Skip to main content
OpenTrials
Completed

NCT Number: NCT04564209

Information Visualizations to Enhance HIV-related Communication

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clínica de Familia La Romana, La Romana, Dominican Republic

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Info Viz for Health

Other

During the intervention, health care providers provide HIV-related health education using a mobile app that contains a bilingual database of relevant infographics.

Primary outcomes

  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 outcomes

  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 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.

  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. 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).

  6. 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).

  7. 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.

Other outcomes

  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

    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.

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

  • National Institute of Nursing Research (NINR)

Registry information

Official study title

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

Acronym: Info Viz: HIV

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Sep 25, 2020
Registry last updated
Mar 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.