Clinical trial NCT05510973: Evaluation of Advanced HIV Disease Differentiated Care Model in Malawi
Official title: Evaluation of Advanced HIV Disease Differentiated Care Model in Malawi: A Mixed Methods Non-randomized Cluster Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Opportunistic Infections, HIV-Related
Cryptococcal Infections
AIDS With Tuberculosis
AIDS-related Kaposi Sarcoma
AIDS and Infections
Lead sponsor: Elizabeth Glaser Pediatric AIDS Foundation
Sponsor class: OTHER
Collaborators: name: Bill and Melinda Gates Foundation
First posted: 2022-08-22
Enrollment: 700
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Non-randomized controlled clustered study
Primary purpose: OTHER

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 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Proportion of AHD patients alive and retained in care
timeFrame: 6 and 12 months after initiation on ART after AHD diagnosis
measure: Proportion of AHD patients in care and treatment virally suppressed
timeFrame: 6 and 12 months after initiation of ART after AHD diagnosis
Secondary outcomes:
measure: Cost analysis of implementing the hub and spoke enhanced AHD package of care
timeFrame: 12 months after intervention implementation
Other outcomes:
Locations:
city: Mlambe
country: Malawi
facility: Mlambe Mission Hospital
state: Blantyre
city: Lobi
country: Malawi
facility: Lobi rural hospital
state: Dedza
city: Mtakataka
country: Malawi
facility: Mua Mission Hospital
state: Dedza
city: Kapiri
country: Malawi
facility: Kapiri Mission Hospital
state: McHinji
city: Domasi
country: Malawi
facility: Domasi Rural Hospital
state: Zomba
city: Chiradzulu
country: Malawi
facility: Chiradzulu District Hospital
city: Dedza
country: Malawi
facility: Dedza district hospital
city: Mchinji
country: Malawi
facility: Mchinji District Hopsital
city: Mchinji
country: Malawi
facility: St Michael's Guilleme Community Hospital
city: Ntcheu
country: Malawi
facility: Ntcheu District Hospital
city: Ntcheu
country: Malawi
facility: Sister Theresa Community Hospital
city: Thyolo
country: Malawi
facility: Malamulo Mission Hospital
city: Zomba
country: Malawi
facility: Saint Luke's Mission Hospital
Study officials:
affiliation: Elizabeth Glaser Pediatric AIDS Foundation
name: Thulani Maphosa, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Elizabeth Glaser Pediatric AIDS Foundation
name: Appolinaire Tiam, MBChB, MMed, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ministry of Health, Malawi
name: Rose Nyirenda, MPH, PhD
role: PRINCIPAL_INVESTIGATOR
References: