Evaluation of Advanced HIV Disease Differentiated Care Model in Malawi

NCT05510973 | Unknown

• 1 other identifier: EG0264
• Study Type: interventional
• Target: 700
• Locations: 1 country
• Sites: 13

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.

Conditions

Opportunistic Infections, HIV-Related; Cryptococcal Infections; AIDS With Tuberculosis; AIDS-related Kaposi Sarcoma; AIDS and Infections

Outcome Measures

Primary Outcomes (2)

• Proportion of AHD patients alive and retained in care

  Number of AHD patients alive and retained in care divided by the number of AHD patients initiated on antiretroviral therapy (ART) after diagnosis of AHD

  6 and 12 months after initiation on ART after AHD diagnosis

• Proportion of AHD patients in care and treatment virally suppressed

  Number of AHD patients in care and treatment virally suppressed (\<50 cells/ml) divided by the number of AHD patients in care and treatment

  6 and 12 months after initiation of ART after AHD diagnosis

Secondary Outcomes (1)

• Cost analysis of implementing the hub and spoke enhanced AHD package of care

  12 months after intervention implementation

Study Arms (2)

Control

NO INTERVENTION

standard of care

Intervention

EXPERIMENTAL

Enhanced package of AHD care

Other: Enhanced package for AHD care

Interventions

Enhanced package for AHD care OTHER

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)

Intervention

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• None

Sponsors & Collaborators

• Elizabeth Glaser Pediatric AIDS Foundation: lead
• Bill and Melinda Gates Foundation: collaborator

Study Sites (13)

Mlambe Mission Hospital

Mlambe, Blantyre, Malawi

Location

Lobi rural hospital

Lobi, Dedza, Malawi

Location

Mua Mission Hospital

Mtakataka, Dedza, Malawi

Location

Kapiri Mission Hospital

Kapiri, McHinji, Malawi

Location

Domasi Rural Hospital

Domasi, Zomba, Malawi

Location

Chiradzulu District Hospital

Chiradzulu, Malawi

Location

Dedza district hospital

Dedza, Malawi

Location

Mchinji District Hopsital

Mchinji, Malawi

Location

St Michael's Guilleme Community Hospital

Mchinji, Malawi

Location

Ntcheu District Hospital

Ntcheu, Malawi

Location

Sister Theresa Community Hospital

Ntcheu, Malawi

Location

Malamulo Mission Hospital

Thyolo, Malawi

Location

Saint Luke's Mission Hospital

Zomba, Malawi

Location

Related Publications (1)

• 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.

  PMID: 38041058 DERIVED

MeSH Terms

Conditions

AIDS-Related Opportunistic Infections; AIDS-related Kaposi sarcoma; Acquired Immunodeficiency Syndrome; Infections

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Opportunistic Infections; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases

Study Officials

• Thulani Maphosa, PhD

  Elizabeth Glaser Pediatric AIDS Foundation

  PRINCIPAL INVESTIGATOR

• Appolinaire Tiam, MBChB, MMed, PhD

  Elizabeth Glaser Pediatric AIDS Foundation

  PRINCIPAL INVESTIGATOR

• Rose Nyirenda, MPH, PhD

  Ministry of Health, Malawi

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Non-randomized controlled clustered study

Study Record Dates

• First Submitted: August 15, 2022
• First Posted: August 22, 2022
• Study Start: June 1, 2021
• Primary Completion: March 31, 2023
• Study Completion: June 30, 2023
• Last Updated: February 15, 2023

Record last verified: 2023-02

Locations

MA (13)