Trial Outcomes & Findings for Information Visualizations to Facilitate HIV-related Patient-provider Communication (Info Viz: HIV) (NCT NCT03616106)
NCT ID: NCT03616106
Last Updated: 2020-09-03
Results Overview
Association between mean CD4 count at baseline and 3-month visits.
COMPLETED
NA
59 participants
Baseline and 3-month visit
2020-09-03
Participant Flow
Recruitment of interventionists Initially, 2 interventionists were enrolled, then one left the study and a replacement interventionist was recruited. Patient participant recruitment Initially, 50 participants were enrolled. Data was deleted for 6 participants due to a technical error. They were replaced with 6 additional patients.
Participant milestones
| Measure |
Intervention Group
Participants in the intervention group will receive health education using infographics (Infographic Intervention) during their regularly scheduled clinic visits.
Infographic intervention: All study participants will receive health education using infographics during their regularly scheduled clinic appointments.
|
Interventionists
Interventionists were the three health care providers who administered the infographic intervention to patient participants.
|
|---|---|---|
|
Overall Study
STARTED
|
56
|
3
|
|
Overall Study
COMPLETED
|
42
|
2
|
|
Overall Study
NOT COMPLETED
|
14
|
1
|
Reasons for withdrawal
| Measure |
Intervention Group
Participants in the intervention group will receive health education using infographics (Infographic Intervention) during their regularly scheduled clinic visits.
Infographic intervention: All study participants will receive health education using infographics during their regularly scheduled clinic appointments.
|
Interventionists
Interventionists were the three health care providers who administered the infographic intervention to patient participants.
|
|---|---|---|
|
Overall Study
Removed by PI
|
6
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
|
Overall Study
Lost to Follow-up
|
7
|
0
|
Baseline Characteristics
Information Visualizations to Facilitate HIV-related Patient-provider Communication (Info Viz: HIV)
Baseline characteristics by cohort
| Measure |
Providers
n=3 Participants
This group is comprised of the health care providers who administered the infographic intervention to patient participants.
|
Intervention (Patient Participants)
n=50 Participants
The intervention group is comprised of the patient participants who received the intervention during clinic visits.
|
Total
n=53 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
|
3 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Age, Continuous
|
26.7 years
n=5 Participants
|
40.4 years
n=7 Participants
|
39.5 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
49 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
|
4 Participants
n=7 Participants
|
4 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
|
0 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
Dominican Republic
|
3 participants
n=5 Participants
|
50 participants
n=7 Participants
|
53 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and 3-month visitPopulation: Only the intervention group was analyzed for this outcome measure.
Association between mean CD4 count at baseline and 3-month visits.
Outcome measures
| Measure |
Intervention (Patient Participants)
n=50 Participants
The intervention group is comprised of the patient participants who received the intervention during clinic visits.
|
|---|---|
|
Association Between Mean CD4 Count at Baseline and 3-month Visit
Baseline
|
385.86 cells/mm^3
Standard Deviation 271.53
|
|
Association Between Mean CD4 Count at Baseline and 3-month Visit
3 months
|
373.69 cells/mm^3
Standard Deviation 243.26
|
PRIMARY outcome
Timeframe: Baseline and 6-month visitPopulation: Only the intervention group was analyzed for this outcome measure.
Association between mean CD4 count at baseline and 6-month visits.
Outcome measures
| Measure |
Intervention (Patient Participants)
n=50 Participants
The intervention group is comprised of the patient participants who received the intervention during clinic visits.
|
|---|---|
|
Association Between Mean CD4 Count at Baseline and 6-month Visit
Baseline
|
385.86 cells/mm^3
Standard Deviation 271.53
|
|
Association Between Mean CD4 Count at Baseline and 6-month Visit
6 months
|
414.41 cells/mm^3
Standard Deviation 273.43
|
PRIMARY outcome
Timeframe: Baseline and 9-month visitPopulation: Only the intervention group was analyzed for this outcome measure.
Association between mean CD4 count at baseline and 9-month visits.
Outcome measures
| Measure |
Intervention (Patient Participants)
n=50 Participants
The intervention group is comprised of the patient participants who received the intervention during clinic visits.
|
|---|---|
|
Association Between Mean CD4 Count at Baseline and 9-month Visit
Baseline
|
385.86 cells/mm^3
Standard Deviation 271.53
|
|
Association Between Mean CD4 Count at Baseline and 9-month Visit
9 months
|
445.42 cells/mm^3
Standard Deviation 279.25
|
PRIMARY outcome
Timeframe: Baseline and 3-monthsPopulation: Interventionists were not analyzed for this outcome measure.
Test of association of mean viral load at baseline and at 3-month visits.
Outcome measures
| Measure |
Intervention (Patient Participants)
n=50 Participants
The intervention group is comprised of the patient participants who received the intervention during clinic visits.
|
|---|---|
|
Association Between Mean Viral Load at Baseline and at 3-month Visits
Baseline
|
84,326 copies/mL
Standard Deviation 238,545
|
|
Association Between Mean Viral Load at Baseline and at 3-month Visits
3-months
|
81,470 copies/mL
Standard Deviation 240,834
|
PRIMARY outcome
Timeframe: Baseline and 6-monthsPopulation: Interventionists were not analyzed for this outcome measure.
Test of association of mean viral load at baseline and at 6-month visits.
Outcome measures
| Measure |
Intervention (Patient Participants)
n=50 Participants
The intervention group is comprised of the patient participants who received the intervention during clinic visits.
|
|---|---|
|
Association Between Mean Viral Load at Baseline and at 6-month Visits
Baseline
|
84,326 copies/mL
Standard Deviation 238,545
|
|
Association Between Mean Viral Load at Baseline and at 6-month Visits
6-months
|
91,590 copies/mL
Standard Deviation 284090
|
PRIMARY outcome
Timeframe: Baseline and 9-monthsPopulation: Interventionists were not analyzed for this outcome measure.
Test of association of mean viral load at baseline and at 9-month visits.
Outcome measures
| Measure |
Intervention (Patient Participants)
n=50 Participants
The intervention group is comprised of the patient participants who received the intervention during clinic visits.
|
|---|---|
|
Association Between Mean Viral Load at Baseline and at 9-month Visits
Baseline
|
84,326 copies/mL
Standard Deviation 238,545
|
|
Association Between Mean Viral Load at Baseline and at 9-month Visits
9-months
|
45,581 copies/mL
Standard Deviation 151,116
|
SECONDARY outcome
Timeframe: Baseline, 3-, 6-, and 9-month visitsPopulation: Interventionists did not receive the intervention and, therefore, are not included in the analysis of outcome measures.
3 questions from the overall evaluation of the HIV clinic scale were administered for a total of 19 possible points on this scale. Range of possible scores is 1-19, with 19 being highest possible satisfaction with care. The breakdown of scoring by question is as follows: * Question 1 is a 1-7 scale with 1 being completely unsatisfied and 7 being completely satisfied * Question 2 is a 1-5 scale where 1 is definitely not and 5 is definitely yes * Question 3 is a 1-7 scale where 1 is terrible and 7 is marvelous
Outcome measures
| Measure |
Intervention (Patient Participants)
n=50 Participants
The intervention group is comprised of the patient participants who received the intervention during clinic visits.
|
|---|---|
|
Satisfaction With Care Scale Score
Baseline
|
18.04 score on a scale
Standard Deviation 1.37
|
|
Satisfaction With Care Scale Score
3-months
|
18.52 score on a scale
Standard Deviation 0.58
|
|
Satisfaction With Care Scale Score
6-months
|
18.49 score on a scale
Standard Deviation 0.55
|
|
Satisfaction With Care Scale Score
9-months
|
18.31 score on a scale
Standard Deviation 0.47
|
SECONDARY outcome
Timeframe: Baseline, 3-, 6-, and 9-month visitsPopulation: Interventionists were not exposed to the intervention and are, therefore, not included in the analyses of outcome measures.
Adherence will be measured with the validated simplified medication adherence questionnaire (SMAQ)-6 scale, a 6-item questionnaire. A person is considered "non-adherent" if there is a "yes" answer for any of items 1,2,3, and 5. Additionally, if they answer that they have missed more than two doses in the past week (item 4) or if they have gone more than two days without taking their medication in the past 3 months (item 6). Therefore, participants are classified as either adherent or not adherent based on their answers to these questions. Any participant that didn't complete study visits or did not answer that question was considered "missing."
Outcome measures
| Measure |
Intervention (Patient Participants)
n=50 Participants
The intervention group is comprised of the patient participants who received the intervention during clinic visits.
|
|---|---|
|
Medication Adherence
Baseline · Adherent
|
9 Participants
|
|
Medication Adherence
Baseline · Non-adherent
|
41 Participants
|
|
Medication Adherence
Baseline · Missing
|
0 Participants
|
|
Medication Adherence
3-months · Adherent
|
24 Participants
|
|
Medication Adherence
3-months · Non-adherent
|
22 Participants
|
|
Medication Adherence
3-months · Missing
|
4 Participants
|
|
Medication Adherence
6-months · Adherent
|
28 Participants
|
|
Medication Adherence
6-months · Non-adherent
|
15 Participants
|
|
Medication Adherence
6-months · Missing
|
7 Participants
|
|
Medication Adherence
9-months · Adherent
|
39 Participants
|
|
Medication Adherence
9-months · Non-adherent
|
3 Participants
|
|
Medication Adherence
9-months · Missing
|
8 Participants
|
SECONDARY outcome
Timeframe: Up to 9 months from baselinePopulation: Interventionists did not receive the intervention and are, therefore, not included in the analyses of outcome measures.
Health-related quality of life will be measured with the Patient-Reported Outcomes Measurement Information System® (PROMIS)-29 measure, which measures 7 domains of health-related quality of life with 4 questions in each section pertaining to how that participant's health influences their life. In general, each question has five response options ranging in values from 1-5. To find the total raw score for this form with all the questions answered, the values from the responses of each question are summed. Raw scores are then translated into a T-score for each participant, which rescales the raw score into a standardized T-score with a mean of 50 and standard deviation (SD) of 10. Consequently, a person with a T-score of 40 would be one SD below the mean.
Outcome measures
| Measure |
Intervention (Patient Participants)
n=50 Participants
The intervention group is comprised of the patient participants who received the intervention during clinic visits.
|
|---|---|
|
Participant's Self-reported Health-related Quality of Life Score - Physical Functioning
Baseline
|
55.37 t-score
Standard Deviation 4.20
|
|
Participant's Self-reported Health-related Quality of Life Score - Physical Functioning
3-months
|
57 t-score
Standard Deviation 0.00
|
|
Participant's Self-reported Health-related Quality of Life Score - Physical Functioning
6-months
|
56.2 t-score
Standard Deviation 3.11
|
|
Participant's Self-reported Health-related Quality of Life Score - Physical Functioning
9-months
|
56.64 t-score
Standard Deviation 2.33
|
SECONDARY outcome
Timeframe: Baseline, 3-months, 6-months, and 9-monthsPopulation: Interventionists did not receive the intervention and, therefore, are not included in analyses of outcome measures.
General health status was assessed with one item where participants are asked to rank their health in the past four weeks as excellent, good, fair, poor, or very poor. Results are presented as the number of participants that self-rated their health in each of those categories.
Outcome measures
| Measure |
Intervention (Patient Participants)
n=50 Participants
The intervention group is comprised of the patient participants who received the intervention during clinic visits.
|
|---|---|
|
Participants' Self-reported Health Status Over Past 4 Weeks.
Baseline · Excellent
|
7 Participants
|
|
Participants' Self-reported Health Status Over Past 4 Weeks.
Baseline · Good
|
8 Participants
|
|
Participants' Self-reported Health Status Over Past 4 Weeks.
Baseline · Fair
|
16 Participants
|
|
Participants' Self-reported Health Status Over Past 4 Weeks.
Baseline · Poor
|
16 Participants
|
|
Participants' Self-reported Health Status Over Past 4 Weeks.
Baseline · Very poor
|
1 Participants
|
|
Participants' Self-reported Health Status Over Past 4 Weeks.
Baseline · Missing
|
2 Participants
|
|
Participants' Self-reported Health Status Over Past 4 Weeks.
3-months · Excellent
|
21 Participants
|
|
Participants' Self-reported Health Status Over Past 4 Weeks.
3-months · Good
|
9 Participants
|
|
Participants' Self-reported Health Status Over Past 4 Weeks.
3-months · Fair
|
13 Participants
|
|
Participants' Self-reported Health Status Over Past 4 Weeks.
3-months · Poor
|
5 Participants
|
|
Participants' Self-reported Health Status Over Past 4 Weeks.
3-months · Very poor
|
0 Participants
|
|
Participants' Self-reported Health Status Over Past 4 Weeks.
3-months · Missing
|
2 Participants
|
|
Participants' Self-reported Health Status Over Past 4 Weeks.
6-months · Excellent
|
13 Participants
|
|
Participants' Self-reported Health Status Over Past 4 Weeks.
6-months · Good
|
19 Participants
|
|
Participants' Self-reported Health Status Over Past 4 Weeks.
6-months · Fair
|
9 Participants
|
|
Participants' Self-reported Health Status Over Past 4 Weeks.
6-months · Poor
|
2 Participants
|
|
Participants' Self-reported Health Status Over Past 4 Weeks.
6-months · Very poor
|
0 Participants
|
|
Participants' Self-reported Health Status Over Past 4 Weeks.
6-months · Missing
|
7 Participants
|
|
Participants' Self-reported Health Status Over Past 4 Weeks.
9-months · Excellent
|
8 Participants
|
|
Participants' Self-reported Health Status Over Past 4 Weeks.
9-months · Good
|
21 Participants
|
|
Participants' Self-reported Health Status Over Past 4 Weeks.
9-months · Fair
|
13 Participants
|
|
Participants' Self-reported Health Status Over Past 4 Weeks.
9-months · Poor
|
0 Participants
|
|
Participants' Self-reported Health Status Over Past 4 Weeks.
9-months · Very poor
|
0 Participants
|
|
Participants' Self-reported Health Status Over Past 4 Weeks.
9-months · Missing
|
8 Participants
|
SECONDARY outcome
Timeframe: Baseline visit onlyPopulation: Interventionists were not exposed to the intervention. Therefore, they are not included in the analyses of outcome measures.
Health literacy will be assessed using the short assessment of health literacy- Spanish. Scores range from 0 - 18 and above a 15 indicates that participants are likely to have adequate health literacy. Participants are then categorized as health literate or not health literate. The final number of participants who are health literate are reported here.
Outcome measures
| Measure |
Intervention (Patient Participants)
n=50 Participants
The intervention group is comprised of the patient participants who received the intervention during clinic visits.
|
|---|---|
|
Health Literacy
|
18 Participants
|
SECONDARY outcome
Timeframe: 9 months from baselinePopulation: The percentage of participants who agreed to participate in an in-depth 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.
Outcome measures
| Measure |
Intervention (Patient Participants)
n=50 Participants
The intervention group is comprised of the patient participants who received the intervention during clinic visits.
|
|---|---|
|
Percent of Participants Who Complete an In-depth Qualitative Interview
|
52 percent of participants
|
SECONDARY outcome
Timeframe: Baseline, 3-, 6-, and 9-monthsPopulation: Interventionists did not receive the intervention and are, therefore, not included in the analyses of outcome measures.
Health-related quality of life will be measured with the Patient-Reported Outcomes Measurement Information System® (PROMIS)-29 measure, which measures 7 domains of health-related quality of life with 4 questions in each section pertaining to how that participant's health influences their life. In general, each question has five response options ranging in values from 1-5. To find the total raw score for this form with all the questions answered, the values from the responses of each question are summed. Raw scores are then translated into a T-score for each participant, which rescales the raw score into a standardized T-score with a mean of 50 and standard deviation (SD) of 10. Consequently, a person with a T-score of 40 would be one SD below the mean.
Outcome measures
| Measure |
Intervention (Patient Participants)
n=50 Participants
The intervention group is comprised of the patient participants who received the intervention during clinic visits.
|
|---|---|
|
Participant's Self-reported Health-related Quality of Life Score - Anxiety
Baseline
|
54.09 t-score
Standard Deviation 11.54
|
|
Participant's Self-reported Health-related Quality of Life Score - Anxiety
3-months
|
44.33 t-score
Standard Deviation 8.18
|
|
Participant's Self-reported Health-related Quality of Life Score - Anxiety
6-months
|
46.23 t-score
Standard Deviation 9.45
|
|
Participant's Self-reported Health-related Quality of Life Score - Anxiety
9-months
|
42.5 t-score
Standard Deviation 6.92
|
SECONDARY outcome
Timeframe: Baseline, 3-, 6-, and 9-monthsPopulation: Interventionists did not receive the intervention and are, therefore, not included in the analyses of outcome measures.
Health-related quality of life will be measured with the Patient-Reported Outcomes Measurement Information System® (PROMIS)-29 measure, which measures 7 domains of health-related quality of life with 4 questions in each section pertaining to how that participant's health influences their life. In general, each question has five response options ranging in values from 1-5. To find the total raw score for this form with all the questions answered, the values from the responses of each question are summed. Raw scores are then translated into a T-score for each participant, which rescales the raw score into a standardized T-score with a mean of 50 and standard deviation (SD) of 10. Consequently, a person with a T-score of 40 would be one SD below the mean.
Outcome measures
| Measure |
Intervention (Patient Participants)
n=50 Participants
The intervention group is comprised of the patient participants who received the intervention during clinic visits.
|
|---|---|
|
Participant's Self-reported Health-related Quality of Life Score - Depression
Baseline
|
53.40 t-score
Standard Deviation 11.49
|
|
Participant's Self-reported Health-related Quality of Life Score - Depression
3-months
|
45.51 t-score
Standard Deviation 8.64
|
|
Participant's Self-reported Health-related Quality of Life Score - Depression
6-months
|
45.27 t-score
Standard Deviation 8.02
|
|
Participant's Self-reported Health-related Quality of Life Score - Depression
9-months
|
43.19 t-score
Standard Deviation 6.9
|
SECONDARY outcome
Timeframe: Baseline, 3-, 6-, and 9-monthsPopulation: Interventionists did not receive the intervention and are, therefore, not included in the analyses of outcome measures.
Health-related quality of life will be measured with the Patient-Reported Outcomes Measurement Information System® (PROMIS)-29 measure, which measures 7 domains of health-related quality of life with 4 questions in each section pertaining to how that participant's health influences their life. In general, each question has five response options ranging in values from 1-5. To find the total raw score for this form with all the questions answered, the values from the responses of each question are summed. Raw scores are then translated into a T-score for each participant, which rescales the raw score into a standardized T-score with a mean of 50 and standard deviation (SD) of 10. Consequently, a person with a T-score of 40 would be one SD below the mean.
Outcome measures
| Measure |
Intervention (Patient Participants)
n=50 Participants
The intervention group is comprised of the patient participants who received the intervention during clinic visits.
|
|---|---|
|
Participant's Self-reported Health-related Quality of Life Score - Fatigue
Baseline
|
42.46 t-score
Standard Deviation 10.01
|
|
Participant's Self-reported Health-related Quality of Life Score - Fatigue
3-months
|
38.06 t-score
Standard Deviation 8.01
|
|
Participant's Self-reported Health-related Quality of Life Score - Fatigue
6-months
|
36.38 t-score
Standard Deviation 5.65
|
|
Participant's Self-reported Health-related Quality of Life Score - Fatigue
9-months
|
34.76 t-score
Standard Deviation 3.88
|
SECONDARY outcome
Timeframe: Baseline, 3-, 6-, and 9-monthsPopulation: Interventionists did not receive the intervention and are, therefore, not included in the analyses of outcome measures.
Health-related quality of life will be measured with the Patient-Reported Outcomes Measurement Information System® (PROMIS)-29 measure, which measures 7 domains of health-related quality of life with 4 questions in each section pertaining to how that participant's health influences their life. In general, each question has five response options ranging in values from 1-5. To find the total raw score for this form with all the questions answered, the values from the responses of each question are summed. Raw scores are then translated into a T-score for each participant, which rescales the raw score into a standardized T-score with a mean of 50 and standard deviation (SD) of 10. Consequently, a person with a T-score of 40 would be one SD below the mean.
Outcome measures
| Measure |
Intervention (Patient Participants)
n=50 Participants
The intervention group is comprised of the patient participants who received the intervention during clinic visits.
|
|---|---|
|
Participant's Self-reported Health-related Quality of Life Score - Sleep Disturbance
Baseline
|
45.37 t-score
Standard Deviation 12.04
|
|
Participant's Self-reported Health-related Quality of Life Score - Sleep Disturbance
3-months
|
40.60 t-score
Standard Deviation 8.58
|
|
Participant's Self-reported Health-related Quality of Life Score - Sleep Disturbance
6-months
|
41.70 t-score
Standard Deviation 5.74
|
|
Participant's Self-reported Health-related Quality of Life Score - Sleep Disturbance
9-months
|
43.54 t-score
Standard Deviation 6.31
|
SECONDARY outcome
Timeframe: Baseline, 3-, 6-, and 9-monthsPopulation: Interventionists did not receive the intervention and are, therefore, not included in the analyses of outcome measures.
Health-related quality of life will be measured with the Patient-Reported Outcomes Measurement Information System® (PROMIS)-29 measure, which measures 7 domains of health-related quality of life with 4 questions in each section pertaining to how that participant's health influences their life. In general, each question has five response options ranging in values from 1-5. To find the total raw score for this form with all the questions answered, the values from the responses of each question are summed. Raw scores are then translated into a T-score for each participant, which rescales the raw score into a standardized T-score with a mean of 50 and standard deviation (SD) of 10. Consequently, a person with a T-score of 40 would be one SD below the mean.
Outcome measures
| Measure |
Intervention (Patient Participants)
n=50 Participants
The intervention group is comprised of the patient participants who received the intervention during clinic visits.
|
|---|---|
|
Participant's Self-reported Health-related Quality of Life Score - Social Activity Participation
Baseline
|
60.91 t-score
Standard Deviation 6.98
|
|
Participant's Self-reported Health-related Quality of Life Score - Social Activity Participation
3-months
|
63.65 t-score
Standard Deviation 2.84
|
|
Participant's Self-reported Health-related Quality of Life Score - Social Activity Participation
6-months
|
63.83 t-score
Standard Deviation 2.46
|
|
Participant's Self-reported Health-related Quality of Life Score - Social Activity Participation
9-months
|
63.72 t-score
Standard Deviation 3.09
|
SECONDARY outcome
Timeframe: Baseline, 3-, 6-, and 9-monthsPopulation: Interventionists did not receive the intervention and are, therefore, not included in the analyses of outcome measures.
Health-related quality of life will be measured with the Patient-Reported Outcomes Measurement Information System® (PROMIS)-29 measure, which measures 7 domains of health-related quality of life with 4 questions in each section pertaining to how that participant's health influences their life. In general, each question has five response options ranging in values from 1-5. To find the total raw score for this form with all the questions answered, the values from the responses of each question are summed. Raw scores are then translated into a T-score for each participant, which rescales the raw score into a standardized T-score with a mean of 50 and standard deviation (SD) of 10. Consequently, a person with a T-score of 40 would be one SD below the mean.
Outcome measures
| Measure |
Intervention (Patient Participants)
n=50 Participants
The intervention group is comprised of the patient participants who received the intervention during clinic visits.
|
|---|---|
|
Participant's Self-reported Health-related Quality of Life Score - Pain Interference
Baseline
|
46.11 t-score
Standard Deviation 7.08
|
|
Participant's Self-reported Health-related Quality of Life Score - Pain Interference
3-months
|
42.52 t-score
Standard Deviation 3.19
|
|
Participant's Self-reported Health-related Quality of Life Score - Pain Interference
6-months
|
42.88 t-score
Standard Deviation 3.64
|
|
Participant's Self-reported Health-related Quality of Life Score - Pain Interference
9-months
|
43.59 t-score
Standard Deviation 5.10
|
SECONDARY outcome
Timeframe: Baseline, 3-, 6-, and 9-month visitsPopulation: Interventionists did not receive the intervention and, therefore, are not included in the analysis of outcome measures.
4 questions from the overall evaluation of the health care provider scale were administered for a total score of 29. The range of scores is 3-29, with 29 being the highest possible satisfaction with their health care provider. The scoring breakdown by each included question is as follows: * Question 1 is 1- 7 points where 1 is completely dissatisfied and 7 is completely satisfied * Question 2 is providing an integer value of trust in care provider on a scale from 1 to 10 * Question 3 is 1- 7 points where 1 is terrible and 7 is marvelous * Question 4 is 0- 5 points where 0 is definitely not and 5 is definitely yes
Outcome measures
| Measure |
Intervention (Patient Participants)
n=50 Participants
The intervention group is comprised of the patient participants who received the intervention during clinic visits.
|
|---|---|
|
Satisfaction With Provider Scale Score at Each Time Point
Baseline
|
26.96 score on a scale
Standard Deviation 3.25
|
|
Satisfaction With Provider Scale Score at Each Time Point
3-months
|
27.69 score on a scale
Standard Deviation 1.39
|
|
Satisfaction With Provider Scale Score at Each Time Point
6-months
|
27.49 score on a scale
Standard Deviation 1.56
|
|
Satisfaction With Provider Scale Score at Each Time Point
9-months
|
27.64 score on a scale
Standard Deviation 1.01
|
SECONDARY outcome
Timeframe: Baseline and 3-month visitsPopulation: Interventionists were not included in the assessment of outcome measures.
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 |
Intervention (Patient Participants)
n=50 Participants
The intervention group is comprised of the patient participants who received the intervention during clinic visits.
|
|---|---|
|
Association Between Mean HIV-related Knowledge Scores at Baseline and 3-month Visits.
Baseline
|
10.26 score on a scale
Standard Deviation 2.4
|
|
Association Between Mean HIV-related Knowledge Scores at Baseline and 3-month Visits.
3-months
|
12.43 score on a scale
Standard Deviation 1.53
|
SECONDARY outcome
Timeframe: Baseline and 6-month visitsPopulation: Interventionists were not included in the assessment of outcome measures.
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 |
Intervention (Patient Participants)
n=50 Participants
The intervention group is comprised of the patient participants who received the intervention during clinic visits.
|
|---|---|
|
Association Between Mean HIV-related Knowledge Scores at Baseline and 6-month Visits.
Baseline
|
10.26 score on a scale
Standard Deviation 2.4
|
|
Association Between Mean HIV-related Knowledge Scores at Baseline and 6-month Visits.
6-months
|
13.14 score on a scale
Standard Deviation 1.39
|
SECONDARY outcome
Timeframe: Baseline and 9-month visitsPopulation: Interventionists were not included in the assessment of outcome measures.
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 |
Intervention (Patient Participants)
n=50 Participants
The intervention group is comprised of the patient participants who received the intervention during clinic visits.
|
|---|---|
|
Association Between Mean HIV-related Knowledge Scores at Baseline and 9-month Visits.
Baseline
|
10.26 score on a scale
Standard Deviation 2.4
|
|
Association Between Mean HIV-related Knowledge Scores at Baseline and 9-month Visits.
9-months
|
13.44 score on a scale
Standard Deviation 0.68
|
SECONDARY outcome
Timeframe: Baseline and 3-monthsPopulation: Interventionists did not receive the intervention and were, therefore, not included in outcome measure analysis.
The Engagement with Health Care Providers scale is a 13 item scale through which clients rate how they feel about their interactions with their providers. Answers are recorded on a 4-point scale (1=always true and 4=never true). The range of scores is between 13 and 52. Lower scores (with 13 being the lowest score) indicate more provider engagement.
Outcome measures
| Measure |
Intervention (Patient Participants)
n=50 Participants
The intervention group is comprised of the patient participants who received the intervention during clinic visits.
|
|---|---|
|
Association of Engagement With Clinician Scale Score at Baseline and 3-months.
Baseline
|
13 score on a scale
Interval 13.0 to 16.0
|
|
Association of Engagement With Clinician Scale Score at Baseline and 3-months.
3-months
|
13 score on a scale
Interval 13.0 to 13.0
|
SECONDARY outcome
Timeframe: Baseline and 6-monthsPopulation: Interventionists did not receive the intervention and were, therefore, not included in outcome measure analysis.
The Engagement with Health Care Providers scale is a 13 item scale through which clients rate how they feel about their interactions with their providers. Answers are recorded on a 4-point scale (1=always true and 4=never true). The range of scores is between 13 and 52. Lower scores (with 13 being the lowest score) indicate more provider engagement.
Outcome measures
| Measure |
Intervention (Patient Participants)
n=50 Participants
The intervention group is comprised of the patient participants who received the intervention during clinic visits.
|
|---|---|
|
Association of Engagement With Clinician Scale Score at Baseline and 6-months.
Baseline
|
13 score on a scale
Interval 13.0 to 16.0
|
|
Association of Engagement With Clinician Scale Score at Baseline and 6-months.
6-months
|
13 score on a scale
Interval 13.0 to 13.0
|
SECONDARY outcome
Timeframe: Baseline and 9-monthsPopulation: Interventionists did not receive the intervention and were, therefore, not included in outcome measure analysis.
The Engagement with Health Care Providers scale is a 13 item scale through which clients rate how they feel about their interactions with their providers. Answers are recorded on a 4-point scale (1=always true and 4=never true). The range of scores is between 13 and 52. Lower scores (with 13 being the lowest score) indicate more provider engagement.
Outcome measures
| Measure |
Intervention (Patient Participants)
n=50 Participants
The intervention group is comprised of the patient participants who received the intervention during clinic visits.
|
|---|---|
|
Association of Engagement With Clinician Scale Score at Baseline and 9-months.
Baseline
|
13 score on a scale
Interval 13.0 to 16.0
|
|
Association of Engagement With Clinician Scale Score at Baseline and 9-months.
9-months
|
13 score on a scale
Interval 13.0 to 13.0
|
SECONDARY outcome
Timeframe: Baseline, 3-month visitsPopulation: Interventionists did not receive the intervention and were, therefore, not included in the analyses of outcome measures.
Self-efficacy to manage chronic disease scale (SEMCD) will be used. This is a 6-item measure where 1 is not at all confident and 10 is completely confident. The total range of scores is 1-10. Final scores are calculated as the mean of the 6 questions, where higher scores indicate higher self-efficacy.
Outcome measures
| Measure |
Intervention (Patient Participants)
n=50 Participants
The intervention group is comprised of the patient participants who received the intervention during clinic visits.
|
|---|---|
|
Association Between SEMCD Scale Score at Baseline and 3-month Visits
Baseline
|
7.16 score on a scale
Standard Deviation 2.7
|
|
Association Between SEMCD Scale Score at Baseline and 3-month Visits
3-months
|
9.07 score on a scale
Standard Deviation 1.07
|
SECONDARY outcome
Timeframe: Baseline, 6-month visitsPopulation: Interventionists did not receive the intervention and were, therefore, not included in the analyses of outcome measures.
Self-efficacy to manage chronic disease scale (SEMCD) will be used. This is a 6-item measure where 1 is not at all confident and 10 is completely confident. The total range of scores is 1-10. Final scores are calculated as the mean of the 6 questions, where higher scores indicate higher self-efficacy.
Outcome measures
| Measure |
Intervention (Patient Participants)
n=50 Participants
The intervention group is comprised of the patient participants who received the intervention during clinic visits.
|
|---|---|
|
Association Between SEMCD Scale Score at Baseline and 6-month Visits
Baseline
|
7.16 score on a scale
Standard Deviation 2.7
|
|
Association Between SEMCD Scale Score at Baseline and 6-month Visits
6-months
|
9.27 score on a scale
Standard Deviation 0.58
|
SECONDARY outcome
Timeframe: Baseline, 9-month visitsPopulation: Interventionists did not receive the intervention and were, therefore, not included in the analyses of outcome measures.
Self-efficacy to manage chronic disease scale (SEMCD) will be used. This is a 6-item measure where 1 is not at all confident and 10 is completely confident. The total range of scores is 1-10. Final scores are calculated as the mean of the 6 questions, where higher scores indicate higher self-efficacy.
Outcome measures
| Measure |
Intervention (Patient Participants)
n=50 Participants
The intervention group is comprised of the patient participants who received the intervention during clinic visits.
|
|---|---|
|
Association Between SEMCD Scale Score at Baseline and 9-month Visits
Baseline
|
7.16 score on a scale
Standard Deviation 2.7
|
|
Association Between SEMCD Scale Score at Baseline and 9-month Visits
9-months
|
9.7 score on a scale
Standard Deviation 0.46
|
SECONDARY outcome
Timeframe: Baseline, 3-monthsPopulation: Interventionists were not included in the intervention and were, therefore, not included in the analyses of outcome measures.
Participants are asked to rank their current health status on a scale between 0 and 100 where 0 is "death" or the worst possible health (as bad or worse than being dead) and 100 is "perfect health", or the best possible health (without HIV infection).
Outcome measures
| Measure |
Intervention (Patient Participants)
n=50 Participants
The intervention group is comprised of the patient participants who received the intervention during clinic visits.
|
|---|---|
|
Association Between Current Self-reported Health Status as Reported at Baseline and 3-months
Baseline
|
90 units on a scale
Interval 70.0 to 100.0
|
|
Association Between Current Self-reported Health Status as Reported at Baseline and 3-months
3-months
|
90 units on a scale
Interval 89.5 to 100.0
|
SECONDARY outcome
Timeframe: Baseline, 6-monthsPopulation: Interventionists were not included in the intervention and were, therefore, not included in the analyses of outcome measures.
Participants are asked to rank their current health status on a scale between 0 and 100 where 0 is "death" or the worst possible health (as bad or worse than being dead) and 100 is "perfect health", or the best possible health (without HIV infection).
Outcome measures
| Measure |
Intervention (Patient Participants)
n=50 Participants
The intervention group is comprised of the patient participants who received the intervention during clinic visits.
|
|---|---|
|
Association Between Current Self-reported Health Status as Reported at Baseline and 6-months
Baseline
|
90 units on a scale
Interval 70.0 to 100.0
|
|
Association Between Current Self-reported Health Status as Reported at Baseline and 6-months
6-months
|
95 units on a scale
Interval 90.0 to 100.0
|
SECONDARY outcome
Timeframe: Baseline, 9-monthsPopulation: Interventionists were not included in the intervention and were, therefore, not included in the analyses of outcome measures.
Participants are asked to rank their current health status on a scale between 0 and 100 where 0 is "death" or the worst possible health (as bad or worse than being dead) and 100 is "perfect health", or the best possible health (without HIV infection).
Outcome measures
| Measure |
Intervention (Patient Participants)
n=50 Participants
The intervention group is comprised of the patient participants who received the intervention during clinic visits.
|
|---|---|
|
Association Between Current Self-reported Health Status as Reported at Baseline and 9-months
Baseline
|
90 units on a scale
Interval 70.0 to 100.0
|
|
Association Between Current Self-reported Health Status as Reported at Baseline and 9-months
9-months
|
98 units on a scale
Interval 90.0 to 100.0
|
Adverse Events
Intervention Group
Interventionists
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Samantha Stonbraker, Assistant Professor
University of Colorado College of Nursing
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place