Clinical trial NCT03508310: A Waiting Room-Delivered Video to Enhance Clinical Outcomes Among Persons Living With HIV
Official title: A Waiting Room-Delivered Video to Enhance Antiretroviral Therapy Readiness, Adherence, and Retention in Care for Minority Persons Living With HIV Infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infections
Lead sponsor: Centers for Disease Control and Prevention
Sponsor class: FED
Collaborators: name: Sentient Research
name: UCLA David Geffen School of Medicine and Fielding School of Public Health
name: Denver STD Prevention Training Center, Denver Public Health Department
name: California State University, Long Beach
name: Education Development Center, Inc.
First posted: 2018-04-25
Enrollment: 4003
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: PREVENTION

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.

Eligibility criteria: 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:

-

Primary outcomes:
measure: Antiretroviral therapy (ART) medication adherence (suppression level)
timeFrame: By 6 months (183 days) after the patient's index (first) visit to the clinic
measure: Antiretroviral therapy (ART) medication adherence (undetectable level)
timeFrame: By 6 months (183 days) after the patient's index (first) visit to the clinic
Secondary outcomes:
measure: Treatment initiation
timeFrame: on, before, or within 7 days after, their index visit, as documented by OAMC visits in patient EMRs.
measure: Retention in HIV medical care
timeFrame: 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
Other outcomes:
Locations:
Study officials:
affiliation: Centers for Disease Control and Prevention
name: Mary S. Neumann, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Sentient Research
name: Aaron Plant, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.