Clinical Trials Logo

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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05510973
Study type Interventional
Source Elizabeth Glaser Pediatric AIDS Foundation
Contact
Status Active, not recruiting
Phase N/A
Start date June 1, 2021
Completion date June 30, 2023

See also
  Status Clinical Trial Phase
Completed NCT03596918 - Evaluating Quality of Life in Patients With AIDS-Associated Kaposi Sarcoma Treated With Bleomycin and Vincristine
Not yet recruiting NCT05567601 - Doxil/Caelyx BE Study Phase 1
Terminated NCT04893018 - NT-I7 for Kaposi Sarcoma in Patients With or Without HIV Phase 1
Completed NCT00064142 - Halofuginone Hydrobromide in Treating Patients With HIV-Related Kaposi's Sarcoma Phase 2
Terminated NCT00020683 - A Phase II Trial of COL-3 in Patients With HIV Related Kaposi's Sarcoma Phase 2
Completed NCT00003350 - Paclitaxel Compared With Doxorubicin in Treating Patients With Advanced AIDS-Related Kaposi's Sarcoma Phase 3
Not yet recruiting NCT05411237 - Paclitaxel and Pegylated Liposomal Doxorubicin for Treatment of HIV-related Kaposi Sarcoma Phase 3
Recruiting NCT05510908 - Use of a Screening Tool to Describe HIV-Related Cancer Burden and Patient Characteristics in the AMC
Withdrawn NCT02137564 - Gamma Secretase Inhibitor PF-03084014 in Treating Patients With AIDS-Associated Kaposi Sarcoma Phase 2
Completed NCT01016730 - Bortezomib in Treating Patients With Relapsed or Refractory AIDS-Related Kaposi Sarcoma Phase 1
Withdrawn NCT00521092 - Sunitinib Malate in Treating East African Patients With Kaposi Sarcoma Phase 2
Completed NCT01057121 - Lenalidomide in Treating Patients With AIDS-Associated Kaposi's Sarcoma Phase 1/Phase 2