Information Visualizations to Enhance HIV-related Communication

NCT04564209 | Completed Results DMC

• 2 other identifiers: 20-0163R00NR017829
• Study Type: interventional
• Target: 164
• Locations: 2 countries
• Sites: 2

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.

Conditions

HIV; Communication Research

Keywords

Health literacy; HIV; Infographic; Information-visualization; Clinician-patient communication; Health education

Outcome Measures

Primary Outcomes (1)

• Change in CD4 Count Over Time

  Change in Cluster of Differentiation 4 (CD4) count measured at 3-month intervals following baseline visit

  Baseline, 3-month, 6-month, 9-month

Secondary Outcomes (7)

• Change in Viral Load Over Time

  Baseline, 3-month, 6-month, 9-month

• HIV-related Knowledge Assessment

  Baseline, 3-month, 6-month, 9-month

• Satisfaction With Provider Scale Score

  Baseline, 3-month, 6-month, 9-month

• SEMCD Scale Score

  Baseline, 3-month, 6-month, 9-month

• Simplified Medication Adherence Questionnaire (SMAQ)

  Baseline, 3-month, 6-month, 9-month

Other Outcomes (3)

• Health Literacy Score: Short Assessment of Health Literacy Spanish & English (SAHL S&E)

  Baseline visit only

• Health Literacy Score: Newest Vital Sign (NVS)

  Baseline visit only

• Brief Acculturation Rating Scale for Mexican Americans-II

  Baseline visit only

Study Arms (2)

Treatment

EXPERIMENTAL

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

Control

NO INTERVENTION

The control groups will receive standard health education.

Interventions

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.

Treatment

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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.

Sponsors & Collaborators

• University of Colorado, Denver: lead
• National Institute of Nursing Research (NINR): collaborator

Study Sites (2)

Denver Health and Hospital Authority

Denver, Colorado, 80204, United States

Location

Clínica de Familia La Romana

La Romana, 22000, Dominican Republic

Location

Related Publications (68)

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MeSH Terms

Conditions

Health Education

Interventions

Health

Condition Hierarchy (Ancestors)

Adherence Interventions; Medication Adherence; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Population Characteristics

Results Point of Contact

• Title: Dr. Samantha Stonbraker, Study PI
• Organization: University of Colorado College of Nursing

Samantha.Stonbraker@CUAnschutz.edu

720-880-8194

Study Officials

• Samantha Stonbraker, PhD, MPH, RN

  University of Colorado College of Nursing

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Study team members who are recruiting will not be aware of which group study participants are being assigned to.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: There is a treatment and a control group at each site.

Study Record Dates

• First Submitted: September 21, 2020
• First Posted: September 25, 2020
• Study Start: August 18, 2021
• Primary Completion: June 28, 2023
• Study Completion: June 28, 2023
• Last Updated: March 6, 2025
• Results First Posted: March 6, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: 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.

Locations

US (1); DO (1)