Clinical trial NCT05694546: Re-engagement at Discharge 2
Official title: Re-engagement at Discharge 2: Improving Post-hospital Outcomes for Adults With HIV in Zambia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV/AIDS
Hospitalization
Transitions of Care
Opportunistic Infections
Lead sponsor: University of Maryland, Baltimore
Sponsor class: OTHER
Collaborators: name: University Teaching Hospital, Lusaka, Zambia
name: University of Alabama at Birmingham
name: University of Maryland, College Park
First posted: 2023-01-23
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Community health worker follow-up after discharge from hospital
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Post-Discharge Visits
timeFrame: Through three months post-discharge
measure: Comprehensive Post-Discharge Visits
timeFrame: Through three months post-discharge
measure: Post-Discharge Clinic Visits
timeFrame: Through three months post-discharge
Secondary outcomes:
measure: HIV viral load suppression
timeFrame: 6 months post-discharge
measure: Mortality
timeFrame: 6 months post-discharge
measure: Retention in HIV care
timeFrame: 6 months post-discharge
measure: Antiretroviral therapy clinic visit
timeFrame: 1 month post-discharge
Other outcomes:
Locations:
city: Lusaka
country: Zambia
facility: Levy Mwanawasa University Teaching Hospital
city: Lusaka
country: Zambia
facility: University Teaching Hospital
Study officials:
affiliation: University of Maryland, Baltimore
name: Cassidy Claassen, MD
role: PRINCIPAL_INVESTIGATOR
References: