NCT06931431

UNCPM 22322 - Adaption of the Transition of Care Model for Post-Discharge HIV-NCD Care in Lilongwe, Malawi - MLATHO

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 75 (estimated)
• Sponsor: University of North Carolina, Chapel Hill · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an implementation research study that will adapt and pilot test the Transitional Of Care Model (TCM), originally conceived and developed in the USA, for targeted use as a post-discharge intervention for adults hospitalized with comorbid HIV and NCDs in Malawi using a mixed methods approach.

Detailed description

This study will enroll 75 consecutive adults hospitalized with comorbid HIV and at least have one common cardiometabolic condition (e.g., hypertensive urgency, heart failure, stroke, or diabetes) and provide them with the adapted TCM according to the SOP developed in the prior phase. It is expected that 15-20% will also have comorbid opportunistic infections. The study will evaluate the acceptability and feasibility of the adapted intervention. Using mixed methods, including surveys and interviews, the study will evaluate the acceptability and feasibility of providing the inpatient and post-discharge components of the adapted TCM. The study will also describe key 3-month post-discharge clinical outcomes (mortality, readmission) and indicators that may mediate clinical outcomes (linkages/retention in care, adherence to antiretroviral therapy/non-communicable disease (ART/ NCDs) medications, dual control of HIV and NCDs, social demographic variables). Clinical outcomes and indicators in the pilot participants will be compared with a comparable historical control group of patients who had routine care at KCH in the recent past.

Conditions

• HIV
• Noncommunicable Diseases

Interventions

Type	Name	Description
BEHAVIORAL	Transition of Care Model (TCM)	Key components of the TCM include discharge assessment, care planning, provider communication with outpatient follow-up teams, and community-based follow-up

Timeline

• Start date: 2025-05-12
• Primary completion: 2027-03-01
• Completion: 2027-03-01
• First posted: 2025-04-17
• Last updated: 2025-06-18

Locations

1 site across 1 country: Malawi