Re-engagement at Discharge 2 (ReCharge2)

March 5, 2024 updated by: Cassidy Claassen, University of Maryland, Baltimore

Re-engagement at Discharge 2: Improving Post-hospital Outcomes for Adults With HIV in Zambia

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.

Study Overview

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

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
Through three months post-discharge

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.
6 months post-discharge
Mortality
Time Frame: 6 months post-discharge
Proportion of clients alive at 6 months post-discharge.
6 months post-discharge
Retention in HIV care
Time Frame: 6 months post-discharge
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
Antiretroviral therapy clinic visit within 1 month of discharge
1 month post-discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Cassidy Claassen, MD, University of Maryland, Baltimore

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 8, 2023

Primary Completion (Actual)

December 10, 2023

Study Completion (Estimated)

July 31, 2024

Study Registration Dates

First Submitted

January 7, 2022

First Submitted That Met QC Criteria

January 11, 2023

First Posted (Actual)

January 23, 2023

Study Record Updates

Last Update Posted (Actual)

March 7, 2024

Last Update Submitted That Met QC Criteria

March 5, 2024

Last Verified

March 1, 2024

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)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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