Regression
Secondary

Mean Score on 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.

Time frame: Baseline, 3-, and 6-months

Population: 2 participants were withdrawn from the study by the PI, therefore, 30 subjects were included in the analysis.

ArmMeasureGroupValue (MEAN)Dispersion
Infographic Intervention GroupMean Score on HIV-related Knowledge AssessmentBaseline/exposure 110.10 score on a scaleStandard Deviation 2.43
Infographic Intervention GroupMean Score on HIV-related Knowledge AssessmentExposure 212.23 score on a scaleStandard Deviation 1.51
Infographic Intervention GroupMean Score on HIV-related Knowledge AssessmentExposure 312.21 score on a scaleStandard Deviation 1.59
Comparison: Statistical analysis of HIV-related knowledge scores between baseline/exposure 1 and exposure 2 to the intervention.p-value: <0.000195% CI: [1.2, 3]Quantile Regression
Comparison: Statistical analysis of HIV-related knowledge scores between baseline/exposure 1 and exposure 3 to the intervention.p-value: <0.000195% CI: [1.2, 2.8]Quantile Regression
Secondary

Mean Score on Satisfaction With Care Scale

7 questions on patients' satisfaction with health care provider and the health care center adapted from previously validated instruments were included. Each question response from included questions has a different score range: Question 1: 1 - 7 Question 2: 1 - 10 Question 3: 1 - 7 Question 4: 1 - 5 Question 5: 1 - 7 Question 6: 1 - 7 Question 7: 1 - 5 Total scores range from 7 - 48, which is calculated from the lowest and highest possible scores on each of the included questions. Higher scores indicating more satisfaction with care.

Time frame: Baseline, 3-, and 6-months

Population: 2 participants were withdrawn from the study by the PI, therefore, 30 subjects were included in the analysis.

ArmMeasureGroupValue (MEAN)Dispersion
Infographic Intervention GroupMean Score on Satisfaction With Care ScaleBaseline/exposure 144.93 score on a scaleStandard Deviation 3.4
Infographic Intervention GroupMean Score on Satisfaction With Care ScaleExposure 245.18 score on a scaleStandard Deviation 2.81
Infographic Intervention GroupMean Score on Satisfaction With Care ScaleExposure 344.29 score on a scaleStandard Deviation 5.06
Secondary

Mean Score on the SEMCD Scale

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).

Time frame: Baseline, 3-, and 6-months

Population: 2 participants were withdrawn from the study by the PI, therefore, 30 subjects were included in the analysis.

ArmMeasureGroupValue (MEAN)Dispersion
Infographic Intervention GroupMean Score on the SEMCD ScaleBaseline/exposure 18.01 score on a scaleStandard Deviation 1.72
Infographic Intervention GroupMean Score on the SEMCD ScaleExposure 28.13 score on a scaleStandard Deviation 1.46
Infographic Intervention GroupMean Score on the SEMCD ScaleExposure 38.48 score on a scaleStandard Deviation 1.89
Comparison: Statistical analysis of self-efficacy to manage HIV scale score between baseline/exposure 1 and exposure 2 to the intervention.p-value: 0.987995% CI: [-0.7, 0.7]Quantile Regression
Comparison: Statistical analysis of self-efficacy to manage HIV scale score between baseline/exposure 1 and exposure 3 to the intervention.p-value: 0.15595% CI: [-0.2, 1.4]Quantile Regression
Secondary

Number of Participants in Each Acculturation Category Presented in the Brief ARSMA

The Brief Acculturation Rating Scale for Mexican Americans-II (Brief ARSMA)12 item instrument that assesses level of acculturation that has been used in Mexican Americans as well as other Latino subgroups, including Dominicans. Scores are calculated by summing the scores and dividing by 12 to get a mean acculturation. Higher scores indicate greater acculturation.

Time frame: Baseline visit only

Population: 2 participants were withdrawn from the study by the PI and, therefore, were not included in analyses

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Infographic Intervention GroupNumber of Participants in Each Acculturation Category Presented in the Brief ARSMAVery oriented to original culture13 Participants
Infographic Intervention GroupNumber of Participants in Each Acculturation Category Presented in the Brief ARSMAOriented to original culture to approximately balanced bicultural6 Participants
Infographic Intervention GroupNumber of Participants in Each Acculturation Category Presented in the Brief ARSMASlightly Anglo oriented bicultural4 Participants
Infographic Intervention GroupNumber of Participants in Each Acculturation Category Presented in the Brief ARSMAStrongly Anglo oriented4 Participants
Infographic Intervention GroupNumber of Participants in Each Acculturation Category Presented in the Brief ARSMAVery assimilated3 Participants
Secondary

Number of Participants Who Are Adherent to Their Medications

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.

Time frame: Baseline, 3-, and 6-months

Population: 2 participants were withdrawn from the study by the PI, therefore, 30 subjects were included in the analysis.

ArmMeasureGroupCategoryValue (COUNT_OF_PARTICIPANTS)
Infographic Intervention GroupNumber of Participants Who Are Adherent to Their MedicationsBaseline/exposure 1Adherent10 Participants
Infographic Intervention GroupNumber of Participants Who Are Adherent to Their MedicationsBaseline/exposure 1Non-adherent20 Participants
Infographic Intervention GroupNumber of Participants Who Are Adherent to Their MedicationsBaseline/exposure 1Missing0 Participants
Infographic Intervention GroupNumber of Participants Who Are Adherent to Their MedicationsExposure 2Adherent7 Participants
Infographic Intervention GroupNumber of Participants Who Are Adherent to Their MedicationsExposure 2Non-adherent15 Participants
Infographic Intervention GroupNumber of Participants Who Are Adherent to Their MedicationsExposure 2Missing8 Participants
Infographic Intervention GroupNumber of Participants Who Are Adherent to Their MedicationsExposure 3Adherent11 Participants
Infographic Intervention GroupNumber of Participants Who Are Adherent to Their MedicationsExposure 3Non-adherent13 Participants
Infographic Intervention GroupNumber of Participants Who Are Adherent to Their MedicationsExposure 3Missing6 Participants
Comparison: For analysis, we dichotomized participants adherence as adherent or non-adherent.p-value: 0.81995% CI: [0.3, 4.52]Regression, Logistic
Comparison: For analysis, we dichotomized participants adherence as adherent or non-adherent.p-value: 0.133295% CI: [0.07, 1.43]Regression, Logistic
Secondary

Number of Participants Who Reported Each of the 5 General Health Categories

Participants rated their general health as excellent, very good, good, more or less, or bad.

Time frame: Baseline, 3-, and 6-months

Population: 2 participants were withdrawn from the study by the PI, therefore, 30 subjects were included in the analysis.

ArmMeasureGroupCategoryValue (COUNT_OF_PARTICIPANTS)
Infographic Intervention GroupNumber of Participants Who Reported Each of the 5 General Health CategoriesBaseline/exposure 1Bad1 Participants
Infographic Intervention GroupNumber of Participants Who Reported Each of the 5 General Health CategoriesBaseline/exposure 1More or less15 Participants
Infographic Intervention GroupNumber of Participants Who Reported Each of the 5 General Health CategoriesBaseline/exposure 1Good6 Participants
Infographic Intervention GroupNumber of Participants Who Reported Each of the 5 General Health CategoriesBaseline/exposure 1Very Good4 Participants
Infographic Intervention GroupNumber of Participants Who Reported Each of the 5 General Health CategoriesBaseline/exposure 1Excellent4 Participants
Infographic Intervention GroupNumber of Participants Who Reported Each of the 5 General Health CategoriesBaseline/exposure 1Missing0 Participants
Infographic Intervention GroupNumber of Participants Who Reported Each of the 5 General Health CategoriesExposure 2Bad0 Participants
Infographic Intervention GroupNumber of Participants Who Reported Each of the 5 General Health CategoriesExposure 2More or less10 Participants
Infographic Intervention GroupNumber of Participants Who Reported Each of the 5 General Health CategoriesExposure 2Good7 Participants
Infographic Intervention GroupNumber of Participants Who Reported Each of the 5 General Health CategoriesExposure 2Very Good1 Participants
Infographic Intervention GroupNumber of Participants Who Reported Each of the 5 General Health CategoriesExposure 2Excellent4 Participants
Infographic Intervention GroupNumber of Participants Who Reported Each of the 5 General Health CategoriesExposure 2Missing8 Participants
Infographic Intervention GroupNumber of Participants Who Reported Each of the 5 General Health CategoriesExposure 3Bad0 Participants
Infographic Intervention GroupNumber of Participants Who Reported Each of the 5 General Health CategoriesExposure 3More or less11 Participants
Infographic Intervention GroupNumber of Participants Who Reported Each of the 5 General Health CategoriesExposure 3Good5 Participants
Infographic Intervention GroupNumber of Participants Who Reported Each of the 5 General Health CategoriesExposure 3Very Good4 Participants
Infographic Intervention GroupNumber of Participants Who Reported Each of the 5 General Health CategoriesExposure 3Excellent4 Participants
Infographic Intervention GroupNumber of Participants Who Reported Each of the 5 General Health CategoriesExposure 3Missing6 Participants
Comparison: For analysis, we dichotomized participants' responses into the following categories: good vs bad health, where good included participant responses: excellent, very good, good, and bad included the participant responses: more or less and bad.p-value: 0.31695% CI: [0.57, 5.46]Regression, Logistic
Comparison: For analysis, we dichotomized participants' responses into the following categories: good vs bad health, where good included participant responses: excellent, very good, good, and bad included the participant responses: more or less and bad.p-value: 0.860995% CI: [0.32, 3.93]Regression, Logistic
Secondary

Number of Participants With Likely Limited, Possibly Limited, or Adequate Health Literacy According to NVS Measurement

A second measure of health literacy, the Newest Vital Sign (NVS) will also be administered. Scores on this scale range from 0-6 where a score of 0-1 suggests high likelihood of limited literacy, a score of 2-3 indicates the possibility of limited literacy, and a score of 4-6 almost always indicates adequate literacy.

Time frame: Baseline visit only

Population: 2 participants were withdrawn from the study by the PI and, therefore, their data are not included in analyses.

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Infographic Intervention GroupNumber of Participants With Likely Limited, Possibly Limited, or Adequate Health Literacy According to NVS MeasurementLikely adequate health literacy5 Participants
Infographic Intervention GroupNumber of Participants With Likely Limited, Possibly Limited, or Adequate Health Literacy According to NVS MeasurementPossibility of limited health literacy11 Participants
Infographic Intervention GroupNumber of Participants With Likely Limited, Possibly Limited, or Adequate Health Literacy According to NVS MeasurementLikely limited health literacy14 Participants
Secondary

Number of Participants With Likely Low vs. Adequate Health Literacy According to SAHL-S&E Measurement

Health literacy will be assessed using the short assessment of health literacy- Spanish. Scores range from 0 - 18 and a score above a 15 indicates that participants are likely to have adequate health literacy.

Time frame: Baseline visit only

Population: 2 participants were withdrawn from the study by the PI and, therefore, their data are not included in the analysis.

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Infographic Intervention GroupNumber of Participants With Likely Low vs. Adequate Health Literacy According to SAHL-S&E MeasurementMissing1 Participants
Infographic Intervention GroupNumber of Participants With Likely Low vs. Adequate Health Literacy According to SAHL-S&E MeasurementLikely adequate health literacy16 Participants
Infographic Intervention GroupNumber of Participants With Likely Low vs. Adequate Health Literacy According to SAHL-S&E MeasurementLikely low health literacy13 Participants
Secondary

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.

Time frame: 6 months after baseline

Population: 2 participants were withdrawn from the study by the PI and, therefore, they are not included in analyses.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Infographic Intervention GroupPercent of Participants Who Complete an In-depth Qualitative Interview24 Participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026