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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05694546
Other study ID # R34MH122265
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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