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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of North Carolina, Chapel Hill

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

patients living beyond Lilongwe urban

Trial design

Design model

Single group

Treatments tested in this trial

  • 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

Treatment groups

75 Participants
are divided into 1 treatment group
Group A: Transition of Care Model (TCM)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Post-discharge home visits

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

Time frame
Through 3-months post-discharge
2

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

Time frame
Through 3-months post-discharge
3

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.

Time frame
At 3 months post-discharge
4

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.

Time frame
At 3 months post-discharge

Secondary outcomes

1

The number of participants re-hospitalization after discharge

Proportion of participants who are discharged and then readmitted

Time frame
Through 3 months post-discharge
2

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

Time frame
At 3 months post-discharge
3

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%

Time frame
At 3 months post-discharge
4

Control of hypertension

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

Time frame
At 3 months post-discharge

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of North Carolina, Chapel Hill

Lead sponsor

National Institutes of Health (NIH)

Collaborator

Fogarty International Center of the National Institute of Health

Collaborator