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

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.

Study Overview

• Status: Recruiting
• Conditions: HIV; Noncommunicable Diseases
• Intervention / Treatment: Behavioral: Transition of Care Model (TCM)

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.

• Study Type: Interventional
• Enrollment (Estimated): 75
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Chimwemwe Chawinga; Phone Number: 265884409026; Email: cchawinga@unclilongwe.org.mw

Study Locations

• Malawi
  • Lilongwe, Malawi
    • Recruiting
    • Kamuzu Central Hospital
    • Contact: Chimwemwe Chawinga; Phone Number: 265884409026; Email: cchawinga@unclilongwe.org.mw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Transition of Care Model (TCM); Following hospitalization for comorbid HIV and non-communicable diseases, participants will be followed for 3 months post discharge using the adopted Transition of Care Model (TCM).	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-discharge home visits	Proportion of discharged participants who have a home visit by a nurse within 1 week of discharge	Through 3-months post-discharge
Completion of comprehensive needs assessment	Proportion of participants who have an assessment of social support, food insecurity, medication adherence self-efficacy during hospitalization or within 1 week of discharge	Through 3-months post-discharge
Feasibility rating from health worker perspective.	Feasibility of intervention measure (FIM) score among health workers involved in the implementation of the post-discharge intervention.The FIM is a 4-item/ statement measure; The post-discharge intervention program seems implementable in our setting; The post-discharge intervention seems possible in our setting; The post-discharge intervention seems doable in our setting; The post-discharge intervention seems easy to use for our setting The FIM is measured on a five-point rating scale:( 1= completely disagree, 2= disagree,3=neither agree nor disagree, 4= agree, and 5 = completely agree) The mean score ranges from 1 to 5, with 1 indicating the least feasibility and 5 indicating the most feasibility.	At 3 months post-discharge
Feasibility rating from patient and caregiver perspective	Feasibility of implementation measure (FIM) score among patients and caregivers who were assigned to receive the post-discharge intervention.The FIM is a 4-item/ statement measure; The post-discharge intervention program seems implementable in our setting; The post-discharge intervention seems possible in our setting; The post-discharge intervention seems doable in our setting; The post-discharge intervention seems easy to use for our setting The FIM is measured on a five-point rating scale:( 1= completely disagree, 2= disagree,3=neither agree nor disagree, 4= agree, and 5 = completely agree) The mean score ranges from 1 to 5, with 1 indicating the least feasibility and 5 the most feasibility.	At 3 months post-discharge
Reach among eligible hospitalized adults with HIV/NCD comorbidity	Proportion of eligible adults admitted with HIV/NCD comorbidity who participate in the study during the enrollment period	At completion of enrollment
Acceptability of Intervention Measures(AIM) rating from patient and caregiver perspective	The AIM is a 4-item/ statement measure; The post-discharge intervention implementation program meets my approval; The post-discharge intervention is appealing to me; I like the post-discharge intervention; I welcome the post-discharge intervention The AIM is measured on a five-point rating scale:( 1= completely disagree, 2= disagree,3=neither agree nor disagree, 4= agree, and 5 = completely agree) The mean score ranges from 1 to 5, with 1 indicating poorly acceptable and five highly acceptable	At 3 months post-discharge
Acceptability of Intervention Measures(AIM) rating from Healthcare Workers perspective	The AIM is a 4-item/ statement measure; The post-discharge intervention implementation program meets my approval; The post-discharge intervention is appealing to me; I like the post-discharge intervention; I welcome the post-discharge intervention The AIM is measured on a five-point rating scale:( 1= completely disagree, 2= disagree,3=neither agree nor disagree, 4= agree, and 5 = completely agree) The mean score ranges from 1 to 5, with 1 indicating poorly acceptable and 5 highly acceptable.	At 3 months post-discharge
Intervention Appropriateness Measure(IAM) rating from Healthcare Workers perspective	The IAM is a 4-item/ statement measure; The post-discharge intervention program seems fitting in our setting; The post-discharge intervention seems suitable for our setting; The post-discharge intervention seems applicable to our setting; The post-discharge intervention seems a good match in our setting The IAM is measured on a five-point rating scale:( 1= completely disagree, 2= disagree,3=neither agree nor disagree, 4= agree, and 5 = completely agree) The mean score ranges from 1 to 5, with 1 indicating the least appropriate and 5 the most appropriate	At 3 months post-discharge
Intervention Appropriateness Measure(IAM) rating for patient and caregiver	The IAM is a 4-item/ statement measure; The post-discharge intervention program seems fitting in our setting; The post-discharge intervention seems suitable for our setting; The post-discharge intervention seems applicable to our setting; The post-discharge intervention seems a good match in our setting The IAM is measured on a five-point rating scale:( 1= completely disagree, 2= disagree,3=neither agree nor disagree, 4= agree, and 5 = completely agree) The mean score ranges from 1 to 5, with 1 indicating the least appropriate and 5 the most appropriate.	At 3 months post-discharge

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The number of participants re-hospitalization after discharge	Proportion of participants who are discharged and then readmitted	Through 3 months post-discharge
Dual control of HIV and hypertension	Among participants with hypertension and HIV, the proportion with both HIV viral load below assay detection (<40 copies/ml) and blood pressure below 140/90	At 3 months post-discharge
Dual control of HIV and diabetes	Among participants with diabetes and HIV, the proportion with HIV viral load below assay detection (<40 copies/ml) and hemoglobin A1C <7%	At 3 months post-discharge
Control of hypertension	Among participants with hypertension, the proportion with blood pressure below 140/90	At 3 months post-discharge
Control of diabetes	Among participants with diabetes, the proportion with hemoglobin A1C <7%	At 3 months post-discharge
HIV viral suppression	The proportion with HIV viral load below assay detection (<40 copies/ml)	At 3 months post-discharge
All-cause post-discharge mortality	The proportion with death after discharge from the index admission	Through 3-months post-discharge

Collaborators and Investigators

• Sponsor: University of North Carolina, Chapel Hill
• Collaborators: National Institutes of Health (NIH); Fogarty International Center of the National Institute of Health
• Investigators: Principal Investigator: Cecilia Kanyama, MBBS, University of North Carolina at Chapel Hill (Project Malawi)

Study record dates

Study Major Dates

• Study Start (Actual): May 12, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027

Study Registration Dates

• First Submitted: April 14, 2025
• First Submitted That Met QC Criteria: April 14, 2025
• First Posted (Actual): April 17, 2025

Study Record Updates

• Last Update Posted (Actual): June 18, 2025
• Last Update Submitted That Met QC Criteria: June 17, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Noncommunicable Diseases
• Other Study ID Numbers: 23-2753; 1R21TW012647-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.

More information provided by University of North Carolina, Chapel Hill

• IPD Sharing Time Frame: beginning 9 and continuing for 36 months following publication
• IPD Sharing Access Criteria: Investigator has approved IRB, IEC, or REB and an executed data use/sharing agreement with UNC.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No