Trial Title:
Evaluation of Advanced HIV Disease Differentiated Care Model in Malawi
NCT ID:
NCT05510973
Condition:
Opportunistic Infections, HIV-Related
Cryptococcal Infections
AIDS With Tuberculosis
AIDS-related Kaposi Sarcoma
AIDS and Infections
Conditions: Official terms:
Infections
Communicable Diseases
Tuberculosis
Sarcoma, Kaposi
Opportunistic Infections
HIV Infections
AIDS-Related Opportunistic Infections
Study type:
Interventional
Study phase:
N/A
Overall status:
Active, not recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Non-randomized controlled clustered study
Primary purpose:
Other
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
Enhanced package for AHD care
Description:
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)
Arm group label:
Intervention
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.
Criteria for 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
Gender:
All
Minimum age:
N/A
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Mlambe Mission Hospital
Address:
City:
Mlambe
Country:
Malawi
Facility:
Name:
Lobi rural hospital
Address:
City:
Lobi
Country:
Malawi
Facility:
Name:
Mua Mission Hospital
Address:
City:
Mtakataka
Country:
Malawi
Facility:
Name:
Kapiri Mission Hospital
Address:
City:
Kapiri
Country:
Malawi
Facility:
Name:
Domasi Rural Hospital
Address:
City:
Domasi
Country:
Malawi
Facility:
Name:
Chiradzulu District Hospital
Address:
City:
Chiradzulu
Country:
Malawi
Facility:
Name:
Dedza district hospital
Address:
City:
Dedza
Country:
Malawi
Facility:
Name:
Mchinji District Hopsital
Address:
City:
Mchinji
Country:
Malawi
Facility:
Name:
St Michael's Guilleme Community Hospital
Address:
City:
Mchinji
Country:
Malawi
Facility:
Name:
Ntcheu District Hospital
Address:
City:
Ntcheu
Country:
Malawi
Facility:
Name:
Sister Theresa Community Hospital
Address:
City:
Ntcheu
Country:
Malawi
Facility:
Name:
Malamulo Mission Hospital
Address:
City:
Thyolo
Country:
Malawi
Facility:
Name:
Saint Luke's Mission Hospital
Address:
City:
Zomba
Country:
Malawi
Start date:
June 1, 2021
Completion date:
June 30, 2023
Lead sponsor:
Agency:
Elizabeth Glaser Pediatric AIDS Foundation
Agency class:
Other
Collaborator:
Agency:
Bill and Melinda Gates Foundation
Agency class:
Other
Source:
Elizabeth Glaser Pediatric AIDS Foundation
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05510973
