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

HIV Infections Clinical Trial

— TCOM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03508310
• Other study ID #: 1163249
• Status: Completed
• Phase: N/A
• First received: April 16, 2018
• Last updated: April 16, 2018
• Start date: June 1, 2016
• Est. completion date: May 17, 2017

Study information

• Verified date: April 2018
• Source: Centers for Disease Control and Prevention
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4003
• Est. completion date: May 17, 2017
• Est. primary completion date: March 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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:

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• Infection

Intervention

Other:
• Taking Care of Me Video
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).

Locations

Country	Name	City	State
n/a

Sponsors (6)

Lead Sponsor	Collaborator
Centers for Disease Control and Prevention	California State University, Long Beach, Denver STD Prevention Training Center, Denver Public Health Department, Education Development Center, Inc. (EDC), Sentient Research, UCLA David Geffen School of Medicine and Fielding School of Public Health

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Treatment initiation	Treatment initiation was measured by a patient's receipt of an ART prescription	on, before, or within 7 days after, their index visit, as documented by OAMC visits in patient EMRs.
Secondary	Retention in HIV medical care	Measured by an adaptation of the Health Resources and Services Administration's (HRSA) definition in the Annual Ryan White HIV/AIDS Program Services Report	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