Clinical trial NCT06931431: UNCPM 22322 - Adaption of the Transition of Care Model for Post-Discharge HIV-NCD Care in Lilongwe, Malawi - MLATHO
Official title: UNCPM 22322 - Adaption of the Transition of Care Model for Post-Discharge HIV-NCD Care in Lilongwe, Malawi - MLATHO
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: HIV
Noncommunicable Diseases
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: Fogarty International Center of the National Institute of Health
First posted: 2025-04-17
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The Transition of Care Model (TCM) is an evidence-based model in the United States of America (USA) focused on continuity of care for patients with complex needs, particularly mature adults, as they move through the health care system.
Primary purpose: PREVENTION

Brief 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.

Eligibility criteria: Inclusion Criteria:

* 18 years of age or older
* living with HIV
* admitted to internal medicine
* has at least a cardiometabolic NCO as the primary or secondary reason for admission based on the HIV inpatient consultation

Exclusion Criteria:

* patients living beyond Lilongwe urban

Primary outcomes:
measure: Post-discharge home visits
timeFrame: Through 3-months post-discharge
measure: Completion of comprehensive needs assessment
timeFrame: Through 3-months post-discharge
measure: Feasibility rating from health worker perspective.
timeFrame: At 3 months post-discharge
measure: Feasibility rating from patient and caregiver perspective
timeFrame: At 3 months post-discharge
measure: Reach among eligible hospitalized adults with HIV/NCD comorbidity
timeFrame: At completion of enrollment
measure: Acceptability of Intervention Measures(AIM) rating from patient and caregiver perspective
timeFrame: At 3 months post-discharge
measure: Acceptability of Intervention Measures(AIM) rating from Healthcare Workers perspective
timeFrame: At 3 months post-discharge
measure: Intervention Appropriateness Measure(IAM) rating from Healthcare Workers perspective
timeFrame: At 3 months post-discharge
measure: Intervention Appropriateness Measure(IAM) rating for patient and caregiver
timeFrame: At 3 months post-discharge
Secondary outcomes:
measure: The number of participants re-hospitalization after discharge
timeFrame: Through 3 months post-discharge
measure: Dual control of HIV and hypertension
timeFrame: At 3 months post-discharge
measure: Dual control of HIV and diabetes
timeFrame: At 3 months post-discharge
measure: Control of hypertension
timeFrame: At 3 months post-discharge
measure: Control of diabetes
timeFrame: At 3 months post-discharge
measure: HIV viral suppression
timeFrame: At 3 months post-discharge
measure: All-cause post-discharge mortality
timeFrame: Through 3-months post-discharge
Other outcomes:
Locations:
city: Lilongwe
country: Malawi
facility: Kamuzu Central Hospital
Study officials:
affiliation: University of North Carolina at Chapel Hill (Project Malawi)
name: Cecilia Kanyama, MBBS
role: PRINCIPAL_INVESTIGATOR
References: