Wits Reproductive Health and HIV Institute Research Centre Clinical Research Site

Klein St & Esselen St, Hillbrow, Johannesburg, 2001, South Africa

University or Academic Center, Government Research Institution

Serves Southern Africa

Wits RHI is the largest research institution of the University of the Witwatersrand in Hillbrow, Johannesburg, South Africa. The Wits RHI Research Centre Clinical Research Site (CRS) is one of three clinical research sites at Wits RHI, collectively managing over 500 clinical trial participants at any given time. The CRS has a team of 52 clinical staff and recruits participants within Region F in Johannesburg, including migrant populations from various countries in East and Southern Africa living in Johannesburg.
The CRS has a strong track record of hosting a wide range of clinical trials, including Phase 1, 2, 3, and Open-label extension trials involving investigational new drugs, active pharmaceutical ingredients, medical devices, as well as conducting socio-behavioral studies on sexual reproductive health, HIV, STI diagnostics. antimicrobial resistance (AMR) and management, gender-based violence and contraceptives. The CRS includes an on-site laboratory with qualified Medical Technologists and Medical Technicians, as well as an on-site South African Pharmacy Council (SAPC)-accredited pharmacy with Responsible Pharmacists on site. The laboratory has the capacity to run rapid diagnostic tests such as HIV and pregnancy rapid tests, urinalysis, and Polymerase Chain Reaction (PCR) testing for Chlamydia trachomatis, Neisseria gonorrhea, Trichomonas vaginalis, and HIV Viral load, allowing participants to receive results timeously during their clinic visits. The Geenius HIV ½ confirmatory assay is used for HIV clade detection and confirmation of HIV serostatus. Bacterial vaginosis and Trichomonas vaginalis can be diagnosed through wet mount analysis with photo-microscopic capacity. The laboratory also houses storage facilities and a sample repository for long-term sample storage. For tests beyond the onsite laboratory’s diagnostic scope, the CRS collaborates with local laboratories and tertiary hospital providers and engages specialty staff from other units within Wits RHI and the University of the Witwatersrand. To maintain high standards of testing, External Quality Control measures have been implemented.

While the CRS performs well across multiple dimensions, it currently does not treat cancer patients directly as we do not have in-house oncologists at site. However, plans are underway to collaborate with local gynecologists, urologists, and oncologists to advance work in these areas through collaboration.

The on-site pharmacy is well-equipped with sufficient storage and shelving for room temperature investigational products (IP), as well as three refrigerators for IP requiring storage at 2-8°C. The pharmacy has a backup uninterrupted power supply system, as well as a backup generator to ensure that there is consistent power supply and temperature is maintained at all times. It is also fitted with a continuous monitoring system, manual min/max thermometers, two air conditioners, and a clean room containing a class 2 biosafety cabinet to ensure that IP is prepared according to aseptic technique guidelines. The CRS offers free treatment for common illnesses as well as free contraception to all our participants. The pharmacy is well-stocked with essential medication from the South African Essential medications list as well as concomitant medication. Propharm, an electronic dispensing management system is used to capture and ensure all dispensed medications are documented and labeled correctly. An in-house printer is available to prevent any accidental unblinding. Access to the pharmacy is controlled via an electronic keycard system which ensures access is reserved for approved pharmacy personnel only.

Links to previous clinical trials:

https://mtnstopshiv.org/research/studies/mtn-020

https://clinicaltrials.gov/ct2/show/NCT04092114

https://clinicaltrials.gov/ct2/show/NCT02550067

ttps://clinicaltrials.gov/study/NCT04994509

https://clinicaltrials.gov/study/NCT04925752

https://investors.vaxart.com/news-releases/news-release-details/vaxart-announces-positive-results-its-bivalent-norovirus-vaccine

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: Monthly

    Application turnaround time (IRB/IEC): 5-6 weeks

    Average time from receipt of final protocol to review and approval of study by all relevant committees: 12 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)
    -Training in Good Clinical Laboratory Practice (GCLP)
    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)
    -Training in Good Clinical Laboratory Practice (GCLP)
    BiostatisticiansNo
    Database programmersNo
    EpidemiologistsNo
    PathologistsNo
    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:

  • College of American Pathologists (CAP)
  • Good Laboratory Practices (GLP)
  • South African National Accreditation System

    • 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:

  • N/A

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

  • N/A

    • 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:

  • Hepatitis B

    • Infectious disease treatment services performed on site:

  • Antimicrobial/antibiotic drugs (small molecules or biologics; including antibacterial, antifungal, antiparasitic, antiviral medicines)
  • Immunotherapies: Monoclonal antibodies for HIV treatment-experienced people
  • Supportive care/symptom management
  • Surgery
  • Viral load monitoring

    • Investigators at Wits Reproductive Health and HIV Institute Research Centre Clinical Research Site

    Thesla Palanee-Phillips, Ph.D.

    Associate Professor, Director of Clinical Trials, and Lab Director, University of the Witwatersrand Reproductive Health and HIV Institute; Affiliate Associate Professor, University of Washington

  • Cancer
  • Infectious Diseases

    • Overview

    Prof. Thesla Palanee-Phillips is Associate Professor, Director of Clinical Trials, and Lab Director at University of the Witwatersrand Reproductive Health and HIV Institute (Wits RHI); and Affiliate Associate Professor at University of Washington. In addition to her Ph.D. (physiology/biochemistry), she has MSc degrees in medical science and clinical trials. Her clinical trial interests and experience include behavioral, diagnostic, drug (biologic and small molecule), epidemiological, observational, and vaccine studies for infectious diseases (herpes simplex virus [HSV], HIV, human papillomavirus [HPV], influenza, sexually transmitted infections [STIs], tuberculosis) and cancer (anorectal, oropharyngeal, prostate). Prof. Palanee-Phillips is the principal investigator on numerous investigator-initiated and sponsor-driven studies, including multicenter HIV prevention clinical trials to assess safety and efficacy of microbicides, vaginal rings, and oral and injectable pre-exposure prophylaxis (PrEP). She co-leads two U.S. National Institutes of Health [NIH]-supported projects at Wits RHI: an R34 exploring opportunities for STI self-testing and diagnosis to trigger PrEP restart in adolescent girls and young women; and an R01 assessing acceptability of point-of-care STI testing and expedited partner therapy to reduce STI recurrence among a cohort of cisgender adolescent girls and young women in South Africa. Prof. Palanee-Phillipsis also Deputy Director of the U.S. Agency for International Development (USAID)-funded MATRIX award, a collaborative initiative focused on expanding HIV and dual prevention options for women.

    Formal Clinical Trial Training*

  • Formal GCP Training
  • Formal HSP Training
  • Formal GCLP Training

    • Trial Phases

  • Phase I
  • Phase III
  • Phase II

    • Experience Conducting or Participating in Clinical Trials: Yes

    Previous Clinical Trials

    https://clinicaltrials.gov/study/NCT04994509

    https://clinicaltrials.gov/study/NCT04925752

    https://clinicaltrials.gov/study/NCT06570733

    *Definitions

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