- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05694546
Re-engagement at Discharge 2 (ReCharge2)
Re-engagement at Discharge 2: Improving Post-hospital Outcomes for Adults With HIV in Zambia
Study Overview
Status
Intervention / Treatment
Detailed Description
Many people living with HIV (PLHIV) have poor outcomes following hospitalization, including high mortality, readmission, and gaps in HIV care engagement. This is likely multi-factorial and not all etiologies may be modifiable. While high mortality may due to incurable cancer, the majority of deaths in PLHIV are thought to be caused by infectious diseases for which treatments exist. However, succumbing to these life-threatening infections after discharge may be due to poor understanding of discharge instructions, lack of post hospital care, and poor understanding of required follow up. Psychosocial support also plays a role in the mental and physical health of these sick patients.
In ReCharge 1, the investigators gathered formative data and identified at least three major factors that undermine HIV clinical outcomes after hospital discharge. First, there are gaps in continuity of care between the discharging facility and outpatient. Second, support from family is often suboptimal due to lack of understanding on the cause of illness, lack of HIV status disclosure, and the cost of care. Third, HIV comorbidities may underpin or complicate the immediate reason for discharge or the post-discharge engagement in care. These data were disseminated to local experts in Zambia including from the Ministry of Health and used to create a new care model for post-discharge HIV care. The care model draws from other successful programs in Zambia. In ReCharge 2 the investigators now propose to pilot the program and assess feasibility, acceptability, and potential for clinical impact.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Cassidy Claassen, MD
- Phone Number: +260971075439
- Email: cclaassen@ihv.umaryland.edu
Study Contact Backup
- Name: Michael Vinikoor, MD
- Email: michaelvinikoor@uabmc.edu
Study Locations
-
-
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Lusaka, Zambia
- University Teaching Hospital
-
Contact:
- Cassidy Claassen, MD
- Phone Number: +260971075439
- Email: cclaassen@ihv.umaryland.edu
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Contact:
- Michael Vinikoor, MD
- Email: michaelvinikoor@uabmc.edu
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Lusaka, Zambia
- Levy Mwanawasa University Teaching Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age 18+ years
- HIV-positive
- Hospitalized for at least 1 night at study site
- Clinically stable and expected to be discharged according to their clinician
- Objective evidence of suboptimal HIV outcome, defined as HIV viral load above the lower limit of the assay or T-cell cluster of differentiation 4 count <=200.
Exclusion Criteria:
- Unable to provide informed consent
- No phone
- Planning to reside outside of Lusaka urban district after discharge
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Community Health Worker Post-Discharge Intervention
This group will be offered a community-based visit from a community health worker following hospital discharge.
|
Clients will be offered a community-based follow-up from a community health worker after hospital discharge.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Post-Discharge Visits
Time Frame: Through three months post-discharge
|
Proportion of discharged patients who are successfully visited after discharge.
|
Through three months post-discharge
|
Comprehensive Post-Discharge Visits
Time Frame: Through three months post-discharge
|
Proportion of discharge follow-up visits by a community health worker that are comprehensive
|
Through three months post-discharge
|
Post-Discharge Clinic Visits
Time Frame: Through three months post-discharge
|
Proportion of initial post-discharge visits to the HIV clinic that are attended by the participant's community health worker
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Through three months post-discharge
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
HIV viral load suppression
Time Frame: 6 months post-discharge
|
Proportion of clients with suppressed HIV viral load at 6 months post-discharge.
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6 months post-discharge
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Mortality
Time Frame: 6 months post-discharge
|
Proportion of clients alive at 6 months post-discharge.
|
6 months post-discharge
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Retention in HIV care
Time Frame: 6 months post-discharge
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Retention in HIV care after discharge defined by no gap of >28 days off antiretroviral therapy from discharge date to 6 months post-discharge date
|
6 months post-discharge
|
Antiretroviral therapy clinic visit
Time Frame: 1 month post-discharge
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Antiretroviral therapy clinic visit within 1 month of discharge
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1 month post-discharge
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Cassidy Claassen, MD, University of Maryland, Baltimore
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R34MH122265 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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