HIV InfectionsTCOMNCT03508310

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

A study testing Taking Care of Me Video in people with HIV Infections, run by Centers for Disease Control and Prevention.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 87 years
Conditions the study is for: HIV Infections
What is being tested?: Taking Care of Me Video
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 4,003 participants
Where: No sites listed yet
Study dates: 1 Jun 2016to 17 May 2017
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 87 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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).

Who cannot join

About this study

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

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).

Read the 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.

Conditions: HIV Infections
Being tested: Taking Care of Me Video
Medical subject headings: HIV Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Taking Care of Me VideoOther
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).

Study groups in NCT03508310
Study group	Role	What they receive
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. Receives: 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).

What is being measured

The primary outcome is the main question the study is designed to answer.

Antiretroviral therapy (ART) medication adherence (suppression level)
Adherence was measured by whether viral load suppression (<200 RNA copies/mL) was achieved
Measured: 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
Measured: By 6 months (183 days) after the patient's index (first) visit to the clinic

Secondary outcomes (2)

Treatment initiation
Treatment initiation was measured by a patient's receipt of an ART prescription
Measured: on, before, or within 7 days after, their index visit, as documented by OAMC visits in patient EMRs.
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
Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jun 201617 May 2017

First posted25 Apr 2018
Study start1 Jun 2016
Primary completion30 Mar 2017
Study completion17 May 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for HIV InfectionsStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Parallel groups
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.
Masking: None (open label)
Enrolment: 4,003 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03508310
Sponsor's protocol ID: 1163249
Acronym: TCOM
Status last verified: Sep 2025
First submitted: 16 Apr 2018
Last updated: 17 Sep 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: When appropriate, data sets will be made available to interested researchers following discussion with study team.

Publications

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.
PubMed 30289884

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All HIV Infections trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Waiting Room-Delivered Video to Enhance Antiretroviral Therapy Readiness, Adherence, and Retention in Care for Minority Persons Living With HIV Infection
ClinicalTrials.gov ID: NCT03508310
Acronym / sponsor ID: TCOM / 1163249
Conditions: HIV Infections
Study type: Interventional
Recruitment status: Completed
Enrolment: 4,003 participants (actual)
Lead sponsor: Centers for Disease Control and PreventionUS federal agency
Collaborators: Sentient Research, UCLA David Geffen School of Medicine and Fielding School of Public Health, Denver STD Prevention Training Center, Denver Public Health Department, California State University, Long Beach, Education Development Center, Inc.
Study start: 1 Jun 2016 (actual)
Primary completion: 30 Mar 2017 (actual)
Study completion: 17 May 2017 (actual)
First posted: 25 Apr 2018 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
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.

Arm	Type	Receives
Intervention	Experimental	Other: Taking Care of Me Video29-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.
Comparison	No intervention	–Historical comparison condition. Patients were exposed to standard waiting room environment (absent of intervention video and posters).

Who may qualify

Ages: 18 to 87 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

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;

Key exclusion criteria (1 listed)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Taking Care of Me VideoThe 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).	Other	Intervention

Primary outcome

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

2 secondary outcomes

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

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2025.
Derived from this study: PubMed 30289884Neumann 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.
Individual participant dataSharing planned: Yes. When appropriate, data sets will be made available to interested researchers following discussion with study team.

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Not yet recruiting
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Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
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Recruiting
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Mary S. Neumann, PhD principal investigator

Centers for Disease Control and Prevention

Aaron Plant, MPH principal investigator

Sentient Research

Questions about this trial

What is this clinical trial studying?

A study testing Taking Care of Me Video in people with HIV Infections, run by Centers for Disease Control and Prevention.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Antiretroviral therapy (ART) medication adherence (suppression level) (time frame: By 6 months (183 days) after the patient's index (first) visit to the clinic). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03508310, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2025; AzTrials last refreshed its copy on 8 Nov 2026.