Information Visualizations to Enhance HIV-related Communication

HIV Clinical Trial

— Info Viz: HIV  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04564209
• Other study ID #: 20-0163
• Secondary ID: R00NR017829
• Status: Completed
• Phase: N/A
• Start date: August 18, 2021
• Est. completion date: June 28, 2023

Study information

• Verified date: August 2023
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 164
• Est. completion date: June 28, 2023
• Est. primary completion date: June 28, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Communication Research
• HIV

Intervention

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.

Locations

Country	Name	City	State
Dominican Republic	Clínica de Familia La Romana	La Romana
United States	Denver Health and Hospital Authority	Denver	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
University of Colorado, Denver	National Institute of Nursing Research (NINR)

Countries where clinical trial is conducted

United States,  Dominican Republic, 

References & Publications (68)

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* Note: There are 68 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Health Literacy Score: Short Assessment of Health Literacy Spanish & English (SAHL S&E)	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
Other	Health Literacy Score: Newest Vital Sign (NVS)	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
Other	Brief Acculturation Rating Scale for Mexican Americans-II	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.	Baseline visit only
Primary	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	Change in viral load over time	Change in viral load count measured at 3-month intervals following baseline	Baseline, 3-month, 6-month, 9-month
Secondary	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	Baseline, 3-month, 6-month, 9-month
Secondary	Satisfaction with Care Scale Score	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	Baseline, 3-month, 6-month, 9-month
Secondary	SEMCD Scale Score	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
Secondary	Medication Adherence Score	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".	Baseline, 3-month, 6-month, 9-month
Secondary	Health Status Average Score	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.	Baseline, 3-month, 6-month, 9-month