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

Not Applicable

Not yet recruiting

• Conditions: HIV; Noncommunicable Diseases

• Registration Number: NCT06931431
• Lead Sponsor: University of North Carolina, Chapel Hill

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.

Study Timeline

• Status Verified: 2025-03
• Study First Submitted: 2025-04-14
• Study First Submitted QC: 2025-04-14
• Last Update Submitted: 2025-04-14
• Study First Posted: 2025-04-17
• Last Update Posted: 2025-04-17
• Study Start: 2025-05
• Primary Completion: 2027-03
• Study Completion: 2027-03

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 75

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Post-discharge home visits	Through 3-months post-discharge	Proportion of discharged participants who have a home visit by a nurse within 1 week of discharge
Completion of comprehensive needs assessment	Through 3-months post-discharge	Proportion of participants who have an assessment of social support, food insecurity, medication adherence self-efficacy during hospitalization or within 1 week of discharge
Feasibility rating from health worker perspective.	At 3 months post-discharge	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; 1. The post-discharge intervention program seems implementable in our setting; 2. The post-discharge intervention seems possible in our setting; 3. The post-discharge intervention seems doable in our setting; 4. 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.
Feasibility rating from patient and caregiver perspective	At 3 months post-discharge	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; 1. The post-discharge intervention program seems implementable in our setting; 2. The post-discharge intervention seems possible in our setting; 3. The post-discharge intervention seems doable in our setting; 4. 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.
Reach among eligible hospitalized adults with HIV/NCD comorbidity	At completion of enrollment	Proportion of eligible adults admitted with HIV/NCD comorbidity who participate in the study during the enrollment period
Acceptability of Intervention Measures(AIM) rating from patient and caregiver perspective	At 3 months post-discharge	The AIM is a 4-item/ statement measure; 1. The post-discharge intervention implementation program meets my approval; 2. The post-discharge intervention is appealing to me; 3. I like the post-discharge intervention; 4. 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
Acceptability of Intervention Measures(AIM) rating from Healthcare Workers perspective	At 3 months post-discharge	The AIM is a 4-item/ statement measure; 1. The post-discharge intervention implementation program meets my approval; 2. The post-discharge intervention is appealing to me; 3. I like the post-discharge intervention; 4. 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.
Intervention Appropriateness Measure(IAM) rating from Healthcare Workers perspective	At 3 months post-discharge	The IAM is a 4-item/ statement measure; 1. The post-discharge intervention program seems fitting in our setting; 2. The post-discharge intervention seems suitable for our setting; 3. The post-discharge intervention seems applicable to our setting; 4. 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
Intervention Appropriateness Measure(IAM) rating for patient and caregiver	At 3 months post-discharge	The IAM is a 4-item/ statement measure; 1. The post-discharge intervention program seems fitting in our setting; 2. The post-discharge intervention seems suitable for our setting; 3. The post-discharge intervention seems applicable to our setting; 4. 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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Kamuzu Central Hospital; 🇲🇼 Lilongwe, Malawi