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

Sponsor

University of Colorado, Denver (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT04564209

Collaborator

National Institute of Nursing Research (NINR) (NIH)

164

Enrollment

Locations

Arms

19.4

Anticipated Duration (Months)

Patients Per Site

4.2

Patients Per Site Per Month

Study Details

Study Description

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	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

164 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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

Aug 18, 2021

Anticipated Primary Completion Date :

Mar 30, 2023

Anticipated Study Completion Date :

Mar 30, 2023

Arms and Interventions

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.

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

Primary Outcome Measures

Change in CD4 count over time [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

Change in viral load over time [Baseline, 3-month, 6-month, 9-month]
Change in viral load count measured at 3-month intervals following baseline
HIV-related knowledge assessment [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
Satisfaction with Care Scale Score [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
SEMCD Scale Score [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).
Medication Adherence Score [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".
Health Status Average Score [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

Health Literacy Score: Short Assessment of Health Literacy Spanish & English (SAHL S&E) [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.
Health Literacy Score: Newest Vital Sign (NVS) [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.
Brief Acculturation Rating Scale for Mexican Americans-II [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

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.