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Clinical Trials/NCT03508310
NCT03508310CompletedNot Applicable

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

Centers for Disease Control and Prevention0 sites4,003 target enrollmentStarted: June 1, 2016Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
4,003
Primary Endpoint
Antiretroviral therapy (ART) medication adherence (suppression level)

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
18 Years to 87 Years (Adult, Older Adult)
Sex
All
Accepts 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:
  • 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

  • Not provided

Arms & Interventions

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.

Intervention: Taking Care of Me Video (Other)

Comparison

No Intervention

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

Outcomes

Primary Outcomes

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

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

  • 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)

Investigators

Sponsor Class
Fed
Responsible Party
Sponsor

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