Ignite Creation Date:
2024-05-06 @ 6:01 PM
Last Modification Date:
2024-10-26 @ 2:39 PM
Study NCT ID:
NCT05510973
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-02-15
First Post:
2022-08-15
Brief Title:
Evaluation of Advanced HIV Disease Differentiated Care Model in Malawi
Sponsor:
Elizabeth Glaser Pediatric AIDS Foundation
Organization:
Elizabeth Glaser Pediatric AIDS Foundation
Study Overview
Official Title:
Evaluation of Advanced HIV Disease Differentiated Care Model in Malawi A Mixed Methods Non-randomized Cluster Study
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 copiesml 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:
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 HIVAIDS 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
1 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
2 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 copiesml at 6 and 12 months after AHD care and treatment enrollment
3 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
4 To evaluate the acceptability and feasibility of the AHD package of care among patients utilizing AHD services and HCWs providing related health services
5 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
1 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
2 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 SitesFacilities 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
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
1 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
2 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 copiesml at 6 and 12 months after AHD care and treatment enrollment
3 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
4 To evaluate the acceptability and feasibility of the AHD package of care among patients utilizing AHD services and HCWs providing related health services
5 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
1 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
2 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 SitesFacilities 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None