NCT03616106

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
59

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2018

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

July 23, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

August 6, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

October 9, 2018

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 9, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 9, 2019

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

September 3, 2020

Completed
Last Updated

September 3, 2020

Status Verified

August 1, 2020

Enrollment Period

10 months

First QC Date

July 23, 2018

Results QC Date

August 6, 2020

Last Update Submit

August 23, 2020

Conditions

Keywords

Information Visualization

Outcome Measures

Primary Outcomes (6)

  • Association Between Mean CD4 Count at Baseline and 3-month Visit

    Association between mean CD4 count at baseline and 3-month visits.

    Baseline and 3-month visit

  • Association Between Mean CD4 Count at Baseline and 6-month Visit

    Association between mean CD4 count at baseline and 6-month visits.

    Baseline and 6-month visit

  • Association Between Mean CD4 Count at Baseline and 9-month Visit

    Association between mean CD4 count at baseline and 9-month visits.

    Baseline and 9-month visit

  • Association Between Mean Viral Load at Baseline and at 3-month Visits

    Test of association of mean viral load at baseline and at 3-month visits.

    Baseline and 3-months

  • Association Between Mean Viral Load at Baseline and at 6-month Visits

    Test of association of mean viral load at baseline and at 6-month visits.

    Baseline and 6-months

  • Association Between Mean Viral Load at Baseline and at 9-month Visits

    Test of association of mean viral load at baseline and at 9-month visits.

    Baseline and 9-months

Secondary Outcomes (25)

  • Satisfaction With Care Scale Score

    Baseline, 3-, 6-, and 9-month visits

  • Medication Adherence

    Baseline, 3-, 6-, and 9-month visits

  • Participant's Self-reported Health-related Quality of Life Score - Physical Functioning

    Up to 9 months from baseline

  • Participants' Self-reported Health Status Over Past 4 Weeks.

    Baseline, 3-months, 6-months, and 9-months

  • Health Literacy

    Baseline visit only

  • +20 more secondary outcomes

Study Arms (1)

Intervention Group

EXPERIMENTAL

Participants in the intervention group will receive health education using infographics (Infographic Intervention) during their regularly scheduled clinic visits.

Other: Infographic intervention

Interventions

All study participants will receive health education using infographics during their regularly scheduled clinic appointments.

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
  • Spanish-speaking
  • Living with HIV and have a detectable viral load
  • Attend ClĂ­nica de Familia La Romana
  • Plan to receive care at the same clinic for the next year

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)

ClĂ­nica de Familia La Romana

La Romana, Dominican Republic

Location

Related Publications (27)

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    PMID: 24356327BACKGROUND
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    PMID: 28718497BACKGROUND
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    PMID: 22407860BACKGROUND
  • 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.

    PMID: 24222474BACKGROUND
  • 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.

    PMID: 24464408BACKGROUND
  • 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.

    PMID: 11114834BACKGROUND
  • 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.

    PMID: 24619949BACKGROUND
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    PMID: 22551013BACKGROUND
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    PMID: 21323820BACKGROUND
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    PMID: 20500222BACKGROUND

Related Links

Results Point of Contact

Title
Samantha Stonbraker, Assistant Professor
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
Yes
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 group pretest-posttest design to evaluate if using infographics during clinic visits 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

July 23, 2018

First Posted

August 6, 2018

Study Start

October 9, 2018

Primary Completion

August 9, 2019

Study Completion

August 9, 2019

Last Updated

September 3, 2020

Results First Posted

September 3, 2020

Record last verified: 2020-08

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 all 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