HIVMLATHONCT06931431
UNCPM 22322 - Adaption of the Transition of Care Model for Post-Discharge HIV-NCD Care in Lilongwe, Malawi - MLATHO
A study testing Transition of Care Model (TCM) in people with HIV and Noncommunicable Diseases, run by University of North Carolina, Chapel Hill at 1 site in Malawi.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV, Noncommunicable Diseases
- What is being tested?
- Transition of Care Model (TCM)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteMalawi
- Study dates
- 12 May 2025to 19 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- patients living beyond Lilongwe urban
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- HIV, Noncommunicable Diseases
- Being tested
- Transition of Care Model (TCM)
- Medical subject headings
- Noncommunicable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transition of Care Model (TCM)Behavioural
Key components of the TCM include discharge assessment, care planning, provider communication with outpatient follow-up teams, and community-based follow-up
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Behavioral: Transition of Care Model (TCM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-discharge home visits
Proportion of discharged participants who have a home visit by a nurse within 1 week of discharge
Measured: 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
Measured: 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
- 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.
Measured: 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
- 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.
Measured: 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
Measured: At completion of enrollment
Acceptability of Intervention Measures(AIM) rating from patient and caregiver perspective
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
Measured: At 3 months post-discharge
Acceptability of Intervention Measures(AIM) rating from Healthcare Workers perspective
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.
Measured: At 3 months post-discharge
Intervention Appropriateness Measure(IAM) rating from Healthcare Workers perspective
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
Measured: At 3 months post-discharge
Intervention Appropriateness Measure(IAM) rating for patient and caregiver
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.
Measured: At 3 months post-discharge
Secondary outcomes (7)
The number of participants re-hospitalization after discharge
Proportion of participants who are discharged and then readmitted
Measured: Through 3 months post-discharge
Dual control of HIV and hypertension
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
Measured: At 3 months post-discharge
Dual control of HIV and diabetes
Among participants with diabetes and HIV, the proportion with HIV viral load below assay detection (<40 copies/ml) and hemoglobin A1C <7%
Measured: At 3 months post-discharge
Control of hypertension
Among participants with hypertension, the proportion with blood pressure below 140/90
Measured: At 3 months post-discharge
Control of diabetes
Among participants with diabetes, the proportion with hemoglobin A1C <7%
Measured: At 3 months post-discharge
HIV viral suppression
The proportion with HIV viral load below assay detection (<40 copies/ml)
Measured: At 3 months post-discharge
All-cause post-discharge mortality
The proportion with death after discharge from the index admission
Measured: Through 3-months post-discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2025
- Study start12 May 2025
- Primary completion19 Feb 2026
- Study completion19 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), Fogarty International Center of the National Institute of Health
- Responsible party
- Sponsor
- Investigators
- Cecilia Kanyama, MBBS, Principal investigator, University of North Carolina at Chapel Hill (Project Malawi)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06931431
- Sponsor's protocol ID
- 23-2753
- Other IDs
- 1R21TW012647-01
- Acronym
- MLATHO
- Status last verified
- Aug 2026
- First submitted
- 14 Apr 2025
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC. More information provided by University of North Carolina, Chapel Hill
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- UNCPM 22322 - Adaption of the Transition of Care Model for Post-Discharge HIV-NCD Care in Lilongwe, Malawi - MLATHO
- ClinicalTrials.gov ID
- NCT06931431
- Acronym / sponsor ID
- MLATHO / 23-2753
- Conditions
- HIV, Noncommunicable Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), Fogarty International Center of the National Institute of Health
- Study start
- 12 May 2025 (actual)
- Primary completion
- 19 Feb 2026 (actual)
- Study completion
- 19 Feb 2026 (actual)
- First posted
- 17 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Transition of Care Model (TCM) | Experimental | Behavioral: Transition of Care Model (TCM)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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- patients living beyond Lilongwe urban
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Behavioural | Transition of Care Model (TCM) |
Primary outcome
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
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
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 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
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 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
7 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
- Individual participant dataSharing planned: Yes. Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC. More information provided by University of North Carolina, Chapel Hill
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cecilia Kanyama, MBBS principal investigator
University of North Carolina at Chapel Hill (Project Malawi)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transition of Care Model (TCM) in people with HIV and Noncommunicable Diseases, run by University of North Carolina, Chapel Hill at 1 site in Malawi.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malawi. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-discharge home visits (time frame: Through 3-months post-discharge). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2026; AzTrials last refreshed its copy on 8 Nov 2026.