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.: PACTR201605001615280 Date of Approval: 05/05/2016
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Incentivised Testing for Adolescents (ITA)
Official scientific title Trial of an incentivisation strategy to improve uptake of HIV testing in adolescents
Brief summary describing the background and objectives of the trial HIV testing rates in adolescents in sub-Saharan Africa lack behind the rates in adults. Failure to receive testing may have a profound impact on health through delayed diagnosis and treatment. Few studies have investigated new and innovative testing strategies outside conventional healthcare facilities targeting this age group. This trial aims to investigate the role of incentives and price draws on test uptake in children and adolescents aged 8-17. The trial is nested in a population based HIV prevalence survey conducted in this age group. All children and adolescents participating in the anonymous HIV prevalence survey are referred to a primary health care clinic for HIV testing. The trial investigated the impact of a fixed monetary incentive (U$ 2), a price draw or no incentive on test uptake at the primary health clinics.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) ITA
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied HIV/AIDS
Purpose of the trial Diagnosis / Prognosis
Anticipated trial start date 02/02/2015
Actual trial start date 02/02/2015
Anticipated date of last follow up 30/12/2015
Actual Last follow-up date 30/12/2015
Anticipated target sample size (number of participants) 0
Actual target sample size (number of participants) 2796
Recruitment status Completed
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 Randomised An independent statistician generated the randomization schedule using STATA 13. The unit of randomisation was the household. Allocation was determined by the holder of the sequence who is situated off site. An allocation list was given to each Research Assistant Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group No incentive The participant did not receive any incentive when presenting for testing at the clinic 941 Active-Treatment of Control Group
Experimental Group Fixed monetary incentive of U$2 The participant received U$2 when presenting for testing at the clinic 948
Experimental Group Price draw The participant had a 33% chance of winning a price of U$0/ U$5/ U$10 when presenting for testing at the clinic 911
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Being a household member 8-17 years old Caregiver willing and able to give consent Child willing and able to give consent or assent Less than 8 years old More than 17 years old Caregiver does not provide consent Child does not provide consent or assent Evidence that the child has been diagnosed with HIV before Evidence that the child has been tested HIV negative in the 6 months prior to the trial 8 Year(s) 17 Year(s) Male
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 London School of Hygiene and Tropical Medicine
Ethics Committee Address
Street address City Postal code Country
Keppel Street London WC1E 7HT United Kingdom
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Test uptake (presenting for testing at the primary health care clinic) 4 weeks post enrolment
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Households Harare Zimbabwe
FUNDING SOURCES
Name of source Street address City Postal code Country
Wellcome Trust 215 Euston Road London NW1 2BE United Kingdom
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor London School of Hygiene and Tropical Medicine Keppel Street London WC1E 7HT United Kingdom University
COLLABORATORS
Name Street address City Postal code Country
Rashida Ferrand 10 Seagrove Road Harare Zimbabwe
Vicky Simms Keppel Street London WC1E 7HT United Kingdom
Helen Weiss Keppel Street London WC1E 7HT United Kingdom
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Rashida Ferrand rashida.ferrand@lshtm.ac.uk 00263772165755 10 Seagrove Road
City Postal code Country Position/Affiliation
Harare Zimbabwe Reader, London School of Hygiene and Tropical Medicine
Role Name Email Phone Street address
Public Enquiries Rashida Ferrand rashida.ferrand@lshtm.ac.uk 00263772165755 10 Seagrove Road
City Postal code Country Position/Affiliation
Harare Zimbabwe Reader, London School of Hygiene and Tropical Medicine
Role Name Email Phone Street address
Scientific Enquiries Katharina Kranzer katharina.kranzer@lshtm.ac.uk 004916092984509 Parkallee 18
City Postal code Country Position/Affiliation
Borstel Germany Head of the National TB Reference Laboratory, Research Centre Borstel
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
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