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

Not Applicable

Completed

• Conditions: Health Communication
• Interventions: Other: Infographic intervention

• Registration Number: NCT03616106
• Lead Sponsor: Columbia University

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-07-23
• Study First Submitted QC: 2018-07-31
• Study First Posted: 2018-08-06
• Study Start: 2018-10-09
• Primary Completion: 2019-08-09
• Study Completion: 2019-08-09
• Status Verified: 2020-08
• Results First Submitted: 2020-08-06
• Results First Submitted QC: 2020-08-23
• Last Update Submitted: 2020-08-23
• Results First Posted: 2020-09-03
• Last Update Posted: 2020-09-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 59

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention Group	Infographic intervention	Participants in the intervention group will receive health education using infographics (Infographic Intervention) during their regularly scheduled clinic visits.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Medication Adherence	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."
Association Between Mean HIV-related Knowledge Scores at Baseline and 3-month Visits.	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.
Association of Engagement With Clinician Scale Score at Baseline and 3-months.	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.
Association Between Current Self-reported Health Status as Reported at Baseline and 3-months	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).
Health Literacy	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.
Association of Engagement With Clinician Scale Score at Baseline and 6-months.	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.
Association Between SEMCD Scale Score at Baseline and 3-month Visits	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.
Participant's Self-reported Health-related Quality of Life Score - Depression	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.
Participant's Self-reported Health-related Quality of Life Score - Sleep Disturbance	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.
Participant's Self-reported Health-related Quality of Life Score - Social Activity Participation	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.
Association of Engagement With Clinician Scale Score at Baseline and 9-months.	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.
Satisfaction With Care Scale Score	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
Participants' Self-reported Health Status Over Past 4 Weeks.	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.
Participant's Self-reported Health-related Quality of Life Score - Fatigue	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.
Satisfaction With Provider Scale Score at Each Time Point	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
Association Between SEMCD Scale Score at Baseline and 9-month Visits	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.
Participant's Self-reported Health-related Quality of Life Score - Physical Functioning	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.
Percent of Participants Who Complete an In-depth Qualitative Interview	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.
Participant's Self-reported Health-related Quality of Life Score - Anxiety	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.
Participant's Self-reported Health-related Quality of Life Score - Pain Interference	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.
Association Between Mean HIV-related Knowledge Scores at Baseline and 6-month Visits.	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.
Association Between Mean HIV-related Knowledge Scores at Baseline and 9-month Visits.	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.
Association Between SEMCD Scale Score at Baseline and 6-month Visits	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.
Association Between Current Self-reported Health Status as Reported at Baseline and 6-months	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).
Association Between Current Self-reported Health Status as Reported at Baseline and 9-months	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).

Trial Locations

Locations (1)

Clínica de Familia La Romana; 🇩🇴 La Romana, Dominican Republic