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

Health Communication Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03616106
• Other study ID #: AAAR9023
• Secondary ID: 1K99NR017829-01A
• Status: Completed
• Phase: N/A
• Start date: October 9, 2018
• Est. completion date: August 9, 2019

Study information

• Verified date: August 2020
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: August 9, 2019
• Est. primary completion date: August 9, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Health Communication

Intervention

Other:
• Infographic intervention
All study participants will receive health education using infographics during their regularly scheduled clinic appointments.

Locations

Country	Name	City	State
Dominican Republic	Clínica de Familia La Romana	La Romana

Sponsors (2)

Lead Sponsor	Collaborator
Columbia University	National Institute of Nursing Research (NINR)

Country where clinical trial is conducted

Dominican Republic, 

References & Publications (27)

Arcia A, Suero-Tejeda N, Bales ME, Merrill JA, Yoon S, Woollen J, Bakken S. Sometimes more is more: iterative participatory design of infographics for engagement of community members with varying levels of health literacy. J Am Med Inform Assoc. 2016 Jan;23(1):174-83. doi: 10.1093/jamia/ocv079. Epub 2015 Jul 13. — View Citation

Bakken S, Holzemer WL, Brown MA, Powell-Cope GM, Turner JG, Inouye J, Nokes KM, Corless IB. Relationships between perception of engagement with health care provider and demographic characteristics, health status, and adherence to therapeutic regimen in persons with HIV/AIDS. AIDS Patient Care STDS. 2000 Apr;14(4):189-97. — View Citation

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Barreto SM, Miranda JJ, Figueroa JP, Schmidt MI, Munoz S, Kuri-Morales PP, Silva JB Jr. Epidemiology in Latin America and the Caribbean: current situation and challenges. Int J Epidemiol. 2012 Apr;41(2):557-71. doi: 10.1093/ije/dys017. Epub 2012 Mar 9. — View Citation

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Cella D, Riley W, Stone A, Rothrock N, Reeve B, Yount S, Amtmann D, Bode R, Buysse D, Choi S, Cook K, Devellis R, DeWalt D, Fries JF, Gershon R, Hahn EA, Lai JS, Pilkonis P, Revicki D, Rose M, Weinfurt K, Hays R; PROMIS Cooperative Group. The Patient-Reported Outcomes Measurement Information System (PROMIS) developed and tested its first wave of adult self-reported health outcome item banks: 2005-2008. J Clin Epidemiol. 2010 Nov;63(11):1179-94. doi: 10.1016/j.jclinepi.2010.04.011. Epub 2010 Aug 4. — View Citation

Dang BN, Westbrook RA, Hartman CM, Giordano TP. Retaining HIV Patients in Care: The Role of Initial Patient Care Experiences. AIDS Behav. 2016 Oct;20(10):2477-2487. doi: 10.1007/s10461-016-1340-y. — View Citation

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Figueroa JP. Review of HIV in the Caribbean: significant progress and outstanding challenges. Curr HIV/AIDS Rep. 2014 Jun;11(2):158-67. doi: 10.1007/s11904-014-0199-7. Review. — View Citation

Garcia-Retamero R, Dhami MK. Pictures speak louder than numbers: on communicating medical risks to immigrants with limited non-native language proficiency. Health Expect. 2011 Mar;14 Suppl 1:46-57. doi: 10.1111/j.1369-7625.2011.00670.x. — View Citation

Garcia-Retamero R, Okan Y, Cokely ET. Using visual aids to improve communication of risks about health: a review. ScientificWorldJournal. 2012;2012:562637. doi: 10.1100/2012/562637. Epub 2012 May 2. Review. — View Citation

Gebre Y, Forbes NM, Peters A. Review of HIV treatment progress, gaps, and challenges in the Caribbean, 2005-2015. Rev Panam Salud Publica. 2016 Dec;40(6):468-473. Review. — View Citation

Houts PS, Doak CC, Doak LG, Loscalzo MJ. The role of pictures in improving health communication: a review of research on attention, comprehension, recall, and adherence. Patient Educ Couns. 2006 May;61(2):173-90. Epub 2005 Aug 24. Review. Erratum in: Patient Educ Couns. 2006 Dec;64(1-3):393-4. — View Citation

Kalichman SC, Rompa D. Functional health literacy is associated with health status and health-related knowledge in people living with HIV-AIDS. J Acquir Immune Defic Syndr. 2000 Dec 1;25(4):337-44. — View Citation

Knobel H, Alonso J, Casado JL, Collazos J, González J, Ruiz I, Kindelan JM, Carmona A, Juega J, Ocampo A; GEEMA Study Group. Validation of a simplified medication adherence questionnaire in a large cohort of HIV-infected patients: the GEEMA Study. AIDS. 2002 Mar 8;16(4):605-13. — View Citation

Laws MB, Lee Y, Rogers WH, Beach MC, Saha S, Korthuis PT, Sharp V, Cohn J, Moore R, Wilson IB. Provider-patient communication about adherence to anti-retroviral regimens differs by patient race and ethnicity. AIDS Behav. 2014 Jul;18(7):1279-87. doi: 10.1007/s10461-014-0697-z. — View Citation

Lee SY, Stucky BD, Lee JY, Rozier RG, Bender DE. Short Assessment of Health Literacy-Spanish and English: a comparable test of health literacy for Spanish and English speakers. Health Serv Res. 2010 Aug;45(4):1105-20. doi: 10.1111/j.1475-6773.2010.01119.x. Epub 2010 May 24. — View Citation

Mackey LM, Doody C, Werner EL, Fullen B. Self-Management Skills in Chronic Disease Management: What Role Does Health Literacy Have? Med Decis Making. 2016 Aug;36(6):741-59. doi: 10.1177/0272989X16638330. Epub 2016 Apr 6. Review. — View Citation

Pérez-Escamilla R. Acculturation, nutrition, and health disparities in Latinos. Am J Clin Nutr. 2011 May;93(5):1163S-7S. doi: 10.3945/ajcn.110.003467. Epub 2011 Mar 2. Review. — View Citation

Rao JK, Anderson LA, Inui TS, Frankel RM. Communication interventions make a difference in conversations between physicians and patients: a systematic review of the evidence. Med Care. 2007 Apr;45(4):340-9. Review. — View Citation

Ritter PL, Lorig K. The English and Spanish Self-Efficacy to Manage Chronic Disease Scale measures were validated using multiple studies. J Clin Epidemiol. 2014 Nov;67(11):1265-73. doi: 10.1016/j.jclinepi.2014.06.009. Epub 2014 Aug 3. — View Citation

Rojas P, Malow R, Ruffin B, Rothe EM, Rosenberg R. The HIV/AIDS Epidemic in the Dominican Republic: Key Contributing Factors. J Int Assoc Physicians AIDS Care (Chic). 2011 Sep-Oct;10(5):306-15. doi: 10.1177/1545109710397770. Epub 2011 Mar 2. Review. — View Citation

Schulman-Green D, Jaser S, Martin F, Alonzo A, Grey M, McCorkle R, Redeker NS, Reynolds N, Whittemore R. Processes of self-management in chronic illness. J Nurs Scholarsh. 2012 Jun;44(2):136-44. doi: 10.1111/j.1547-5069.2012.01444.x. Epub 2012 May 2. — View Citation

Stonbraker S, Befus M, Lerebours Nadal L, Halpern M, Larson E. Factors Associated with Health Information Seeking, Processing, and Use Among HIV Positive Adults in the Dominican Republic. AIDS Behav. 2017 Jun;21(6):1588-1600. doi: 10.1007/s10461-016-1569-5. — View Citation

Stonbraker S, Smaldone A, Luft H, Cushman LF, Lerebours Nadal L, Halpern M, Larson E. Associations between health literacy, HIV-related knowledge, and information behavior among persons living with HIV in the Dominican Republic. Public Health Nurs. 2018 May;35(3):166-175. doi: 10.1111/phn.12382. Epub 2017 Dec 29. — View Citation

Wawrzyniak AJ, Ownby RL, McCoy K, Waldrop-Valverde D. Health literacy: impact on the health of HIV-infected individuals. Curr HIV/AIDS Rep. 2013 Dec;10(4):295-304. doi: 10.1007/s11904-013-0178-4. Review. — View Citation

Zhang NJ, Terry A, McHorney CA. Impact of health literacy on medication adherence: a systematic review and meta-analysis. Ann Pharmacother. 2014 Jun;48(6):741-51. doi: 10.1177/1060028014526562. Epub 2014 Mar 11. Review. — View Citation

* Note: There are 27 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Association Between Mean CD4 Count at Baseline and 3-month Visit	Association between mean CD4 count at baseline and 3-month visits.	Baseline and 3-month visit
Primary	Association Between Mean CD4 Count at Baseline and 6-month Visit	Association between mean CD4 count at baseline and 6-month visits.	Baseline and 6-month visit
Primary	Association Between Mean CD4 Count at Baseline and 9-month Visit	Association between mean CD4 count at baseline and 9-month visits.	Baseline and 9-month visit
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.	Baseline and 3-months
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.	Baseline and 6-months
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.	Baseline and 9-months
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	Baseline, 3-, 6-, and 9-month visits
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."	Baseline, 3-, 6-, and 9-month visits
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.	Up to 9 months from baseline
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.	Baseline, 3-months, 6-months, and 9-months
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.	Baseline visit only
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.	9 months from baseline
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.	Baseline, 3-, 6-, and 9-months
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.	Baseline, 3-, 6-, and 9-months
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.	Baseline, 3-, 6-, and 9-months
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.	Baseline, 3-, 6-, and 9-months
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.	Baseline, 3-, 6-, and 9-months
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.	Baseline, 3-, 6-, and 9-months
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	Baseline, 3-, 6-, and 9-month visits
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.	Baseline and 3-month visits
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.	Baseline and 6-month visits
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.	Baseline and 9-month visits
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.	Baseline and 3-months
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.	Baseline and 6-months
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.	Baseline and 9-months
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.	Baseline, 3-month visits
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.	Baseline, 6-month visits
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.	Baseline, 9-month visits
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).	Baseline, 3-months
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).	Baseline, 6-months
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).	Baseline, 9-months

External Links

•   Link to article, Health communication in health disparities settings, by R. Schiavo
•   Source of the Health Status Assessment published by the AIDS Clinical Trials Group (ACTG) Outcomes Committee