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

August 23, 2020 updated by: Rebecca Schnall, RN, MPH, PhD, Columbia University

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

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.

Study Overview

Status

Completed

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

59

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention Group
Participants in the intervention group will receive health education using infographics (Infographic Intervention) during their regularly scheduled clinic visits.
All study participants will receive health education using infographics during their regularly scheduled clinic appointments.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Association Between Mean CD4 Count at Baseline and 3-month Visit
Time Frame: Baseline and 3-month visit
Association between mean CD4 count at baseline and 3-month visits.
Baseline and 3-month visit
Association Between Mean CD4 Count at Baseline and 6-month Visit
Time Frame: Baseline and 6-month visit
Association between mean CD4 count at baseline and 6-month visits.
Baseline and 6-month visit
Association Between Mean CD4 Count at Baseline and 9-month Visit
Time Frame: Baseline and 9-month visit
Association between mean CD4 count at baseline and 9-month visits.
Baseline and 9-month visit
Association Between Mean Viral Load at Baseline and at 3-month Visits
Time Frame: Baseline and 3-months
Test of association of mean viral load at baseline and at 3-month visits.
Baseline and 3-months
Association Between Mean Viral Load at Baseline and at 6-month Visits
Time Frame: Baseline and 6-months
Test of association of mean viral load at baseline and at 6-month visits.
Baseline and 6-months
Association Between Mean Viral Load at Baseline and at 9-month Visits
Time Frame: Baseline and 9-months
Test of association of mean viral load at baseline and at 9-month visits.
Baseline and 9-months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Satisfaction With Care Scale Score
Time Frame: Baseline, 3-, 6-, and 9-month visits

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
Baseline, 3-, 6-, and 9-month visits
Medication Adherence
Time Frame: Baseline, 3-, 6-, and 9-month visits
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."
Baseline, 3-, 6-, and 9-month visits
Participant's Self-reported Health-related Quality of Life Score - Physical Functioning
Time Frame: Up to 9 months from baseline
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.
Up to 9 months from baseline
Participants' Self-reported Health Status Over Past 4 Weeks.
Time Frame: Baseline, 3-months, 6-months, and 9-months
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.
Baseline, 3-months, 6-months, and 9-months
Health Literacy
Time Frame: Baseline visit only
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.
Baseline visit only
Percent of Participants Who Complete an In-depth Qualitative Interview
Time Frame: 9 months from baseline
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.
9 months from baseline
Participant's Self-reported Health-related Quality of Life Score - Anxiety
Time Frame: Baseline, 3-, 6-, and 9-months
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.
Baseline, 3-, 6-, and 9-months
Participant's Self-reported Health-related Quality of Life Score - Depression
Time Frame: Baseline, 3-, 6-, and 9-months
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.
Baseline, 3-, 6-, and 9-months
Participant's Self-reported Health-related Quality of Life Score - Fatigue
Time Frame: Baseline, 3-, 6-, and 9-months
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.
Baseline, 3-, 6-, and 9-months
Participant's Self-reported Health-related Quality of Life Score - Sleep Disturbance
Time Frame: Baseline, 3-, 6-, and 9-months
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.
Baseline, 3-, 6-, and 9-months
Participant's Self-reported Health-related Quality of Life Score - Social Activity Participation
Time Frame: Baseline, 3-, 6-, and 9-months
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.
Baseline, 3-, 6-, and 9-months
Participant's Self-reported Health-related Quality of Life Score - Pain Interference
Time Frame: Baseline, 3-, 6-, and 9-months
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.
Baseline, 3-, 6-, and 9-months
Satisfaction With Provider Scale Score at Each Time Point
Time Frame: Baseline, 3-, 6-, and 9-month visits

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
Baseline, 3-, 6-, and 9-month visits
Association Between Mean HIV-related Knowledge Scores at Baseline and 3-month Visits.
Time Frame: 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.
Baseline and 3-month visits
Association Between Mean HIV-related Knowledge Scores at Baseline and 6-month Visits.
Time Frame: 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.
Baseline and 6-month visits
Association Between Mean HIV-related Knowledge Scores at Baseline and 9-month Visits.
Time Frame: 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.
Baseline and 9-month visits
Association of Engagement With Clinician Scale Score at Baseline and 3-months.
Time Frame: 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.
Baseline and 3-months
Association of Engagement With Clinician Scale Score at Baseline and 6-months.
Time Frame: 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.
Baseline and 6-months
Association of Engagement With Clinician Scale Score at Baseline and 9-months.
Time Frame: 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.
Baseline and 9-months
Association Between SEMCD Scale Score at Baseline and 3-month Visits
Time Frame: Baseline, 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.
Baseline, 3-month visits
Association Between SEMCD Scale Score at Baseline and 6-month Visits
Time Frame: Baseline, 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.
Baseline, 6-month visits
Association Between SEMCD Scale Score at Baseline and 9-month Visits
Time Frame: Baseline, 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.
Baseline, 9-month visits
Association Between Current Self-reported Health Status as Reported at Baseline and 3-months
Time Frame: Baseline, 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).
Baseline, 3-months
Association Between Current Self-reported Health Status as Reported at Baseline and 6-months
Time Frame: Baseline, 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).
Baseline, 6-months
Association Between Current Self-reported Health Status as Reported at Baseline and 9-months
Time Frame: Baseline, 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).
Baseline, 9-months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 9, 2018

Primary Completion (Actual)

August 9, 2019

Study Completion (Actual)

August 9, 2019

Study Registration Dates

First Submitted

July 23, 2018

First Submitted That Met QC Criteria

July 31, 2018

First Posted (Actual)

August 6, 2018

Study Record Updates

Last Update Posted (Actual)

September 3, 2020

Last Update Submitted That Met QC Criteria

August 23, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • AAAR9023
  • 1K99NR017829-01A1 (NIH)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

De-identified data of individual participant data will be made available to qualified researchers seeking to replicate methods or to those working on a new study who need the evidence-base to do so in a rigorous way. All de-identified participant data will be shared with other researchers. Please note that all of this data will be in Spanish.

IPD Sharing Time Frame

Data will be available 3 months after the publication of primary results.

IPD Sharing Access Criteria

To request data please email the study director listed on this record with the reason you need the data and your planned use of it.

IPD Sharing Supporting Information Type

  • Clinical Study Report (CSR)
  • Analytic Code

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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