HIV InfectionsARTASNCT05866523
Teamwork Makes the Dream Work
A study testing Team Based Inpatient ARTAS in people with HIV Infections and Inpatient Facility Diagnoses, run by Loma Linda University at 1 site in United States.
Trial summary
Exploring the effect of team-based ARTAS intervention in an inpatient setting on HIV linkage to care and hospital readmission rates. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections, Inpatient Facility Diagnoses
- What is being tested?
- Team Based Inpatient ARTAS
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Oct 2023to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age or greater
- newly diagnosed HIV
- Known diagnosis of HIV not on ART within 30 days of admission
- Known HIV and not virally suppressed based on interview
- Known HIV and has not been under the care of an HIV specialist within the past 6 months
Who cannot join
- All three criteria must be present for exclusion:
- virally suppressed
- actively taking ART
- are under active care of an HIV specialist within the last 6 months
- Less than 18 years of age (stand alone exclusion)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Loma Linda University Medical Center
Loma Linda, California, 92354
Jennifer Veltman, MD, 909-558-2860 ext. 14912, jveltman@llu.edu
About this study
Official title: Teamwork Makes the Dream Work: Team-based Inpatient Anti-Retroviral Treatment and Access to Services (ARTAS)
Exploring the effect of team-based ARTAS intervention in an inpatient setting on HIV linkage to care and hospital readmission rates.
- Conditions
- HIV Infections, Inpatient Facility Diagnoses
- Being tested
- Team Based Inpatient ARTAS, Standard of Care
- Keywords
- HIV, linkage to care, hospital readmission
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Team Based Inpatient ARTASBehavioural
Infectious Disease Team will provide inpatient consultation. Social Work Team will provide 1 session of case management inpatient and up to 5 case management sessions within 90 days post discharge or until the client is linked to medical care as evidenced by visit with HIV specialist within 90 days post discharge.
Standard of CareBehavioural
Subject admitted and seen by routine inpatient medical service.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care Historic Control | Active comparator | Control group will get treatment as usual, which consists of medical care by primary admitting service Receives: Behavioral: Standard of Care |
| Team based inpatient ARTAS | Active comparator | Eligible patients after the study consent process will receive Antiretroviral Treatment Access Study (ARTAS) intervention by social-worker and a medical consultation by an infectious disease physician Receives: Behavioral: Team Based Inpatient ARTAS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of linkage to HIV care post discharge
Subject had one visit with HIV specialist post hospital discharge. This will be determined per medical chart review and phone interview with subject
Measured: Up to 90 days post-study enrollment hospitalization discharge
Secondary outcomes (1)
Readmission Rate after initial post-study hospitalization
Subject had one emergency room visit or one inpatient admission post hospital discharge. This will be determined per medical chart review and phone interview with subject.
Measured: Up to 90 days post-study enrollment hospitalization discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2023
- Study start16 Oct 2023
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- This is a prospective, observational cohort study design with patients enrolled at Loma Linda University Medical Center (LLUMC), evaluating a multidisciplinary inpatient linkage to care program compared to historical control.
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Loma Linda University
- Sponsor type
- University, hospital or other
- Collaborators
- Gilead Sciences
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05866523
- Sponsor's protocol ID
- 5230236
- Acronym
- ARTAS
- Status last verified
- Feb 2026
- First submitted
- 10 May 2023
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Craw JA, Gardner LI, Marks G, Rapp RC, Bosshart J, Duffus WA, Rossman A, Coughlin SL, Gruber D, Safford LA, Overton J, Schmitt K. Brief strengths-based case management promotes entry into HIV medical care: results of the antiretroviral treatment access study-II. J Acquir Immune Defic Syndr. 2008 Apr 15;47(5):597-606. doi: 10.1097/QAI.0b013e3181684c51.
PubMed 18285714Gardner LI, Metsch LR, Anderson-Mahoney P, Loughlin AM, del Rio C, Strathdee S, Sansom SL, Siegal HA, Greenberg AE, Holmberg SD; Antiretroviral Treatment and Access Study Study Group. Efficacy of a brief case management intervention to link recently diagnosed HIV-infected persons to care. AIDS. 2005 Mar 4;19(4):423-31. doi: 10.1097/01.aids.0000161772.51900.eb.
PubMed 15750396Gardner LI, Marks G, Craw J, Metsch L, Strathdee S, Anderson-Mahoney P, del Rio C; Antiretroviral Treatment Access Study Group. Demographic, psychological, and behavioral modifiers of the Antiretroviral Treatment Access Study (ARTAS) intervention. AIDS Patient Care STDS. 2009 Sep;23(9):735-42. doi: 10.1089/apc.2008.0262.
PubMed 19645619
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Teamwork Makes the Dream Work: Team-based Inpatient Anti-Retroviral Treatment and Access to Services (ARTAS)
- ClinicalTrials.gov ID
- NCT05866523
- Acronym / sponsor ID
- ARTAS / 5230236
- Conditions
- HIV Infections, Inpatient Facility Diagnoses
- Keywords
- HIV, linkage to care, hospital readmission
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Loma Linda UniversityUniversity, hospital or other
- Collaborators
- Gilead Sciences
- Study start
- 16 Oct 2023 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 19 May 2023 (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.
Exploring the effect of team-based ARTAS intervention in an inpatient setting on HIV linkage to care and hospital readmission rates.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a prospective, observational cohort study design with patients enrolled at Loma Linda University Medical Center (LLUMC), evaluating a multidisciplinary inpatient linkage to care program compared to historical control.
| Arm | Type | Receives |
|---|---|---|
| Standard of Care Historic Control | Active comparator | Behavioral: Standard of CareControl group will get treatment as usual, which consists of medical care by primary admitting service |
| Team based inpatient ARTAS | Active comparator | Behavioral: Team Based Inpatient ARTASEligible patients after the study consent process will receive Antiretroviral Treatment Access Study (ARTAS) intervention by social-worker and a medical consultation by an infectious disease physician |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18 years of age or greater
- newly diagnosed HIV
- Known diagnosis of HIV not on ART within 30 days of admission
- Known HIV and not virally suppressed based on interview
- Known HIV and has not been under the care of an HIV specialist within the past 6 months
Key exclusion criteria (5 listed)
- All three criteria must be present for exclusion:
- virally suppressed
- actively taking ART
- are under active care of an HIV specialist within the last 6 months
- Less than 18 years of age (stand alone exclusion)
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 |
|---|---|---|
| Team Based Inpatient ARTASInfectious Disease Team will provide inpatient consultation. Social Work Team will provide 1 session of case management inpatient and up to 5 case management sessions within 90 days post discharge or until the client is linked to medical care as evidenced by visit with HIV specialist within 90 days post discharge. | Behavioural | Team based inpatient ARTAS |
| Standard of CareSubject admitted and seen by routine inpatient medical service. | Behavioural | Standard of Care Historic Control |
Primary outcome
Rate of linkage to HIV care post discharge
Time frame: Up to 90 days post-study enrollment hospitalization discharge
Subject had one visit with HIV specialist post hospital discharge. This will be determined per medical chart review and phone interview with subject
1 secondary outcome
Readmission Rate after initial post-study hospitalization
Time frame: Up to 90 days post-study enrollment hospitalization discharge
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Background: PubMed 18285714Craw JA, Gardner LI, Marks G, Rapp RC, Bosshart J, Duffus WA, Rossman A, Coughlin SL, Gruber D, Safford LA, Overton J, Schmitt K. Brief strengths-based case management promotes entry into HIV medical care: results of the antiretroviral treatment access study-II. J Acquir Immune Defic Syndr. 2008 Apr 15;47(5):597-606. doi: 10.1097/QAI.0b013e3181684c51.
- Background: PubMed 15750396Gardner LI, Metsch LR, Anderson-Mahoney P, Loughlin AM, del Rio C, Strathdee S, Sansom SL, Siegal HA, Greenberg AE, Holmberg SD; Antiretroviral Treatment and Access Study Study Group. Efficacy of a brief case management intervention to link recently diagnosed HIV-infected persons to care. AIDS. 2005 Mar 4;19(4):423-31. doi: 10.1097/01.aids.0000161772.51900.eb.
- Background: PubMed 19645619Gardner LI, Marks G, Craw J, Metsch L, Strathdee S, Anderson-Mahoney P, del Rio C; Antiretroviral Treatment Access Study Group. Demographic, psychological, and behavioral modifiers of the Antiretroviral Treatment Access Study (ARTAS) intervention. AIDS Patient Care STDS. 2009 Sep;23(9):735-42. doi: 10.1089/apc.2008.0262.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Team Based Inpatient ARTAS in people with HIV Infections and Inpatient Facility Diagnoses, run by Loma Linda University at 1 site in United States.
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 5 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jennifer Veltman, MD (909 558 4000 ext. 14912, jveltman@llu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of linkage to HIV care post discharge (time frame: Up to 90 days post-study enrollment hospitalization discharge). 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 NCT05866523, which also lists 3 linked publications.
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 27 Feb 2026.