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Re-engagement at Discharge 2 (ReCharge2)

Primary Purpose

HIV/AIDS, Hospitalization, Transitions of Care

Status
Recruiting
Phase
Not Applicable
Locations
Zambia
Study Type
Interventional
Intervention
Community Health Worker Post-Discharge Intervention
Sponsored by
University of Maryland, Baltimore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for HIV/AIDS

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Levy Mwanawasa University Teaching HospitalRecruiting
  • University Teaching HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Community Health Worker Post-Discharge Intervention

Arm Description

This group will be offered a community-based visit from a community health worker following hospital discharge.

Outcomes

Primary Outcome Measures

Post-Discharge Visits
Proportion of discharged patients who are successfully visited after discharge.
Comprehensive Post-Discharge Visits
Proportion of discharge follow-up visits by a community health worker that are comprehensive
Post-Discharge Clinic Visits
Proportion of initial post-discharge visits to the HIV clinic that are attended by the participant's community health worker

Secondary Outcome Measures

HIV viral load suppression
Proportion of clients with suppressed HIV viral load at 6 months post-discharge.
Mortality
Proportion of clients alive at 6 months post-discharge.
Retention in HIV care
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
Antiretroviral therapy clinic visit
Antiretroviral therapy clinic visit within 1 month of discharge

Full Information

First Posted
January 7, 2022
Last Updated
September 25, 2023
Sponsor
University of Maryland, Baltimore
Collaborators
University Teaching Hospital, Lusaka, Zambia, University of Alabama at Birmingham, University of Maryland, College Park
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1. Study Identification

Unique Protocol Identification Number
NCT05694546
Brief Title
Re-engagement at Discharge 2
Acronym
ReCharge2
Official Title
Re-engagement at Discharge 2: Improving Post-hospital Outcomes for Adults With HIV in Zambia
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 8, 2023 (Actual)
Primary Completion Date
January 31, 2024 (Anticipated)
Study Completion Date
January 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Maryland, Baltimore
Collaborators
University Teaching Hospital, Lusaka, Zambia, University of Alabama at Birmingham, University of Maryland, College Park

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Early post-discharge mortality is high among Zambians living with HIV admitted to the hospital. This may be due to missed opportunities in post-discharge care, such as inadequate follow-up and treatment. In this study the investigators will develop and pilot a new approach to post-discharge HIV care to improve care coordination and treatment adherence.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV/AIDS, Hospitalization, Transitions of Care, Opportunistic Infections

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Community health worker follow-up after discharge from hospital
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Community Health Worker Post-Discharge Intervention
Arm Type
Experimental
Arm Description
This group will be offered a community-based visit from a community health worker following hospital discharge.
Intervention Type
Behavioral
Intervention Name(s)
Community Health Worker Post-Discharge Intervention
Intervention Description
Clients will be offered a community-based follow-up from a community health worker after hospital discharge.
Primary Outcome Measure Information:
Title
Post-Discharge Visits
Description
Proportion of discharged patients who are successfully visited after discharge.
Time Frame
Through three months post-discharge
Title
Comprehensive Post-Discharge Visits
Description
Proportion of discharge follow-up visits by a community health worker that are comprehensive
Time Frame
Through three months post-discharge
Title
Post-Discharge Clinic Visits
Description
Proportion of initial post-discharge visits to the HIV clinic that are attended by the participant's community health worker
Time Frame
Through three months post-discharge
Secondary Outcome Measure Information:
Title
HIV viral load suppression
Description
Proportion of clients with suppressed HIV viral load at 6 months post-discharge.
Time Frame
6 months post-discharge
Title
Mortality
Description
Proportion of clients alive at 6 months post-discharge.
Time Frame
6 months post-discharge
Title
Retention in HIV care
Description
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
Time Frame
6 months post-discharge
Title
Antiretroviral therapy clinic visit
Description
Antiretroviral therapy clinic visit within 1 month of discharge
Time Frame
1 month post-discharge

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cassidy Claassen, MD
Phone
+260971075439
Email
cclaassen@ihv.umaryland.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Michael Vinikoor, MD
Email
michaelvinikoor@uabmc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cassidy Claassen, MD
Organizational Affiliation
University of Maryland, Baltimore
Official's Role
Principal Investigator
Facility Information:
Facility Name
Levy Mwanawasa University Teaching Hospital
City
Lusaka
Country
Zambia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cassidy Claassen, MD
Phone
+260971075439
Email
cclaassen@ihv.umaryland.edu
First Name & Middle Initial & Last Name & Degree
Michael Vinikoor, MD
Email
michaelvinikoor@uabmc.edu
Facility Name
University Teaching Hospital
City
Lusaka
Country
Zambia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cassidy Claassen, MD
Phone
+260971075439
Email
cclaassen@ihv.umaryland.edu
First Name & Middle Initial & Last Name & Degree
Michael Vinikoor, MD
Email
michaelvinikoor@uabmc.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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Re-engagement at Discharge 2

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