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NCT Number: NCT03508310

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

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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Key information

Conditions

HIV Infections Blood-Borne Infections Communicable Diseases Genital Diseases Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

18 year–87 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

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).

Primary outcomes

  1. Antiretroviral therapy (ART) medication adherence (suppression level)

    Time frame: 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

  2. Antiretroviral therapy (ART) medication adherence (undetectable level)

    Time frame: 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

  1. Treatment initiation

    Time frame: 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

  2. Retention in HIV medical care

    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

    Measured by an adaptation of the Health Resources and Services Administration's (HRSA) definition in the Annual Ryan White HIV/AIDS Program Services Report

Sponsors and collaborators

Lead sponsor

Centers for Disease Control and Prevention

Fed

Collaborators

  • California State University, Long Beach
  • Denver STD Prevention Training Center, Denver Public Health Department
  • Education Development Center, Inc.
  • Sentient Research
  • UCLA David Geffen School of Medicine and Fielding School of Public Health

Registry information

Official study title

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

Acronym: TCOM

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Apr 25, 2018
Registry last updated
Sep 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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