Evaluation of Advanced HIV Disease Differentiated Care Model in Malawi
NCT ID: NCT05510973
Last Updated: 2023-02-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
700 participants
INTERVENTIONAL
2021-06-01
2023-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Control
standard of care
No interventions assigned to this group
Intervention
Enhanced package of AHD care
Enhanced package for AHD care
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)
Interventions
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Enhanced package for AHD care
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)
Eligibility Criteria
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Inclusion Criteria
* 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
ALL
No
Sponsors
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Bill and Melinda Gates Foundation
OTHER
Elizabeth Glaser Pediatric AIDS Foundation
OTHER
Responsible Party
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Principal Investigators
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Thulani Maphosa, PhD
Role: PRINCIPAL_INVESTIGATOR
Elizabeth Glaser Pediatric AIDS Foundation
Appolinaire Tiam, MBChB, MMed, PhD
Role: PRINCIPAL_INVESTIGATOR
Elizabeth Glaser Pediatric AIDS Foundation
Rose Nyirenda, MPH, PhD
Role: PRINCIPAL_INVESTIGATOR
Ministry of Health, Malawi
Locations
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Mlambe Mission Hospital
Mlambe, Blantyre, Malawi
Lobi rural hospital
Lobi, Dedza, Malawi
Mua Mission Hospital
Mtakataka, Dedza, Malawi
Kapiri Mission Hospital
Kapiri, McHinji, Malawi
Domasi Rural Hospital
Domasi, Zomba, Malawi
Chiradzulu District Hospital
Chiradzulu, , Malawi
Dedza district hospital
Dedza, , Malawi
Mchinji District Hopsital
Mchinji, , Malawi
St Michael's Guilleme Community Hospital
Mchinji, , Malawi
Ntcheu District Hospital
Ntcheu, , Malawi
Sister Theresa Community Hospital
Ntcheu, , Malawi
Malamulo Mission Hospital
Thyolo, , Malawi
Saint Luke's Mission Hospital
Zomba, , Malawi
Countries
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References
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Katirayi L, Maphosa T, Chilikutali L, Chamanga RK, Petersson J, Khatib S, Munthali B, Nyirenda R, Matiya E, Nyirenda L, Tiam A, Denoeud-Ndam L. Understanding gender differences of people with HIV newly diagnosed or returning to care with advanced HIV disease in Malawi: a qualitative study. BMC Public Health. 2023 Dec 1;23(1):2382. doi: 10.1186/s12889-023-17384-y.
Other Identifiers
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EG0264
Identifier Type: -
Identifier Source: org_study_id
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