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NCT06931431 | NOT YET RECRUITING | HIV


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

Condition or disease

HIV

Noncommunicable Diseases

Intervention/treatment

Transition of Care Model (TCM)

Phase

NA

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
Estimated Enrollment : 75 participants
Masking : NONE
Primary Purpose : PREVENTION
Official Title : UNCPM 22322 - Adaption of the Transition of Care Model for Post-Discharge HIV-NCD Care in Lilongwe, Malawi - MLATHO
Actual Study Start Date : 2025-05
Estimated Primary Completion Date : 2027-03
Estimated Study Completion Date : 2027-03

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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

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

Location Details

NCT06931431


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Locations


Not yet recruiting

Malawi,

Kamuzu Central Hospital

Lilongwe, Malawi,

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