Trial Outcomes & Findings for Information Visualizations to Facilitate HIV-related Patient-provider Communication in New York City (Info Viz: HIV-NYC) (NCT NCT04102540)
NCT ID: NCT04102540
Last Updated: 2021-09-17
Results Overview
Mean Cluster of Differentiation 4 (CD4) count at each time point.
COMPLETED
NA
32 participants
Baseline, 3-, and 6-months
2021-09-17
Participant Flow
Participant milestones
| Measure |
Infographic 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.
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|---|---|
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Overall Study
STARTED
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32
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Overall Study
COMPLETED
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24
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Overall Study
NOT COMPLETED
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8
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Reasons for withdrawal
| Measure |
Infographic 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.
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|---|---|
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Overall Study
Withdrawn by PI
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2
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Overall Study
Lost to Follow-up
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6
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Baseline Characteristics
Information Visualizations to Facilitate HIV-related Patient-provider Communication in New York City (Info Viz: HIV-NYC)
Baseline characteristics by cohort
| Measure |
Intervention Group
n=30 Participants
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.
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|---|---|
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Age, Continuous
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52.4 years
STANDARD_DEVIATION 14.19 • n=5 Participants
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Sex/Gender, Customized
Male
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18 Participants
n=5 Participants
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Sex/Gender, Customized
Female
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11 Participants
n=5 Participants
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Sex/Gender, Customized
Other
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1 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Hispanic or Latino
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30 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
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0 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=5 Participants
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Asian
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Black or African American
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4 Participants
n=5 Participants
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Race (NIH/OMB)
White
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4 Participants
n=5 Participants
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Race (NIH/OMB)
More than one race
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12 Participants
n=5 Participants
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Race (NIH/OMB)
Unknown or Not Reported
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10 Participants
n=5 Participants
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Region of Enrollment
United States
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30 Participants
n=5 Participants
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Country of birth
United States
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9 Participants
n=5 Participants
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Country of birth
Dominican Republic
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15 Participants
n=5 Participants
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Country of birth
Other
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6 Participants
n=5 Participants
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Married or in a serious relationship
Married or in a serious relationship
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7 Participants
n=5 Participants
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Married or in a serious relationship
NOT married or in a serious relationship
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23 Participants
n=5 Participants
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Highest level of education completed
0-5 years of school
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4 Participants
n=5 Participants
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Highest level of education completed
6-8 years of school
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6 Participants
n=5 Participants
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Highest level of education completed
9-11 years of school
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6 Participants
n=5 Participants
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Highest level of education completed
Finished HS/ has GED
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10 Participants
n=5 Participants
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Highest level of education completed
University or other education past HS
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4 Participants
n=5 Participants
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New Patient
New patient
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4 Participants
n=5 Participants
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New Patient
Established patient
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26 Participants
n=5 Participants
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Years living with HIV
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16.28 Years
STANDARD_DEVIATION 9.7 • n=5 Participants
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Years attending the clinic
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10.04 Years
STANDARD_DEVIATION 9.41 • n=5 Participants
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Preferred language of participation
English-speaking
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12 Participants
n=5 Participants
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Preferred language of participation
Spanish-speaking
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18 Participants
n=5 Participants
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PRIMARY outcome
Timeframe: Baseline, 3-, and 6-monthsPopulation: 2 participants were withdrawn by the PI and were not included in analyses.
Mean Cluster of Differentiation 4 (CD4) count at each time point.
Outcome measures
| Measure |
Infographic Intervention Group
n=30 Participants
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.
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|---|---|
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Mean CD4 Count
CD4 Count at Baseline
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321.5 Cells/mm^3
Standard Deviation 1038
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Mean CD4 Count
CD4 Count after second exposure to intervention
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418 Cells/mm^3
Standard Deviation 944
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Mean CD4 Count
CD4 Count after third exposure to intervention
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390.5 Cells/mm^3
Standard Deviation 834
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PRIMARY outcome
Timeframe: Baseline, 3-, and 6-monthsPopulation: 2 participants were withdrawn from the study by the PI, therefore, 30 subjects were included in the analysis.
Mean viral load at each time point
Outcome measures
| Measure |
Infographic Intervention Group
n=30 Participants
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.
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Mean Viral Load
Baseline/exposure 1
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97,266 copies/mL
Standard Deviation 340,644
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Mean Viral Load
Exposure 2
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93,242 copies/mL
Standard Deviation 286,207
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Mean Viral Load
Exposure 3
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21,116 copies/mL
Standard Deviation 79,176
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SECONDARY outcome
Timeframe: Baseline, 3-, and 6-monthsPopulation: 2 participants were withdrawn from the study by the PI, therefore, 30 subjects were included in the analysis.
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.
Outcome measures
| Measure |
Infographic Intervention Group
n=30 Participants
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.
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|---|---|
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Mean Score on HIV-related Knowledge Assessment
Baseline/exposure 1
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10.10 score on a scale
Standard Deviation 2.43
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Mean Score on HIV-related Knowledge Assessment
Exposure 2
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12.23 score on a scale
Standard Deviation 1.51
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Mean Score on HIV-related Knowledge Assessment
Exposure 3
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12.21 score on a scale
Standard Deviation 1.59
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SECONDARY outcome
Timeframe: Baseline, 3-, and 6-monthsPopulation: 2 participants were withdrawn from the study by the PI, therefore, 30 subjects were included in the analysis.
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.
Outcome measures
| Measure |
Infographic Intervention Group
n=30 Participants
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.
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Mean Score on Satisfaction With Care Scale
Baseline/exposure 1
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44.93 score on a scale
Standard Deviation 3.40
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Mean Score on Satisfaction With Care Scale
Exposure 2
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45.18 score on a scale
Standard Deviation 2.81
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Mean Score on Satisfaction With Care Scale
Exposure 3
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44.29 score on a scale
Standard Deviation 5.06
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SECONDARY outcome
Timeframe: Baseline, 3-, and 6-monthsPopulation: 2 participants were withdrawn from the study by the PI, therefore, 30 subjects were included in the analysis.
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).
Outcome measures
| Measure |
Infographic Intervention Group
n=30 Participants
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.
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Mean Score on the SEMCD Scale
Baseline/exposure 1
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8.01 score on a scale
Standard Deviation 1.72
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Mean Score on the SEMCD Scale
Exposure 2
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8.13 score on a scale
Standard Deviation 1.46
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Mean Score on the SEMCD Scale
Exposure 3
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8.48 score on a scale
Standard Deviation 1.89
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SECONDARY outcome
Timeframe: Baseline, 3-, and 6-monthsPopulation: 2 participants were withdrawn from the study by the PI, therefore, 30 subjects were included in the analysis.
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."
Outcome measures
| Measure |
Infographic Intervention Group
n=30 Participants
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.
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Number of Participants Who Are Adherent to Their Medications
Baseline/exposure 1 · Adherent
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10 Participants
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Number of Participants Who Are Adherent to Their Medications
Baseline/exposure 1 · Non-adherent
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20 Participants
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Number of Participants Who Are Adherent to Their Medications
Baseline/exposure 1 · Missing
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0 Participants
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Number of Participants Who Are Adherent to Their Medications
Exposure 2 · Adherent
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7 Participants
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Number of Participants Who Are Adherent to Their Medications
Exposure 2 · Non-adherent
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15 Participants
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Number of Participants Who Are Adherent to Their Medications
Exposure 2 · Missing
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8 Participants
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Number of Participants Who Are Adherent to Their Medications
Exposure 3 · Adherent
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11 Participants
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Number of Participants Who Are Adherent to Their Medications
Exposure 3 · Non-adherent
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13 Participants
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Number of Participants Who Are Adherent to Their Medications
Exposure 3 · Missing
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6 Participants
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SECONDARY outcome
Timeframe: Baseline, 3-, and 6-monthsPopulation: 2 participants were withdrawn from the study by the PI, therefore, 30 subjects were included in the analysis.
Participants rated their general health as "excellent," "very good," "good," "more or less," or "bad."
Outcome measures
| Measure |
Infographic Intervention Group
n=30 Participants
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.
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Number of Participants Who Reported Each of the 5 General Health Categories
Baseline/exposure 1 · Bad
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1 Participants
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Number of Participants Who Reported Each of the 5 General Health Categories
Baseline/exposure 1 · More or less
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15 Participants
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Number of Participants Who Reported Each of the 5 General Health Categories
Baseline/exposure 1 · Good
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6 Participants
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|
Number of Participants Who Reported Each of the 5 General Health Categories
Baseline/exposure 1 · Very Good
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4 Participants
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|
Number of Participants Who Reported Each of the 5 General Health Categories
Baseline/exposure 1 · Excellent
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4 Participants
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Number of Participants Who Reported Each of the 5 General Health Categories
Baseline/exposure 1 · Missing
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0 Participants
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Number of Participants Who Reported Each of the 5 General Health Categories
Exposure 2 · Bad
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0 Participants
|
|
Number of Participants Who Reported Each of the 5 General Health Categories
Exposure 2 · More or less
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10 Participants
|
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Number of Participants Who Reported Each of the 5 General Health Categories
Exposure 2 · Good
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7 Participants
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Number of Participants Who Reported Each of the 5 General Health Categories
Exposure 2 · Very Good
|
1 Participants
|
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Number of Participants Who Reported Each of the 5 General Health Categories
Exposure 2 · Excellent
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4 Participants
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Number of Participants Who Reported Each of the 5 General Health Categories
Exposure 2 · Missing
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8 Participants
|
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Number of Participants Who Reported Each of the 5 General Health Categories
Exposure 3 · Bad
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0 Participants
|
|
Number of Participants Who Reported Each of the 5 General Health Categories
Exposure 3 · More or less
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11 Participants
|
|
Number of Participants Who Reported Each of the 5 General Health Categories
Exposure 3 · Good
|
5 Participants
|
|
Number of Participants Who Reported Each of the 5 General Health Categories
Exposure 3 · Very Good
|
4 Participants
|
|
Number of Participants Who Reported Each of the 5 General Health Categories
Exposure 3 · Excellent
|
4 Participants
|
|
Number of Participants Who Reported Each of the 5 General Health Categories
Exposure 3 · Missing
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6 Participants
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SECONDARY outcome
Timeframe: Baseline, 3-, and 6-monthsPopulation: 2 participants were withdrawn from the study by the PI, therefore, 30 subjects were included in the analysis.
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.
Outcome measures
| Measure |
Infographic Intervention Group
n=30 Participants
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.
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|---|---|
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Mean Score on Current Health Status
Baseline/exposure 1
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68 score on a scale
Standard Deviation 20.66
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Mean Score on Current Health Status
Exposure 2
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75.45 score on a scale
Standard Deviation 17.03
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Mean Score on Current Health Status
Exposure 3
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82.29 score on a scale
Standard Deviation 16.8
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SECONDARY outcome
Timeframe: Baseline visit onlyPopulation: 2 participants were withdrawn from the study by the PI and, therefore, their data are not included in the analysis.
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.
Outcome measures
| Measure |
Infographic Intervention Group
n=30 Participants
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.
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|---|---|
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Number of Participants With Likely Low vs. Adequate Health Literacy According to SAHL-S&E Measurement
Missing
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1 Participants
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Number of Participants With Likely Low vs. Adequate Health Literacy According to SAHL-S&E Measurement
Likely adequate health literacy
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16 Participants
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Number of Participants With Likely Low vs. Adequate Health Literacy According to SAHL-S&E Measurement
Likely low health literacy
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13 Participants
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SECONDARY outcome
Timeframe: Baseline visit onlyPopulation: 2 participants were withdrawn from the study by the PI and, therefore, their data are not included in analyses.
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.
Outcome measures
| Measure |
Infographic Intervention Group
n=30 Participants
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.
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|---|---|
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Number of Participants With Likely Limited, Possibly Limited, or Adequate Health Literacy According to NVS Measurement
Likely adequate health literacy
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5 Participants
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Number of Participants With Likely Limited, Possibly Limited, or Adequate Health Literacy According to NVS Measurement
Possibility of limited health literacy
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11 Participants
|
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Number of Participants With Likely Limited, Possibly Limited, or Adequate Health Literacy According to NVS Measurement
Likely limited health literacy
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14 Participants
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SECONDARY outcome
Timeframe: Baseline visit onlyPopulation: 2 participants were withdrawn from the study by the PI and, therefore, were not included in analyses
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.
Outcome measures
| Measure |
Infographic Intervention Group
n=30 Participants
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.
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Number of Participants in Each Acculturation Category Presented in the Brief ARSMA
Very oriented to original culture
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13 Participants
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Number of Participants in Each Acculturation Category Presented in the Brief ARSMA
Oriented to original culture to approximately balanced bicultural
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6 Participants
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Number of Participants in Each Acculturation Category Presented in the Brief ARSMA
Slightly Anglo oriented bicultural
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4 Participants
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Number of Participants in Each Acculturation Category Presented in the Brief ARSMA
Strongly Anglo oriented
|
4 Participants
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Number of Participants in Each Acculturation Category Presented in the Brief ARSMA
Very assimilated
|
3 Participants
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SECONDARY outcome
Timeframe: 6 months after baselinePopulation: 2 participants were withdrawn from the study by the PI and, therefore, they are not included in analyses.
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.
Outcome measures
| Measure |
Infographic Intervention Group
n=30 Participants
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.
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|---|---|
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Percent of Participants Who Complete an In-depth Qualitative Interview
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24 Participants
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Adverse Events
Intervention Group
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Samantha Stonbraker
University of Colorado College of Nursing
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place