Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202406879847801 Date of Registration: 20/06/2024
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Urine-Based HPV Screening
Official scientific title Validation of a Device for Urine-Based Human Papillomavirus (HPV) Screening
Brief summary describing the background and objectives of the trial Approximately 95% of cervical cancers are caused by human papillomavirus (HPV). Less than 3% of eligible women in Ghana have been screened for HPV, despite availability of the gold standard, Papanicolaou test (Pap smears). Barriers include cost and patient discomfort with pelvic exams and male providers. To eliminate these barriers, we have designed a device which allows for women to urinate normally and collect only the first 20 milliliters (mL) of urine for polymerase chain reaction (PCR)-based HPV screening. 1. To explore the acceptability and feasibility of our device among KBTH healthcare clinicians. 2. To validate that our device facilitates highly accurate urine-based HPV screening. 3. To explore the acceptability and feasibility of our device among KBTH patients.
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied Human Papillomavirus Virus screening
Purpose of the trial Early detection /Screening
Anticipated trial start date 01/07/2024
Actual trial start date 15/01/2025
Anticipated date of last follow up 03/03/2025
Actual Last follow-up date 01/08/2025
Anticipated target sample size (number of participants) 75
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Crossover: all participants receive all interventions in different sequence during study Non-randomised Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Urine based HPV screening then Papanicolaou smear One time collection One time collection The process for the urine-based screening will be described to the participant by an OBGYN on the research team with a standardized dialogue, then the participant will perform self-collection in the Korle Bu Teaching Hospital Reproductive Health and Family Planning Unit. Our device is positioned in the center of a toilet bowl on a bracket fitting between the toilet bowl and seat. While the user is urinating, the urine travels through the funnel to a check valve, enabling one-way flow to a single-use vial collecting the first 20mL of urine. The device does not come in contact with the patient. The Pap smear will be performed according to standard gynecologic procedures, by an OBGYN on the research team, at the Korle Bu Teaching Hospital Reproductive Health and Family Planning Unit. 75
Control Group Papanicolaou smear One time collection One time collection The Pap smear will be performed according to standard gynecologic procedures, by an OBGYN on the research team, at the Korle Bu Teaching Hospital Reproductive Health and Family Planning Unit. 0 Historical
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
• Between age 30 and 65 years old • Fluency in English, Twi, or Ga • Previous positive HPV screen • Below 75 kg • History of cervical cancer Adult: 18 Year(s)-44 Year(s),Middle Aged: 45 Year(s)-64 Year(s) 30 Year(s) 65 Year(s) Female
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
No 22/04/2024 Korle Bu Teaching Hospital Institutional Review Board
Ethics Committee Address
Street address City Postal code Country
Guggisberg Ave Accra 00233 Ghana
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome HPV status Immediately after sample collection
Secondary Outcome None NA
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Korle Bu Teaching Hospital Reproductive Health and Family Planning Unit Guggisberg Ave Accra Ghana
FUNDING SOURCES
Name of source Street address City Postal code Country
University of Michigan 1500 E. Medical Center Dr. Ann Arbor 48109 United States of America
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor University of Michigan 1500 E. Medical Center Dr. Ann Arbor United States of America University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Kwaku Asah Opoku kasahopoku@yahoo.com +27233206300692 Guggisberg Ave
City Postal code Country Position/Affiliation
Accra Ghana Head of Reproductive Health and Family Planning Unit
Role Name Email Phone Street address
Public Enquiries Dhanalakshmi Thiyagarajan dthiyag@med.umich.edu +14845231399 1500 E. Medical Center Dr. L4000
City Postal code Country Position/Affiliation
Ann Arbor United States of America OBGYN Global Health Researcher
Role Name Email Phone Street address
Scientific Enquiries Dhanalakshmi Thiyagarajan dthiyag@med.umich.edu +14845231399 1500 E. Medical Center Dr. L4000
City Postal code Country Position/Affiliation
Ann Arbor United States of America OBGYN Global Health Researcher
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices). Informed Consent Form,Statistical Analysis Plan,Study Protocol Immediately following publication and ending 5 years following article publication Investigators whose proposed use of the data has been approved by an independent review committee (“learned intermediary”) identified for this purpose
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Actual trial start date 14/03/2025 Trial has now started 15 Jan 2025
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Completion date 14/03/2025 Delay in trial start, so anticipated delay in completion 01 Aug 2025
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Recruitment status 14/03/2025 Now recruiting patients Not yet recruiting Recruiting
Section Name Field Name Date Reason Old Value Updated Value
Study Design Intervention assignment 19/06/2024 They all receive it in the same sequence during the study. Single Group Crossover: all participants receive all interventions in different sequence during study
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 12/06/2024 I misunderstood the directions. It is only one group - the same participants are doing both the standard of care and trial with the new device. Experimental Group, Urine based HPV screening then Papanicolaou smear, One time collection, One time collection, The process for the urine-based screening will be described to the participant by an OBGYN on the research team with a standardized dialogue, then the participant will perform self-collection in the Korle Bu Teaching Hospital Reproductive Health and Family Planning Unit. Our device is positioned in the center of a toilet bowl on a bracket fitting between the toilet bowl and seat. While the user is urinating, the urine travels through the funnel to a check valve, enabling one-way flow to a single-use vial collecting the first 20mL of urine. The device does not come in contact with the patient. The Pap smear will be performed according to standard gynecologic procedures, by an OBGYN on the research team, at the Korle Bu Teaching Hospital Reproductive Health and Family Planning Unit., 75,
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 12/06/2024 I am required to have a control group to submit, but it is only a single group design with the same participants doing the urine based screening as well as the Pap smear screening. Control Group, Papanicolaou smear, One time collection, One time collection, The Pap smear will be performed according to standard gynecologic procedures, by an OBGYN on the research team, at the Korle Bu Teaching Hospital Reproductive Health and Family Planning Unit. , 75, Historical Control Group, Papanicolaou smear, One time collection, One time collection, The Pap smear will be performed according to standard gynecologic procedures, by an OBGYN on the research team, at the Korle Bu Teaching Hospital Reproductive Health and Family Planning Unit. , 0, Historical
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 19/06/2024 Email updated. FALSE, Korle Bu Teaching Hospital Institutional Review Board, Guggisberg Ave, Accra, 00233, Ghana, 22 Apr 2024, , +27233302739510, vonnortey@gmail.com, 30593_29642_4737.pdf FALSE, Korle Bu Teaching Hospital Institutional Review Board, Guggisberg Ave, Accra, 00233, Ghana, 22 Apr 2024, , +27233302739510, rdo@kbth.gov.gh, 30593_29642_4737.pdf
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 14/08/2024 Approval letter uploaded FALSE, Korle Bu Teaching Hospital Institutional Review Board, Guggisberg Ave, Accra, 00233, Ghana, 22 Apr 2024, , +27233302739510, rdo@kbth.gov.gh, 30593_29642_4737.pdf FALSE, Korle Bu Teaching Hospital Institutional Review Board, Guggisberg Ave, Accra, 00233, Ghana, 22 Apr 2024, , +27233302739510, rdo@kbth.gov.gh, 30593_29642_4737.pdf