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

NCT06931431 | Recruiting

• 2 other identifiers: 23-27531R21TW012647-01
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV; Noncommunicable Diseases

Outcome Measures

Primary Outcomes (9)

• 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 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.

  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 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.

  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 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

  At 3 months post-discharge

• Acceptability of Intervention Measures(AIM) rating from Healthcare Workers perspective

  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.

  At 3 months post-discharge

• Intervention Appropriateness Measure(IAM) rating from Healthcare Workers perspective

  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

  At 3 months post-discharge

• Intervention Appropriateness Measure(IAM) rating for patient and caregiver

  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.

  At 3 months post-discharge

Secondary Outcomes (7)

• The number of participants re-hospitalization after discharge

  Through 3 months post-discharge

• Dual control of HIV and hypertension

  At 3 months post-discharge

• Dual control of HIV and diabetes

  At 3 months post-discharge

• Control of hypertension

  At 3 months post-discharge

• Control of diabetes

  At 3 months post-discharge

Study Arms (1)

Transition of Care Model (TCM)

EXPERIMENTAL

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)

Interventions

Transition of Care Model (TCM) BEHAVIORAL

Key components of the TCM include discharge assessment, care planning, provider communication with outpatient follow-up teams, and community-based follow-up

Transition of Care Model (TCM)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• patients living beyond Lilongwe urban

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• National Institutes of Health (NIH): collaborator
• Fogarty International Center of the National Institute of Health: collaborator

Study Sites (1)

Kamuzu Central Hospital

Lilongwe, Malawi

RECRUITING

MeSH Terms

Conditions

Noncommunicable Diseases

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Cecilia Kanyama, MBBS

  University of North Carolina at Chapel Hill (Project Malawi)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chimwemwe Chawinga

CONTACT

265884409026; cchawinga@unclilongwe.org.mw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 14, 2025
• First Posted: April 17, 2025
• Study Start: May 12, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: June 18, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: beginning 9 and continuing for 36 months following publication
• Access Criteria: Investigator has approved IRB, IEC, or REB and an executed data use/sharing agreement with UNC.

Locations

MA (1)