Hawassa University Comprehensive Specialized Hospital

1245 6 Street, 2FG8+W6X, Hawassa, Ethiopia

Public Hospital

Serves Eastern Africa

The Hawassa research University Teaching Hospital (Hawassa university compressive specialized hospital) is a public hospital in Hawassa, Sidama State, Ethiopia. HUCSH is one of four federally-funded Cancer Centers of Excellence across Ethiopia and serves as a referral center for much of southern part of Ethiopia, including nearby Oromia and other southern states. HUCSH is connected to several international research networks and has previously hosted Phase IV clinical trials for infectious diseases (ART), gynecological conditions, surgical and neonatal conditions.

Links to previous clinical trials:

https://clinicaltrials.gov/study/NCT05865873?locStr=Hawassa,%20Ethiopia&country=Ethiopia&state=Southern%20Nations,%20Nationalities%20and%20Peoples&city=Hawassa&rank=2

https://clinicaltrials.gov/study/NCT04780243?locStr=Hawassa,%20Ethiopia&country=Ethiopia&state=Southern%20Nations,%20Nationalities%20and%20Peoples&city=Hawassa&rank=7

Site Capabilities

Clinical Trial Experience

Therapeutic area interests:

  • Cancer
  • Infectious disease

    • Institution has received grant(s) from:

  • National Funder(s)
  • International Funder(s)

    • Sponsors for previous clinical trials include:

  • Academic
  • Government
  • Industry
  • Investigator-initiated

    • Previous clinical trials conducted:

  • Behavioral
  • Diagnostic
  • Drug – biologic
  • Drug – small molecule
  • Epidemiological
  • Observational
  • Surgical
  • Vaccine

    • Study phase capabilities:

  • Phase I
  • Phase II
  • Phase III
  • Phase IV

    • Pediatric research capabilities:

  • Yes

    • Institution Regulatory/Research Ethics Committees

    Frequency of meetings: Three times monthly

    Application turnaround time (IRB/IEC): 3-4 weeks

    Average time from receipt of final protocol to review and approval of study by all relevant committees: 3-4 weeks

    Additional compliance:

  • IRB/IEC in compliance with IC E6(R2) in terms of composition, functions, and operations guidelines
  • Institution and/or local regulation mandates the distribution of study safety reports to IRB/IEC

    • Institution Staffing Resources

    Staff typeStaff available (y/n) and specialty experience
    Research coordinatorYes
    -Experience in Clinical Trials
    -Training in Human Subjects Protection (HSP)
    -Training in Good Clinical Practice (GCP)
    Research nurseYes
    -Experience in Clinical Trials
    -Training in Human Subjects Protection (HSP)
    -Training in Good Clinical Practice (GCP)
    -Training in Good Clinical Laboratory Practice (GCLP)
    Research data managerYes
    -Experience in Clinical Trials
    -Training in Human Subjects Protection (HSP)
    -Training in Good Clinical Practice (GCP)
    Quality assurance managerYes
    -Experience in Clinical Trials
    -Training in Human Subjects Protection (HSP)
    -Training in Good Clinical Practice (GCP)
    BiostatisticiansYes
    -Experience in Clinical Trials
    -Training in Human Subjects Protection (HSP)
    -Training in Good Clinical Practice (GCP)
    Database programmersYes
    -Experience in Clinical Trials
    -Training in Human Subjects Protection (HSP)
    -Training in Good Clinical Practice (GCP)
    EpidemiologistsYes
    -Experience in Clinical Trials
    -Training in Human Subjects Protection (HSP)
    -Training in Good Clinical Practice (GCP)
    -Training in Good Clinical Laboratory Practice (GCLP)
    PathologistsYes
    -Experience in Clinical Trials
    -Training in Human Subjects Protection (HSP)
    -Training in Good Clinical Practice (GCP)
    -Training in Good Clinical Laboratory Practice (GCLP)
    PharmacistsYes
    -Experience in Clinical Trials
    -Training in Human Subjects Protection (HSP)
    -Training in Good Clinical Practice (GCP)

    Institution Diagnostic Capabilities

  • Institution has personnel capable of performing diagnostic biopsies

    • Biopsies performed on-site:

  • Core needle biopsy
  • Endoscopic biopsy
  • Fine needle aspirate
  • Liquid biopsy
  • Sentinel lymph node biopsy
  • Skin biopsy
  • Surgical biopsy

    • Laboratory basics:

  • Institution has a laboratory on site
  • Institution sends diagnostic samples to external laboratory
  • Institution’s laboratory has been inspected or audited

    • Laboratory accreditations:

  • International Organization for Standardization (ISO)

    • Tests performed on-site:

  • Complete blood count (CBC) with differential
  • Comprehensive metabolic-chemistry panel (CMP)
  • Routine urinalysis
  • Antibody tests
  • Antigen tests
  • Antimicrobial susceptibility and sensitivity
  • Bacterial smear and culture
  • Flow cytometry
  • Fluorescent in situ hybridization (FISH)
  • Fungal culture
  • Genetic testing
  • Histology
  • Immunohistochemistry (IHC)
  • Laboratory-developed tests (LDTs)
  • Microscopy
  • Ova and parasite (O&P) test
  • PCR and/or RT-PCR
  • Other nucleic acid amplification tests (NAATs)
  • Viral culture
  • Viral load

    • Imaging capabilities:

  • Computed tomography (CT)
  • Magnetic resonance imaging (MRI)
  • Positron emission tomography (PET)
  • Nuclear imaging
  • Ultrasound
  • X-ray
  • Pediatric imaging

    • Institution Research Systems, Recordkeeping, and Data Management

  • Institution adheres to informed consent processes compliant with ICH E6(R2)
  • Institution follows ICH E6(R2) for collection and storage of source documentation for paper and/or electronic records
  • Institution stores patient records/source documents (paper/electronic) in a secured, limited access location during and after the trial
  • For source documents collected via electronic data capture, institution has a validated system and site procedures that follow ICH E6(R2) 5.5 guidelines
  • Institution has process in place for proper storage, archiving, and retrieval of essential study document per ICH 8.1
  • Institution study monitors have full access to source documents or certified copies of source documents (if electronic) if direct access can’t be obtained
  • Institution has a finance administration team
  • Institution undergoes routine financial audits

    • Institution Pharmacy

  • Pharmacy on site
  • Pharmacy has secure, limited access storage area with daily temperature monitoring and backup generator
  • Pharmacy has standard processes in place to ensure proper receipt, handling, and storage of investigational study drug/vaccine and comparators
  • Pharmacy has standard processes in place to ensure proper dispensing
  • Pharmacy has standard processes in place to ensure proper labeling that maintains the study blind
  • Pharmacy has standard processes in place to ensure proper drug/vaccine accountability, retrieval, and return or destruction of unused product
  • Institution has a secure, limited-access investigational drug/vaccine storage area with daily temperature monitoring
  • Institution’s pharmacy has a backup generator sufficient to run necessary equipment, refrigerators, freezers, etc.

    • Institution Equipment

  • Protocol for managing anaphylactic shock
  • Institution has a blood bank
  • Institution carries out blood transfusions for patients that need it
  • Functioning IV infusion pumps
  • Functioning basic life support equipment (crash cart)
  • Functioning electrocardiogram (EKG)

    • Availability of banked blood at institution:

  • Always available
  • Occasionally available
  • Rarely available

    • Institution performs the following routine blood screening tests on banked blood:

  • HIV
  • HBV
  • HCV
  • HPV
  • HTLVI
  • HTLVII
  • Syphilis

    • Additional information:

  • Institution’s equipment is calibrated and maintained per manufacturer’s guidelines
  • Institution’s equipment calibration and maintenance is documented
  • Institution’s laboratory has a secure, limited access biological specimen storage area with daily temperature monitoring
  • Institution’s laboratory has a backup power source, with alarm, sufficient to run necessary equipment, refrigerators, freezers, etc.
  • Institution maintains and uses a diagnostic imaging protocol manual
  • Laboratory maintains and uses a laboratory protocol manual
  • Laboratory maintains and uses a laboratory protocol manual

    • Program-Specific Capabilities

    Institution Cancer Treatment Capabilities and Equipment

  • Treats cancer patients
  • Performs surgical excisions
  • Administers chemotherapy
  • Uses radiation therapy

    • Radiotherapy machines on site:

  • Linear accelerator
  • Cobalt 60
  • Brachytherapy machine

    • Institution Infectious Disease Treatment Capabilities and Equipment

  • Treats infectious disease patients
  • Protocol for managing sepsis

    • Vaccines administered on site:

  • BCG
  • HBSAG
  • Polio
  • TAT
  • Diphtheriae
  • Pertussis
  • H. influenza B
  • Pneumonia
  • Rota virus
  • Measles during childhood

    • Infectious disease treatment services performed on site:

  • Antimicrobial/antibiotic drugs (small molecules or biologics; including antibacterial, antifungal, antiparasitic, antiviral medicines)
  • Immunotherapies
  • Supportive care/symptom management
  • Surgery
  • Viral load monitoring

    • Investigators at Hawassa University Comprehensive Specialized Hospital

    Netsanet Bogale Akale, M.D.

    Assistant Professor of Clinical Oncology, Hawassa University; Head, Hawassa University Comprehensive Specialized Hospital Cancer Treatment Center

  • Cancer

    • Overview

    Dr. Bogale is an Assistant Professor of Clinical Oncology at Hawassa University and the Head of the Hawassa University Comprehensive Specialized Hospital Cancer Treatment Center. He completed training in modern radiotherapy planning and treatment in India, Italy, South Africa, and USA, and is currently a research fellow at Memorial Sloan Kettering Cancer Center. His clinical trial interests and experience include radiotherapy and cancer screening and treatment in Ethiopia, including (1) prevalence and predictors of cervical cancer screening, (2) use of short-course two-dimensional radiation therapy in the palliative treatment of esophageal cancer, and (3) breast cancer prevalence, treatment, and advocacy.

    Trial Phases

  • Phase II

    • Experience Conducting or Participating in Clinical Trials: Yes

    Previous Clinical Trials

    https://clinicaltrials.gov/study/NCT03455231

    Taye Gari, Ph.D.

    Associate Professor of Epidemiology

  • Infectious Diseases

    • Overview

    Dr. Gari is an Associate Professor of Epidemiology at Hawassa University, as well as the coordinator of the South Ethiopia Network of Universities in Public Health (SENUPH). Funded through the Norwegian Programme for Capacity Development in Higher Education and Research for Development, SENUPH aims to enhance the capacity of southern Ethiopian universities to train essential public health and research staff. Dr. Gari has extensive experience in supervising Ph.D. and master’s students, as well as in conducting clinical and public health work in southern Ethiopia (including biostatistics, epidemiology, and research coordination). His clinical trial interests include behavioral and epidemiological studies focused on prevention, control, and treatment of infectious diseases, particularly malaria and tuberculosis. He is studying risk factors of multidrug-resistant tuberculosis among patients with tuberculosis at selected multidrug resistance treatment initiative centers in southern Ethiopia. He previously conducted a cluster randomized controlled trial investigating the combined use of long-lasting insecticidal nets and indoor residual spraying for malaria prevention in Ethiopia.

    Trial Phases

  • Phase IV

    • Experience Conducting or Participating in Clinical Trials: Yes

    Previous Clinical Trials

    https://trialsearch.who.int/Trial2.aspx?TrialID=PACTR201411000882128

    https://trialsearch.who.int/Trial2.aspx?TrialID=PACTR201809544276357

    *Definitions

    • HSP – Human Subjects Protection
    • GCP – Good Clinical Practice
    • GCLP – Good Clinical Laboratory Practice