Information Visualizations to Facilitate HIV-related Patient-provider Communication (Info Viz: HIV)
NCT ID: NCT03616106
Last Updated: 2020-09-03
Study Results
Results available
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
Recruitment Status
COMPLETED
Clinical Phase
NA
Total Enrollment
59 participants
Study Classification
INTERVENTIONAL
Study Start Date
2018-10-09
Study Completion Date
2019-08-09
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
To complete the study aims, a mixed methods study that includes a single group pretest-posttest study design will be used to pilot test the infographic intervention. In-depth interviews will be completed with a selection of participants to explore participant perceptions of HIV-related communication using infographics. Data will be collected from participants through baseline (at enrollment) and follow up assessments (at 3-, 6-, and 9-month follow up visits). Follow up interviews will be conducted with the providers involved in the intervention to ascertain their perspectives on the clinical utility of infographics.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Information Visualizations to Facilitate HIV-related Patient-provider Communication in New York City (Info Viz: HIV-NYC)
NCT04102540
Health Communication
COMPLETED
NA
Information Visualizations to Enhance HIV-related Communication
NCT04564209
HIV
Communication Research
COMPLETED
NA
A Computer-Based Parent/Adolescent HIV Communication Intervention for Latinos
NCT01084421
HIV/AIDS
STD
Pregnancy
COMPLETED
NA
HIV Testing & Womens Attitudes on HIV Vaccine Trials
NCT00771537
HIV
COMPLETED
PHASE3
Pediatric Impact: Promoting Adherence to Medications Among HIV-infected Children
NCT00134602
HIV Infections
COMPLETED
NA
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The Caribbean has among the highest HIV prevalence in the world. Regionally, the majority of HIV/AIDS cases are located on the island of Hispaniola, comprised of the Dominican Republic (DR) and Haiti. Due to a large international response and widespread availability of antiretroviral therapy (ART), in recent years the incidence of HIV in the DR has declined and prevalence hovers around 1% in the general population. The effective and long-term management of this condition depends on infected individuals being able to acquire ART and apply the learned information and self-management skills that lead to optimal adherence.
HIV-related disparities exist in developing countries, such as the DR, where minority groups and/or those with low socioeconomic status experience higher disease burdens and worse health outcomes than those with higher socioeconomic status. These disparities may be exacerbated when individuals are unable to understand the health information, as low health literacy has been associated with worse health outcomes, less use of healthcare services, poorer knowledge of illness, and worse self-management. The effective management of HIV requires patients to acquire, comprehend, and use large amounts of complex information, including how to manage variations in health status, medications and their side effects, nutrition and exercise needs, and healthy coping. Health care providers can help patients understand pertinent health information by offering it in targeted, culturally-, language-, and literacy-appropriate ways.
One such strategy is to use infographics to assist communication through visual representations of information. Participatory design of infographics supports presentation of information in a culturally appropriate and visually appealing format which can improve information understanding, health behaviors, attention span, and ability to recall information. It is critical to develop and test methods to improve the way health information is delivered to patients in these clinical contexts so patients, including those with low health literacy, can acquire and comprehend the information needed to improve self-management behavior and treatment outcomes.
Preliminary studies showed many persons living with HIV (PLWH) attending Clínica de Familia La Romana do not fully comprehend and use the health information they receive through current modalities. In response, culturally relevant, evidence-based infographics to improve information delivery during clinical visits were developed with a participatory design methodology (manuscript under review). The next phase of this study is to rigorously assess if using these infographics is a feasible, acceptable, and efficacious method to enhance HIV-related clinician-patient communication and lead to improved patient outcomes. Additionally, a thorough exploration into the cultural factors of patient-provider communication in the Dominican Republic that can influence infographic use for clinician-patient communication in a clinical setting is warranted.
HIV-related disparities exist in developing countries, such as the DR, where minority groups and/or those with low socioeconomic status experience higher disease burdens and worse health outcomes than those with higher socioeconomic status. These disparities may be exacerbated when individuals are unable to understand the health information, as low health literacy has been associated with worse health outcomes, less use of healthcare services, poorer knowledge of illness, and worse self-management. The effective management of HIV requires patients to acquire, comprehend, and use large amounts of complex information, including how to manage variations in health status, medications and their side effects, nutrition and exercise needs, and healthy coping. Health care providers can help patients understand pertinent health information by offering it in targeted, culturally-, language-, and literacy-appropriate ways.
One such strategy is to use infographics to assist communication through visual representations of information. Participatory design of infographics supports presentation of information in a culturally appropriate and visually appealing format which can improve information understanding, health behaviors, attention span, and ability to recall information. It is critical to develop and test methods to improve the way health information is delivered to patients in these clinical contexts so patients, including those with low health literacy, can acquire and comprehend the information needed to improve self-management behavior and treatment outcomes.
Preliminary studies showed many persons living with HIV (PLWH) attending Clínica de Familia La Romana do not fully comprehend and use the health information they receive through current modalities. In response, culturally relevant, evidence-based infographics to improve information delivery during clinical visits were developed with a participatory design methodology (manuscript under review). The next phase of this study is to rigorously assess if using these infographics is a feasible, acceptable, and efficacious method to enhance HIV-related clinician-patient communication and lead to improved patient outcomes. Additionally, a thorough exploration into the cultural factors of patient-provider communication in the Dominican Republic that can influence infographic use for clinician-patient communication in a clinical setting is warranted.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Health Communication
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
Allocation Method
NA
Intervention Model
SINGLE_GROUP
This study will use a single group pretest-posttest design to evaluate if using infographics during clinic visits can lead to improved patient outcomes.
Primary Study Purpose
HEALTH_SERVICES_RESEARCH
Blinding Strategy
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Intervention Group
Participants in the intervention group will receive health education using infographics (Infographic Intervention) during their regularly scheduled clinic visits.
Group Type
EXPERIMENTAL
Infographic intervention
Intervention Type
OTHER
All study participants will receive health education using infographics during their regularly scheduled clinic appointments.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Infographic intervention
All study participants will receive health education using infographics during their regularly scheduled clinic appointments.
Intervention Type
OTHER
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Adult (≥) 18 years of age
* Spanish-speaking
* Living with HIV and have a detectable viral load
* Attend Clínica de Familia La Romana
* Plan to receive care at the same clinic for the next year
* Not able to understand study procedures or provide informed consent
* Spanish-speaking
* Living with HIV and have a detectable viral load
* Attend Clínica de Familia La Romana
* Plan to receive care at the same clinic for the next year
* Not able to understand study procedures or provide informed consent
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Institute of Nursing Research (NINR)
NIH
Sponsor Role
collaborator
Columbia University
OTHER
Sponsor Role
lead
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Rebecca Schnall, RN, MPH, PhD
Mary Dickey Lindsay Associate Professor of Disease Prevention and Health Promotion
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Rebecca Schnall, PhD, MPH, RN
Role: PRINCIPAL_INVESTIGATOR
Columbia University
Samantha B Stonbraker, PhD, MPH, RN
Role: STUDY_DIRECTOR
Columbia University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Clínica de Familia La Romana
La Romana, , Dominican Republic
Site Status
Countries
Review the countries where the study has at least one active or historical site.
Dominican Republic
References
Explore related publications, articles, or registry entries linked to this study.
Knobel H, Alonso J, Casado JL, Collazos J, Gonzalez J, Ruiz I, Kindelan JM, Carmona A, Juega J, Ocampo A; GEEMA Study Group. Validation of a simplified medication adherence questionnaire in a large cohort of HIV-infected patients: the GEEMA Study. AIDS. 2002 Mar 8;16(4):605-13. doi: 10.1097/00002030-200203080-00012.
Reference Type
BACKGROUND
Ritter PL, Lorig K. The English and Spanish Self-Efficacy to Manage Chronic Disease Scale measures were validated using multiple studies. J Clin Epidemiol. 2014 Nov;67(11):1265-73. doi: 10.1016/j.jclinepi.2014.06.009. Epub 2014 Aug 3.
Reference Type
BACKGROUND
Bakken S, Holzemer WL, Brown MA, Powell-Cope GM, Turner JG, Inouye J, Nokes KM, Corless IB. Relationships between perception of engagement with health care provider and demographic characteristics, health status, and adherence to therapeutic regimen in persons with HIV/AIDS. AIDS Patient Care STDS. 2000 Apr;14(4):189-97. doi: 10.1089/108729100317795.
Reference Type
BACKGROUND
Dang BN, Westbrook RA, Hartman CM, Giordano TP. Retaining HIV Patients in Care: The Role of Initial Patient Care Experiences. AIDS Behav. 2016 Oct;20(10):2477-2487. doi: 10.1007/s10461-016-1340-y.
Reference Type
BACKGROUND
Cella D, Riley W, Stone A, Rothrock N, Reeve B, Yount S, Amtmann D, Bode R, Buysse D, Choi S, Cook K, Devellis R, DeWalt D, Fries JF, Gershon R, Hahn EA, Lai JS, Pilkonis P, Revicki D, Rose M, Weinfurt K, Hays R; PROMIS Cooperative Group. The Patient-Reported Outcomes Measurement Information System (PROMIS) developed and tested its first wave of adult self-reported health outcome item banks: 2005-2008. J Clin Epidemiol. 2010 Nov;63(11):1179-94. doi: 10.1016/j.jclinepi.2010.04.011. Epub 2010 Aug 4.
Reference Type
BACKGROUND
De 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.
Reference Type
BACKGROUND
Figueroa JP. Review of HIV in the Caribbean: significant progress and outstanding challenges. Curr HIV/AIDS Rep. 2014 Jun;11(2):158-67. doi: 10.1007/s11904-014-0199-7.
Reference Type
BACKGROUND
Rojas 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.
Reference Type
BACKGROUND
Gebre Y, Forbes NM, Peters A. Review of HIV treatment progress, gaps, and challenges in the Caribbean, 2005-2015. Rev Panam Salud Publica. 2016 Dec;40(6):468-473.
Reference Type
BACKGROUND
Perez-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.
Reference Type
BACKGROUND
Barreto 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.
Reference Type
BACKGROUND
Wawrzyniak 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.
Reference Type
BACKGROUND
Laws 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.
Reference Type
BACKGROUND
Kalichman 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.
Reference Type
BACKGROUND
Zhang 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.
Reference Type
BACKGROUND
Mackey LM, Doody C, Werner EL, Fullen B. Self-Management Skills in Chronic Disease Management: What Role Does Health Literacy Have? Med Decis Making. 2016 Aug;36(6):741-59. doi: 10.1177/0272989X16638330. Epub 2016 Apr 6.
Reference Type
BACKGROUND
Schulman-Green D, Jaser S, Martin F, Alonzo A, Grey M, McCorkle R, Redeker NS, Reynolds N, Whittemore R. Processes of self-management in chronic illness. J Nurs Scholarsh. 2012 Jun;44(2):136-44. doi: 10.1111/j.1547-5069.2012.01444.x. Epub 2012 May 2.
Reference Type
BACKGROUND
Barlow 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.
Reference Type
BACKGROUND
Garcia-Retamero R, Dhami MK. Pictures speak louder than numbers: on communicating medical risks to immigrants with limited non-native language proficiency. Health Expect. 2011 Mar;14 Suppl 1(Suppl 1):46-57. doi: 10.1111/j.1369-7625.2011.00670.x.
Reference Type
BACKGROUND
Houts PS, Doak CC, Doak LG, Loscalzo MJ. The role of pictures in improving health communication: a review of research on attention, comprehension, recall, and adherence. Patient Educ Couns. 2006 May;61(2):173-90. doi: 10.1016/j.pec.2005.05.004. Epub 2005 Aug 24.
Reference Type
BACKGROUND
Garcia-Retamero R, Okan Y, Cokely ET. Using visual aids to improve communication of risks about health: a review. ScientificWorldJournal. 2012;2012:562637. doi: 10.1100/2012/562637. Epub 2012 May 2.
Reference Type
BACKGROUND
Arcia A, Suero-Tejeda N, Bales ME, Merrill JA, Yoon S, Woollen J, Bakken S. Sometimes more is more: iterative participatory design of infographics for engagement of community members with varying levels of health literacy. J Am Med Inform Assoc. 2016 Jan;23(1):174-83. doi: 10.1093/jamia/ocv079. Epub 2015 Jul 13.
Reference Type
BACKGROUND
Rao JK, Anderson LA, Inui TS, Frankel RM. Communication interventions make a difference in conversations between physicians and patients: a systematic review of the evidence. Med Care. 2007 Apr;45(4):340-9. doi: 10.1097/01.mlr.0000254516.04961.d5.
Reference Type
BACKGROUND
Stonbraker S, Smaldone A, Luft H, Cushman LF, Lerebours Nadal L, Halpern M, Larson E. Associations between health literacy, HIV-related knowledge, and information behavior among persons living with HIV in the Dominican Republic. Public Health Nurs. 2018 May;35(3):166-175. doi: 10.1111/phn.12382. Epub 2017 Dec 29.
Reference Type
BACKGROUND
Stonbraker S, Befus M, Lerebours Nadal L, Halpern M, Larson E. Factors Associated with Health Information Seeking, Processing, and Use Among HIV Positive Adults in the Dominican Republic. AIDS Behav. 2017 Jun;21(6):1588-1600. doi: 10.1007/s10461-016-1569-5.
Reference Type
BACKGROUND
Bowen DJ, Kreuter M, Spring B, Cofta-Woerpel L, Linnan L, Weiner D, Bakken S, Kaplan CP, Squiers L, Fabrizio C, Fernandez M. How we design feasibility studies. Am J Prev Med. 2009 May;36(5):452-7. doi: 10.1016/j.amepre.2009.02.002.
Reference Type
BACKGROUND
Lee SY, Stucky BD, Lee JY, Rozier RG, Bender DE. Short Assessment of Health Literacy-Spanish and English: a comparable test of health literacy for Spanish and English speakers. Health Serv Res. 2010 Aug;45(4):1105-20. doi: 10.1111/j.1475-6773.2010.01119.x. Epub 2010 May 24.
Reference Type
BACKGROUND
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
Access external resources that provide additional context or updates about the study.
https://www.frontierscience.org/apps/cfmx/apps/common/QOLAdherenceForms/index.cfm?project=ACTG
Source of the Health Status Assessment published by the AIDS Clinical Trials Group (ACTG) Outcomes Committee
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
AAAR9023
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.
Enhancing Communication and HIV Outcomes
NCT00675610
COMPLETED
PHASE3
Prevention of HIV/AIDS and STDs in Women Over Fifty
NCT03810170
COMPLETED
PHASE2
Evaluating Methods to Increase HIV Testing, Access to HIV Care, and HIV Prevention Strategies
NCT01152918
COMPLETED
NA
An Automated, Tailored Information Application for Medication Health Literacy
NCT01304186
COMPLETED
NA
A Nurse-led Intervention to Extend the HIV Treatment Cascade for Cardiovascular Disease Prevention
NCT03643705
COMPLETED
NA
Group Clinical Visit Adherence Intervention for HIV+ Women of Color
NCT03109743
TERMINATED
NA
Feasibility of a Stigma Reduction Intervention for Human Immunodeficiency Virus (HIV)-Infected Women
NCT01385241
COMPLETED
NA
HIV Prevention for PLHIV: Evaluation of an Intervention Toolkit for HIV Care & Treatment Settings
NCT01256463
COMPLETED
NA
Improve Functional Health Status in Minority Women With HIV
NCT04315675
UNKNOWN
NA
An mHealth Intervention to Improve Outcomes for Women With HIV/AIDS
NCT03738410
RECRUITING
NA
Evaluation of Web-based Interventions to Support People Living With HIV in the Adoption of Health Behaviors
NCT02378766
COMPLETED
NA
Video-based Intervention Study to Prevent HIV/Sexually Transmitted Diseases (STDs) Among STD Clinic Patients
NCT00137670
COMPLETED
NA
Enhanced Access to HIV Care for Drug Users in San Juan, Puerto Rico
NCT01792752
COMPLETED
NA
Empowering Knowledge, Self-Testing & Resilience Through Innovative Methods for HIV
NCT07039682
NOT_YET_RECRUITING
NA
ID and Testing Via Friendship Networks
NCT00841360
COMPLETED
Medications for Chronic HIV: Education and Collaboration
NCT01038076
COMPLETED
NA
A Patient Portal and PROMs to Improve Health Problem Detection and Retention in HIV Care: The DRHIVe Study
NCT06928961
NOT_YET_RECRUITING
NA
Evaluation of a Tailored Virtual Intervention to Empower Persons Living With HIV for Therapy Self-management
NCT01510340
COMPLETED
PHASE3
The Healthy Life Choices Project in HIV-Positive Patients
NCT00017810
COMPLETED
PHASE2
HIV- Risk Reduction Behavioral Intervention for Commercial Sex Workers in Yerevan Armenia
NCT00886561
COMPLETED
PHASE2
Enhanced HIV Prevention in Couples: Feasibility Study #3
NCT02027519
COMPLETED
Same-Day Antiretroviral Therapy as a Behavioral Design Intervention to Reduce Stigma in Key Affected Populations
NCT07053514
NOT_YET_RECRUITING
NA
A Waiting Room-Delivered Video to Enhance Clinical Outcomes Among Persons Living With HIV
NCT03508310
COMPLETED
NA
HIV Prevention Program for Patients Receiving Care at a Sexually Transmitted Diseases Clinic
NCT00183573
COMPLETED
PHASE2/PHASE3
Theoretically Informed Behavioral Intervention
NCT06580184
NOT_YET_RECRUITING
NA