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.: PACTR202004529189733 Date of Approval: 02/04/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Health Education for Early Detection of ocular surface squamous neoplasia in Kenya.
Official scientific title Health Education for Early Detection of ocular surface squamous neoplasia in Kenya.
Brief summary describing the background and objectives of the trial Ocular surface squamous neoplasia (OSSN) is a tumour that grows on the conjunctiva and cornea. It is an important public eye health problem because it leads to blindness and even death. Africa has the highest incidence in the world equating to about 800 new cases annually in Kenya. Most patients are young (age 30s & 40s), 67% are women and 74% are living with HIV. About two thirds of OSSN patients living with HIV were enrolled in HIV care programs for antiretroviral therapy (ART). This suggests that the HIV care program may be a feasible intervention point to promote early detection and treatment of these tumours. There is no OSSN screening program in place and no evidence that an early detection intervention through a health education and training programme is effective in reducing the delay in accessing treatment for OSSN. This study proposes to develop a health education tool for health workers and patients in comprehensive care clinics (CCC) and voluntary counselling centres (VCT) then evaluate the efficacy of the intervention in shortening the time it takes between noticing the tumour and visiting the eye clinic by conducting a cluster randomized trial involving different HIV centres not including the development site .The primary outcome would be assessed 6 months later to compare the time taken between noticing the tumour and having an eye examination at an eye centre (time-to-referral).
Type of trial RCT
Acronym (If the trial has an acronym then please provide) HEED 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 01/06/2020
Actual trial start date
Anticipated date of last follow up 07/12/2020
Actual Last follow-up date
Anticipated target sample size (number of participants) 320
Actual target sample size (number of participants)
Recruitment status Active, not recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
QA 087 sponsor ref London School of Hygiene and Tropical Medicine
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 Randomised Simple randomization using a randomization table created by a computer software program Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Health education 6 months from intervention to outcome assessment A health education package delivered once to nurses and participants. The staff would be sensitized through the health education tool to be aware of the effects of HIV infection on the eye including conjunctival lesions. The patients attending HIV care clinics would also be handed a leaflet with information on the effects of HIV on the eye and photos of conjunctival lesions. Referrals would be made to the ophthalmic centres and reminders sent to the patient via the mobile phone SMS system. 140
Control Group Usual care 6 months from trial start to outcome assessment Usual care - patients present to eye centers when they notice eye lesions that are of concern then they are referred to other eye clinics formally up the referral pathway or they self-refer. 140 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Any HIV care centre (CCC or VCT) that would be in the geographical vicinity of the eye care centres (KNH and Kikuyu hospital) would be included. Adults infected with HIV who receive care from these centres would be invited to participate. The HIV care centre that participated in development and validation of the health education tools would be excluded. 80 and over: 80+ Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 99 Year(s) Both
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 16/04/2019 Kenyatta National Hospital and University of Nairobi Ethics and Research Committee
Ethics Committee Address
Street address City Postal code Country
PO Box 19676 Nairobi 00202 Kenya
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 27/03/2020 Kenyatta National Hospital and University of Nairobi
Ethics Committee Address
Street address City Postal code Country
PO Box 19676 Nairobi 00202 Kenya
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Period between participants’ awareness of the conjunctival lesion and examination in an eye clinic (time-to-referral). 6 months
Secondary Outcome (i) The proportion of HIV care clinic population who present with OSSN lesions. (ii) The size of lesions – estimated by the longest diameter in millimeters at the slit lamp. (iii) The time-to-surgery (between noticing the lesion and having surgical excision). (iv) The proportion of lesions excised that are histologically proven to be OSSN 6 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Department of Ophthalmology University of Nairobi PO Box 19676 Nairobi 00202 Kenya
FUNDING SOURCES
Name of source Street address City Postal code Country
Commonwealth Eye Health Consortium Keppel Street London United Kingdom
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Research Governance and Integrity office London School of hygiene and tropical medicine Keppel street London United Kingdom University
COLLABORATORS
Name Street address City Postal code Country
International Center for Eye Health London School of Hygiene and Tropical Medicine Keppel Street London United Kingdom
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Stephen Gichuhi sgichuhi@uonbi.ac.ke +254722873059 PO Box 19676
City Postal code Country Position/Affiliation
Nairobi 00202 Kenya Consultant Ophthalmologist and Senior Lecturer
Role Name Email Phone Street address
Scientific Enquiries Matthew Burton matthew.burton@lshtm.ac.uk +442076368636 Keppel Street
City Postal code Country Position/Affiliation
London United Kingdom Professor
Role Name Email Phone Street address
Public Enquiries Stephen Gichuhi sgichuhi@uonbi.ac.ke +254722873059 PO Box 347
City Postal code Country Position/Affiliation
Nairobi 00202 Kenya Consultant Ophthalmologist and Senior Lecturer
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) Study Protocol A link to the protocol will be provided with the published article that will report results within 12 month of study completion or results publication whichever comes earlier Anyone who wishes to access it
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