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Recruiting NCT06931431

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

No phase Interventional HIV Noncommunicable Diseases

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Transition of Care Model (TCM).
Who it may be relevant to
Registry conditions: HIV, Noncommunicable Diseases. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Malawi
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • 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

Primary outcome measures

  • Post-discharge home visits [Time frame: Through 3-months post-discharge]
  • Completion of comprehensive needs assessment [Time frame: Through 3-months post-discharge]
  • Feasibility rating from health worker perspective. [Time frame: At 3 months post-discharge]
  • Feasibility rating from patient and caregiver perspective [Time frame: At 3 months post-discharge]
  • Reach among eligible hospitalized adults with HIV/NCD comorbidity [Time frame: At completion of enrollment]
  • Acceptability of Intervention Measures(AIM) rating from patient and caregiver perspective [Time frame: At 3 months post-discharge]
  • Acceptability of Intervention Measures(AIM) rating from Healthcare Workers perspective [Time frame: At 3 months post-discharge]
  • Intervention Appropriateness Measure(IAM) rating from Healthcare Workers perspective [Time frame: At 3 months post-discharge]
  • Intervention Appropriateness Measure(IAM) rating for patient and caregiver [Time frame: At 3 months post-discharge]
Secondary outcome measures (7)
  • The number of participants re-hospitalization after discharge [Time frame: Through 3 months post-discharge]
  • Dual control of HIV and hypertension [Time frame: At 3 months post-discharge]
  • Dual control of HIV and diabetes [Time frame: At 3 months post-discharge]
  • Control of hypertension [Time frame: At 3 months post-discharge]
  • Control of diabetes [Time frame: At 3 months post-discharge]
  • HIV viral suppression [Time frame: At 3 months post-discharge]
  • All-cause post-discharge mortality [Time frame: Through 3-months post-discharge]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Prevention

Study locations

Malawi · 1 center
  • Kamuzu Central Hospital — Lilongwe

Identifiers

NCT: NCT06931431 · 23-2753 · 1R21TW012647-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗