Re-engagement at Discharge 2

NCT ID: NCT05694546

Last Updated: 2025-08-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 97 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-18
• Study Completion Date: 2025-03-13

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.

Conditions

HIV/AIDS; Hospitalization; Transitions of Care; Opportunistic Infections

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Community Health Worker Post-Discharge Intervention

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

Group Type: EXPERIMENTAL

Community Health Worker Post-Discharge Intervention

Intervention Type: BEHAVIORAL

Clients will be offered a community-based follow-up from a community health worker after hospital discharge.

Interventions

Community Health Worker Post-Discharge Intervention

Clients will be offered a community-based follow-up from a community health worker after hospital discharge.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Teaching Hospital, Lusaka, Zambia

OTHER

Sponsor Role: collaborator

University of Alabama at Birmingham

OTHER

Sponsor Role: collaborator

University of Maryland, College Park

OTHER

Sponsor Role: collaborator

University of Maryland, Baltimore

OTHER

Sponsor Role: lead

Responsible Party

Cassidy Claassen

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Cassidy Claassen, MD

Role: PRINCIPAL_INVESTIGATOR

University of Maryland, Baltimore

Locations

Levy Mwanawasa University Teaching Hospital

Lusaka, , Zambia

University Teaching Hospital

Lusaka, , Zambia

Countries

Zambia

Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

R34MH122265

Identifier Type: NIH

Identifier Source: org_study_id

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