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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05510973
Other study ID # EG0264
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date June 1, 2021
Est. completion date June 30, 2023

Study information

Verified date February 2023
Source Elizabeth Glaser Pediatric AIDS Foundation
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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 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.


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 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 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 copies/ml) 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 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 700
Est. completion date June 30, 2023
Est. primary completion date March 31, 2023
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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

Study Design


Intervention

Other:
Enhanced package for AHD care
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)

Locations

Country Name City State
Malawi Chiradzulu District Hospital Chiradzulu
Malawi Dedza district hospital Dedza
Malawi Domasi Rural Hospital Domasi Zomba
Malawi Kapiri Mission Hospital Kapiri McHinji
Malawi Lobi rural hospital Lobi Dedza
Malawi Mchinji District Hopsital Mchinji
Malawi St Michael's Guilleme Community Hospital Mchinji
Malawi Mlambe Mission Hospital Mlambe Blantyre
Malawi Mua Mission Hospital Mtakataka Dedza
Malawi Ntcheu District Hospital Ntcheu
Malawi Sister Theresa Community Hospital Ntcheu
Malawi Malamulo Mission Hospital Thyolo
Malawi Saint Luke's Mission Hospital Zomba

Sponsors (2)

Lead Sponsor Collaborator
Elizabeth Glaser Pediatric AIDS Foundation Bill and Melinda Gates Foundation

Country where clinical trial is conducted

Malawi, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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 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
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