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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: www.pactr.org

Trial no.: PACTR201304000533711 Date registered: 2013/04/21
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) ACCESS-A
Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 2014-06-02
Actual trial start date
Anticipated date of last follow up 2019-05-31
Actual date of last follow up
Anticipated target sample size (number of participants) 80000   
Actual target sample size (number of participants)   
Recruitment status Not yet recruiting
Secondary Ids Issuing authority/Trial register Links to Secondary ID

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 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
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

ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Min age Max 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 Years 65 Years 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 2013/04/26 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
Ghana Health Service P.O.Box KB 493, Korle-Bu Accra 493 Ghana

SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Andreas Kaufmann PhD Hindenburgdamm 30 Berlin 12200 Germany University
Secondary Sponsor Kofi Effah, MD Main Street Battor 190 Ghana Hospital

COLLABORATORS
Name Street address City Postal code Country
Dr. Kofi Nyako MD, MPH, MGCP P.O.Box KB 493, Korle-Bu Accra 493 Ghana
Dr. John Koku Awoonor-Williams MD, MPH, MPP, FGCP Private Mail Bag Ministries BLK B2 Bolgatanga, UER Bolgatanga BLK B2 Ghana

CONTACT PEOPLE
Role Name Email Phone Fax
Principal Investigator Dr Kofi Effah vandidi@yahoo.co.uk 233 275271027
Street address City Postal code Country Position / Affiliation
Main Street Battor 190 Ghana Gynecologist
Role Name Email Phone Fax
Public Enquiries Dr Kofi Effah vandidi@yahoo.co.uk 233 275271027
Street address City Postal code Country Position / Affiliation
Main Street Battor 190 Ghana Gynecologist
Role Name Email Phone Fax
Scientific Enquiries Dr Andreas Kaufmann Andreas.kaufmann@charite.de +493084452756 +493084452937
Street address City Postal code Country Position / Affiliation
Hindenburgdamm 30 Berlin 12200 Germany Biologist, head of laboratory