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NCT Number: NCT06931431

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

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Key information

Conditions

HIV Disease Attributes Noncommunicable Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Post-discharge home visits

    Time frame: Through 3-months post-discharge

    Proportion of discharged participants who have a home visit by a nurse within 1 week of discharge

  2. Completion of comprehensive needs assessment

    Time frame: 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

  3. Feasibility rating from health worker perspective.

    Time frame: 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

    • 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.

  4. Feasibility rating from patient and caregiver perspective

    Time frame: 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

    • 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.

  5. Reach among eligible hospitalized adults with HIV/NCD comorbidity

    Time frame: At completion of enrollment

    Proportion of eligible adults admitted with HIV/NCD comorbidity who participate in the study during the enrollment period

  6. Acceptability of Intervention Measures(AIM) rating from patient and caregiver perspective

    Time frame: At 3 months post-discharge

    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

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

    Time frame: At 3 months post-discharge

    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.

  8. Intervention Appropriateness Measure(IAM) rating from Healthcare Workers perspective

    Time frame: At 3 months post-discharge

    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

  9. Intervention Appropriateness Measure(IAM) rating for patient and caregiver

    Time frame: At 3 months post-discharge

    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.

Secondary outcomes

  1. The number of participants re-hospitalization after discharge

    Time frame: Through 3 months post-discharge

    Proportion of participants who are discharged and then readmitted

  2. Dual control of HIV and hypertension

    Time frame: 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

  3. Dual control of HIV and diabetes

    Time frame: 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%

  4. Control of hypertension

    Time frame: At 3 months post-discharge

    Among participants with hypertension, the proportion with blood pressure below 140/90

  5. Control of diabetes

    Time frame: At 3 months post-discharge

    Among participants with diabetes, the proportion with hemoglobin A1C <7%

  6. HIV viral suppression

    Time frame: At 3 months post-discharge

    The proportion with HIV viral load below assay detection (<40 copies/ml)

  7. All-cause post-discharge mortality

    Time frame: Through 3-months post-discharge

    The proportion with death after discharge from the index admission

Study contacts

Contact information is provided by the study sponsor or research team.

Chimwemwe Chawinga

CONTACT

[email protected]

265884409026

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

  • Fogarty International Center of the National Institute of Health
  • National Institutes of Health (NIH)

Registry information

Acronym: MLATHO

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Apr 17, 2025
Registry last updated
Jun 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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