Building Rapid Inpatient Delivery of ART to Generate Engagement in HIV Care

NCT07847567 — Not yet recruiting, 40 participants, University of Chicago

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Building Rapid Inpatient Delivery of ART to Generate Engagement in HIV Care (BRIDGE)

RegistryNCT07847567, acronym BRIDGE
StatusNot yet recruiting
Study typeObservational
Enrollment40 (Estimated)
SponsorUniversity of Chicago (Other)
ConditionsHIV Treatment
Datesstart 2027-02-01 (estimated), primary completion 2028-02-01 (estimated), completion 2028-05-01 (estimated), first posted 2026-09-29, last updated 2026-09-29
Locations1 site in United States

Related Papers Related Patents Related Grants Related Experts
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-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. 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.

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+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.

+Outcome measures

Primary outcomes

  • Proportion of eligible inpatients with HIV who are started on ART within 24-48 hours of qualifying hospitalization [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

Secondary outcomes

  • Time from admission to ART initiation [Baseline to month 12]: 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
  • Rates of successful linkage to post-discharge HIV care [Baseline to month 12]: 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)
  • Short-term retention in care [Baseline through 12 months]: 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)
  • HIV viral suppression rates [Baseline to month 12]: 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)
  • Acceptability of Intervention Measure (AIM) [Post-implementation (month 13 to month 14, or 15)]: 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.
  • Intervention Appropriateness Measure (IAM) [Post-implementation (month 13 to month 14, or 15)]: 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.
  • Feasibility of Intervention Measure (FIM) [Post-implementation (month 13 to month 14, or 15)]: 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.
  • Fidelity [Post-implementation (month 13 to month 14, or 15)]: Fidelity, as measured by qualitative data from staff interviews
  • Penetration [Baseline to month 12]: 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

+Eligibility

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

+Locations (1)

FacilityCityCountryStatus
University of ChicagoChicago, IllinoisUnited States

+Investigators