Re-engagement at Discharge 2

Not Applicable

Completed

• Conditions: Opportunistic Infections; Hospitalization; Transitions of Care; HIV/AIDS
• Interventions: Behavioral: Community Health Worker Post-Discharge Intervention

• Registration Number: NCT05694546
• Lead Sponsor: University of Maryland, Baltimore

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.

Study Timeline

• Study First Submitted: 2022-01-07
• Study First Submitted QC: 2023-01-11
• Study First Posted: 2023-01-23
• Study Start: 2023-08-08
• Primary Completion: 2023-12-10
• Study Completion: 2024-06-24
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-02
• Last Update Posted: 2024-10-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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.

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Exclusion Criteria

• Unable to provide informed consent
• No phone
• Planning to reside outside of Lusaka urban district after discharge

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Community Health Worker Post-Discharge Intervention	Community Health Worker Post-Discharge Intervention	This group will be offered a community-based visit from a community health worker following hospital discharge.

Primary Outcome Measures

Name	Time	Method
Post-Discharge Clinic Visits	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
Comprehensive Post-Discharge Visits	Through three months post-discharge	Proportion of discharge follow-up visits by a community health worker that are comprehensive
Post-Discharge Visits	Through three months post-discharge	Proportion of discharged patients who are successfully visited after discharge.

Secondary Outcome Measures

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

Trial Locations

Locations (2)

University Teaching Hospital; 🇿🇲 Lusaka, Zambia

Levy Mwanawasa University Teaching Hospital; 🇿🇲 Lusaka, Zambia