Skip to content

Information Visualizations to Facilitate HIV-related Patient-provider Communication (Info Viz: HIV)

Information Visualizations to Facilitate Patient-provider Communication in HIV Care: Info Viz HIV

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03616106
Enrollment
59
Registered
2018-08-06
Start date
2018-10-09
Completion date
2019-08-09
Last updated
2020-09-03

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

Conditions

Health Communication

Keywords

Information Visualization

Brief summary

To complete the study aims, a mixed methods study that includes a single group pretest-posttest study design will be used to pilot test the infographic intervention. In-depth interviews will be completed with a selection of participants to explore participant perceptions of HIV-related communication using infographics. Data will be collected from participants through baseline (at enrollment) and follow up assessments (at 3-, 6-, and 9-month follow up visits). Follow up interviews will be conducted with the providers involved in the intervention to ascertain their perspectives on the clinical utility of infographics.

Detailed description

The Caribbean has among the highest HIV prevalence in the world. Regionally, the majority of HIV/AIDS cases are located on the island of Hispaniola, comprised of the Dominican Republic (DR) and Haiti. Due to a large international response and widespread availability of antiretroviral therapy (ART), in recent years the incidence of HIV in the DR has declined and prevalence hovers around 1% in the general population. The effective and long-term management of this condition depends on infected individuals being able to acquire ART and apply the learned information and self-management skills that lead to optimal adherence. HIV-related disparities exist in developing countries, such as the DR, where minority groups and/or those with low socioeconomic status experience higher disease burdens and worse health outcomes than those with higher socioeconomic status. These disparities may be exacerbated when individuals are unable to understand the health information, as low health literacy has been associated with worse health outcomes, less use of healthcare services, poorer knowledge of illness, and worse self-management. The effective management of HIV requires patients to acquire, comprehend, and use large amounts of complex information, including how to manage variations in health status, medications and their side effects, nutrition and exercise needs, and healthy coping. Health care providers can help patients understand pertinent health information by offering it in targeted, culturally-, language-, and literacy-appropriate ways. One such strategy is to use infographics to assist communication through visual representations of information. Participatory design of infographics supports presentation of information in a culturally appropriate and visually appealing format which can improve information understanding, health behaviors, attention span, and ability to recall information. It is critical to develop and test methods to improve the way health information is delivered to patients in these clinical contexts so patients, including those with low health literacy, can acquire and comprehend the information needed to improve self-management behavior and treatment outcomes. Preliminary studies showed many persons living with HIV (PLWH) attending Clínica de Familia La Romana do not fully comprehend and use the health information they receive through current modalities. In response, culturally relevant, evidence-based infographics to improve information delivery during clinical visits were developed with a participatory design methodology (manuscript under review). The next phase of this study is to rigorously assess if using these infographics is a feasible, acceptable, and efficacious method to enhance HIV-related clinician-patient communication and lead to improved patient outcomes. Additionally, a thorough exploration into the cultural factors of patient-provider communication in the Dominican Republic that can influence infographic use for clinician-patient communication in a clinical setting is warranted.

Interventions

All study participants will receive health education using infographics during their regularly scheduled clinic appointments.

Sponsors

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

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Intervention model description

This study will use a single group pretest-posttest design to evaluate if using infographics during clinic visits can lead to improved patient outcomes.

Eligibility

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

Inclusion criteria

* Adult (≥) 18 years of age * Spanish-speaking * Living with HIV and have a detectable viral load * Attend Clínica de Familia La Romana * Plan to receive care at the same clinic for the next year

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Association Between Mean CD4 Count at Baseline and 3-month VisitBaseline and 3-month visitAssociation between mean CD4 count at baseline and 3-month visits.
Association Between Mean CD4 Count at Baseline and 6-month VisitBaseline and 6-month visitAssociation between mean CD4 count at baseline and 6-month visits.
Association Between Mean CD4 Count at Baseline and 9-month VisitBaseline and 9-month visitAssociation between mean CD4 count at baseline and 9-month visits.
Association Between Mean Viral Load at Baseline and at 3-month VisitsBaseline and 3-monthsTest of association of mean viral load at baseline and at 3-month visits.
Association Between Mean Viral Load at Baseline and at 6-month VisitsBaseline and 6-monthsTest of association of mean viral load at baseline and at 6-month visits.
Association Between Mean Viral Load at Baseline and at 9-month VisitsBaseline and 9-monthsTest of association of mean viral load at baseline and at 9-month visits.

Secondary

MeasureTime frameDescription
Participant's Self-reported Health-related Quality of Life Score - AnxietyBaseline, 3-, 6-, and 9-monthsHealth-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.
Participant's Self-reported Health-related Quality of Life Score - DepressionBaseline, 3-, 6-, and 9-monthsHealth-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.
Participant's Self-reported Health-related Quality of Life Score - FatigueBaseline, 3-, 6-, and 9-monthsHealth-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.
Association Between SEMCD Scale Score at Baseline and 9-month VisitsBaseline, 9-month visitsSelf-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.
Participant's Self-reported Health-related Quality of Life Score - Sleep DisturbanceBaseline, 3-, 6-, and 9-monthsHealth-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.
Participant's Self-reported Health-related Quality of Life Score - Social Activity ParticipationBaseline, 3-, 6-, and 9-monthsHealth-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.
Participant's Self-reported Health-related Quality of Life Score - Pain InterferenceBaseline, 3-, 6-, and 9-monthsHealth-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.
Association Between Current Self-reported Health Status as Reported at Baseline and 3-monthsBaseline, 3-monthsParticipants 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).
Satisfaction With Provider Scale Score at Each Time PointBaseline, 3-, 6-, and 9-month visits4 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
Satisfaction With Care Scale ScoreBaseline, 3-, 6-, and 9-month visits3 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
Association Between Mean HIV-related Knowledge Scores at Baseline and 6-month Visits.Baseline and 6-month visits14 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.
Association Between Mean HIV-related Knowledge Scores at Baseline and 9-month Visits.Baseline and 9-month visits14 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.
Association of Engagement With Clinician Scale Score at Baseline and 3-months.Baseline and 3-monthsThe 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.
Association of Engagement With Clinician Scale Score at Baseline and 6-months.Baseline and 6-monthsThe 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.
Association of Engagement With Clinician Scale Score at Baseline and 9-months.Baseline and 9-monthsThe 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.
Association Between SEMCD Scale Score at Baseline and 3-month VisitsBaseline, 3-month visitsSelf-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.
Association Between SEMCD Scale Score at Baseline and 6-month VisitsBaseline, 6-month visitsSelf-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.
Association Between Current Self-reported Health Status as Reported at Baseline and 6-monthsBaseline, 6-monthsParticipants 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).
Association Between Current Self-reported Health Status as Reported at Baseline and 9-monthsBaseline, 9-monthsParticipants 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).
Association Between Mean HIV-related Knowledge Scores at Baseline and 3-month Visits.Baseline and 3-month visits14 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.
Medication AdherenceBaseline, 3-, 6-, and 9-month visitsAdherence 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.
Participant's Self-reported Health-related Quality of Life Score - Physical FunctioningUp to 9 months from baselineHealth-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.
Participants' Self-reported Health Status Over Past 4 Weeks.Baseline, 3-months, 6-months, and 9-monthsGeneral 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.
Health LiteracyBaseline visit onlyHealth 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.
Percent of Participants Who Complete an In-depth Qualitative Interview9 months from baselineParticipants will be invited to participate in an in-depth qualitative interview regarding their experiences. The number who participate will be reported as a percent of the total who are enrolled.

Countries

Dominican Republic

Participant flow

Recruitment details

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.

Participants by arm

ArmCount
Providers
This group is comprised of the health care providers who administered the infographic intervention to patient participants.
3
Intervention (Patient Participants)
The intervention group is comprised of the patient participants who received the intervention during clinic visits.
50
Total53

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyLost to Follow-up70
Overall StudyRemoved by PI60
Overall StudyWithdrawal by Subject11

Baseline characteristics

CharacteristicProvidersIntervention (Patient Participants)Total
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
0 Participants1 Participants1 Participants
Age, Categorical
Between 18 and 65 years
3 Participants49 Participants52 Participants
Age, Continuous26.7 years40.4 years39.5 years
Ethnicity (NIH/OMB)
Hispanic or Latino
3 Participants46 Participants49 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
0 Participants0 Participants0 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants4 Participants4 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
0 Participants17 Participants17 Participants
Race (NIH/OMB)
More than one race
3 Participants29 Participants32 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants1 Participants1 Participants
Race (NIH/OMB)
White
0 Participants3 Participants3 Participants
Region of Enrollment
Dominican Republic
3 participants50 participants53 participants
Sex: Female, Male
Female
3 Participants28 Participants31 Participants
Sex: Female, Male
Male
0 Participants22 Participants22 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 500 / 3
other
Total, other adverse events
0 / 500 / 3
serious
Total, serious adverse events
0 / 500 / 3

Outcome results

Primary

Association Between Mean CD4 Count at Baseline and 3-month Visit

Association between mean CD4 count at baseline and 3-month visits.

Time frame: Baseline and 3-month visit

Population: Only the intervention group was analyzed for this outcome measure.

ArmMeasureGroupValue (MEAN)Dispersion
Intervention (Patient Participants)Association Between Mean CD4 Count at Baseline and 3-month VisitBaseline385.86 cells/mm^3Standard Deviation 271.53
Intervention (Patient Participants)Association Between Mean CD4 Count at Baseline and 3-month Visit3 months373.69 cells/mm^3Standard Deviation 243.26
p-value: 0.85995% CI: [-184.574, 154.369]Regression, Linear
Primary

Association Between Mean CD4 Count at Baseline and 6-month Visit

Association between mean CD4 count at baseline and 6-month visits.

Time frame: Baseline and 6-month visit

Population: Only the intervention group was analyzed for this outcome measure.

ArmMeasureGroupValue (MEAN)Dispersion
Intervention (Patient Participants)Association Between Mean CD4 Count at Baseline and 6-month VisitBaseline385.86 cells/mm^3Standard Deviation 271.53
Intervention (Patient Participants)Association Between Mean CD4 Count at Baseline and 6-month Visit6 months414.41 cells/mm^3Standard Deviation 273.43
p-value: 0.21395% CI: [-16.694, 73.179]Regression, Linear
Primary

Association Between Mean CD4 Count at Baseline and 9-month Visit

Association between mean CD4 count at baseline and 9-month visits.

Time frame: Baseline and 9-month visit

Population: Only the intervention group was analyzed for this outcome measure.

ArmMeasureGroupValue (MEAN)Dispersion
Intervention (Patient Participants)Association Between Mean CD4 Count at Baseline and 9-month VisitBaseline385.86 cells/mm^3Standard Deviation 271.53
Intervention (Patient Participants)Association Between Mean CD4 Count at Baseline and 9-month Visit9 months445.42 cells/mm^3Standard Deviation 279.25
p-value: 0.03195% CI: [5.713, 112.274]Regression, Linear
Primary

Association Between Mean Viral Load at Baseline and at 3-month Visits

Test of association of mean viral load at baseline and at 3-month visits.

Time frame: Baseline and 3-months

Population: Interventionists were not analyzed for this outcome measure.

ArmMeasureGroupValue (MEAN)
Intervention (Patient Participants)Association Between Mean Viral Load at Baseline and at 3-month VisitsBaseline84,326 copies/mL
Intervention (Patient Participants)Association Between Mean Viral Load at Baseline and at 3-month Visits3-months81,470 copies/mL
Comparison: Viral load variables were log transformed for regression analyses.p-value: 0.05395% CI: [-1.313, 0.01]Regression, Linear
Primary

Association Between Mean Viral Load at Baseline and at 6-month Visits

Test of association of mean viral load at baseline and at 6-month visits.

Time frame: Baseline and 6-months

Population: Interventionists were not analyzed for this outcome measure.

ArmMeasureGroupValue (MEAN)Dispersion
Intervention (Patient Participants)Association Between Mean Viral Load at Baseline and at 6-month VisitsBaseline84,326 copies/mL
Intervention (Patient Participants)Association Between Mean Viral Load at Baseline and at 6-month Visits6-months91,590 copies/mLStandard Deviation 284090
p-value: 0.00895% CI: [-2.761, -0.442]Regression, Linear
Primary

Association Between Mean Viral Load at Baseline and at 9-month Visits

Test of association of mean viral load at baseline and at 9-month visits.

Time frame: Baseline and 9-months

Population: Interventionists were not analyzed for this outcome measure.

ArmMeasureGroupValue (MEAN)
Intervention (Patient Participants)Association Between Mean Viral Load at Baseline and at 9-month VisitsBaseline84,326 copies/mL
Intervention (Patient Participants)Association Between Mean Viral Load at Baseline and at 9-month Visits9-months45,581 copies/mL
p-value: 095% CI: [-3.934, -1.415]Regression, Linear
Secondary

Association Between Current Self-reported Health Status as Reported at Baseline and 3-months

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).

Time frame: Baseline, 3-months

Population: Interventionists were not included in the intervention and were, therefore, not included in the analyses of outcome measures.

ArmMeasureGroupValue (MEDIAN)
Intervention (Patient Participants)Association Between Current Self-reported Health Status as Reported at Baseline and 3-monthsBaseline90 units on a scale
Intervention (Patient Participants)Association Between Current Self-reported Health Status as Reported at Baseline and 3-months3-months90 units on a scale
p-value: 0.1167Wilcoxon signed rank
Secondary

Association Between Current Self-reported Health Status as Reported at Baseline and 6-months

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).

Time frame: Baseline, 6-months

Population: Interventionists were not included in the intervention and were, therefore, not included in the analyses of outcome measures.

ArmMeasureGroupValue (MEDIAN)
Intervention (Patient Participants)Association Between Current Self-reported Health Status as Reported at Baseline and 6-monthsBaseline90 units on a scale
Intervention (Patient Participants)Association Between Current Self-reported Health Status as Reported at Baseline and 6-months6-months95 units on a scale
p-value: 0.0036Wilcoxon signed rank
Secondary

Association Between Current Self-reported Health Status as Reported at Baseline and 9-months

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).

Time frame: Baseline, 9-months

Population: Interventionists were not included in the intervention and were, therefore, not included in the analyses of outcome measures.

ArmMeasureGroupValue (MEDIAN)
Intervention (Patient Participants)Association Between Current Self-reported Health Status as Reported at Baseline and 9-monthsBaseline90 units on a scale
Intervention (Patient Participants)Association Between Current Self-reported Health Status as Reported at Baseline and 9-months9-months98 units on a scale
p-value: 0.0004Wilcoxon signed rank
Secondary

Association Between Mean HIV-related Knowledge Scores at Baseline and 3-month Visits.

14 questions pertaining to HIV-related knowledge were developed according to the information that will be included in the intervention. Participants will receive one point for each correct answer and then the scores for each question will be summed to obtain a final score. Therefore, the minimum score will be 0 and maximum score will be 14 where the scores closer to 14 indicate patients have more HIV-related knowledge.

Time frame: Baseline and 3-month visits

Population: Interventionists were not included in the assessment of outcome measures.

ArmMeasureGroupValue (MEAN)Dispersion
Intervention (Patient Participants)Association Between Mean HIV-related Knowledge Scores at Baseline and 3-month Visits.Baseline10.26 score on a scaleStandard Deviation 2.4
Intervention (Patient Participants)Association Between Mean HIV-related Knowledge Scores at Baseline and 3-month Visits.3-months12.43 score on a scaleStandard Deviation 1.53
p-value: 095% CI: [1.448, 2.895]Regression, Linear
Secondary

Association Between Mean HIV-related Knowledge Scores at Baseline and 6-month Visits.

14 questions pertaining to HIV-related knowledge were developed according to the information that will be included in the intervention. Participants will receive one point for each correct answer and then the scores for each question will be summed to obtain a final score. Therefore, the minimum score will be 0 and maximum score will be 14 where the scores closer to 14 indicate patients have more HIV-related knowledge.

Time frame: Baseline and 6-month visits

Population: Interventionists were not included in the assessment of outcome measures.

ArmMeasureGroupValue (MEAN)Dispersion
Intervention (Patient Participants)Association Between Mean HIV-related Knowledge Scores at Baseline and 6-month Visits.Baseline10.26 score on a scaleStandard Deviation 2.4
Intervention (Patient Participants)Association Between Mean HIV-related Knowledge Scores at Baseline and 6-month Visits.6-months13.14 score on a scaleStandard Deviation 1.39
p-value: 095% CI: [2.1, 3.643]Regression, Linear
Secondary

Association Between Mean HIV-related Knowledge Scores at Baseline and 9-month Visits.

14 questions pertaining to HIV-related knowledge were developed according to the information that will be included in the intervention. Participants will receive one point for each correct answer and then the scores for each question will be summed to obtain a final score. Therefore, the minimum score will be 0 and maximum score will be 14 where the scores closer to 14 indicate patients have more HIV-related knowledge.

Time frame: Baseline and 9-month visits

Population: Interventionists were not included in the assessment of outcome measures.

ArmMeasureGroupValue (MEAN)Dispersion
Intervention (Patient Participants)Association Between Mean HIV-related Knowledge Scores at Baseline and 9-month Visits.Baseline10.26 score on a scaleStandard Deviation 2.4
Intervention (Patient Participants)Association Between Mean HIV-related Knowledge Scores at Baseline and 9-month Visits.9-months13.44 score on a scaleStandard Deviation 0.68
p-value: 095% CI: [2.487, 3.846]Regression, Linear
Secondary

Association Between SEMCD Scale Score at Baseline and 3-month Visits

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.

Time frame: Baseline, 3-month visits

Population: Interventionists did not receive the intervention and were, therefore, not included in the analyses of outcome measures.

ArmMeasureGroupValue (MEAN)Dispersion
Intervention (Patient Participants)Association Between SEMCD Scale Score at Baseline and 3-month VisitsBaseline7.16 score on a scaleStandard Deviation 2.7
Intervention (Patient Participants)Association Between SEMCD Scale Score at Baseline and 3-month Visits3-months9.07 score on a scaleStandard Deviation 1.07
p-value: 095% CI: [1.055, 2.815]Regression, Linear
Secondary

Association Between SEMCD Scale Score at Baseline and 6-month Visits

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.

Time frame: Baseline, 6-month visits

Population: Interventionists did not receive the intervention and were, therefore, not included in the analyses of outcome measures.

ArmMeasureGroupValue (MEAN)Dispersion
Intervention (Patient Participants)Association Between SEMCD Scale Score at Baseline and 6-month Visits6-months9.27 score on a scaleStandard Deviation 0.58
Intervention (Patient Participants)Association Between SEMCD Scale Score at Baseline and 6-month VisitsBaseline7.16 score on a scaleStandard Deviation 2.7
p-value: 095% CI: [1.184, 3.062]Regression, Linear
Secondary

Association Between SEMCD Scale Score at Baseline and 9-month Visits

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.

Time frame: Baseline, 9-month visits

Population: Interventionists did not receive the intervention and were, therefore, not included in the analyses of outcome measures.

ArmMeasureGroupValue (MEAN)Dispersion
Intervention (Patient Participants)Association Between SEMCD Scale Score at Baseline and 9-month VisitsBaseline7.16 score on a scaleStandard Deviation 2.7
Intervention (Patient Participants)Association Between SEMCD Scale Score at Baseline and 9-month Visits9-months9.7 score on a scaleStandard Deviation 0.46
p-value: 095% CI: [1.612, 3.492]Regression, Linear
Secondary

Association of Engagement With Clinician Scale Score at Baseline and 3-months.

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.

Time frame: Baseline and 3-months

Population: Interventionists did not receive the intervention and were, therefore, not included in outcome measure analysis.

ArmMeasureGroupValue (MEDIAN)
Intervention (Patient Participants)Association of Engagement With Clinician Scale Score at Baseline and 3-months.Baseline13 score on a scale
Intervention (Patient Participants)Association of Engagement With Clinician Scale Score at Baseline and 3-months.3-months13 score on a scale
p-value: 0.0011Wilcoxon signed rank
Secondary

Association of Engagement With Clinician Scale Score at Baseline and 6-months.

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.

Time frame: Baseline and 6-months

Population: Interventionists did not receive the intervention and were, therefore, not included in outcome measure analysis.

ArmMeasureGroupValue (MEDIAN)
Intervention (Patient Participants)Association of Engagement With Clinician Scale Score at Baseline and 6-months.Baseline13 score on a scale
Intervention (Patient Participants)Association of Engagement With Clinician Scale Score at Baseline and 6-months.6-months13 score on a scale
p-value: 0.0001Wilcoxon signed rank
Secondary

Association of Engagement With Clinician Scale Score at Baseline and 9-months.

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.

Time frame: Baseline and 9-months

Population: Interventionists did not receive the intervention and were, therefore, not included in outcome measure analysis.

ArmMeasureGroupValue (MEDIAN)
Intervention (Patient Participants)Association of Engagement With Clinician Scale Score at Baseline and 9-months.Baseline13 score on a scale
Intervention (Patient Participants)Association of Engagement With Clinician Scale Score at Baseline and 9-months.9-months13 score on a scale
p-value: 0Wilcoxon signed rank
Secondary

Health Literacy

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.

Time frame: Baseline visit only

Population: Interventionists were not exposed to the intervention. Therefore, they are not included in the analyses of outcome measures.

ArmMeasureValue (NUMBER)
Intervention (Patient Participants)Health Literacy18 Participants
Secondary

Medication Adherence

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.

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

Population: Interventionists were not exposed to the intervention and are, therefore, not included in the analyses of outcome measures.

ArmMeasureGroupCategoryValue (COUNT_OF_PARTICIPANTS)
Intervention (Patient Participants)Medication AdherenceBaselineAdherent9 Participants
Intervention (Patient Participants)Medication AdherenceBaselineNon-adherent41 Participants
Intervention (Patient Participants)Medication AdherenceBaselineMissing0 Participants
Intervention (Patient Participants)Medication Adherence3-monthsAdherent24 Participants
Intervention (Patient Participants)Medication Adherence3-monthsNon-adherent22 Participants
Intervention (Patient Participants)Medication Adherence3-monthsMissing4 Participants
Intervention (Patient Participants)Medication Adherence6-monthsAdherent28 Participants
Intervention (Patient Participants)Medication Adherence6-monthsNon-adherent15 Participants
Intervention (Patient Participants)Medication Adherence6-monthsMissing7 Participants
Intervention (Patient Participants)Medication Adherence9-monthsAdherent39 Participants
Intervention (Patient Participants)Medication Adherence9-monthsNon-adherent3 Participants
Intervention (Patient Participants)Medication Adherence9-monthsMissing8 Participants
Secondary

Participant's Self-reported Health-related Quality of Life Score - Anxiety

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.

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

Population: Interventionists did not receive the intervention and are, therefore, not included in the analyses of outcome measures.

ArmMeasureGroupValue (MEAN)Dispersion
Intervention (Patient Participants)Participant's Self-reported Health-related Quality of Life Score - AnxietyBaseline54.09 t-scoreStandard Deviation 11.54
Intervention (Patient Participants)Participant's Self-reported Health-related Quality of Life Score - Anxiety3-months44.33 t-scoreStandard Deviation 8.18
Intervention (Patient Participants)Participant's Self-reported Health-related Quality of Life Score - Anxiety6-months46.23 t-scoreStandard Deviation 9.45
Intervention (Patient Participants)Participant's Self-reported Health-related Quality of Life Score - Anxiety9-months42.5 t-scoreStandard Deviation 6.92
Secondary

Participant's Self-reported Health-related Quality of Life Score - Depression

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.

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

Population: Interventionists did not receive the intervention and are, therefore, not included in the analyses of outcome measures.

ArmMeasureGroupValue (MEAN)Dispersion
Intervention (Patient Participants)Participant's Self-reported Health-related Quality of Life Score - Depression9-months43.19 t-scoreStandard Deviation 6.9
Intervention (Patient Participants)Participant's Self-reported Health-related Quality of Life Score - DepressionBaseline53.40 t-scoreStandard Deviation 11.49
Intervention (Patient Participants)Participant's Self-reported Health-related Quality of Life Score - Depression3-months45.51 t-scoreStandard Deviation 8.64
Intervention (Patient Participants)Participant's Self-reported Health-related Quality of Life Score - Depression6-months45.27 t-scoreStandard Deviation 8.02
Secondary

Participant's Self-reported Health-related Quality of Life Score - Fatigue

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.

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

Population: Interventionists did not receive the intervention and are, therefore, not included in the analyses of outcome measures.

ArmMeasureGroupValue (MEAN)Dispersion
Intervention (Patient Participants)Participant's Self-reported Health-related Quality of Life Score - FatigueBaseline42.46 t-scoreStandard Deviation 10.01
Intervention (Patient Participants)Participant's Self-reported Health-related Quality of Life Score - Fatigue3-months38.06 t-scoreStandard Deviation 8.01
Intervention (Patient Participants)Participant's Self-reported Health-related Quality of Life Score - Fatigue6-months36.38 t-scoreStandard Deviation 5.65
Intervention (Patient Participants)Participant's Self-reported Health-related Quality of Life Score - Fatigue9-months34.76 t-scoreStandard Deviation 3.88
Secondary

Participant's Self-reported Health-related Quality of Life Score - Pain Interference

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.

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

Population: Interventionists did not receive the intervention and are, therefore, not included in the analyses of outcome measures.

ArmMeasureGroupValue (MEAN)Dispersion
Intervention (Patient Participants)Participant's Self-reported Health-related Quality of Life Score - Pain InterferenceBaseline46.11 t-scoreStandard Deviation 7.08
Intervention (Patient Participants)Participant's Self-reported Health-related Quality of Life Score - Pain Interference3-months42.52 t-scoreStandard Deviation 3.19
Intervention (Patient Participants)Participant's Self-reported Health-related Quality of Life Score - Pain Interference6-months42.88 t-scoreStandard Deviation 3.64
Intervention (Patient Participants)Participant's Self-reported Health-related Quality of Life Score - Pain Interference9-months43.59 t-scoreStandard Deviation 5.1
Secondary

Participant's Self-reported Health-related Quality of Life Score - Physical Functioning

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.

Time frame: Up to 9 months from baseline

Population: Interventionists did not receive the intervention and are, therefore, not included in the analyses of outcome measures.

ArmMeasureGroupValue (MEAN)Dispersion
Intervention (Patient Participants)Participant's Self-reported Health-related Quality of Life Score - Physical FunctioningBaseline55.37 t-scoreStandard Deviation 4.2
Intervention (Patient Participants)Participant's Self-reported Health-related Quality of Life Score - Physical Functioning3-months57 t-scoreStandard Deviation 0
Intervention (Patient Participants)Participant's Self-reported Health-related Quality of Life Score - Physical Functioning6-months56.2 t-scoreStandard Deviation 3.11
Intervention (Patient Participants)Participant's Self-reported Health-related Quality of Life Score - Physical Functioning9-months56.64 t-scoreStandard Deviation 2.33
Secondary

Participant's Self-reported Health-related Quality of Life Score - Sleep Disturbance

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.

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

Population: Interventionists did not receive the intervention and are, therefore, not included in the analyses of outcome measures.

ArmMeasureGroupValue (MEAN)Dispersion
Intervention (Patient Participants)Participant's Self-reported Health-related Quality of Life Score - Sleep DisturbanceBaseline45.37 t-scoreStandard Deviation 12.04
Intervention (Patient Participants)Participant's Self-reported Health-related Quality of Life Score - Sleep Disturbance3-months40.60 t-scoreStandard Deviation 8.58
Intervention (Patient Participants)Participant's Self-reported Health-related Quality of Life Score - Sleep Disturbance6-months41.70 t-scoreStandard Deviation 5.74
Intervention (Patient Participants)Participant's Self-reported Health-related Quality of Life Score - Sleep Disturbance9-months43.54 t-scoreStandard Deviation 6.31
Secondary

Participant's Self-reported Health-related Quality of Life Score - Social Activity Participation

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.

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

Population: Interventionists did not receive the intervention and are, therefore, not included in the analyses of outcome measures.

ArmMeasureGroupValue (MEAN)Dispersion
Intervention (Patient Participants)Participant's Self-reported Health-related Quality of Life Score - Social Activity Participation9-months63.72 t-scoreStandard Deviation 3.09
Intervention (Patient Participants)Participant's Self-reported Health-related Quality of Life Score - Social Activity ParticipationBaseline60.91 t-scoreStandard Deviation 6.98
Intervention (Patient Participants)Participant's Self-reported Health-related Quality of Life Score - Social Activity Participation3-months63.65 t-scoreStandard Deviation 2.84
Intervention (Patient Participants)Participant's Self-reported Health-related Quality of Life Score - Social Activity Participation6-months63.83 t-scoreStandard Deviation 2.46
Secondary

Participants' Self-reported Health Status Over Past 4 Weeks.

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.

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

Population: Interventionists did not receive the intervention and, therefore, are not included in analyses of outcome measures.

ArmMeasureGroupCategoryValue (COUNT_OF_PARTICIPANTS)
Intervention (Patient Participants)Participants' Self-reported Health Status Over Past 4 Weeks.BaselineExcellent7 Participants
Intervention (Patient Participants)Participants' Self-reported Health Status Over Past 4 Weeks.BaselineGood8 Participants
Intervention (Patient Participants)Participants' Self-reported Health Status Over Past 4 Weeks.BaselineFair16 Participants
Intervention (Patient Participants)Participants' Self-reported Health Status Over Past 4 Weeks.BaselinePoor16 Participants
Intervention (Patient Participants)Participants' Self-reported Health Status Over Past 4 Weeks.BaselineVery poor1 Participants
Intervention (Patient Participants)Participants' Self-reported Health Status Over Past 4 Weeks.BaselineMissing2 Participants
Intervention (Patient Participants)Participants' Self-reported Health Status Over Past 4 Weeks.3-monthsExcellent21 Participants
Intervention (Patient Participants)Participants' Self-reported Health Status Over Past 4 Weeks.3-monthsGood9 Participants
Intervention (Patient Participants)Participants' Self-reported Health Status Over Past 4 Weeks.3-monthsFair13 Participants
Intervention (Patient Participants)Participants' Self-reported Health Status Over Past 4 Weeks.3-monthsPoor5 Participants
Intervention (Patient Participants)Participants' Self-reported Health Status Over Past 4 Weeks.3-monthsVery poor0 Participants
Intervention (Patient Participants)Participants' Self-reported Health Status Over Past 4 Weeks.3-monthsMissing2 Participants
Intervention (Patient Participants)Participants' Self-reported Health Status Over Past 4 Weeks.6-monthsExcellent13 Participants
Intervention (Patient Participants)Participants' Self-reported Health Status Over Past 4 Weeks.6-monthsGood19 Participants
Intervention (Patient Participants)Participants' Self-reported Health Status Over Past 4 Weeks.9-monthsMissing8 Participants
Intervention (Patient Participants)Participants' Self-reported Health Status Over Past 4 Weeks.6-monthsFair9 Participants
Intervention (Patient Participants)Participants' Self-reported Health Status Over Past 4 Weeks.6-monthsPoor2 Participants
Intervention (Patient Participants)Participants' Self-reported Health Status Over Past 4 Weeks.6-monthsVery poor0 Participants
Intervention (Patient Participants)Participants' Self-reported Health Status Over Past 4 Weeks.6-monthsMissing7 Participants
Intervention (Patient Participants)Participants' Self-reported Health Status Over Past 4 Weeks.9-monthsExcellent8 Participants
Intervention (Patient Participants)Participants' Self-reported Health Status Over Past 4 Weeks.9-monthsGood21 Participants
Intervention (Patient Participants)Participants' Self-reported Health Status Over Past 4 Weeks.9-monthsFair13 Participants
Intervention (Patient Participants)Participants' Self-reported Health Status Over Past 4 Weeks.9-monthsPoor0 Participants
Intervention (Patient Participants)Participants' Self-reported Health Status Over Past 4 Weeks.9-monthsVery poor0 Participants
Secondary

Percent of Participants Who Complete an In-depth Qualitative Interview

Participants will be invited to participate in an in-depth qualitative interview regarding their experiences. The number who participate will be reported as a percent of the total who are enrolled.

Time frame: 9 months from baseline

Population: The percentage of participants who agreed to participate in an in-depth interview.

ArmMeasureValue (NUMBER)
Intervention (Patient Participants)Percent of Participants Who Complete an In-depth Qualitative Interview52 percent of participants
Secondary

Satisfaction With Care Scale Score

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

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

Population: Interventionists did not receive the intervention and, therefore, are not included in the analysis of outcome measures.

ArmMeasureGroupValue (MEAN)Dispersion
Intervention (Patient Participants)Satisfaction With Care Scale ScoreBaseline18.04 score on a scaleStandard Deviation 1.37
Intervention (Patient Participants)Satisfaction With Care Scale Score3-months18.52 score on a scaleStandard Deviation 0.58
Intervention (Patient Participants)Satisfaction With Care Scale Score6-months18.49 score on a scaleStandard Deviation 0.55
Intervention (Patient Participants)Satisfaction With Care Scale Score9-months18.31 score on a scaleStandard Deviation 0.47
Secondary

Satisfaction With Provider Scale Score at Each Time Point

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

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

Population: Interventionists did not receive the intervention and, therefore, are not included in the analysis of outcome measures.

ArmMeasureGroupValue (MEAN)Dispersion
Intervention (Patient Participants)Satisfaction With Provider Scale Score at Each Time PointBaseline26.96 score on a scaleStandard Deviation 3.25
Intervention (Patient Participants)Satisfaction With Provider Scale Score at Each Time Point3-months27.69 score on a scaleStandard Deviation 1.39
Intervention (Patient Participants)Satisfaction With Provider Scale Score at Each Time Point6-months27.49 score on a scaleStandard Deviation 1.56
Intervention (Patient Participants)Satisfaction With Provider Scale Score at Each Time Point9-months27.64 score on a scaleStandard Deviation 1.01

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