NCT04102540

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- and 6-month follow up visits). Follow up interviews will be conducted with members of the clinical team to ascertain their perspectives on the clinical utility of infographics.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 23, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 25, 2019

Completed
12 days until next milestone

Study Start

First participant enrolled

October 7, 2019

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 29, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 29, 2020

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

September 17, 2021

Completed
Last Updated

September 17, 2021

Status Verified

August 1, 2021

Enrollment Period

10 months

First QC Date

September 23, 2019

Results QC Date

July 14, 2021

Last Update Submit

August 23, 2021

Conditions

Keywords

Information Visualization

Outcome Measures

Primary Outcomes (2)

  • Mean CD4 Count

    Mean Cluster of Differentiation 4 (CD4) count at each time point.

    Baseline, 3-, and 6-months

  • Mean Viral Load

    Mean viral load at each time point

    Baseline, 3-, and 6-months

Secondary Outcomes (10)

  • Mean Score on HIV-related Knowledge Assessment

    Baseline, 3-, and 6-months

  • Mean Score on Satisfaction With Care Scale

    Baseline, 3-, and 6-months

  • Mean Score on the SEMCD Scale

    Baseline, 3-, and 6-months

  • Number of Participants Who Are Adherent to Their Medications

    Baseline, 3-, and 6-months

  • Number of Participants Who Reported Each of the 5 General Health Categories

    Baseline, 3-, and 6-months

  • +5 more secondary outcomes

Study Arms (1)

Infographic intervention group

EXPERIMENTAL

Participants in the infographic intervention group will receive health education using infographics during a study visit scheduled immediately following their regularly scheduled clinic visits.

Other: Infographic intervention

Interventions

Information visualizations (infographics) will be used to teach participants about HIV during study visits immediately following their normal clinic visits.

Infographic intervention group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult ≥ 18 years of age
  • Living with HIV and has a detectable viral load
  • Self-identifies as Hispanic/Latino
  • Plan to receive care at the same clinic for the next 6 months

You may not qualify if:

  • Not able to understand study procedures or provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Comprehensive HIV Program of NewYork-Presbyterian Hospital

New York, New York, 10032, United States

Location

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Limitations and Caveats

The global COVID-19 pandemic caused a research pause in mid-March 2020. This made it so that some of our participants were not able to complete their second out of three possible visits. Research activities were able to resume in May 2020 with strict COVID-19 safety measures in place. However, participants' third study visits were delayed.

Results Point of Contact

Title
Dr. Samantha Stonbraker
Organization
University of Colorado College of Nursing

Study Officials

  • Rebecca Schnall, PhD, MPH, RN

    Columbia University

    PRINCIPAL INVESTIGATOR
  • Samantha B Stonbraker, PhD, MPH, RN

    Columbia University

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Model Details: This study will use a single pretest-posttest design to evaluate if using infographics for patient education can lead to improved patient outcomes.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Mary Dickey Lindsay Associate Professor of Disease Prevention and Health Promotion

Study Record Dates

First Submitted

September 23, 2019

First Posted

September 25, 2019

Study Start

October 7, 2019

Primary Completion

July 29, 2020

Study Completion

July 29, 2020

Last Updated

September 17, 2021

Results First Posted

September 17, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
CSR, ANALYTIC CODE
Time Frame
Data will be available 3 months after the publication of primary results.
Access Criteria
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.

Locations