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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03508310
Acronym
TCOM
Enrollment
4003
Registered
2018-04-25
Start date
2016-06-01
Completion date
2017-05-17
Last updated
2025-09-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections

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.

Interventions

OTHERTaking 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).

Sponsors

Sentient Research
CollaboratorINDUSTRY
UCLA David Geffen School of Medicine and Fielding School of Public Health
CollaboratorUNKNOWN
Denver STD Prevention Training Center, Denver Public Health Department
CollaboratorUNKNOWN
California State University, Long Beach
CollaboratorOTHER
Education Development Center, Inc.
CollaboratorINDUSTRY
Centers for Disease Control and Prevention
Lead SponsorFED

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Intervention 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.

Eligibility

Sex/Gender
ALL
Age
18 Years to 87 Years
Healthy volunteers
No

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

\-

Design outcomes

Primary

MeasureTime frameDescription
Antiretroviral therapy (ART) medication adherence (suppression level)By 6 months (183 days) after the patient's index (first) visit to the clinicAdherence was measured by whether viral load suppression (\<200 RNA copies/mL) was achieved
Antiretroviral therapy (ART) medication adherence (undetectable level)By 6 months (183 days) after the patient's index (first) visit to the clinicAdherence was measured by whether viral load suppression (\<50 RNA copies/mL) was achieved

Secondary

MeasureTime frameDescription
Treatment initiationon, before, or within 7 days after, their index visit, as documented by OAMC visits in patient EMRs.Treatment initiation was measured by a patient's receipt of an ART prescription
Retention in HIV medical care2 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 yearMeasured by an adaptation of the Health Resources and Services Administration's (HRSA) definition in the Annual Ryan White HIV/AIDS Program Services Report

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 23, 2026