South African National Clinical Trials Registry
South African Medical Research Council, Cochrane South Africa
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: sactradmin@mrc.ac.za Website: sanctr.samrc.ac.za
Trial no.: DOH-27-042021-6796 Date of Approval: 20/04/2021
Trial Status: Approved
TRIAL DESCRIPTION
Public title An in-field trial evaluating the utility of a machine guided tool for assessing risk behavior associated with contracting HIV in three sites in South Africa (HSTAR016)
Official scientific title An in-field trial evaluating the utility of a machine guided tool for assessing risk behavior associated with contracting HIV in three sites in South Africa (HSTAR016)
Brief summary describing the background and objectives of the trial A machine guided tool is a set of simple and easy to understand questions which are answered by the participant(s) using a mobile device and based on the responses from the participant(s), it calculates the Risk Probability. The questions are related to participant’s Demography, Sexual Behaviour & History, Personal Behaviour & Lifestyle and Symptoms. The tool makes use of scientific algorithms to determine the risk probability and gives the outcome as “Low Risk” or “Medium Risk” or “High Risk”. This assessment is completed by the participant using the mobile device and is not coerced into answering a question in any particular way thereby influencing the algorithm. Recruitment will involve 200 individuals in 3 sites in South Africa – two semi-rural and one urban and the overall process includes i) completing a series of behavioural questions on an app system without the assistance of trained staff ii) HIV testing performed by the nurse/counsellor according to National Guidelines and Policy iii) communication of test results and completion of a survey questionnaire to collect data on user experience. All participants will have 2 rapid HIV tests performed as part of the confirmatory testing algorithm. Primary objective: to assess the participant’s risk behaviour using an automatic machine guided tool and compare these results to HIV outcomes. We aim to understand risky behaviour patterns and its effect on a participant remaining negative. Secondary objectives; • To evaluate the participant’s interaction with the tool in terms of effectiveness and efficiency, i.e. successful / unsuccessful completion and difficulty with using the tool • To assess the ability of the participant’s to correctly comprehend and complete specific behavioural questions on a digital platform • Participants will be surveyed for user experience, and satisfaction with the overall process; in addition, users will be asked for comments and recommended improvements for the machine guided tool
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied HIV/AIDS
Purpose of the trial Early detection /Screening
Anticipated trial start date 31/03/2020
Actual trial start date 26/08/2020
Anticipated date of last follow up 30/04/2021
Actual Last follow-up date 31/05/2021
Anticipated target sample size (number of participants) 600
Actual target sample size (number of participants) 600
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 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 behavioral assement participants found HIV negative are invited to return for visit 2 three months after their first visit 8 months The developed machine guided tool will be tested in a population of i) HIV negative (as declared by participant) ii) unknown HIV status; to assess capability of identifying those that are potentially high risk for contracting HIV, from device interaction. All participants will be consented and asked to participate voluntarily. Each eligible participant will be assigned with a unique participant number. Once the participant number has been assigned, the number will not be reused even if the participant withdraws. Participants will be encouraged to use the digital tool and will have 2 rapid HIV confirmatory tests performed (visit 1). Those that test negative will be invited for retesting after 3 months at visit 2. 600
Control Group Not applicable Not applicable Not applicable Not applicable 0 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
• Understands and signs the written informed Consent Form • Able to complete the required testing on the allocated testing day[s] • Agree to provide accurate medical history and the required specimens for 2 finger prick blood tests • Able to speak and read English • ≥18 years of age • Provide level of education • Do not meet the inclusion criteria • Are known HIV positive • Have received any experimental HIV vaccine • Are currently on a PrEP regimen or any ARV medication • Cannot provide Identity Number or Identity Documentation for age verification • Any condition which, in the opinion of the facilitator, would make the participant unsuitable or unsafe for enrolment or could interfere with the completion of the assessment, consent form and questionnaire etc. or bias the outcome, i.e. being unable to see / read by forgetting to bring reading glasses, being intoxicated or acute sickness Adult: 19 Year(s)-105 Year(s) 18 Year(s) 100 Year(s) Both
APPROVALS
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 20/08/2020 University of the Witwatersrand Human Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
31 Princess of Wales Terrace Johannesburg 2193 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome To assess the participant’s risk behaviour using an automatic machine guided tool and compare these results to HIV outcomes. We aim to understand risky behaviour patterns and the correlation to having an HIV positive rapid test At the end of the study
Secondary Outcome • To evaluate the participant’s interaction with the tool in terms of effectiveness and efficiency, i.e. successful / unsuccessful completion and difficulty with using the tool • To assess the ability of the participant’s to correctly comprehend and complete specific behavioural questions on a digital platform • Participants will be surveyed for user experience, and satisfaction with the overall process; in addition, users will be asked for comments and recommended improvements for the machine guided tool development At the end of the study
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Ezintsha research centre 32 Princess of wales terrace, Parktown Johannesburg 2193 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
IPRD Solutions 96 4th Street, Parkmore, Sandton Johannesburg 2196 South Africa
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Ezintsha Research Centre 32 Princess of Wales Terrace Johannesburg 2193 South Africa Charities/Societies/Foundation
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mohammed Majam mmajam@ezintsha.org +27828260180 32 Princess of Wales Terrace
City Postal code Country Position/Affiliation
Johannesburg 2193 South Africa Head of Medical Technologies at Ezintsha Research Centre
Role Name Email Phone Street address
Scientific Enquiries Naleni Rhagnath nrhagnath@ezintsha.org +27839225654 32 Princess of Wales Terrace
City Postal code Country Position/Affiliation
Johannesburg 2193 South Africa Program Manager
Role Name Email Phone Street address
Public Enquiries Lovkesh Arora larora@iprdgroup.com +27793793214 96 4th Street, Parkmore, Sandton
City Postal code Country Position/Affiliation
Johannesburg 2196 South Africa General Manager
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All documents, reports, and other records will be identified in a manner designed to maintain participant confidentiality. All records will be kept in a secure storage area with limited access. Clinical information will not be released without the written permission of the participant, except as necessary for monitoring and auditing by the regulatory authorities or the HREC. Informed Consent Form,Statistical Analysis Plan,Study Protocol 8 months The principal investigator or designee and all employees and co-workers involved with this study may not disclose or use for any purpose other than performance of the study, any data, record, or other unpublished confidential information disclosed to those individuals for the purpose of the study. All computers are password-protected and records can only be accessed by permitted study staff.
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
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Trial type 16/04/2021 there is no randomization in this study. RCT CCT