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.: PACTR201304000533711 Date of Approval: 21/04/2013
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title ACCESS-A: Adequate Cervical cancer Capacity building, Education and Screening in Subsaharan-Africa
Official scientific title Adequate Cervical cancer Capacity building, Education and Screening in Subsaharan-Africa
Brief summary describing the background and objectives of the trial The aim is to measure epidemiology of Human Papillomavirus infection, cervical premalignant and invasive disease and to test comparatively different screening methods, recording of beliefs and attitudes towards cervical cancer, screening and HPV vaccination. Bringing cervical sampling and screening to the doorstep of the women and into the villages using trained community health workers who teach women about cervical cancer.
Type of trial CCT
Acronym (If the trial has an acronym then please provide) HPV
Disease(s) or condition(s) being studied HPV infection, cervical cancer,Urological and Genital Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Early detection /Screening
Anticipated trial start date 02/06/2014
Actual trial start date
Anticipated date of last follow up 31/05/2019
Actual Last follow-up date
Anticipated target sample size (number of participants) 80000
Actual target sample size (number of participants)
Recruitment status Stopped early/ terminated
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
Parallel: different groups receive different interventions at same time 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 HPV screening by VIA twice 4 years cervical inspection using acetic acid 20000
Experimental Group HPV screening by careHPV test twice 4 years HPV test from cervical smear using CareHPV test 20000
Experimental Group HPV test by low resource HPV typing twice 4 years HPV test from cervical smear using PCR and oncoprotein test 20000
Control Group only second round screening once 4th year HPV testing by Care HPV/PCR/oncoprotein 20000
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
women age 18 to 65, inhabitants of certain districts in Ghana, giving consent to participation pregnant women women not aboe to give consent 18 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 26/04/2013 Ghana Health Service Ethical Review Committee
Ethics Committee Address
Street address City Postal code Country
P. O. Box MB Accra 190 Ghana
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Data on the prevalence of HPV infection, cervical dysplasia and most effective screening algorithm in low resource settings HPV prevalence, cervical dysplasia prevalence at first screening round effective screening algorithm as closure of the project
Secondary Outcome Attitudes of women to HPV vaccination and cervical cancer screening; Increase in knowledge about cervical cancer; Training of health workers to detect and treat cervical dysplasia; Identification of suitable new low resource-adapted screening tools in a real life setting; Model for sustainable methods of cervical cancer screening in developing countries at closure of the project
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Catholic Hospital Battor Main Street Battor 00000 Ghana
FUNDING SOURCES
Name of source Street address City Postal code Country
No Funding
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor Kofi Effah, MD Main Street Battor 190 Ghana Hospital
Primary Sponsor Andreas Kaufmann PhD Hindenburgdamm 30 Berlin 12200 Germany University
COLLABORATORS
Name Street address City Postal code Country
No Collaborators
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Kofi Effah vandidi@yahoo.co.uk 233 275271027 Main Street
City Postal code Country Position/Affiliation
Battor 190 Ghana Gynecologist
Role Name Email Phone Street address
Public Enquiries Kofi Effah vandidi@yahoo.co.uk 233 275271027 Main Street
City Postal code Country Position/Affiliation
Battor 190 Ghana Gynecologist
Role Name Email Phone Street address
Scientific Enquiries Andreas Kaufmann Andreas.kaufmann@charite.de +493084452756 Hindenburgdamm 30
City Postal code Country Position/Affiliation
Berlin 12200 Germany Biologist, head of laboratory
REPORTING
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information