A Waiting Room-Delivered Video to Enhance Clinical Outcomes Among Persons Living With HIV (TCOM)

A Waiting Room-Delivered Video to Enhance Antiretroviral Therapy Readiness, Adherence, and Retention in Care for Minority Persons Living With HIV Infection

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).

Study Overview

• Status: Completed
• Conditions: HIV Infections
• Intervention / Treatment: Other: Taking Care of Me Video

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.

• Study Type: Interventional
• Enrollment (Actual): 4003
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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:

1. located in a jurisdiction with high AIDS prevalence;
2. managing more than 500 unique HIV-positive patients annually;
3. serving minority persons such that minimally 55% of the clinic population is African-American and Hispanic/Latino;
4. at least 163 patients have unsuppressed viral load;
5. utilizing an electronic medical record (EMR) system; and
6. 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:

-

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; 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.	Other: Taking Care of Me Video; 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).
No Intervention: Comparison; Historical comparison condition. Patients were exposed to standard waiting room environment (absent of intervention video and posters).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Antiretroviral therapy (ART) medication adherence (suppression level)	Adherence was measured by whether viral load suppression (<200 RNA copies/mL) was achieved	By 6 months (183 days) after the patient's index (first) visit to the clinic
Antiretroviral therapy (ART) medication adherence (undetectable level)	Adherence was measured by whether viral load suppression (<50 RNA copies/mL) was achieved	By 6 months (183 days) after the patient's index (first) visit to the clinic

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment initiation	Treatment initiation was measured by a patient's receipt of an ART prescription	on, before, or within 7 days after, their index visit, as documented by OAMC visits in patient EMRs.
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	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

Collaborators and Investigators

• Sponsor: Centers for Disease Control and Prevention
• Collaborators: Education Development Center, Inc.; California State University, Long Beach; Sentient Research; UCLA David Geffen School of Medicine and Fielding School of Public Health; Denver STD Prevention Training Center, Denver Public Health Department
• Investigators: Principal Investigator: Mary S. Neumann, PhD, Centers for Disease Control and Prevention; Principal Investigator: Aaron Plant, MPH, Sentient Research

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2016
• Primary Completion (Actual): March 30, 2017
• Study Completion (Actual): May 17, 2017

Study Registration Dates

• First Submitted: April 16, 2018
• First Submitted That Met QC Criteria: April 16, 2018
• First Posted (Actual): April 25, 2018

Study Record Updates

• Last Update Posted (Actual): April 25, 2018
• Last Update Submitted That Met QC Criteria: April 16, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases; HIV Infections; Infections; Acquired Immunodeficiency Syndrome
• Other Study ID Numbers: 1163249

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No