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Completed

NCT Number: NCT03616106

Information Visualizations to Facilitate HIV-related Patient-provider Communication (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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clínica de Familia La Romana

La Romana, Dominican Republic

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Infographic intervention

Other

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

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

Secondary outcomes

  1. 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
  2. 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."

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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
  14. 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.

  15. 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.

  16. 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.

  17. 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.

  18. 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.

  19. 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.

  20. 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.

  21. 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.

  22. 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.

  23. 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).

  24. 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).

  25. 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).

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Collaborators

  • National Institute of Nursing Research (NINR)

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Aug 6, 2018
Registry last updated
Sep 3, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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