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Information Visualizations to Enhance HIV-related Communication (Info Viz: HIV)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04564209
Recruitment Status : Recruiting
First Posted : September 25, 2020
Last Update Posted : September 28, 2021
Sponsor:
Collaborator:
National Institute of Nursing Research (NINR)
Information provided by (Responsible Party):
University of Colorado, Denver

Study Description
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Brief Summary:

HIV disproportionately affects Latinos who have more infections, faster disease progression, more HIV-related deaths, and slower diagnosis and treatment than their white/majority counterparts. This is a concern across the United States (US) and in developing countries, such as the Dominican Republic (DR). The HIV-related health disparities experienced by Latinos are made worse when those living with HIV have low health literacy and difficulty understanding the information they need to manage their health.

The PI developed a set of images to assist clinicians in providing information to Latino people living with HIV (PLWH). These images have been put into a mobile health app so clinicians can easily access them during clinic visits. The PI has tested her with PLWH in the DR and in New York City. So, the next steps in this research are to ensure the images are relevant and useful to Latinos across the United States (US) and to further assess if, and to what extent, the images can improve health outcomes among PLWH in the US and in the DR. We will therefore, adapt images to Latinos of Mexican origin/descent and then test them to determine if these images help clinicians provide information to patients by conducting a study at clinical sites in the US and in the DR.


Condition or disease Intervention/treatment Phase
HIV Communication Research Other: Info Viz for Health Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 164 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: There is a treatment and a control group at each site.
Masking: Single (Investigator)
Masking Description: Study team members who are recruiting will not be aware of which group study participants are being assigned to.
Primary Purpose: Health Services Research
Official Title: Information Visualizations to Facilitate Clinician-patient Communication in HIV Care (Info Viz: HIV)
Actual Study Start Date : August 18, 2021
Estimated Primary Completion Date : September 30, 2022
Estimated Study Completion Date : September 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arms and Interventions
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Arm Intervention/treatment
Experimental: Treatment
The treatment group will be exposed to the infographic intervention when they present for clinic/study visits. During their visit with the provider, the provider offer health education while using infographics.
 Other: Info Viz for Health
During the intervention, health care providers provide HIV-related health education using a mobile app that contains a bilingual database of relevant infographics.
No Intervention: Control
The control groups will receive standard health education.


Outcome Measures
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Primary Outcome Measures :
  1. Change in CD4 count over time [ Time Frame: Baseline, 3-month, 6-month, 9-month ]
    Change in Cluster of Differentiation 4 (CD4) count measured at 3-month intervals following baseline visit


Secondary Outcome Measures :
  1. Change in viral load over time [ Time Frame: Baseline, 3-month, 6-month, 9-month ]
    Change in viral load count measured at 3-month intervals following baseline

  2. HIV-related knowledge assessment [ Time Frame: Baseline, 3-month, 6-month, 9-month ]
    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

  3. Satisfaction with Care Scale Score [ Time Frame: Baseline, 3-month, 6-month, 9-month ]

    11 questions on patients' satisfaction with health care provider and the health care center adapted from previously validated instruments are included.

    Each question response has a different scale:

    Question 1: High Score 7 Question 2: High Score 10 Question 3: High Score 7 Question 4: High Score 5 Question 5:

    High Score 5 Question 6: High Score 6 Question 7: High Score 7 Question 8: High Score 7 Question 9: High Score 5 Question 10: High Score 5 Question 11: High Score 10


  4. SEMCD Scale Score [ Time Frame: Baseline, 3-month, 6-month, 9-month ]

    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).


  5. Medication Adherence Score [ Time Frame: Baseline, 3-month, 6-month, 9-month ]

    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".


  6. Health Status Average Score [ Time Frame: Baseline, 3-month, 6-month, 9-month ]
    Health status will be assessed with the Health Status Assessment which includes two quality of life measures. The first, a general health item scored on a five-point scale where 1 is excellent and 5 is poor and the second, a health assessment scale from 0 - 100 where 0=death or worst possible health and 100=perfect or best possible health.


Other Outcome Measures:
  1. Health Literacy Score: Short Assessment of Health Literacy Spanish & English (SAHL S&E) [ Time Frame: Baseline visit only ]
    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.

  2. Health Literacy Score: Newest Vital Sign (NVS) [ Time Frame: Baseline visit only ]
    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.

  3. Brief Acculturation Rating Scale for Mexican Americans-II [ Time Frame: Baseline visit only ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

- Participants must self-identify as Latino, be English or Spanish-speaking, living with HIV with a detectable viral load (>200 copies/mL) at any point in the past year or have an indication of adherence risk, and planning to receive care at the study site for the next year.

Exclusion Criteria:

  • Not meeting inclusion criteria or not having the mental capacity to understand the study or provide informed consent.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04564209


Contacts
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Contact: Samantha Stonbraker, PhD, MPH, RN 720-880-8194 Samantha.Stonbraker@cuanschutz.edu

Locations
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United States, Colorado
Denver Health and Hospital Authority Recruiting
Denver, Colorado, United States, 80204
Contact: Edward M Gardner, MD       edward.m.gardner@dhha.org   
Dominican Republic
Clínica de Familia La Romana Recruiting
La Romana, Dominican Republic, 22000
Contact: Pamela Baez Caraballo, MD, MSc       Pamela@clinicadefamilia.org.do   
Sponsors and Collaborators
University of Colorado, Denver
National Institute of Nursing Research (NINR)
Investigators
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Principal Investigator: Samantha Stonbraker, PhD, MPH, RN University of Colorado College of Nursing
More Information
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Publications:

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Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT04564209    
Other Study ID Numbers: 20-0163
R00NR017829 ( U.S. NIH Grant/Contract )
First Posted: September 25, 2020    Key Record Dates
Last Update Posted: September 28, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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.
Supporting Materials: Clinical Study Report (CSR)
Analytic Code
Time Frame: Data will be available 3 months after the publication of primary results.
Access Criteria: To request data please email the study director listed on this record with the reason you need the data and your planned use of it.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Colorado, Denver:
Health literacy
HIV
Infographic
 Information-visualization
Clinician-patient communication
Health education