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Information Visualizations to Enhance HIV-related Communication

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04564209
Acronym
Info Viz: HIV
Enrollment
164
Registered
2020-09-25
Start date
2021-08-18
Completion date
2023-06-28
Last updated
2025-03-06

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

Conditions

Communication Research, HIV

Keywords

Health literacy, HIV, Infographic, Information-visualization, Clinician-patient communication, Health education

Brief summary

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.

Interventions

OTHERInfo Viz for Health

During the intervention, health care providers provide HIV-related health education using a mobile app that contains a bilingual database of relevant infographics.

Sponsors

National Institute of Nursing Research (NINR)
CollaboratorNIH
University of Colorado, Denver
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Investigator)

Masking description

Study team members who are recruiting will not be aware of which group study participants are being assigned to.

Intervention model description

There is a treatment and a control group at each site.

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Change in CD4 Count Over TimeBaseline, 3-month, 6-month, 9-monthChange in Cluster of Differentiation 4 (CD4) count measured at 3-month intervals following baseline visit

Secondary

MeasureTime frameDescription
Satisfaction With Provider Scale ScoreBaseline, 3-month, 6-month, 9-monthSatisfaction with provider was measured with the Overall Satisfaction with Provider and Clinic scale published by Dang et al., 2016. We asked a selection of questions from this scale based on their appropriateness for our study. The questions asked and the range of possible scores are as follows. Question 1: 1 - 7 Question 2: 1 - 10 Question 3: 1 - 7 Question 4: 1 - 5 Total scores are then calculated by adding participant responses on each of the four questions. The total possible score range for the questions asked from this scale was 4 - 29, with higher scores indicating more satisfaction with HIV provider.
Simplified Medication Adherence Questionnaire (SMAQ)Baseline, 3-month, 6-month, 9-monthWe measured adherence to prescribed antiretroviral therapy with the validated simplified medication adherence questionnaire (SMAQ) (Knobel 2002). This is a 6- item questionnaire that measures medication adherence. There is no minimum or maximum score on this scale. Participants are considered either adherent (better outcome) or non-adherent (worse outcome) based on their responses to these 6 questions. They are considered non-adherent if they answer yes to questions 1, 2, 3, OR 5, regardless of their answers on the other questions. Participants are also considered non-adherent when they indicate that they have missed more than two doses of their medication in the past week (response to question 4), or over 2 days of total non-medication during the past 3 months (response on question 6).
Health Status Average ScoreBaseline, 3-month, 6-month, 9-monthHealth status will be assessed with a question on the health status assessment scale, on which participants rank their current health status on a scale of 0 - 100 where 0=death or worst possible health and 100=perfect or best possible health (without HIV infection).
Satisfaction With ClinicBaseline, 3-, 6-, and 9-monthsSatisfaction with clinic was measured with a selection of questions from the Overall Satisfaction with Provider and Clinic scale published by Dang et al., 2016. To assess satisfaction with the clinics, we asked a selection of questions from this scale based on their appropriateness for our study. The included questions and the associated range of possible scores are as follows. Question 7: 1 - 7 points possible Question 8: 1 - 7 points possible Question 9: 1 - 5 points possible Total scores are then calculated by adding participant responses on each of the three questions. The total possible score range for the questions asked from this scale was 3 - 19, with higher scores indicating more satisfaction with the clinic.
Change in Viral Load Over TimeBaseline, 3-month, 6-month, 9-monthChange in viral load count measured at 3-month intervals following baseline
HIV-related Knowledge AssessmentBaseline, 3-month, 6-month, 9-month14 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
SEMCD Scale ScoreBaseline, 3-month, 6-month, 9-monthThe 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).

Other

MeasureTime frameDescription
Brief Acculturation Rating Scale for Mexican Americans-IIBaseline visit onlyThe Brief Acculturation Rating Scale for Mexican Americans- II (ARMSA-II) is a 12-item scale that measures acculturation with 6 items from the AOS (Anglo Oriented Scale) of the ARSMA-II and 6 items from the MOS (Mexican Oriented Scale) (Bauman 2005). Responses are collected with Likert-type questions on which the scores range from 1 (not at all) to 5 (almost always/extremely often) on each item. The ARMSA-II has been used in Mexican Americans as well as other Latino subgroups, including Dominicans. Scores are calculated by summing the scores on each of the six item subscales and then dividing by 12 to get a mean acculturation score. Therefore, the possible range of scores is 1-5 with higher scores indicating greater acculturation. Note: The scale was only administered to participants who were not born in the country where data collection took place.
Health Literacy Score: Short Assessment of Health Literacy Spanish & English (SAHL S&E)Baseline 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.
Health Literacy Score: Newest Vital Sign (NVS)Baseline 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.

Countries

Dominican Republic, United States

Participant flow

Participants by arm

ArmCount
Treatment
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. Info Viz for Health: During the intervention, health care providers provide HIV-related health education using a mobile app that contains a bilingual database of relevant infographics.
83
Control
The control groups will receive standard health education.
81
Total164

Baseline characteristics

CharacteristicTreatmentControlTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
2 Participants2 Participants4 Participants
Age, Categorical
Between 18 and 65 years
81 Participants79 Participants160 Participants
Age, Continuous42.98 Years
STANDARD_DEVIATION 12.55
40.53 Years
STANDARD_DEVIATION 11.1
41.77 Years
STANDARD_DEVIATION 11.88
Ethnicity (NIH/OMB)
Hispanic or Latino
83 Participants81 Participants164 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
0 Participants0 Participants0 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Health Literacy47 Participants47 Participants94 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
21 Participants25 Participants46 Participants
Race (NIH/OMB)
More than one race
26 Participants26 Participants52 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
14 Participants15 Participants29 Participants
Race (NIH/OMB)
White
22 Participants15 Participants37 Participants
Region of Enrollment
Dominican Republic
41 participants41 participants82 participants
Region of Enrollment
United States
42 participants40 participants82 participants
Sex/Gender, Customized
Female
60 Participants60 Participants120 Participants
Sex/Gender, Customized
Male
23 Participants20 Participants43 Participants
Sex/Gender, Customized
Other
0 Participants1 Participants1 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
1 / 831 / 81
other
Total, other adverse events
0 / 830 / 81
serious
Total, serious adverse events
0 / 830 / 81

Outcome results

Primary

Change in CD4 Count Over Time

Change in Cluster of Differentiation 4 (CD4) count measured at 3-month intervals following baseline visit

Time frame: Baseline, 3-month, 6-month, 9-month

Population: There was some attrition over time.

ArmMeasureGroupValue (MEAN)Dispersion
TreatmentChange in CD4 Count Over TimeBaseline446.71 Cells/mm3Standard Deviation 291.298
TreatmentChange in CD4 Count Over Time3-Month498.04 Cells/mm3Standard Deviation 313.08
TreatmentChange in CD4 Count Over Time6-Month517.77 Cells/mm3Standard Deviation 301.422
TreatmentChange in CD4 Count Over Time9-Month505.05 Cells/mm3Standard Deviation 295.086
ControlChange in CD4 Count Over Time9-Month461.71 Cells/mm3Standard Deviation 281.784
ControlChange in CD4 Count Over TimeBaseline453.99 Cells/mm3Standard Deviation 319.543
ControlChange in CD4 Count Over Time6-Month449.14 Cells/mm3Standard Deviation 263.617
ControlChange in CD4 Count Over Time3-Month537.90 Cells/mm3Standard Deviation 855.711
p-value: 0.455ANOVA
Secondary

Change in Viral Load Over Time

Change in viral load count measured at 3-month intervals following baseline

Time frame: Baseline, 3-month, 6-month, 9-month

Population: There was some attrition over time.

ArmMeasureGroupValue (MEAN)Dispersion
TreatmentChange in Viral Load Over TimeBaseline78824.11 copies/mLStandard Deviation 236642.836
TreatmentChange in Viral Load Over Time3 Month12522.70 copies/mLStandard Deviation 50299.069
TreatmentChange in Viral Load Over Time6 Month4369.15 copies/mLStandard Deviation 17184.787
TreatmentChange in Viral Load Over Time9 Month6057.83 copies/mLStandard Deviation 39523.642
ControlChange in Viral Load Over Time9 Month19439.14 copies/mLStandard Deviation 96963.36
ControlChange in Viral Load Over TimeBaseline63904.54 copies/mLStandard Deviation 234399.365
ControlChange in Viral Load Over Time6 Month26125.96 copies/mLStandard Deviation 117233.253
ControlChange in Viral Load Over Time3 Month30596.87 copies/mLStandard Deviation 110589.762
p-value: 0.415ANOVA
Secondary

Health Status Average Score

Health status will be assessed with a question on the health status assessment scale, on which participants rank their current health status on a scale of 0 - 100 where 0=death or worst possible health and 100=perfect or best possible health (without HIV infection).

Time frame: Baseline, 3-month, 6-month, 9-month

Population: There was some attrition over time.

ArmMeasureGroupValue (MEAN)Dispersion
TreatmentHealth Status Average ScoreBaseline84.34 score on a scaleStandard Deviation 17.95
TreatmentHealth Status Average Score3 Month89.52 score on a scaleStandard Deviation 13.292
TreatmentHealth Status Average Score6 Month92.47 score on a scaleStandard Deviation 11.129
TreatmentHealth Status Average Score9 Month91.52 score on a scaleStandard Deviation 14.664
ControlHealth Status Average Score9 Month90.67 score on a scaleStandard Deviation 14.06
ControlHealth Status Average ScoreBaseline85.33 score on a scaleStandard Deviation 14.374
ControlHealth Status Average Score6 Month92.38 score on a scaleStandard Deviation 11.225
ControlHealth Status Average Score3 Month87.09 score on a scaleStandard Deviation 17.853
p-value: 0.723ANOVA
Secondary

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-month, 6-month, 9-month

Population: There was some attrition over time.

ArmMeasureGroupValue (MEAN)Dispersion
TreatmentHIV-related Knowledge AssessmentBaseline10.0843 HIV-related Knowledge Assessment ScoresStandard Deviation 1.97672
TreatmentHIV-related Knowledge Assessment6 Month12.1867 HIV-related Knowledge Assessment ScoresStandard Deviation 1.39684
TreatmentHIV-related Knowledge Assessment3 Month11.7975 HIV-related Knowledge Assessment ScoresStandard Deviation 1.59831
TreatmentHIV-related Knowledge Assessment9 Month12.2692 HIV-related Knowledge Assessment ScoresStandard Deviation 1.72997
ControlHIV-related Knowledge Assessment9 Month12.0435 HIV-related Knowledge Assessment ScoresStandard Deviation 1.55
ControlHIV-related Knowledge AssessmentBaseline10.8210 HIV-related Knowledge Assessment ScoresStandard Deviation 2.05595
ControlHIV-related Knowledge Assessment3 Month11.4091 HIV-related Knowledge Assessment ScoresStandard Deviation 1.80592
ControlHIV-related Knowledge Assessment6 Month11.7230 HIV-related Knowledge Assessment ScoresStandard Deviation 1.62629
p-value: 0.443ANOVA
Secondary

Satisfaction With Clinic

Satisfaction with clinic was measured with a selection of questions from the Overall Satisfaction with Provider and Clinic scale published by Dang et al., 2016. To assess satisfaction with the clinics, we asked a selection of questions from this scale based on their appropriateness for our study. The included questions and the associated range of possible scores are as follows. Question 7: 1 - 7 points possible Question 8: 1 - 7 points possible Question 9: 1 - 5 points possible Total scores are then calculated by adding participant responses on each of the three questions. The total possible score range for the questions asked from this scale was 3 - 19, with higher scores indicating more satisfaction with the clinic.

Time frame: Baseline, 3-, 6-, and 9-months

Population: There was some attrition over time.

ArmMeasureGroupValue (MEAN)Dispersion
TreatmentSatisfaction With ClinicBaseline18.1 score on a scaleStandard Deviation 1.4
TreatmentSatisfaction With Clinic3-months18.7 score on a scaleStandard Deviation 0.6
TreatmentSatisfaction With Clinic6-months18.7 score on a scaleStandard Deviation 0.7
TreatmentSatisfaction With Clinic9-months18.6 score on a scaleStandard Deviation 1
ControlSatisfaction With Clinic9-months18.5 score on a scaleStandard Deviation 1
ControlSatisfaction With ClinicBaseline18.2 score on a scaleStandard Deviation 1.1
ControlSatisfaction With Clinic6-months18.6 score on a scaleStandard Deviation 1
ControlSatisfaction With Clinic3-months18.5 score on a scaleStandard Deviation 1
Secondary

Satisfaction With Provider Scale Score

Satisfaction with provider was measured with the Overall Satisfaction with Provider and Clinic scale published by Dang et al., 2016. We asked a selection of questions from this scale based on their appropriateness for our study. The questions asked and the range of possible scores are as follows. Question 1: 1 - 7 Question 2: 1 - 10 Question 3: 1 - 7 Question 4: 1 - 5 Total scores are then calculated by adding participant responses on each of the four questions. The total possible score range for the questions asked from this scale was 4 - 29, with higher scores indicating more satisfaction with HIV provider.

Time frame: Baseline, 3-month, 6-month, 9-month

Population: There was some attrition over time.

ArmMeasureGroupValue (MEAN)Dispersion
TreatmentSatisfaction With Provider Scale ScoreBaseline27.5783 Satisfaction with provider scale scoreStandard Deviation 2.36911
TreatmentSatisfaction With Provider Scale Score3 Month28.4430 Satisfaction with provider scale scoreStandard Deviation 0.82814
TreatmentSatisfaction With Provider Scale Score6 Month28.2933 Satisfaction with provider scale scoreStandard Deviation 1.45911
TreatmentSatisfaction With Provider Scale Score9 Month28.4923 Satisfaction with provider scale scoreStandard Deviation 1.37071
ControlSatisfaction With Provider Scale Score9 Month28.1884 Satisfaction with provider scale scoreStandard Deviation 1.8172
ControlSatisfaction With Provider Scale ScoreBaseline27.4877 Satisfaction with provider scale scoreStandard Deviation 2.61483
ControlSatisfaction With Provider Scale Score6 Month28.0405 Satisfaction with provider scale scoreStandard Deviation 1.80136
ControlSatisfaction With Provider Scale Score3 Month27.8961 Satisfaction with provider scale scoreStandard Deviation 2.02994
p-value: 0.457ANOVA
Secondary

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).

Time frame: Baseline, 3-month, 6-month, 9-month

Population: There was some attrition over time.

ArmMeasureGroupValue (MEAN)Dispersion
TreatmentSEMCD Scale ScoreBaseline8.6174 SEMCD Scale ScoreStandard Deviation 1.52319
TreatmentSEMCD Scale Score6 Month9.1678 SEMCD Scale ScoreStandard Deviation 1.05592
TreatmentSEMCD Scale Score3 Month9.0011 SEMCD Scale ScoreStandard Deviation 1.30174
TreatmentSEMCD Scale Score9 Month9.0141 SEMCD Scale ScoreStandard Deviation 1.18215
ControlSEMCD Scale Score9 Month8.6860 SEMCD Scale ScoreStandard Deviation 1.55831
ControlSEMCD Scale ScoreBaseline8.4372 SEMCD Scale ScoreStandard Deviation 1.53408
ControlSEMCD Scale Score3 Month8.6147 SEMCD Scale ScoreStandard Deviation 1.63579
ControlSEMCD Scale Score6 Month8.8276 SEMCD Scale ScoreStandard Deviation 1.25087
p-value: 0.099ANOVA
Secondary

Simplified Medication Adherence Questionnaire (SMAQ)

We measured adherence to prescribed antiretroviral therapy with the validated simplified medication adherence questionnaire (SMAQ) (Knobel 2002). This is a 6- item questionnaire that measures medication adherence. There is no minimum or maximum score on this scale. Participants are considered either adherent (better outcome) or non-adherent (worse outcome) based on their responses to these 6 questions. They are considered non-adherent if they answer yes to questions 1, 2, 3, OR 5, regardless of their answers on the other questions. Participants are also considered non-adherent when they indicate that they have missed more than two doses of their medication in the past week (response to question 4), or over 2 days of total non-medication during the past 3 months (response on question 6).

Time frame: Baseline, 3-month, 6-month, 9-month

Population: There was some attrition over time.

ArmMeasureGroupCategoryValue (COUNT_OF_PARTICIPANTS)
TreatmentSimplified Medication Adherence Questionnaire (SMAQ)BaselineAdherent35 Participants
TreatmentSimplified Medication Adherence Questionnaire (SMAQ)6 MonthAdherent48 Participants
TreatmentSimplified Medication Adherence Questionnaire (SMAQ)3 MonthAdherent35 Participants
TreatmentSimplified Medication Adherence Questionnaire (SMAQ)6 MonthNon Adherent27 Participants
TreatmentSimplified Medication Adherence Questionnaire (SMAQ)9 MonthAdherent29 Participants
TreatmentSimplified Medication Adherence Questionnaire (SMAQ)BaselineNon Adherent48 Participants
TreatmentSimplified Medication Adherence Questionnaire (SMAQ)9 MonthNon Adherent36 Participants
TreatmentSimplified Medication Adherence Questionnaire (SMAQ)3 MonthNon Adherent44 Participants
ControlSimplified Medication Adherence Questionnaire (SMAQ)9 MonthNon Adherent37 Participants
ControlSimplified Medication Adherence Questionnaire (SMAQ)BaselineAdherent30 Participants
ControlSimplified Medication Adherence Questionnaire (SMAQ)BaselineNon Adherent51 Participants
ControlSimplified Medication Adherence Questionnaire (SMAQ)3 MonthAdherent35 Participants
ControlSimplified Medication Adherence Questionnaire (SMAQ)3 MonthNon Adherent42 Participants
ControlSimplified Medication Adherence Questionnaire (SMAQ)6 MonthAdherent37 Participants
ControlSimplified Medication Adherence Questionnaire (SMAQ)9 MonthAdherent32 Participants
ControlSimplified Medication Adherence Questionnaire (SMAQ)6 MonthNon Adherent37 Participants
p-value: 0.338ANOVA
Other Pre-specified

Brief Acculturation Rating Scale for Mexican Americans-II

The Brief Acculturation Rating Scale for Mexican Americans- II (ARMSA-II) is a 12-item scale that measures acculturation with 6 items from the AOS (Anglo Oriented Scale) of the ARSMA-II and 6 items from the MOS (Mexican Oriented Scale) (Bauman 2005). Responses are collected with Likert-type questions on which the scores range from 1 (not at all) to 5 (almost always/extremely often) on each item. The ARMSA-II has been used in Mexican Americans as well as other Latino subgroups, including Dominicans. Scores are calculated by summing the scores on each of the six item subscales and then dividing by 12 to get a mean acculturation score. Therefore, the possible range of scores is 1-5 with higher scores indicating greater acculturation. Note: The scale was only administered to participants who were not born in the country where data collection took place.

Time frame: Baseline visit only

ArmMeasureValue (MEAN)Dispersion
TreatmentBrief Acculturation Rating Scale for Mexican Americans-II2.64 score on a scaleStandard Deviation 1.48
ControlBrief Acculturation Rating Scale for Mexican Americans-II2.70 score on a scaleStandard Deviation 1.52
p-value: 0.864t-test, 2 sided
Other Pre-specified

Health Literacy Score: Newest Vital Sign (NVS)

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

ArmMeasureValue (MEAN)Dispersion
TreatmentHealth Literacy Score: Newest Vital Sign (NVS)1.37 Health Literacy Score: Newest Vital SignStandard Deviation 1.998
ControlHealth Literacy Score: Newest Vital Sign (NVS)1.41 Health Literacy Score: Newest Vital SignStandard Deviation 2.017
p-value: 0.998t-test, 2 sided
Other Pre-specified

Health Literacy Score: Short Assessment of Health Literacy Spanish & English (SAHL S&E)

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

ArmMeasureValue (MEAN)Dispersion
TreatmentHealth Literacy Score: Short Assessment of Health Literacy Spanish & English (SAHL S&E)12.41 Health Literacy ScoreStandard Deviation 6.28
ControlHealth Literacy Score: Short Assessment of Health Literacy Spanish & English (SAHL S&E)12.81 Health Literacy ScoreStandard Deviation 6.062
p-value: 0.578t-test, 2 sided

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