Back to resultsA Waiting Room-Delivered Video to Enhance Clinical Outcomes Among Persons Living With HIV (TCOM)
Primary Purpose
HIV Infections
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Taking Care of Me Video
Sponsored by
About this trial
This is an interventional prevention trial for HIV Infections
Eligibility Criteria
Inclusion Criteria:
HIV/AIDS treatment facility inclusion: The participating treatment facilities will have a combined total of at least 2,700 monthly patient visits during the study period. Each of the HIV/AIDS treatment facilities meets the following inclusion criteria:
- located in a jurisdiction with high AIDS prevalence;
- managing more than 500 unique HIV-positive patients annually;
- serving minority persons such that minimally 55% of the clinic population is African-American and Hispanic/Latino;
- at least 163 patients have unsuppressed viral load;
- utilizing an electronic medical record (EMR) system; and
- not participating in another behavioral intervention research project during the historical comparison data period (August 2015 through May 2016) or during the 10-month intervention period (June 2016 through March 2017).
Exclusion Criteria:
-
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention
Comparison
Arm Description
29-minute clinic waiting room video intervention that includes three vignettes and a 2-part animation sequence about main characters who model overcoming challenges to optimal HIV care. The video was played on continuous loop in recognition of typically short patient wait times. Waiting room posters used images from the video to direct patients' attention to the video and reinforce prevention messages.
Historical comparison condition. Patients were exposed to standard waiting room environment (absent of intervention video and posters).
Outcomes
Primary Outcome Measures
Antiretroviral therapy (ART) medication adherence (suppression level)
Adherence was measured by whether viral load suppression (<200 RNA copies/mL) was achieved
Antiretroviral therapy (ART) medication adherence (undetectable level)
Adherence was measured by whether viral load suppression (<50 RNA copies/mL) was achieved
Secondary Outcome Measures
Treatment initiation
Treatment initiation was measured by a patient's receipt of an ART prescription
Retention in HIV medical care
Measured by an adaptation of the Health Resources and Services Administration's (HRSA) definition in the Annual Ryan White HIV/AIDS Program Services Report
Full Information
NCT ID
NCT03508310
First Posted
April 16, 2018
Last Updated
April 16, 2018
Sponsor
Centers for Disease Control and Prevention
Collaborators
Sentient Research, UCLA David Geffen School of Medicine and Fielding School of Public Health, Denver STD Prevention Training Center, Denver Public Health Department, California State University, Long Beach, Education Development Center, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT03508310
Brief Title
A Waiting Room-Delivered Video to Enhance Clinical Outcomes Among Persons Living With HIV
Acronym
TCOM
Official Title
A Waiting Room-Delivered Video to Enhance Antiretroviral Therapy Readiness, Adherence, and Retention in Care for Minority Persons Living With HIV Infection
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
June 1, 2016 (Actual)
Primary Completion Date
March 30, 2017 (Actual)
Study Completion Date
May 17, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centers for Disease Control and Prevention
Collaborators
Sentient Research, UCLA David Geffen School of Medicine and Fielding School of Public Health, Denver STD Prevention Training Center, Denver Public Health Department, California State University, Long Beach, Education Development Center, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this project is to beta-test a brief waiting room video intervention that promotes early initiation of antiretroviral treatment among treatment-naïve HIV-positive patients, adherence to antiretroviral treatment and retention in care among HIV-positive patients currently on therapy, sexual risk reduction tailored to HIV-positive persons, and patient-initiated discussion of these topics with their health providers. The video is currently being created, and will be ready for beta-testing by June 1, 2016. Results of the beta-testing will be used to refine and improve the video before dissemination to HIV/AIDS treatment facilities nationally. This video project is being funded by the Centers for Disease Control and Prevention, Division of HIV/AIDS Prevention (DHAP).
Detailed Description
The overall goal of this study is to beta-test the waiting room video in three HIV/AIDS treatment facilities in different US jurisdictions with high AIDS prevalence. These results will be used to refine the video and to increase its effectiveness among minority persons living with HIV infection. The beta-testing will consist of: 1) unobtrusive observations of waiting room patients for one day at each facility and 2) de-identified, existing patient medical data abstracted from each facility's electronic medical record (EMR) system to investigate outcomes relevant to HIV medication adherence and retention in care.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Quasi-experimental design, in which the intervention condition (i.e., video and posters) was implemented for 10 months and the historical comparison condition (i.e., standard waiting room environment) was the prior 10-month period.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
4003 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
29-minute clinic waiting room video intervention that includes three vignettes and a 2-part animation sequence about main characters who model overcoming challenges to optimal HIV care. The video was played on continuous loop in recognition of typically short patient wait times. Waiting room posters used images from the video to direct patients' attention to the video and reinforce prevention messages.
Arm Title
Comparison
Arm Type
No Intervention
Arm Description
Historical comparison condition. Patients were exposed to standard waiting room environment (absent of intervention video and posters).
Intervention Type
Other
Intervention Name(s)
Taking Care of Me Video
Intervention Description
The video's conceptual framework incorporates Social Cognitive Theory, Information-Motivation-Behavioral Skills model, and Social Action Theory, which together address cognitive and behavioral factors related to study outcomes. Storylines embedded prevention messages aimed at increasing treatment initiation (n=9), medication adherence (n=35), retention in care (n=22), partner protection (n=12), and communication with health care providers (n=7).
Primary Outcome Measure Information:
Title
Antiretroviral therapy (ART) medication adherence (suppression level)
Description
Adherence was measured by whether viral load suppression (<200 RNA copies/mL) was achieved
Time Frame
By 6 months (183 days) after the patient's index (first) visit to the clinic
Title
Antiretroviral therapy (ART) medication adherence (undetectable level)
Description
Adherence was measured by whether viral load suppression (<50 RNA copies/mL) was achieved
Time Frame
By 6 months (183 days) after the patient's index (first) visit to the clinic
Secondary Outcome Measure Information:
Title
Treatment initiation
Description
Treatment initiation was measured by a patient's receipt of an ART prescription
Time Frame
on, before, or within 7 days after, their index visit, as documented by OAMC visits in patient EMRs.
Title
Retention in HIV medical care
Description
Measured by an adaptation of the Health Resources and Services Administration's (HRSA) definition in the Annual Ryan White HIV/AIDS Program Services Report
Time Frame
2 or more clinic visits for any reason at least 90 days apart in the past year divided by all active clients who had had at least one such visit in the past year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
HIV/AIDS treatment facility inclusion: The participating treatment facilities will have a combined total of at least 2,700 monthly patient visits during the study period. Each of the HIV/AIDS treatment facilities meets the following inclusion criteria:
located in a jurisdiction with high AIDS prevalence;
managing more than 500 unique HIV-positive patients annually;
serving minority persons such that minimally 55% of the clinic population is African-American and Hispanic/Latino;
at least 163 patients have unsuppressed viral load;
utilizing an electronic medical record (EMR) system; and
not participating in another behavioral intervention research project during the historical comparison data period (August 2015 through May 2016) or during the 10-month intervention period (June 2016 through March 2017).
Exclusion Criteria:
-
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mary S. Neumann, PhD
Organizational Affiliation
Centers for Disease Control and Prevention
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Aaron Plant, MPH
Organizational Affiliation
Sentient Research
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
When appropriate, data sets will be made available to interested researchers following discussion with study team.
IPD Sharing Time Frame
To be determined
IPD Sharing Access Criteria
To be determined
Citations:
PubMed Identifier
30289884
Citation
Neumann MS, Plant A, Margolis AD, Borkowf CB, Malotte CK, Rietmeijer CA, Flores SA, O'Donnell L, Robilotto S, Myint-U A, Montoya JA, Javanbakht M, Klausner JD. Effects of a brief video intervention on treatment initiation and adherence among patients attending human immunodeficiency virus treatment clinics. PLoS One. 2018 Oct 5;13(10):e0204599. doi: 10.1371/journal.pone.0204599. eCollection 2018.
Results Reference
derived
Learn more about this trial
A Waiting Room-Delivered Video to Enhance Clinical Outcomes Among Persons Living With HIV
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