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 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202405565669330 Date of Approval: 02/05/2024
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Comparison of Visual Inspection with Acetic Acid against HPV Testing in a Population of Women Living with HIV in Osogbo.
Official scientific title Diagnostic Accuracy of Visual Inspection with Acetic Acid in a Population of Women Living with HIV in Osogbo.
Brief summary describing the background and objectives of the trial Cervical cancer remains a gynaecological cancer of public health importance, HIV as an immunosuppressive condition is a co-factor that aggravates the progression of CIN to cervical cancer. Cervical screening in LMIC has been opportunistic and generally adopts the cheapest screening method available which is Visual inspection with acetic acid/visual inspection with Lugol’s Iodine (VIA/VILI). Studies in Nigeria have shown a lack of objectivity and persistent inter-observer variation in nurse-led VIA cervical screening leading to recommendations for further studies on this subject. Cytology-based screening has been difficult to adopt in rural communities because of the shortage of Histopathologists. The WHO’s global strategy for elimination of cervical cancer calls for regular cervical cancer screening in 70% of eligible women with a high-performance test such as HPV testing; appropriate treatment in 90% of eligible women as well as vaccination of young girls. HPV testing is a highly specific albeit expensive cervical cancer screening test. It is the test of choice in women living with HIV as it is not associated with ambiguity in the interpretation of results. VIA is the most readily available and accessible cervical screening test in Nigeria and other LIMCs. Although, it has been documented to have a low sensitivity, is it an acceptable alternative to HPV DNA testing? Or should the veracity of a negative VIA test be confirmed by another screening method such as HPV DNA testing? This study compare VIA testing with HPV DNA test in women living with HIV in Osogbo. Objectives; 1. To determine the proportion of the study population who screen positive with either HPV DNA or VIA. 2. To determine the proportion of the study population with histologic diagnosis of cervical intra-epithelial neoplasia 3. To determine the socio-demographic factors associated with being HPV DNA positive among women living with HIV in Osogbo. 4. To determine agreement between VIA and HPV DNA.
Type of trial Observational
Acronym (If the trial has an acronym then please provide) DAVIAH Study
Disease(s) or condition(s) being studied Cancer
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Early detection /Screening
Anticipated trial start date 06/12/2023
Actual trial start date 05/12/2023
Anticipated date of last follow up 30/06/2024
Actual Last follow-up date 30/06/2024
Anticipated target sample size (number of participants) 308
Actual target sample size (number of participants) 308
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
Single Group Non-randomised Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Not applicable 6 months Women living with HIV had screening done with HPV DNA and Visual inspection with acetic acid. Both results will be compared. Those who tested positive with either or both had colposcopy and treatment as necessary. 308
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Age 25-45 years Women living with HIV Declining to give consent Women less than 25 years Women above 45 years Adult: 19 Year-44 Year 25 Year(s) 45 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
Yes 21/03/2022 Research Ethics Committee UNIOSUN TEACHING HOSPITAL
Ethics Committee Address
Street address City Postal code Country
STATION ROAD, OSOGBO Osogbo 230221 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Proportion of Subjects who are VIA negative but who test positive for HPV and have histologic diagnosis of cervical intraepithelial neoplasia. At recruitment
Secondary Outcome Determinants of HPV positive status and histological diagnosis of CIN in the studied population. Correlation between viral load status in women living with HIV and HPV DNA status and histologic diagnosis of CIN. Completion
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
UNIOSUN Teaching Hospital Station Road, Osogbo Osogbo 230221 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
African Cancer Research Group ARGO Obafemi Awolowo University Teaching Hospital, Ile Ife 220005 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor African Cancer Research Group Ile Ife Ile Ife 220005 Nigeria Other Collaborative Groups
COLLABORATORS
Name Street address City Postal code Country
Adepiti CA Ile-Ife IleIfe 220005 Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Sekinah BolaOyebamiji sekinah.bola-oyebamiji@uniosun.edu.ng +2348033238808 Station road
City Postal code Country Position/Affiliation
Osogbo 230221 Nigeria Consultant Gynaecologist UNIOSUN Teaching Hospital
Role Name Email Phone Street address
Public Enquiries Taiwo Olaniyan akintayotaiwo.olaniyan@gmail.com +2348062754167 Ile-Ife
City Postal code Country Position/Affiliation
Ile Ife 220005 Nigeria Scientific Officer
Role Name Email Phone Street address
Scientific Enquiries Ibraheem Awowole drawo2001@yahoo.com +2348033767719 Ile-Ife
City Postal code Country Position/Affiliation
Ile Ife 220005 Nigeria Lecturer Obafemi Awolowo University Ile Ife
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All data collecting instruments are annonymous, no personal identifiers are included. Only the Principal investigator, research assistant have access to data. The data is passworded to avoid breach Informed Consent Form within 12 months access criteria is controlled. Only the research assistant and principal investigator have access to data on redcap software.
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