Trial Outcomes & Findings for Information Visualizations to Enhance HIV-related Communication (NCT NCT04564209)
NCT ID: NCT04564209
Last Updated: 2025-03-06
Results Overview
Change in Cluster of Differentiation 4 (CD4) count measured at 3-month intervals following baseline visit
COMPLETED
NA
164 participants
Baseline, 3-month, 6-month, 9-month
2025-03-06
Participant Flow
Participant milestones
| Measure |
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.
|
Control
The control groups will receive standard health education.
|
|---|---|---|
|
Overall Study
STARTED
|
83
|
81
|
|
Overall Study
COMPLETED
|
65
|
69
|
|
Overall Study
NOT COMPLETED
|
18
|
12
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Information Visualizations to Enhance HIV-related Communication
Baseline characteristics by cohort
| Measure |
Treatment
n=83 Participants
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.
|
Control
n=81 Participants
The control groups will receive standard health education.
|
Total
n=164 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
81 Participants
n=5 Participants
|
79 Participants
n=7 Participants
|
160 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Age, Continuous
|
42.98 Years
STANDARD_DEVIATION 12.55 • n=5 Participants
|
40.53 Years
STANDARD_DEVIATION 11.10 • n=7 Participants
|
41.77 Years
STANDARD_DEVIATION 11.88 • n=5 Participants
|
|
Sex/Gender, Customized
Male
|
23 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Female
|
60 Participants
n=5 Participants
|
60 Participants
n=7 Participants
|
120 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Other
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
83 Participants
n=5 Participants
|
81 Participants
n=7 Participants
|
164 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
21 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
22 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
26 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
14 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
42 participants
n=5 Participants
|
40 participants
n=7 Participants
|
82 participants
n=5 Participants
|
|
Region of Enrollment
Dominican Republic
|
41 participants
n=5 Participants
|
41 participants
n=7 Participants
|
82 participants
n=5 Participants
|
|
Health Literacy
|
47 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
94 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, 3-month, 6-month, 9-monthPopulation: There was some attrition over time.
Change in Cluster of Differentiation 4 (CD4) count measured at 3-month intervals following baseline visit
Outcome measures
| Measure |
Treatment
n=83 Participants
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.
|
Control
n=81 Participants
The control groups will receive standard health education.
|
|---|---|---|
|
Change in CD4 Count Over Time
6-Month
|
517.77 Cells/mm3
Standard Deviation 301.422
|
449.14 Cells/mm3
Standard Deviation 263.617
|
|
Change in CD4 Count Over Time
Baseline
|
446.71 Cells/mm3
Standard Deviation 291.298
|
453.99 Cells/mm3
Standard Deviation 319.543
|
|
Change in CD4 Count Over Time
3-Month
|
498.04 Cells/mm3
Standard Deviation 313.080
|
537.90 Cells/mm3
Standard Deviation 855.711
|
|
Change in CD4 Count Over Time
9-Month
|
505.05 Cells/mm3
Standard Deviation 295.086
|
461.71 Cells/mm3
Standard Deviation 281.784
|
SECONDARY outcome
Timeframe: Baseline, 3-month, 6-month, 9-monthPopulation: There was some attrition over time.
Change in viral load count measured at 3-month intervals following baseline
Outcome measures
| Measure |
Treatment
n=83 Participants
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.
|
Control
n=81 Participants
The control groups will receive standard health education.
|
|---|---|---|
|
Change in Viral Load Over Time
Baseline
|
78824.11 copies/mL
Standard Deviation 236642.836
|
63904.54 copies/mL
Standard Deviation 234399.365
|
|
Change in Viral Load Over Time
3 Month
|
12522.70 copies/mL
Standard Deviation 50299.069
|
30596.87 copies/mL
Standard Deviation 110589.762
|
|
Change in Viral Load Over Time
6 Month
|
4369.15 copies/mL
Standard Deviation 17184.787
|
26125.96 copies/mL
Standard Deviation 117233.253
|
|
Change in Viral Load Over Time
9 Month
|
6057.83 copies/mL
Standard Deviation 39523.642
|
19439.14 copies/mL
Standard Deviation 96963.360
|
SECONDARY outcome
Timeframe: Baseline, 3-month, 6-month, 9-monthPopulation: There was some attrition over time.
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 |
Treatment
n=83 Participants
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.
|
Control
n=81 Participants
The control groups will receive standard health education.
|
|---|---|---|
|
HIV-related Knowledge Assessment
Baseline
|
10.0843 HIV-related Knowledge Assessment Scores
Standard Deviation 1.97672
|
10.8210 HIV-related Knowledge Assessment Scores
Standard Deviation 2.05595
|
|
HIV-related Knowledge Assessment
3 Month
|
11.7975 HIV-related Knowledge Assessment Scores
Standard Deviation 1.59831
|
11.4091 HIV-related Knowledge Assessment Scores
Standard Deviation 1.80592
|
|
HIV-related Knowledge Assessment
6 Month
|
12.1867 HIV-related Knowledge Assessment Scores
Standard Deviation 1.39684
|
11.7230 HIV-related Knowledge Assessment Scores
Standard Deviation 1.62629
|
|
HIV-related Knowledge Assessment
9 Month
|
12.2692 HIV-related Knowledge Assessment Scores
Standard Deviation 1.72997
|
12.0435 HIV-related Knowledge Assessment Scores
Standard Deviation 1.55000
|
SECONDARY outcome
Timeframe: Baseline, 3-month, 6-month, 9-monthPopulation: There was some attrition over time.
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.
Outcome measures
| Measure |
Treatment
n=83 Participants
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.
|
Control
n=81 Participants
The control groups will receive standard health education.
|
|---|---|---|
|
Satisfaction With Provider Scale Score
Baseline
|
27.5783 Satisfaction with provider scale score
Standard Deviation 2.36911
|
27.4877 Satisfaction with provider scale score
Standard Deviation 2.61483
|
|
Satisfaction With Provider Scale Score
3 Month
|
28.4430 Satisfaction with provider scale score
Standard Deviation 0.82814
|
27.8961 Satisfaction with provider scale score
Standard Deviation 2.02994
|
|
Satisfaction With Provider Scale Score
6 Month
|
28.2933 Satisfaction with provider scale score
Standard Deviation 1.45911
|
28.0405 Satisfaction with provider scale score
Standard Deviation 1.80136
|
|
Satisfaction With Provider Scale Score
9 Month
|
28.4923 Satisfaction with provider scale score
Standard Deviation 1.37071
|
28.1884 Satisfaction with provider scale score
Standard Deviation 1.81720
|
SECONDARY outcome
Timeframe: Baseline, 3-month, 6-month, 9-monthPopulation: There was some attrition over time.
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 |
Treatment
n=83 Participants
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.
|
Control
n=81 Participants
The control groups will receive standard health education.
|
|---|---|---|
|
SEMCD Scale Score
Baseline
|
8.6174 SEMCD Scale Score
Standard Deviation 1.52319
|
8.4372 SEMCD Scale Score
Standard Deviation 1.53408
|
|
SEMCD Scale Score
3 Month
|
9.0011 SEMCD Scale Score
Standard Deviation 1.30174
|
8.6147 SEMCD Scale Score
Standard Deviation 1.63579
|
|
SEMCD Scale Score
6 Month
|
9.1678 SEMCD Scale Score
Standard Deviation 1.05592
|
8.8276 SEMCD Scale Score
Standard Deviation 1.25087
|
|
SEMCD Scale Score
9 Month
|
9.0141 SEMCD Scale Score
Standard Deviation 1.18215
|
8.6860 SEMCD Scale Score
Standard Deviation 1.55831
|
SECONDARY outcome
Timeframe: Baseline, 3-month, 6-month, 9-monthPopulation: There was some attrition over time.
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).
Outcome measures
| Measure |
Treatment
n=83 Participants
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.
|
Control
n=81 Participants
The control groups will receive standard health education.
|
|---|---|---|
|
Simplified Medication Adherence Questionnaire (SMAQ)
Baseline · Adherent
|
35 Participants
|
30 Participants
|
|
Simplified Medication Adherence Questionnaire (SMAQ)
Baseline · Non Adherent
|
48 Participants
|
51 Participants
|
|
Simplified Medication Adherence Questionnaire (SMAQ)
3 Month · Adherent
|
35 Participants
|
35 Participants
|
|
Simplified Medication Adherence Questionnaire (SMAQ)
3 Month · Non Adherent
|
44 Participants
|
42 Participants
|
|
Simplified Medication Adherence Questionnaire (SMAQ)
6 Month · Adherent
|
48 Participants
|
37 Participants
|
|
Simplified Medication Adherence Questionnaire (SMAQ)
6 Month · Non Adherent
|
27 Participants
|
37 Participants
|
|
Simplified Medication Adherence Questionnaire (SMAQ)
9 Month · Adherent
|
29 Participants
|
32 Participants
|
|
Simplified Medication Adherence Questionnaire (SMAQ)
9 Month · Non Adherent
|
36 Participants
|
37 Participants
|
SECONDARY outcome
Timeframe: Baseline, 3-month, 6-month, 9-monthPopulation: There was some attrition over time.
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).
Outcome measures
| Measure |
Treatment
n=83 Participants
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.
|
Control
n=81 Participants
The control groups will receive standard health education.
|
|---|---|---|
|
Health Status Average Score
9 Month
|
91.52 score on a scale
Standard Deviation 14.664
|
90.67 score on a scale
Standard Deviation 14.060
|
|
Health Status Average Score
Baseline
|
84.34 score on a scale
Standard Deviation 17.950
|
85.33 score on a scale
Standard Deviation 14.374
|
|
Health Status Average Score
3 Month
|
89.52 score on a scale
Standard Deviation 13.292
|
87.09 score on a scale
Standard Deviation 17.853
|
|
Health Status Average Score
6 Month
|
92.47 score on a scale
Standard Deviation 11.129
|
92.38 score on a scale
Standard Deviation 11.225
|
SECONDARY outcome
Timeframe: Baseline, 3-, 6-, and 9-monthsPopulation: There was some attrition over time.
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.
Outcome measures
| Measure |
Treatment
n=83 Participants
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.
|
Control
n=81 Participants
The control groups will receive standard health education.
|
|---|---|---|
|
Satisfaction With Clinic
Baseline
|
18.1 score on a scale
Standard Deviation 1.4
|
18.2 score on a scale
Standard Deviation 1.1
|
|
Satisfaction With Clinic
3-months
|
18.7 score on a scale
Standard Deviation 0.6
|
18.5 score on a scale
Standard Deviation 1.0
|
|
Satisfaction With Clinic
6-months
|
18.7 score on a scale
Standard Deviation 0.7
|
18.6 score on a scale
Standard Deviation 1.0
|
|
Satisfaction With Clinic
9-months
|
18.6 score on a scale
Standard Deviation 1.0
|
18.5 score on a scale
Standard Deviation 1.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 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.
Outcome measures
| Measure |
Treatment
n=83 Participants
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.
|
Control
n=81 Participants
The control groups will receive standard health education.
|
|---|---|---|
|
Health Literacy Score: Short Assessment of Health Literacy Spanish & English (SAHL S&E)
|
12.41 Health Literacy Score
Standard Deviation 6.280
|
12.81 Health Literacy Score
Standard Deviation 6.062
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 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.
Outcome measures
| Measure |
Treatment
n=83 Participants
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.
|
Control
n=81 Participants
The control groups will receive standard health education.
|
|---|---|---|
|
Health Literacy Score: Newest Vital Sign (NVS)
|
1.37 Health Literacy Score: Newest Vital Sign
Standard Deviation 1.998
|
1.41 Health Literacy Score: Newest Vital Sign
Standard Deviation 2.017
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline 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.
Outcome measures
| Measure |
Treatment
n=42 Participants
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.
|
Control
n=40 Participants
The control groups will receive standard health education.
|
|---|---|---|
|
Brief Acculturation Rating Scale for Mexican Americans-II
|
2.64 score on a scale
Standard Deviation 1.48
|
2.70 score on a scale
Standard Deviation 1.52
|
Adverse Events
Treatment
Control
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Samantha Stonbraker, Study PI
University of Colorado College of Nursing
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place