Evaluation of Advanced HIV Disease Differentiated Care Model in Malawi

Study Overview
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Brief Summary
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This study will evaluate the implementation of an enhanced package of care, CD4 and tuberculosis lipoarabinomannan (TB-LAM) tests and the initiation of patients on TB prophylaxis [TPT and CPT], on retention in care and viral suppression ((<50 copies/ml) at 6 and 12 months after AHD care and treatment enrollment. The study will also assess the change in AHD screening, management and service uptake indicators among PLHIV clients before and after implementation of the QI collaborative implementation (QICI) project, evaluate the acceptability and feasibility of the AHD package of care among patients and HCWs providing related health services, and conduct a cost analysis of implementing the enhanced AHD package of care in a hub-and-spoke implementation of care model.

Detailed Description
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Background Despite significant advances in the diagnosis of human immunodeficiency virus (HIV) and expanded access to anti-retroviral therapy (ART), recent data suggest that a third of people living with HIV/AIDS (PLHIV) starting ART do so with advanced HIV disease (AHD), and an increasing number of patients require advanced HIV disease care following a period of disengagement. Despite considerable effort to implement the AHD model in Malawi and bring it to scale, several challenges regarding AHD implementation and outcomes still exist. Description of Study Intervention: To optimize the package of care offered to HIV-infected clients with advanced HIV disease in Malawi, a hub-and-spoke model will be designed and implemented to bring AHD services geographically closer to patients. An enhanced package of AHD interventions such as decentralized cluster of differentiation 4 (CD4) tests, Tuberculosis lipoarabinomannan (TB-LAM) and initiation of patients on prophylaxis [TPT and CPT] will be implemented [system strengthening through quality improvement (QI)]. A client and systems focus will identify challenges experienced by providers and clients while at the same time describing the contextual factors that affect the delivery of AHD services. These lessons learnt will be used to optimize client flow, enhance sample transportation regulation and increase client engagement. Evaluation Description The evaluation will be a mixed method design study: (1) the quantitative component which will be a non-randomized cluster design based on control of intervention vs control sites for outcomes evaluation (2) the qualitative component that will aim at evaluating acceptability and feasibility of the strengthened AHD service provision (3) cost evaluation that will use quantitative methods. Specific Objectives To determine the effect of implementation of enhanced AHD package of care in intervention sites versus control sites on the proportion of PLHIV with AHD who are alive and retained in care at 6 and 12 months after diagnosis of AHD and enrolment into AHD care. To determine the effect of implementation of enhanced AHD package of care in intervention sites versus control sites on the proportion of PLHIV with AHD, who achieve viral suppression (<50 copies/ml) at 6 and 12 months after AHD care and treatment enrollment To estimate the change in AHD screening, management and service uptake indicators among PLHIV clients before and after implementation of the QI collaborative implementation (QICI) project To evaluate the acceptability and feasibility of the AHD package of care among patients utilizing AHD services and HCWs providing related health services To conduct a cost analysis of implementing the hub and spoke enhanced AHD package of care to improve AHD differentiated care in selected sites in Malawi. Endpoints Proportion of PLHIV with advanced disease who will be alive and retained in care at 6 and 12 months after antiretroviral therapy (ART) initiation and after diagnosis of AHD. Proportion of PLHIV with AHD enrolled in care and treatment who are virally suppressed at 6 and 12 months. Study Population: The study population for quantitative study component will include children, adolescents and adults of all ages in all the intervention and control sites identified for the project evaluation who are diagnosed with AHD. The study population for the qualitative component will include PLHIV, HCWs and lay cadre supporting the health facility 18 years of age and above available and willing to participate. Description of Sites/Facilities Enrolling Participants: The project will be implemented in twenty-two intervention sites in Malawi three selected districts and thirteen control sites in other districts where the intervention is not implemented. Study duration: The study will take a period of 18 months, including 4 to 6 months enrolment and up to 12 months follow-up.

Official Title
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Evaluation of Advanced HIV Disease Differentiated Care Model in Malawi: A Mixed Methods Non-randomized Cluster Study

Conditions
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Opportunistic Infections, HIV-Related, Cryptococcal Infections, AIDS With Tuberculosis, AIDS-related Kaposi Sarcoma, AIDS and Infections

Intervention / Treatment
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* Other: Enhanced package for AHD care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: HIV-infected clients (all ages) meeting the WHO definition for AHD: CD4 count of <200c/mm3 or WHO clinical stage 3 or 4 or children under the age of 5 on treatment for less than 12 months or unstable on treatment after 12 months Exclusion Criteria: None
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Non-randomized controlled clustered study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>standard of care | |
| Experimental: Intervention<br>Enhanced package of AHD care | Other: Enhanced package for AHD care<br>* The enhanced package of AHD care includes CD4 and tuberculosis lipoarabinomannan (TB-LAM) tests and the initiation of patients on TB prophylaxis [TPT and CPT], offered through a hub-and-spoke facility system, with continuous quality improvement (QI)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of AHD patients alive and retained in care | Number of AHD patients alive and retained in care divided by the number of AHD patients initiated on antiretroviral therapy (ART) after diagnosis of AHD | 6 and 12 months after initiation on ART after AHD diagnosis | 
| Proportion of AHD patients in care and treatment virally suppressed | Number of AHD patients in care and treatment virally suppressed (<50 cells/ml) divided by the number of AHD patients in care and treatment | 6 and 12 months after initiation of ART after AHD diagnosis | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cost analysis of implementing the hub and spoke enhanced AHD package of care | Estimation of total costs, costs per patients with the intervention, and cost drivers | 12 months after intervention implementation |