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| ID | Type | Description | Link |
|---|---|---|---|
| R00NR017829 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Nursing Research (NINR) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Control | No Intervention | The control groups will receive standard health education. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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:
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| Name | Affiliation | Role |
|---|---|---|
| Samantha Stonbraker, PhD, MPH, RN | University of Colorado College of Nursing | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Denver Health and Hospital Authority | Denver | Colorado | 80204 | United States | ||
| Clínica de Familia La Romana |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23184612 | Background | 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. | |
| 24697557 | Background | Ochoa 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. |
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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.
Data will be available 3 months after the publication of primary results.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. 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. |
| FG001 | Control | The control groups will receive standard health education. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Patient participants for the RCT were adult (≥ 18 years), Hispanic/Latino, English or Spanish-speaking, living with HIV with a detectable viral load (>30 or >40 copies/mL depending on the laboratory test) at any point in the past year or be newly diagnosed with HIV, or have an indication of adherence risk as identified by their provider and be planning to receive care at the study site for the next year. If patient participants are pregnant, they may still be included in the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in CD4 Count Over Time | Change in Cluster of Differentiation 4 (CD4) count measured at 3-month intervals following baseline visit | There was some attrition over time. | Posted | Mean | Standard Deviation | Cells/mm3 | Baseline, 3-month, 6-month, 9-month |
|
Full duration of enrollment (approx 9-18 months).
We used the same definitions as clinicaltrials.gov for adverse event reporting.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Samantha Stonbraker, Study PI | University of Colorado College of Nursing | 720-880-8194 | Samantha.Stonbraker@CUAnschutz.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 20, 2023 | Oct 28, 2024 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 4, 2022 | Jun 22, 2022 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D006266 | Health Education |
| ID | Term |
|---|---|
| D000099060 | Adherence Interventions |
| D055118 | Medication Adherence |
| D010349 | Patient Compliance |
| D010342 | Patient Acceptance of Health Care |
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| ID | Term |
|---|---|
| D006262 | Health |
| ID | Term |
|---|---|
| D011154 | Population Characteristics |
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There is a treatment and a control group at each site.
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Study team members who are recruiting will not be aware of which group study participants are being assigned to.
| 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. | 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). | 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). | 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). | 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. | Baseline, 3-, 6-, and 9-months |
| 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 |
| Brief Acculturation Rating Scale for Mexican Americans-II | 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. | Baseline visit only |
| La Romana |
| 22000 |
| Dominican Republic |
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| 18399360 | Background | Devieux JG, Malow RM, Jean-Gilles MM, Samuels DM, Deschamps MM, Ascencio M Jr, Jean-Baptiste L, Pape JW. Reducing health disparities through culturally sensitive treatment for HIV+ adults in Haiti. ABNF J. 2004 Nov-Dec;15(6):109-15. |
| 24588455 | Background | Ramos Z, Alegria M. Cultural adaptation and health literacy refinement of a brief depression intervention for Latinos in a low-resource setting. Cultur Divers Ethnic Minor Psychol. 2014 Apr;20(2):293-301. doi: 10.1037/a0035021. Epub 2014 Mar 3. |
| 27418347 | Background | Sarkar U, Gourley GI, Lyles CR, Tieu L, Clarity C, Newmark L, Singh K, Bates DW. Usability of Commercially Available Mobile Applications for Diverse Patients. J Gen Intern Med. 2016 Dec;31(12):1417-1426. doi: 10.1007/s11606-016-3771-6. Epub 2016 Jul 14. |
| 26735431 | Background | Abraido-Lanza AF, Echeverria SE, Florez KR. Latino Immigrants, Acculturation, and Health: Promising New Directions in Research. Annu Rev Public Health. 2016;37:219-36. doi: 10.1146/annurev-publhealth-032315-021545. Epub 2016 Jan 6. |
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| BG001 | Control | The control groups will receive standard health education. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | Years |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Health Literacy | Health literacy at baseline was assessed with the Short Assessment of Health Literacy - Spanish and English. The number reported is the number of treatment and control participants who scored >= 15 points on this assessment and are considered "likely to be health literate" | Count of Participants | Participants |
|
The control groups will receive standard health education. |
|
|
|
| Secondary | Change in Viral Load Over Time | Change in viral load count measured at 3-month intervals following baseline | There was some attrition over time. | Posted | Mean | Standard Deviation | copies/mL | Baseline, 3-month, 6-month, 9-month |
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|
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| 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 | There was some attrition over time. | Posted | Mean | Standard Deviation | HIV-related Knowledge Assessment Scores | Baseline, 3-month, 6-month, 9-month |
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| Secondary | 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. | There was some attrition over time. | Posted | Mean | Standard Deviation | Satisfaction with provider scale score | Baseline, 3-month, 6-month, 9-month |
|
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| 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). | There was some attrition over time. | Posted | Mean | Standard Deviation | SEMCD Scale Score | Baseline, 3-month, 6-month, 9-month |
|
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|
| Secondary | 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). | There was some attrition over time. | Posted | Count of Participants | Participants | Baseline, 3-month, 6-month, 9-month |
|
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| Secondary | 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). | There was some attrition over time. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 3-month, 6-month, 9-month |
|
|
|
|
| Secondary | 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. | There was some attrition over time. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 3-, 6-, and 9-months |
|
|
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| Other Pre-specified | 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. | Posted | Mean | Standard Deviation | Health Literacy Score | Baseline visit only |
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| Other Pre-specified | 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. | Posted | Mean | Standard Deviation | Health Literacy Score: Newest Vital Sign | Baseline visit only |
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| Other Pre-specified | Brief Acculturation Rating Scale for Mexican Americans-II | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline visit only |
|
|
|
|
| 1 |
| 83 |
| 0 |
| 83 |
| 0 |
| 83 |
| EG001 | Control | The control groups will receive standard health education. | 1 | 81 | 0 | 81 | 0 | 81 |
Not provided
Not provided
Not provided
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
| 3 Month |
|
|
| 6 Month |
|
|
| 9 Month |
|
|
| 3 Month |
|
|
| 6 Month |
|
|
| 9 Month |
|
|
| 3 Month |
|
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| 6 Month |
|
|
| 9 Month |
|
|
| 3 Month |
|
|
| 6 Month |
|
|
| 9 Month |
|
|
| Non Adherent |
|
| 3 Month |
|
|
| 6 Month |
|
|
| 9 Month |
|
|
| 3 Month |
|
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| 6 Month |
|
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| 9 Month |
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| 3-months |
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| 6-months |
|
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| 9-months |
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