Clinical trial NCT03616106: Information Visualizations to Facilitate HIV-related Patient-provider Communication (Info Viz: HIV)
Official title: Information Visualizations to Facilitate Patient-provider Communication in HIV Care: Info Viz HIV
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Health Communication
Keywords: Information Visualization
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2018-08-06
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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 purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Exclusion Criteria:

* Does not meet inclusion criteria
* Not able to understand study procedures or provide informed consent

Primary outcomes:
measure: Association Between Mean CD4 Count at Baseline and 3-month Visit
timeFrame: Baseline and 3-month visit
measure: Association Between Mean CD4 Count at Baseline and 6-month Visit
timeFrame: Baseline and 6-month visit
measure: Association Between Mean CD4 Count at Baseline and 9-month Visit
timeFrame: Baseline and 9-month visit
measure: Association Between Mean Viral Load at Baseline and at 3-month Visits
timeFrame: Baseline and 3-months
measure: Association Between Mean Viral Load at Baseline and at 6-month Visits
timeFrame: Baseline and 6-months
measure: Association Between Mean Viral Load at Baseline and at 9-month Visits
timeFrame: Baseline and 9-months
Secondary outcomes:
measure: Satisfaction With Care Scale Score
timeFrame: Baseline, 3-, 6-, and 9-month visits
measure: Medication Adherence
timeFrame: Baseline, 3-, 6-, and 9-month visits
measure: Participant's Self-reported Health-related Quality of Life Score - Physical Functioning
timeFrame: Up to 9 months from baseline
measure: Participants' Self-reported Health Status Over Past 4 Weeks.
timeFrame: Baseline, 3-months, 6-months, and 9-months
measure: Health Literacy
timeFrame: Baseline visit only
measure: Percent of Participants Who Complete an In-depth Qualitative Interview
timeFrame: 9 months from baseline
measure: Participant's Self-reported Health-related Quality of Life Score - Anxiety
timeFrame: Baseline, 3-, 6-, and 9-months
measure: Participant's Self-reported Health-related Quality of Life Score - Depression
timeFrame: Baseline, 3-, 6-, and 9-months
measure: Participant's Self-reported Health-related Quality of Life Score - Fatigue
timeFrame: Baseline, 3-, 6-, and 9-months
measure: Participant's Self-reported Health-related Quality of Life Score - Sleep Disturbance
timeFrame: Baseline, 3-, 6-, and 9-months
measure: Participant's Self-reported Health-related Quality of Life Score - Social Activity Participation
timeFrame: Baseline, 3-, 6-, and 9-months
measure: Participant's Self-reported Health-related Quality of Life Score - Pain Interference
timeFrame: Baseline, 3-, 6-, and 9-months
measure: Satisfaction With Provider Scale Score at Each Time Point
timeFrame: Baseline, 3-, 6-, and 9-month visits
measure: Association Between Mean HIV-related Knowledge Scores at Baseline and 3-month Visits.
timeFrame: Baseline and 3-month visits
measure: Association Between Mean HIV-related Knowledge Scores at Baseline and 6-month Visits.
timeFrame: Baseline and 6-month visits
measure: Association Between Mean HIV-related Knowledge Scores at Baseline and 9-month Visits.
timeFrame: Baseline and 9-month visits
measure: Association of Engagement With Clinician Scale Score at Baseline and 3-months.
timeFrame: Baseline and 3-months
measure: Association of Engagement With Clinician Scale Score at Baseline and 6-months.
timeFrame: Baseline and 6-months
measure: Association of Engagement With Clinician Scale Score at Baseline and 9-months.
timeFrame: Baseline and 9-months
measure: Association Between SEMCD Scale Score at Baseline and 3-month Visits
timeFrame: Baseline, 3-month visits
measure: Association Between SEMCD Scale Score at Baseline and 6-month Visits
timeFrame: Baseline, 6-month visits
measure: Association Between SEMCD Scale Score at Baseline and 9-month Visits
timeFrame: Baseline, 9-month visits
measure: Association Between Current Self-reported Health Status as Reported at Baseline and 3-months
timeFrame: Baseline, 3-months
measure: Association Between Current Self-reported Health Status as Reported at Baseline and 6-months
timeFrame: Baseline, 6-months
measure: Association Between Current Self-reported Health Status as Reported at Baseline and 9-months
timeFrame: Baseline, 9-months
Other outcomes:
Locations:
city: La Romana
country: Dominican Republic
facility: Clínica de Familia La Romana
Study officials:
affiliation: Columbia University
name: Rebecca Schnall, PhD, MPH, RN
role: PRINCIPAL_INVESTIGATOR
affiliation: Columbia University
name: Samantha B Stonbraker, PhD, MPH, RN
role: STUDY_DIRECTOR
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