Information Visualizations to Facilitate HIV-related Patient-provider Communication in New York City (Info Viz: HIV-NYC)

Health Communication Clinical Trial

Official title:

Information Visualizations to Facilitate HIV-related Patient-provider Communication in New York City (Info Viz: HIV-NYC)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04102540
• Other study ID #: AAAS4611
• Secondary ID: 1K99NR017829-01A
• Status: Completed
• Phase: N/A
• Start date: October 7, 2019
• Est. completion date: July 29, 2020

Study information

• Verified date: August 2021
• 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- and 6-month follow up visits). Follow up interviews will be conducted with members of the clinical team to ascertain their perspectives on the clinical utility of infographics.

Description:

Latinos are the largest and fastest growing minority group in the US, and they are disproportionately affected by HIV. In 2014, almost 25% of new cases of HIV infections were among Latinos although they only represent 17% of the US population. Additionally, Latinos have a faster rate of progression from HIV to AIDS, higher rates of HIV-related deaths, and marked delay in the diagnosis of infections. Approximately 42% of HIV diagnoses among Latinos in the US are in persons born abroad. In absolute numbers, new HIV diagnoses among foreign-born individuals in the US were the highest among Caribbean-born persons, which may partially be attributed to high rates of bidirectional travel. It is, therefore, critical that HIV prevention and treatment activities incorporate factors associated with Latino immigrant and transnational groups. In Washington Heights, New York City, understanding these factors related with bi-directional travel to the Dominican Republic (DR) is warranted, as the Latino population of Washington Heights is largely comprised of Dominicans.

Many factors contribute to the health disparities experienced by Latinos, of which low health literacy and literacy in general are potential contributors. Health literacy, or "the degree to which individuals have the capacity to obtain, process, and understand basic health information and services needed to make appropriate health decisions," is an established concern affecting vulnerable communities globally. Not surprisingly, Spanish-speaking, less educated, and/or foreign-born Latinos have lower health literacy than those born in the US. Low health literacy can lead to worse health outcomes, less use of services, and poorer knowledge of illness. Also, patients with limited health literacy are likely to have low numeracy which affects interpretations of medication quantities, time between doses, and time between appointments, among other quantitative knowledge relating to effective management of HIV.

Infographics are emerging technologies to help teach complex health concepts to patients with low health literacy. When effectively designed, infographics (information visualizations) contain a depth and breadth of information and lead to improved understanding of concepts. By carefully selecting the design and included content, simple images can convey large amounts of information in a visually appealing and comprehensible way. Methodically constructed infographics have been shown to improve communication about health behaviors and health risks and minimize comprehension differences between individuals with high and low health literacy. They can also help improve information exchange amidst culture and language differences by using images familiar to patients to explain complicated processes as well as augment attention span and recall of learned material. Furthermore, rigorously designed and evaluated infographics can help mitigate health disparities by helping clinicians provide the information that people need for effective health management in an understandable way.

During preliminary studies, the investigators developed a set of infographics designed to facilitate HIV-related clinician-patient communication during clinic visits. Initial infographics were designed by persons living with HIV (PLWH) in the Dominican Republic and are now being tested for feasibility and usability among a cohort in the DR. In this study, the investigators propose to assess the feasibility of using the infographic intervention in a clinic that specializes in HIV care in Washington Heights to improve clinical communication and subsequently, patient outcomes. Additionally, the investigators will collect information about acculturation and bi-directional travel to more thoroughly assess how these factors relate to HIV infection among Hispanic/Latino populations living in the US.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: July 29, 2020
• Est. primary completion date: July 29, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult = 18 years of age

• Living with HIV and has a detectable viral load

• Self-identifies as Hispanic/Latino

• Plan to receive care at the same clinic for the next 6 months

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
Information visualizations (infographics) will be used to teach participants about HIV during study visits immediately following their normal clinic visits.

Locations

Country	Name	City	State
United States	Comprehensive HIV Program of NewYork-Presbyterian Hospital	New York	New York

Sponsors (2)

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

Country where clinical trial is conducted

United States, 

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* Note: There are 61 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean CD4 Count	Mean Cluster of Differentiation 4 (CD4) count at each time point.	Baseline, 3-, and 6-months
Primary	Mean Viral Load	Mean viral load at each time point	Baseline, 3-, and 6-months
Secondary	Mean Score on HIV-related Knowledge Assessment	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, 3-, and 6-months
Secondary	Mean Score on Satisfaction With Care Scale	7 questions on patients' satisfaction with health care provider and the health care center adapted from previously validated instruments were included.; Each question response from included questions has a different score range: Question 1: 1 - 7 Question 2: 1 - 10 Question 3: 1 - 7 Question 4: 1 - 5 Question 5: 1 - 7 Question 6: 1 - 7 Question 7: 1 - 5; Total scores range from 7 - 48, which is calculated from the lowest and highest possible scores on each of the included questions. Higher scores indicating more satisfaction with care.	Baseline, 3-, and 6-months
Secondary	Mean Score on the SEMCD Scale	The Self-Efficacy for Managing Chronic Disease (SEMCD) scale is a 6-item questionnaire that measures confidence in one's ability to manage fatigue, pain, emotional distress, and other symptoms using self-management techniques. Each item is scored from a minimum value of 1 which indicates "not at all confident" to a maximum score of 10, which indicates "completely confident." Final scores are calculated as the mean of the 6 questions ranging from 1(minimum) to 10 (maximum), where higher scores indicate higher self-efficacy (better outcome).	Baseline, 3-, and 6-months
Secondary	Number of Participants Who Are Adherent to Their Medications	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 of their medication 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), they are also considered "non-adherent."	Baseline, 3-, and 6-months
Secondary	Number of Participants Who Reported Each of the 5 General Health Categories	Participants rated their general health as "excellent," "very good," "good," "more or less," or "bad."	Baseline, 3-, and 6-months
Secondary	Mean Score on Current Health Status	Current health status will be assessed with one question from the Health Status Assessment which asks participants to rate their current health by providing a number on a scale from 0 - 100 where 0=death or worst possible health and 100=perfect or best possible health.	Baseline, 3-, and 6-months
Secondary	Number of Participants With Likely Low vs. Adequate Health Literacy According to SAHL-S&E Measurement	Health literacy will be assessed using the short assessment of health literacy- Spanish. Scores range from 0 - 18 and a score above a 15 indicates that participants are likely to have adequate health literacy.	Baseline visit only
Secondary	Number of Participants With Likely Limited, Possibly Limited, or Adequate Health Literacy According to NVS Measurement	A second measure of health literacy, the Newest Vital Sign (NVS) will also be administered. Scores on this scale range from 0-6 where a score of 0-1 suggests high likelihood of limited literacy, a score of 2-3 indicates the possibility of limited literacy, and a score of 4-6 almost always indicates adequate literacy.	Baseline visit only
Secondary	Number of Participants in Each Acculturation Category Presented in the Brief ARSMA	The Brief Acculturation Rating Scale for Mexican Americans-II (Brief ARSMA)12 item instrument that assesses level of acculturation that has been used in Mexican Americans as well as other Latino subgroups, including Dominicans. Scores are calculated by summing the scores and dividing by 12 to get a mean acculturation. Higher scores indicate greater acculturation.	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.	6 months after baseline