Evaluation of Advanced HIV Disease Differentiated Care Model in Malawi

Elizabeth Glaser Pediatric AIDS Foundation

Status

Active, not recruiting

Conditions

AIDS-related Kaposi Sarcoma

Cryptococcal Infections

Opportunistic Infections, HIV-Related

AIDS With Tuberculosis

AIDS and Infections

Treatments

Other: Enhanced package for AHD care

Study type

Interventional

Funder types

Other

Identifiers

NCT05510973

EG0264

Details and patient eligibility

About

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.

Full 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

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.

Enrollment

700 estimated patients

Sex

All

Volunteers

No Healthy Volunteers

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