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

February 28, 2025 updated by: University of Colorado, Denver

Information Visualizations to Facilitate Clinician-patient Communication in HIV Care (Info Viz: HIV)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

164

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Dominican Republic
      • La Romana, Dominican Republic, 22000
        • Clinica de Familia La Romana
  • United States
    • Colorado
      • Denver, Colorado, United States, 80204
        • Denver Health and Hospital Authority

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline, 3-month, 6-month, 9-month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Baseline, 3-month, 6-month, 9-month
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
Baseline, 3-month, 6-month, 9-month
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
Baseline, 3-month, 6-month, 9-month
Satisfaction With Provider Scale Score
Time Frame: Baseline, 3-month, 6-month, 9-month

Satisfaction with provider was measured with the Overall Satisfaction with Provider and Clinic scale published by Dang et al., 2016. We asked a selection of questions from this scale based on their appropriateness for our study. The questions asked and the range of possible scores are as follows.

Question 1: 1 - 7 Question 2: 1 - 10 Question 3: 1 - 7 Question 4: 1 - 5

Total scores are then calculated by adding participant responses on each of the four questions. The total possible score range for the questions asked from this scale was 4 - 29, with higher scores indicating more satisfaction with HIV provider.
Baseline, 3-month, 6-month, 9-month
Simplified Medication Adherence Questionnaire (SMAQ)
Time Frame: Baseline, 3-month, 6-month, 9-month

We measured adherence to prescribed antiretroviral therapy with the validated simplified medication adherence questionnaire (SMAQ) (Knobel 2002). This is a 6- item questionnaire that measures medication adherence. There is no minimum or maximum score on this scale. Participants are considered either "adherent" (better outcome) or "non-adherent" (worse outcome) based on their responses to these 6 questions.

They are considered "non-adherent" if they answer "yes" to questions 1, 2, 3, OR 5, regardless of their answers on the other questions.

Participants are also considered "non-adherent" when they indicate that they have missed more than two doses of their medication in the past week (response to question 4), or over 2 days of total non-medication during the past 3 months (response on question 6).
Baseline, 3-month, 6-month, 9-month
Health Status Average Score
Time Frame: Baseline, 3-month, 6-month, 9-month
Health status will be assessed with a question on the health status assessment scale, on which participants rank their current health status on a scale of 0 - 100 where 0=death or worst possible health and 100=perfect or best possible health (without HIV infection).
Baseline, 3-month, 6-month, 9-month
Satisfaction With Clinic
Time Frame: Baseline, 3-, 6-, and 9-months

Satisfaction with clinic was measured with a selection of questions from the Overall Satisfaction with Provider and Clinic scale published by Dang et al., 2016. To assess satisfaction with the clinics, we asked a selection of questions from this scale based on their appropriateness for our study. The included questions and the associated range of possible scores are as follows.

Question 7: 1 - 7 points possible Question 8: 1 - 7 points possible Question 9: 1 - 5 points possible

Total scores are then calculated by adding participant responses on each of the three questions. The total possible score range for the questions asked from this scale was 3 - 19, with higher scores indicating more satisfaction with the clinic.
Baseline, 3-, 6-, and 9-months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline visit only
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.
Baseline visit only
Brief Acculturation Rating Scale for Mexican Americans-II
Time Frame: Baseline visit only

The Brief Acculturation Rating Scale for Mexican Americans- II (ARMSA-II) is a 12-item scale that measures acculturation with 6 items from the AOS (Anglo Oriented Scale) of the ARSMA-II and 6 items from the MOS (Mexican Oriented Scale) (Bauman 2005). Responses are collected with Likert-type questions on which the scores range from 1 (not at all) to 5 (almost always/extremely often) on each item. The ARMSA-II has been used in Mexican Americans as well as other Latino subgroups, including Dominicans.

Scores are calculated by summing the scores on each of the six item subscales and then dividing by 12 to get a mean acculturation score. Therefore, the possible range of scores is 1-5 with higher scores indicating greater acculturation.

Note: The scale was only administered to participants who were not born in the country where data collection took place.
Baseline visit only

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Colorado, Denver

Collaborators

National Institute of Nursing Research (NINR)

Investigators

  • Principal Investigator: Samantha Stonbraker, PhD, MPH, RN, University of Colorado College of Nursing

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 18, 2021

Primary Completion (Actual)

June 28, 2023

Study Completion (Actual)

June 28, 2023

Study Registration Dates

First Submitted

September 21, 2020

First Submitted That Met QC Criteria

September 21, 2020

First Posted (Actual)

September 25, 2020

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 28, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 20-0163
  • R00NR017829 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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.

IPD Sharing Time Frame

Data will be available 3 months after the publication of primary results.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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