Improvement in cryptococcosis diagnosis among HIV-infected patients in Mozambique

ISRCTN ISRCTN11882960
DOI https://doi.org/10.1186/ISRCTN11882960
Submission date
04/08/2024
Registration date
06/08/2024
Last edited
27/05/2025
Recruitment status
Recruiting
Overall study status
Ongoing
Condition category
Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Background and study aims
Laboratory diagnosis for cryptococcal disease among HIV-infected patients remains a challenge in most low- and middle-income countries (LMIC). Difficulties with sustained access to cryptococcal rapid tests are cited as a major barrier to the routine screening for cryptococcus in many LMICs. Thus, clinicians in these countries often resort to empirical treatment based solely on clinical suspicion of cryptococcosis. To address this challenge, this study aims to evaluate the re-introduction of India ink microscopy testing for the diagnosis of cryptococcosis among HIV-infected patients in southern Mozambique. India ink testing was historically a common first choice, low-cost, laboratory diagnostic tool for cryptococcal infection.

Who can participate?
Clinicians attending adult HIV-infected patients in screening or consultation rooms and laboratory technicians

What does the study involve?
This study involves a multicenter study that will employ a mixed-methods approach, guided by an implementation science framework the Dynamic Adaptation Process (DAP). It will be carried out in three phases (pre-implementation, implementation, and post-implementation). The intervention will be rolled out in six hospitals using a stepped-wedge trial approach. Using a modified RE-AIM, the study will assess the intervention’s implementation at two levels: individual (healthcare providers) and organizational (hospitals and their healthcare system).

What are the possible benefits and risks of participating?
Possible benefits of participating include increasing the opportunity for screening cryptococcosis among HIV-infected patients and making available an etiologic diagnosis to reduce empirical treatment practices among clinicians. The intervention is deemed of negligible risk because a diagnostic tool that offers no risk to healthcare providers is being re-introduced.

Where is the study run from?
University Eduardo Mondlane (Mozambique)

When is the study starting and how long is it expected to run for?
December 2022 to July 2026

Who is funding the study?
Fogarty International Center (USA)

Who is the main contact?
Jose Langa, josecarloslanga@yahoo.com.br

Contact information

Mr Jose Langa
Public, Scientific, Principal Investigator

University Eduardo Mondlane
Avenida Salvador Allende
Maputo
0000
Mozambique

ORCiD logoORCID ID 0000-0001-8143-3219
Phone +258 847301265
Email josecarloslanga@yahoo.com.br

Study information

Study designMulticenter stepped-wedge implementation science trial
Primary study designInterventional
Secondary study designNon randomised study
Study setting(s)Hospital, Laboratory
Study typeDiagnostic, Screening
Participant information sheet 45889_PIS_04Oct2023.pdf
Scientific titleRe-introduction of India ink microscopy testing as a low-cost laboratory diagnostic for cryptococcosis among HIV-infected patients in Southern Mozambique: An implementation research protocol
Study objectivesThe re-introduction of a low-cost laboratory diagnostic for cryptococcoses HIV-infected patients in Southern Mozambique can improve the diagnoses of cryptococcoses in the intervention sites
Ethics approval(s)

Approved 26/10/2023, National Bioethics Committee for Health of Mozambique (Ministry of Health, 2nd Floor, Avenue Eduardo Mondlane, Salvador Allende, Maputo, 00000, Mozambique; +258 824066350; cnbsmocambique@gmail.com), ref: 622/CNBS/23

Health condition(s) or problem(s) studiedRe-introduction of India ink microscopy testing as a low-cost laboratory diagnostic for cryptococcosis among HIV-infected patients
InterventionFollowing completion of the pre-implementation phase assessments and local stakeholder adaptation meetings, each study facility will roll out India Ink microscopy for cryptococcosis diagnosis as per the stepped-wedge design. Upon initiation of implementation, HIV care clinicians will identify suspected cryptococcosis patients based on clinical suspicion. Urine will be requested and submitted to the laboratory on the same day for microscopy testing using India Ink. Once at the laboratory, the urine sample will be analyzed by laboratory technicians trained in the diagnosis of cryptococcosis by the study, and to standardize the procedures they will follow the India Ink microscopy technique on urine samples SOP (Standard Operating Procedure) provided in all the laboratories of the study.
The results will be available on the same day and be transferred from the laboratory back to the clinician through the sample and information flow adapted in this study to enhance the interaction between clinicians and laboratory staff.
Intervention typeOther
Primary outcome measureIncrease opportunity for screening of adult HIV-infected patients suspected of having a cryptococcal disease in study sites measured using microscopy testing with India Ink at one time point
Secondary outcome measures1. Empirical treatment practice time among clinicians managing cryptococcal infections measured using record keeping during the sample and information flow
2. Clinician satisfaction with the availability of the tool for clinical decision support measured using an in-depth interview record and a 5-point Likert scale at 9 months of the adaptation-intervention period (the end of the intervention phase)
Overall study start date15/12/2022
Completion date31/07/2026

Eligibility

Participant type(s)Health professional
Age groupMixed
Lower age limit18 Years
Upper age limit99 Years
SexBoth
Target number of participants98 healthcare providers (67 clinicians and 31 laboratory technicians)
Key inclusion criteriaHealthcare providers: clinicians attending adult HIV-infected patients in screening or consultation rooms and laboratory technicians

Key exclusion criteria1. Clinicians attending to pediatric patients
2. Clinicians who are not engaged in HIV/AIDS care and treatment
3. Laboratory technicians who are not engaged in laboratory diagnostic testing for cryptococcosis
Date of first enrolment01/09/2024
Date of final enrolment31/12/2025

Locations

Countries of recruitment

  • Mozambique

Study participating centres

Maputo Central Hospital
Maputo
0000
Mozambique
Mavalane General Hospital
Maputo
0000
Mozambique
Jose Macamo General Hospital
Maputo
0000
Mozambique
Matola Provincial Hospital
Matola
0000
Mozambique
Xai-Xai Provincial Hospital
Xai-Xai
0000
Mozambique
Carmelo Hospital of Chokwe
Chokwe
0000
Mozambique

Sponsor information

Tulane University
University/education

1440 Canal Street Suite 2316
New Orleans
70112
United States of America

Phone +1 504-862-3412
Email tmoon2@tulane.edu
Website https://sph.tulane.edu/
ROR logo "ROR" https://ror.org/04vmvtb21

Funders

Funder type

Research organisation

Fogarty International Center
Government organisation / Research institutes and centers
Alternative name(s)
Fogarty, Fogarty at NIH, John E. Fogarty International Center, John Edward Fogarty International Center, NIH John F. Fogarty International Center, NIH's Fogarty International Center, NIH Fogarty International Center, Fogarty International Center at NIH, Fogarty International Center, U.S. National Institutes of Health (NIH), Fogarty International Center AT THE NATIONAL INSTITUTES OF HEALTH, FIC
Location
United States of America

Results and Publications

Intention to publish date31/12/2026
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryStored in publicly available repository
Publication and dissemination planAt the study's end, the investigators will prepare a written report for submission to the Mozambican Ministry of Health as well as a manuscript and presentations of results to be submitted to the peer-reviewed literature and for presentation at international and domestic scientific conferences.
IPD sharing planThe de-identified datasets generated during and/or analyzed during the current study will be stored in a publicly available repository at https://osf.io./r2kw4. Consent from participants was required and will be obtained. An original consent form is attached to this registration. Participants will be de-identified through codes. All identifying information will be kept locked in a file at the Faculty of Medicine of Eduardo Mondlane University in Maputo.

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Participant information sheet 04/10/2023 06/08/2024 No Yes
Protocol file version 04 11/10/2023 06/08/2024 No No
Protocol article 23/05/2025 27/05/2025 Yes No

Additional files

45889_Protocol_V04_11Oct2023.pdf
45889_PIS_04Oct2023.pdf

Editorial Notes

27/05/2025: Publication reference added.
05/08/2024: Study's existence confirmed by the National Bioethics Committee for Health of Mozambique.