HIV TreatmentBRIDGENCT07847567
Building Rapid Inpatient Delivery of ART to Generate Engagement in HIV Care
An observational study of HIV Treatment, run by University of Chicago at 1 site in United States.
Trial summary
The study team will pilot rapid antiretroviral therapy (ART) initiation as part of routine inpatient care at the University of Chicago Medicine (UCM), comparing outcomes over a 12-month implementation period. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2027to May 2028
- How long will I take part?
- 12 Months
- Phase
- Observational
- 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
Study population: University of Chicago Medicine adult inpatients living with HIV with elevated viral load
Who may be able to join
- 18 years of age or older
- Admitted to the UCM General Medicine or Hospital Medicine wards during the study time period
- Living with HIV
- HIV viral load > 200 copies/mL
- Able to speak and understand English
- Able and willing to provide informed consent
Who cannot join
- Less than 18 years of age
- Not admitted to the UCM General Medicine or Hospital Medicine wards during the study time period
- Not living with HIV
- HIV viral load < 200 copies/mL
- Not able to speak and understand English
- Unable and/or unwilling to provide informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Building Rapid Inpatient Delivery of ART to Generate Engagement in HIV Care (BRIDGE)
The study team will pilot rapid antiretroviral therapy (ART) initiation as part of routine inpatient care at the University of Chicago Medicine (UCM), comparing outcomes over a 12-month implementation period. Electronic medical record (EMR) data will be used to evaluate clinical outcomes such as ART initiation within 24-48 hours, linkage to HIV care, retention, and viral suppression, as well as demographic and clinical factors associated with these outcomes. Implementation outcomes will be assessed using Proctor's framework, including acceptability, feasibility, fidelity, and appropriateness.
Read the detailed description
The study team will conduct a pilot implementation study to evaluate the adoption and effectiveness of rapid initiation of antiretroviral therapy (ART) among hospitalized patients living with HIV (PLWH). The study will be guided by the integrated Promoting Action on Research Implementation in Health Services (i-PARIHS) framework, which emphasizes facilitation, context, and evidence in guiding implementation efforts.
The pilot implementation phase will occur in the Hospital Medicine and General Medicine Departments at the University of Chicago Medicine (UCM). These departments will be observed over a baseline/control period, followed by a pilot implementation period where rapid ART protocols and strategies are introduced. Data will be collected from the electronic medical record (EMR) to assess outcomes.
The study team will use Proctor's framework to evaluate implementation and clinical outcomes, including: 1) Primary outcome - proportion of eligible inpatients who are started on ART within 24-48 hours of qualifying hospitalization; 2) Secondary outcomes - time from admission to ART initiation, rates of successful linkage to post-discharge HIV care, short-term retention, and viral suppression rates; and 3) Implementation outcomes - acceptability, appropriateness, feasibility, fidelity, and penetration as measured by staff/patient surveys, debriefings, and workflow audits.
- Conditions
- HIV Treatment
- Keywords
- Adherence/Persistence
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of eligible inpatients with HIV who are started on ART within 24-48 hours of qualifying hospitalization
Rate of rapid ART initiation, as measured by the percentage of eligible inpatients with HIV who are started on ART within 24-48 hours of qualifying hospitalization
Measured: Baseline to month 12
Secondary outcomes (9)
Time from admission to ART initiation
Outcome Measure: Time from admission to ART initiation, as measured by the average time in hours from time of admission to time of first ART dose administration among hospitalized inpatients with HIV
Measured: Baseline to month 12
Rates of successful linkage to post-discharge HIV care
Rate of linkage to post-discharge HIV care, as measured by the percentage of PWH who attend at least 1 medical visit during the implementation phase (i.e., 1 year after hospitalization)
Measured: Baseline to month 12
Short-term retention in care
Rate of retention in care, as measured by the percentage of PWH who attend at least two medical visits during the implementation phase (i.e., 1 year after hospitalization)
Measured: Baseline through 12 months
HIV viral suppression rates
Rate of HIV viral suppression, as measured by the percentage of PWH who achieve a viral load less than 200 c/mL at the end of the implementation phase (i.e., within 1 year after hospitalization)
Measured: Baseline to month 12
Acceptability of Intervention Measure (AIM)
Acceptability of Intervention Measure (AIM), as measured by the average score on surveys among patients and providers.
Minimum score: 4 Maximum score: 20 Direction: Higher scores indicate greater perceived acceptability of the intervention.
Scoring: 4 items, each typically rated from 1 (completely unacceptable) to 5 (completely acceptable); items are summed.
Measured: Post-implementation (month 13 to month 14, or 15)
Intervention Appropriateness Measure (IAM)
Intervention Appropriateness Measure (IAM) as measured by the average score on surveys among patients and providers.
Minimum score: 4 Maximum score: 20 Direction: Higher scores indicate greater perceived appropriateness of the intervention.
Scoring: 4 items, each typically rated from 1 (completely inappropriate) to 5 (completely appropriate); items are summed.
Measured: Post-implementation (month 13 to month 14, or 15)
Feasibility of Intervention Measure (FIM)
Feasibility of Intervention Measure (FIM), as measured by the average score on surveys among patients and providers.
Minimum score: 4 Maximum score: 20 Direction: Higher scores indicate greater perceived feasibility of the intervention.
Scoring: 4 items, each rated from 1 (completely disagree) to 5 (completely agree); items are summed.
Measured: Post-implementation (month 13 to month 14, or 15)
Fidelity
Fidelity, as measured by qualitative data from staff interviews
Measured: Post-implementation (month 13 to month 14, or 15)
Penetration
Penetration, as measured by the percentage of providers who start ART among eligible inpatients with HIV and by the percentage of eligible inpatients with HIV who start ART
Measured: Baseline to month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2026
- Study startFeb 2027 (estimated)
- Primary completionFeb 2028 (estimated)
- Study completionMay 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV TreatmentStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jessica P. Ridgway, MD, MS, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07847567
- Sponsor's protocol ID
- IRB26-0992
- Acronym
- BRIDGE
- Status last verified
- Sep 2026
- First submitted
- 15 Sep 2026
- Last updated
- 29 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Building Rapid Inpatient Delivery of ART to Generate Engagement in HIV Care (BRIDGE)
- ClinicalTrials.gov ID
- NCT07847567
- Acronym / sponsor ID
- BRIDGE / IRB26-0992
- Conditions
- HIV Treatment
- Keywords
- Adherence/Persistence
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- Feb 2027 (estimated)
- Primary completion
- Feb 2028 (estimated)
- Study completion
- May 2028 (estimated)
- First posted
- 29 Sep 2026 (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.
The study team will pilot rapid antiretroviral therapy (ART) initiation as part of routine inpatient care at the University of Chicago Medicine (UCM), comparing outcomes over a 12-month implementation period. Electronic medical record (EMR) data will be used to evaluate clinical outcomes such as ART initiation within 24-48 hours, linkage to HIV care, retention, and viral suppression, as well as demographic and clinical factors associated with these outcomes. Implementation outcomes will be assessed using Proctor's framework, including acceptability, feasibility, fidelity, and appropriateness.
Detailed description
The study team will conduct a pilot implementation study to evaluate the adoption and effectiveness of rapid initiation of antiretroviral therapy (ART) among hospitalized patients living with HIV (PLWH). The study will be guided by the integrated Promoting Action on Research Implementation in Health Services (i-PARIHS) framework, which emphasizes facilitation, context, and evidence in guiding implementation efforts.
The pilot implementation phase will occur in the Hospital Medicine and General Medicine Departments at the University of Chicago Medicine (UCM). These departments will be observed over a baseline/control period, followed by a pilot implementation period where rapid ART protocols and strategies are introduced. Data will be collected from the electronic medical record (EMR) to assess outcomes.
The study team will use Proctor's framework to evaluate implementation and clinical outcomes, including: 1) Primary outcome - proportion of eligible inpatients who are started on ART within 24-48 hours of qualifying hospitalization; 2) Secondary outcomes - time from admission to ART initiation, rates of successful linkage to post-discharge HIV care, short-term retention, and viral suppression rates; and 3) Implementation outcomes - acceptability, appropriateness, feasibility, fidelity, and penetration as measured by staff/patient surveys, debriefings, and workflow audits.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 12 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- University of Chicago Medicine adult inpatients living with HIV with elevated viral load
Key inclusion criteria (6 listed)
- 18 years of age or older
- Admitted to the UCM General Medicine or Hospital Medicine wards during the study time period
- Living with HIV
- HIV viral load > 200 copies/mL
- Able to speak and understand English
Key exclusion criteria (6 listed)
- Less than 18 years of age
- Not admitted to the UCM General Medicine or Hospital Medicine wards during the study time period
- Not living with HIV
- HIV viral load < 200 copies/mL
- Not able to speak and understand English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Proportion of eligible inpatients with HIV who are started on ART within 24-48 hours of qualifying hospitalization
Time frame: Baseline to month 12
Rate of rapid ART initiation, as measured by the percentage of eligible inpatients with HIV who are started on ART within 24-48 hours of qualifying hospitalization
9 secondary outcomes
Time from admission to ART initiation
Time frame: Baseline to month 12
Rates of successful linkage to post-discharge HIV care
Time frame: Baseline to month 12
Short-term retention in care
Time frame: Baseline through 12 months
HIV viral suppression rates
Time frame: Baseline to month 12
Acceptability of Intervention Measure (AIM)
Time frame: Post-implementation (month 13 to month 14, or 15)
Intervention Appropriateness Measure (IAM)
Time frame: Post-implementation (month 13 to month 14, or 15)
Feasibility of Intervention Measure (FIM)
Time frame: Post-implementation (month 13 to month 14, or 15)
Fidelity
Time frame: Post-implementation (month 13 to month 14, or 15)
Penetration
Time frame: Baseline to month 12
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 29 Sep 2026.
- 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.
Jessica P. Ridgway, MD, MS principal investigator
University of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Treatment, run by University of Chicago 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 6 inclusion and 6 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: opening soon, as of the sponsor's last update on 29 Sep 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 Jessica P. Ridway, MD, MS (415-264-0348, jridgway@uchicagomedicine.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of eligible inpatients with HIV who are started on ART within 24-48 hours of qualifying hospitalization (time frame: Baseline to month 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Sep 2026.