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Health CommunicationNCT04102540

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

A study testing Infographic intervention in people with Health Communication, run by Columbia University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Health Communication
What is being tested?
Infographic intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
1 siteUnited States
Study dates
7 Oct 2019to 29 Jul 2020
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Comprehensive HIV Program of NewYork-Presbyterian Hospital

    New York, New York, 10032

Other trials in United States

About this study

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.

Read the detailed 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.

Being tested
Infographic intervention
Keywords
Information Visualization

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Infographic interventionOther

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

Study groups in NCT04102540
Study groupRoleWhat they receive
Infographic intervention groupExperimentalParticipants in the infographic intervention group will receive health education using infographics during a study visit scheduled immediately following their regularly scheduled clinic visits.
Receives: Other: Infographic intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mean CD4 Count

    Mean Cluster of Differentiation 4 (CD4) count at each time point.

    Measured: Baseline, 3-, and 6-months

  2. Mean Viral Load

    Mean viral load at each time point

    Measured: Baseline, 3-, and 6-months

Secondary outcomes (10)

  1. 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.

    Measured: Baseline, 3-, and 6-months

  2. 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.

    Measured: Baseline, 3-, and 6-months

  3. 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).

    Measured: Baseline, 3-, and 6-months

  4. 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."

    Measured: Baseline, 3-, and 6-months

  5. 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."

    Measured: Baseline, 3-, and 6-months

  6. 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.

    Measured: Baseline, 3-, and 6-months

  7. 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.

    Measured: Baseline visit only

  8. 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.

    Measured: Baseline visit only

  9. 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.

    Measured: Baseline visit only

  10. 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.

    Measured: 6 months after baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Sep 2019
  2. Study start7 Oct 2019
  3. Primary completion29 Jul 2020
  4. Study completion29 Jul 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Not applicable
Intervention model
Single group
Model description
This study will use a single pretest-posttest design to evaluate if using infographics for patient education can lead to improved patient outcomes.
Masking
None (open label)
Enrolment
32 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04102540
Sponsor's protocol ID
AAAS4611
Other IDs
1K99NR017829-01A1
Status last verified
Aug 2021
First submitted
23 Sep 2019
Last updated
17 Sep 2021
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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 much of this data will be in Spanish.

Publications

  • Passel J, Cohn D, Lopez M. Hispanics account for more than half of nation's growth in past decade. Washington DC: Pew Hispanic Center;2011.

  • Brown A, Hugo Lopez M. Mapping the Latino Population, By State, County and City. Washington DC2013.

  • Henao-Martinez AF, Castillo-Mancilla JR. The Hispanic HIV Epidemic. Curr Infect Dis Rep. 2013 Feb;15(1):46-51. doi: 10.1007/s11908-012-0306-0.

    PubMed 23184612

  • Gonzalez JS, Hendriksen ES, Collins EM, Duran RE, Safren SA. Latinos and HIV/AIDS: examining factors related to disparity and identifying opportunities for psychosocial intervention research. AIDS Behav. 2009 Jun;13(3):582-602. doi: 10.1007/s10461-008-9402-4. Epub 2008 May 23.

    PubMed 18498050

  • Xia Q, Braunstein SL, Wiewel EW, Hadler JL, Torian LV. Persistent Racial Disparities in HIV Infection in the USA: HIV Prevalence Matters. J Racial Ethn Health Disparities. 2017 Feb;4(1):87-93. doi: 10.1007/s40615-015-0205-9. Epub 2016 Jan 8.

    PubMed 26746424

  • Lescano CM, Brown LK, Raffaelli M, Lima LA. Cultural factors and family-based HIV prevention intervention for Latino youth. J Pediatr Psychol. 2009 Nov-Dec;34(10):1041-52. doi: 10.1093/jpepsy/jsn146. Epub 2009 Jan 30.

    PubMed 19181820

  • Centers for Disease Control and Prevention. HIV in the United States: At a Glance. 2015; https://www.cdc.gov/hiv/statistics/overview/ataglance.html. Accessed June, 2017.

  • Vega WA, Rodriguez MA, Gruskin E. Health disparities in the Latino population. Epidemiol Rev. 2009;31:99-112. doi: 10.1093/epirev/mxp008. Epub 2009 Aug 27.

    PubMed 19713270

  • Prosser AT, Tang T, Hall HI. HIV in persons born outside the United States, 2007-2010. JAMA. 2012 Aug 8;308(6):601-7. doi: 10.1001/jama.2012.9046.

    PubMed 22820630

  • Wiewel EW, Torian LV, Hanna DB, Bocour A, Shepard CW. Foreign-Born Persons Diagnosed with HIV: Where are They From and Where Were They Infected? AIDS Behav. 2015 May;19(5):890-8. doi: 10.1007/s10461-014-0954-1.

    PubMed 25524308

  • Gill MJ, Krentz HB. Unappreciated epidemiology: the churn effect in a regional HIV care programme. Int J STD AIDS. 2009 Aug;20(8):540-4. doi: 10.1258/ijsa.2008.008422.

    PubMed 19625584

  • Saint-Jean G, Devieux J, Malow R, Tammara H, Carney K. Substance Abuse, Acculturation, and HIV Risk among Caribbean-Born Immigrants in the United States. J Int Assoc Physicians AIDS Care (Chic). 2011 Sep-Oct;10(5):326-32. doi: 10.1177/1545109711401749. Epub 2011 Apr 21.

    PubMed 21511982

  • McMahon T, Ward PR. HIV among immigrants living in high-income countries: a realist review of evidence to guide targeted approaches to behavioural HIV prevention. Syst Rev. 2012 Nov 20;1:56. doi: 10.1186/2046-4053-1-56.

    PubMed 23168134

  • Shedlin MG, Drucker E, Decena CU, Hoffman S, Bhattacharya G, Beckford S, Barreras R. Immigration and HIV/AIDS in the New York Metropolitan Area. J Urban Health. 2006 Jan;83(1):43-58. doi: 10.1007/s11524-005-9006-5.

    PubMed 16736354

  • Nwosu C, Balaova J. Immigrants from the Dominican Republic in the United States. 2014; https://www.migrationpolicy.org/article/immigrants-dominican-republic-united-states. Accessed May, 2019.

Questions about this trial

What is this clinical trial studying?

A study testing Infographic intervention in people with Health Communication, run by Columbia University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Sep 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean CD4 Count (time frame: Baseline, 3-, and 6-months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04102540, which also lists 61 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2021.

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