NCT03616106

Information Visualizations to Facilitate HIV-related Patient-provider Communication (Info Viz: HIV)

Completed NA Results posted Last updated 3 September 2020

What this trial tests

NA trial testing Infographic intervention in Health Communication in 59 participants. Completed in 9 August 2019.

Timeline

9 October 2018

Primary endpoint
9 August 2019

9 August 2019

Quick facts

Lead sponsor	Columbia University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	health services research
Enrollment	59
Start date	9 October 2018
Primary completion	9 August 2019
Estimated completion	9 August 2019
Sites	1 location across Dominican Republic

Drugs / interventions tested

• Infographic intervention

Conditions studied

• Health Communication — all drugs for Health Communication →

Sponsor

Columbia University

Who can join

18 and older, any sex, with Health Communication. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Association Between Mean CD4 Count at Baseline and 3-month Visit Primary · Baseline and 3-month visit

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

Baseline

Group	Value	95% CI
Intervention (Patient Participants)	385.86	± 271.53

3 months

Group	Value	95% CI
Intervention (Patient Participants)	373.69	± 243.26

Association Between Mean CD4 Count at Baseline and 6-month Visit Primary · Baseline and 6-month visit

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

Baseline

Group	Value	95% CI
Intervention (Patient Participants)	385.86	± 271.53

6 months

Group	Value	95% CI
Intervention (Patient Participants)	414.41	± 273.43

Association Between Mean CD4 Count at Baseline and 9-month Visit Primary · Baseline and 9-month visit

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

Baseline

Group	Value	95% CI
Intervention (Patient Participants)	385.86	± 271.53

9 months

Group	Value	95% CI
Intervention (Patient Participants)	445.42	± 279.25

Association Between Mean Viral Load at Baseline and at 3-month Visits Primary · Baseline and 3-months

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

Baseline

Group	Value	95% CI
Intervention (Patient Participants)	84,326	± 238,545

3-months

Group	Value	95% CI
Intervention (Patient Participants)	81,470	± 240,834

Association Between Mean Viral Load at Baseline and at 6-month Visits Primary · Baseline and 6-months

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

Baseline

Group	Value	95% CI
Intervention (Patient Participants)	84,326	± 238,545

6-months

Group	Value	95% CI
Intervention (Patient Participants)	91,590	± 284090

Association Between Mean Viral Load at Baseline and at 9-month Visits Primary · Baseline and 9-months

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

Baseline

Group	Value	95% CI
Intervention (Patient Participants)	84,326	± 238,545

9-months

Group	Value	95% CI
Intervention (Patient Participants)	45,581	± 151,116

Satisfaction With Care Scale Score Secondary · Baseline, 3-, 6-, and 9-month visits

3 questions from the overall evaluation of the HIV clinic scale were administered for a total of 19 possible points on this scale. Range of possible scores is 1-19, with 19 being highest possible satisfaction with care. The breakdown of scoring by question is as follows: * Question 1 is a 1-7 scale with 1 being completely unsatisfied and 7 being completely satisfied * Question 2 is a 1-5 scale where 1 is definitely not and 5 is definitely yes * Question 3 is a 1-7 scale where 1 is terrible and 7 is marvelous

Baseline

Group	Value	95% CI
Intervention (Patient Participants)	18.04	± 1.37

3-months

Group	Value	95% CI
Intervention (Patient Participants)	18.52	± 0.58

6-months

Group	Value	95% CI
Intervention (Patient Participants)	18.49	± 0.55

9-months

Group	Value	95% CI
Intervention (Patient Participants)	18.31	± 0.47

Medication Adherence Secondary · Baseline, 3-, 6-, and 9-month visits

Adherence will be measured with the validated simplified medication adherence questionnaire (SMAQ)-6 scale, a 6-item questionnaire. A person is considered "non-adherent" if there is a "yes" answer for any of items 1,2,3, and 5. Additionally, if they answer that they have missed more than two doses in the past week (item 4) or if they have gone more than two days without taking their medication in the past 3 months (item 6). Therefore, participants are classified as either adherent or not adherent based on their answers to these questions. Any participant that didn't complete study visits or di

Baseline

Group	Value	95% CI
Intervention (Patient Participants)	9
Intervention (Patient Participants)	41
Intervention (Patient Participants)	0

3-months

Group	Value	95% CI
Intervention (Patient Participants)	24
Intervention (Patient Participants)	22
Intervention (Patient Participants)	4

6-months

Group	Value	95% CI
Intervention (Patient Participants)	28
Intervention (Patient Participants)	15
Intervention (Patient Participants)	7

9-months

Group	Value	95% CI
Intervention (Patient Participants)	39
Intervention (Patient Participants)	3
Intervention (Patient Participants)	8

Participant's Self-reported Health-related Quality of Life Score - Physical Functioning Secondary · Up to 9 months from baseline

Health-related quality of life will be measured with the Patient-Reported Outcomes Measurement Information System® (PROMIS)-29 measure, which measures 7 domains of health-related quality of life with 4 questions in each section pertaining to how that participant's health influences their life. In general, each question has five response options ranging in values from 1-5. To find the total raw score for this form with all the questions answered, the values from the responses of each question are summed. Raw scores are then translated into a T-score for each participant, which rescales the raw

Baseline

Group	Value	95% CI
Intervention (Patient Participants)	55.37	± 4.20

3-months

Group	Value	95% CI
Intervention (Patient Participants)	57	± 0.00

6-months

Group	Value	95% CI
Intervention (Patient Participants)	56.2	± 3.11

9-months

Group	Value	95% CI
Intervention (Patient Participants)	56.64	± 2.33

Participants' Self-reported Health Status Over Past 4 Weeks. Secondary · Baseline, 3-months, 6-months, and 9-months

General health status was assessed with one item where participants are asked to rank their health in the past four weeks as excellent, good, fair, poor, or very poor. Results are presented as the number of participants that self-rated their health in each of those categories.

Baseline

Group	Value	95% CI
Intervention (Patient Participants)	7
Intervention (Patient Participants)	8
Intervention (Patient Participants)	16
Intervention (Patient Participants)	16

3-months

Group	Value	95% CI
Intervention (Patient Participants)	21
Intervention (Patient Participants)	9
Intervention (Patient Participants)	13
Intervention (Patient Participants)	5

6-months

Group	Value	95% CI
Intervention (Patient Participants)	13
Intervention (Patient Participants)	19
Intervention (Patient Participants)	9
Intervention (Patient Participants)	2

9-months

Group	Value	95% CI
Intervention (Patient Participants)	8
Intervention (Patient Participants)	21
Intervention (Patient Participants)	13
Intervention (Patient Participants)	0

Health Literacy Secondary · Baseline visit only

Health literacy will be assessed using the short assessment of health literacy- Spanish. Scores range from 0 - 18 and above a 15 indicates that participants are likely to have adequate health literacy. Participants are then categorized as health literate or not health literate. The final number of participants who are health literate are reported here.

Group	Value	95% CI
Intervention (Patient Participants)	18

Percent of Participants Who Complete an In-depth Qualitative Interview Secondary · 9 months from baseline

Participants will be invited to participate in an in-depth qualitative interview regarding their experiences. The number who participate will be reported as a percent of the total who are enrolled.

Group	Value	95% CI
Intervention (Patient Participants)	52

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.