Improvement in cryptococcosis diagnosis among HIV-infected patients in Mozambique
ISRCTN | ISRCTN11882960 |
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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
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
Public, Scientific, Principal Investigator
University Eduardo Mondlane
Avenida Salvador Allende
Maputo
0000
Mozambique
0000-0001-8143-3219 | |
Phone | +258 847301265 |
josecarloslanga@yahoo.com.br |
Study information
Study design | Multicenter stepped-wedge implementation science trial |
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Primary study design | Interventional |
Secondary study design | Non randomised study |
Study setting(s) | Hospital, Laboratory |
Study type | Diagnostic, Screening |
Participant information sheet | 45889_PIS_04Oct2023.pdf |
Scientific title | Re-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 objectives | The 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) studied | Re-introduction of India ink microscopy testing as a low-cost laboratory diagnostic for cryptococcosis among HIV-infected patients |
Intervention | Following 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 type | Other |
Primary outcome measure | Increase 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 measures | 1. 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 date | 15/12/2022 |
Completion date | 31/07/2026 |
Eligibility
Participant type(s) | Health professional |
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Age group | Mixed |
Lower age limit | 18 Years |
Upper age limit | 99 Years |
Sex | Both |
Target number of participants | 98 healthcare providers (67 clinicians and 31 laboratory technicians) |
Key inclusion criteria | Healthcare providers: clinicians attending adult HIV-infected patients in screening or consultation rooms and laboratory technicians |
Key exclusion criteria | 1. 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 enrolment | 01/09/2024 |
Date of final enrolment | 31/12/2025 |
Locations
Countries of recruitment
- Mozambique
Study participating centres
0000
Mozambique
0000
Mozambique
0000
Mozambique
0000
Mozambique
0000
Mozambique
0000
Mozambique
Sponsor information
University/education
1440 Canal Street Suite 2316
New Orleans
70112
United States of America
Phone | +1 504-862-3412 |
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tmoon2@tulane.edu | |
Website | https://sph.tulane.edu/ |
https://ror.org/04vmvtb21 |
Funders
Funder type
Research organisation
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 date | 31/12/2026 |
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Individual participant data (IPD) Intention to share | Yes |
IPD sharing plan summary | Stored in publicly available repository |
Publication and dissemination plan | At 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 plan | The 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
Editorial Notes
27/05/2025: Publication reference added.
05/08/2024: Study's existence confirmed by the National Bioethics Committee for Health of Mozambique.