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.
