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

NCT03508310 — Not applicable, Completed, 4003 participants, Centers for Disease Control and Prevention

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

RegistryNCT03508310, acronym TCOM
StatusCompleted
PhaseNot applicable
Study typeInterventional; non randomized, parallel, masking: none, prevention
Enrollment4003 (Actual)
SponsorCenters for Disease Control and Prevention (Fed); 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.
ConditionsHIV Infections
InterventionsTaking Care of Me Video (Other)
Datesstart 2016-06-01, primary completion 2017-03-30, completion 2017-05-17, first posted 2018-04-25, last updated 2025-09-17

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-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).

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+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.

+Arms and interventions

ArmTypeInterventionsDescription
InterventionExperimentalOther: Taking Care of Me Video29-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.
ComparisonNo interventionHistorical comparison condition. Patients were exposed to standard waiting room environment (absent of intervention video and posters).
  • Taking Care of Me Video (Other): 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).

+Outcome measures

Primary outcomes

  • Antiretroviral therapy (ART) medication adherence (suppression level) [By 6 months (183 days) after the patient's index (first) visit to the clinic]: Adherence 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 clinic]: Adherence was measured by whether viral load suppression (<50 RNA copies/mL) was achieved

Secondary outcomes

  • Treatment initiation [on, 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 care [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]: Measured by an adaptation of the Health Resources and Services Administration's (HRSA) definition in the Annual Ryan White HIV/AIDS Program Services Report

+Eligibility

Sex: All, ages: 18 Years to 87 Years

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:

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+Publications

  • Results publication: 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. PMID 30289884

+Investigators

My Notes