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

NCT03508310 | Completed

• 1 other identifier: 1163249
• Study Type: interventional
• Target: 4,003
• Locations: 0 countries
• Sites: N/A

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).

Conditions

HIV Infections

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Treatment initiation

  on, before, or within 7 days after, their index visit, as documented by OAMC visits in patient EMRs.

• 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

Study Arms (2)

Intervention

EXPERIMENTAL

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

Comparison

NO INTERVENTION

Historical comparison condition. Patients were exposed to standard waiting room environment (absent of intervention video and posters).

Interventions

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).

Intervention

Eligibility Criteria

• Age: 18 Years - 87 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

Sponsors & Collaborators

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

Related Publications (1)

• 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 DERIVED

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

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

Study Officials

• Mary S. Neumann, PhD

  Centers for Disease Control and Prevention

  PRINCIPAL INVESTIGATOR

• Aaron Plant, MPH

  Sentient Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 16, 2018
• First Posted: April 25, 2018
• Study Start: June 1, 2016
• Primary Completion: March 30, 2017
• Study Completion: May 17, 2017
• Last Updated: September 17, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
• Time Frame: To be determined
• Access Criteria: To be determined