Re-engagement at Discharge 2

HIV/AIDS Clinical Trial

— ReCharge2  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05694546
• Other study ID #: R34MH122265
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 8, 2023
• Est. completion date: July 31, 2024

Study information

• Verified date: March 2024
• Source: University of Maryland, Baltimore
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: July 31, 2024
• Est. primary completion date: December 10, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• Community Health Worker Post-Discharge Intervention
Clients will be offered a community-based follow-up from a community health worker after hospital discharge.

Locations

Country	Name	City	State
Zambia	Levy Mwanawasa University Teaching Hospital	Lusaka
Zambia	University Teaching Hospital	Lusaka

Sponsors (4)

Lead Sponsor	Collaborator
University of Maryland, Baltimore	University of Alabama at Birmingham, University of Maryland, College Park, University Teaching Hospital, Lusaka, Zambia

Country where clinical trial is conducted

Zambia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post-Discharge Visits	Proportion of discharged patients who are successfully visited after discharge.	Through three months post-discharge
Primary	Comprehensive Post-Discharge Visits	Proportion of discharge follow-up visits by a community health worker that are comprehensive	Through three months post-discharge
Primary	Post-Discharge Clinic Visits	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	HIV viral load suppression	Proportion of clients with suppressed HIV viral load at 6 months post-discharge.	6 months post-discharge
Secondary	Mortality	Proportion of clients alive at 6 months post-discharge.	6 months post-discharge
Secondary	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	6 months post-discharge
Secondary	Antiretroviral therapy clinic visit	Antiretroviral therapy clinic visit within 1 month of discharge	1 month post-discharge