HIVInfo Viz: HIVNCT04564209
Information Visualizations to Enhance HIV-related Communication
A study testing Info Viz for Health in people with HIV and Communication Research, run by University of Colorado, Denver at 2 sites in 2 countries.
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). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- HIV, Communication Research
- What is being tested?
- Info Viz for Health
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 164 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 18 Aug 2021to 28 Jun 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Not meeting inclusion criteria or not having the mental capacity to understand the study or provide informed consent.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
Denver Health and Hospital Authority
Denver, Colorado, 80204
Dominican Republic1 site
Clínica de Familia La Romana
La Romana, 22000
About this study
Official title: 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.
- Conditions
- HIV, Communication Research
- Being tested
- Info Viz for Health
- Keywords
- Health literacy, HIV, Infographic, Information-visualization, Clinician-patient communication, Health education
- Medical subject headings
- Health Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Info Viz for HealthOther
During the intervention, health care providers provide HIV-related health education using a mobile app that contains a bilingual database of relevant infographics.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Info Viz for Health |
| Control | No intervention | The control groups will receive standard health education. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in CD4 Count Over Time
Change in Cluster of Differentiation 4 (CD4) count measured at 3-month intervals following baseline visit
Measured: Baseline, 3-month, 6-month, 9-month
Secondary outcomes (7)
Change in Viral Load Over Time
Change in viral load count measured at 3-month intervals following baseline
Measured: Baseline, 3-month, 6-month, 9-month
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
Measured: Baseline, 3-month, 6-month, 9-month
Satisfaction With Provider Scale Score
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.
Measured: Baseline, 3-month, 6-month, 9-month
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).
Measured: Baseline, 3-month, 6-month, 9-month
Simplified Medication Adherence Questionnaire (SMAQ)
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).
Measured: Baseline, 3-month, 6-month, 9-month
Health Status Average Score
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).
Measured: Baseline, 3-month, 6-month, 9-month
Satisfaction With Clinic
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.
Measured: Baseline, 3-, 6-, and 9-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2020
- Study start18 Aug 2021
- Primary completion28 Jun 2023
- Study completion28 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (68)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- There is a treatment and a control group at each site.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 164 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Responsible party
- Sponsor
- Investigators
- Samantha Stonbraker, PhD, MPH, RN, Principal investigator, University of Colorado College of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04564209
- Sponsor's protocol ID
- 20-0163
- Other IDs
- R00NR017829
- Acronym
- Info Viz: HIV
- Status last verified
- Feb 2025
- First submitted
- 21 Sep 2020
- Last updated
- 6 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
Henao-Martinez AF, Castillo-Mancilla JR. The Hispanic HIV Epidemic. Curr Infect Dis Rep. 2013 Feb;15(1):46-51. doi: 10.1007/s11908-012-0306-0.
PubMed 23184612Ochoa SC, Sampalis J. Risk perception and vulnerability to STIs and HIV/AIDS among immigrant Latin-American women in Canada. Cult Health Sex. 2014;16(4):412-25. doi: 10.1080/13691058.2014.884632. Epub 2014 Apr 4.
PubMed 24697557Goldenberg SM, Strathdee SA, Perez-Rosales MD, Sued O. Mobility and HIV in Central America and Mexico: a critical review. J Immigr Minor Health. 2012 Feb;14(1):48-64. doi: 10.1007/s10903-011-9505-2.
PubMed 21789558Gonzalez JS, Hendriksen ES, Collins EM, Duran RE, Safren SA. Latinos and HIV/AIDS: examining factors related to disparity and identifying opportunities for psychosocial intervention research. AIDS Behav. 2009 Jun;13(3):582-602. doi: 10.1007/s10461-008-9402-4. Epub 2008 May 23.
PubMed 18498050Xia Q, Braunstein SL, Wiewel EW, Hadler JL, Torian LV. Persistent Racial Disparities in HIV Infection in the USA: HIV Prevalence Matters. J Racial Ethn Health Disparities. 2017 Feb;4(1):87-93. doi: 10.1007/s40615-015-0205-9. Epub 2016 Jan 8.
PubMed 26746424Rojas P, Malow R, Ruffin B, Rothe EM, Rosenberg R. The HIV/AIDS Epidemic in the Dominican Republic: Key Contributing Factors. J Int Assoc Physicians AIDS Care (Chic). 2011 Sep-Oct;10(5):306-15. doi: 10.1177/1545109710397770. Epub 2011 Mar 2.
PubMed 21368008De Boni R, Veloso VG, Grinsztejn B. Epidemiology of HIV in Latin America and the Caribbean. Curr Opin HIV AIDS. 2014 Mar;9(2):192-8. doi: 10.1097/COH.0000000000000031.
PubMed 24356327Perez-Escamilla R. Acculturation, nutrition, and health disparities in Latinos. Am J Clin Nutr. 2011 May;93(5):1163S-7S. doi: 10.3945/ajcn.110.003467. Epub 2011 Mar 2.
PubMed 21367946Barreto SM, Miranda JJ, Figueroa JP, Schmidt MI, Munoz S, Kuri-Morales PP, Silva JB Jr. Epidemiology in Latin America and the Caribbean: current situation and challenges. Int J Epidemiol. 2012 Apr;41(2):557-71. doi: 10.1093/ije/dys017. Epub 2012 Mar 9.
PubMed 22407860Wawrzyniak AJ, Ownby RL, McCoy K, Waldrop-Valverde D. Health literacy: impact on the health of HIV-infected individuals. Curr HIV/AIDS Rep. 2013 Dec;10(4):295-304. doi: 10.1007/s11904-013-0178-4.
PubMed 24222474Laws MB, Lee Y, Rogers WH, Beach MC, Saha S, Korthuis PT, Sharp V, Cohn J, Moore R, Wilson IB. Provider-patient communication about adherence to anti-retroviral regimens differs by patient race and ethnicity. AIDS Behav. 2014 Jul;18(7):1279-87. doi: 10.1007/s10461-014-0697-z.
PubMed 24464408Kalichman SC, Rompa D. Functional health literacy is associated with health status and health-related knowledge in people living with HIV-AIDS. J Acquir Immune Defic Syndr. 2000 Dec 1;25(4):337-44. doi: 10.1097/00042560-200012010-00007.
PubMed 11114834Kalichman SC, Benotsch E, Suarez T, Catz S, Miller J, Rompa D. Health literacy and health-related knowledge among persons living with HIV/AIDS. Am J Prev Med. 2000 May;18(4):325-31. doi: 10.1016/s0749-3797(00)00121-5.
PubMed 10788736Zhang NJ, Terry A, McHorney CA. Impact of health literacy on medication adherence: a systematic review and meta-analysis. Ann Pharmacother. 2014 Jun;48(6):741-51. doi: 10.1177/1060028014526562. Epub 2014 Mar 11.
PubMed 24619949Barlow J, Wright C, Sheasby J, Turner A, Hainsworth J. Self-management approaches for people with chronic conditions: a review. Patient Educ Couns. 2002 Oct-Nov;48(2):177-87. doi: 10.1016/s0738-3991(02)00032-0.
PubMed 12401421
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Information Visualizations to Facilitate Clinician-patient Communication in HIV Care (Info Viz: HIV)
- ClinicalTrials.gov ID
- NCT04564209
- Acronym / sponsor ID
- Info Viz: HIV / 20-0163
- Conditions
- HIV, Communication Research
- Keywords
- Health literacy, HIV, Infographic, Information-visualization, Clinician-patient communication, Health education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 164 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Study start
- 18 Aug 2021 (actual)
- Primary completion
- 28 Jun 2023 (actual)
- Study completion
- 28 Jun 2023 (actual)
- First posted
- 25 Sep 2020 (actual)
- Results
- Posted 6 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- There is a treatment and a control group at each site.
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Other: Info Viz for HealthThe 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. |
| Control | No intervention | –The control groups will receive standard health education. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Not meeting inclusion criteria or not having the mental capacity to understand the study or provide informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Info Viz for HealthDuring the intervention, health care providers provide HIV-related health education using a mobile app that contains a bilingual database of relevant infographics. | Other | Treatment |
Primary outcome
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
7 secondary outcomes
Change in Viral Load Over Time
Time frame: Baseline, 3-month, 6-month, 9-month
HIV-related Knowledge Assessment
Time frame: Baseline, 3-month, 6-month, 9-month
Satisfaction With Provider Scale Score
Time frame: Baseline, 3-month, 6-month, 9-month
SEMCD Scale Score
Time frame: Baseline, 3-month, 6-month, 9-month
Simplified Medication Adherence Questionnaire (SMAQ)
Time frame: Baseline, 3-month, 6-month, 9-month
Health Status Average Score
Time frame: Baseline, 3-month, 6-month, 9-month
Satisfaction With Clinic
Time frame: Baseline, 3-, 6-, and 9-months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 23184612Henao-Martinez AF, Castillo-Mancilla JR. The Hispanic HIV Epidemic. Curr Infect Dis Rep. 2013 Feb;15(1):46-51. doi: 10.1007/s11908-012-0306-0.
- Background: PubMed 24697557Ochoa SC, Sampalis J. Risk perception and vulnerability to STIs and HIV/AIDS among immigrant Latin-American women in Canada. Cult Health Sex. 2014;16(4):412-25. doi: 10.1080/13691058.2014.884632. Epub 2014 Apr 4.
- Background: PubMed 21789558Goldenberg SM, Strathdee SA, Perez-Rosales MD, Sued O. Mobility and HIV in Central America and Mexico: a critical review. J Immigr Minor Health. 2012 Feb;14(1):48-64. doi: 10.1007/s10903-011-9505-2.
- Background: PubMed 18498050Gonzalez JS, Hendriksen ES, Collins EM, Duran RE, Safren SA. Latinos and HIV/AIDS: examining factors related to disparity and identifying opportunities for psychosocial intervention research. AIDS Behav. 2009 Jun;13(3):582-602. doi: 10.1007/s10461-008-9402-4. Epub 2008 May 23.
- Background: PubMed 26746424Xia Q, Braunstein SL, Wiewel EW, Hadler JL, Torian LV. Persistent Racial Disparities in HIV Infection in the USA: HIV Prevalence Matters. J Racial Ethn Health Disparities. 2017 Feb;4(1):87-93. doi: 10.1007/s40615-015-0205-9. Epub 2016 Jan 8.
- Background: PubMed 21368008Rojas P, Malow R, Ruffin B, Rothe EM, Rosenberg R. The HIV/AIDS Epidemic in the Dominican Republic: Key Contributing Factors. J Int Assoc Physicians AIDS Care (Chic). 2011 Sep-Oct;10(5):306-15. doi: 10.1177/1545109710397770. Epub 2011 Mar 2.
- Background: PubMed 24356327De Boni R, Veloso VG, Grinsztejn B. Epidemiology of HIV in Latin America and the Caribbean. Curr Opin HIV AIDS. 2014 Mar;9(2):192-8. doi: 10.1097/COH.0000000000000031.
- Background: PubMed 21367946Perez-Escamilla R. Acculturation, nutrition, and health disparities in Latinos. Am J Clin Nutr. 2011 May;93(5):1163S-7S. doi: 10.3945/ajcn.110.003467. Epub 2011 Mar 2.
- Background: PubMed 22407860Barreto SM, Miranda JJ, Figueroa JP, Schmidt MI, Munoz S, Kuri-Morales PP, Silva JB Jr. Epidemiology in Latin America and the Caribbean: current situation and challenges. Int J Epidemiol. 2012 Apr;41(2):557-71. doi: 10.1093/ije/dys017. Epub 2012 Mar 9.
- Background: PubMed 24222474Wawrzyniak AJ, Ownby RL, McCoy K, Waldrop-Valverde D. Health literacy: impact on the health of HIV-infected individuals. Curr HIV/AIDS Rep. 2013 Dec;10(4):295-304. doi: 10.1007/s11904-013-0178-4.
- Background: PubMed 24464408Laws MB, Lee Y, Rogers WH, Beach MC, Saha S, Korthuis PT, Sharp V, Cohn J, Moore R, Wilson IB. Provider-patient communication about adherence to anti-retroviral regimens differs by patient race and ethnicity. AIDS Behav. 2014 Jul;18(7):1279-87. doi: 10.1007/s10461-014-0697-z.
- Background: PubMed 11114834Kalichman SC, Rompa D. Functional health literacy is associated with health status and health-related knowledge in people living with HIV-AIDS. J Acquir Immune Defic Syndr. 2000 Dec 1;25(4):337-44. doi: 10.1097/00042560-200012010-00007.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Samantha Stonbraker, PhD, MPH, RN principal investigator
University of Colorado College of Nursing
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Info Viz for Health in people with HIV and Communication Research, run by University of Colorado, Denver at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Dominican Republic. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in CD4 Count Over Time (time frame: Baseline, 3-month, 6-month, 9-month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04564209, which also lists 68 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2025.