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.: PACTR202112699416418 Date of Registration: 01/12/2021
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Nudging men to register for medical circumcision using a free app
Official scientific title A nudge towards Voluntary Medical Male Circumcision using Moya, a free mobile app
Brief summary describing the background and objectives of the trial Medical male circumcision can reduce HIV infection by 60%. Aligned to the World Health Organisation strategies, in 2010 the Department of Health aimed to medically circumcise 80% of HIV negative men in South Africa. Voluntary medical male circumcision (VMMC) coverage reported in 2017 was 32%, with higher coverage in younger men and lower coverage in men 25 years and older. Risky sexual practices, including multiple sexual partners and inconsistent condom use, are higher in the 25-years-and-older age group with HIV prevalence rates increasing with age until approximately 35-39 years old. Right to Care (RTC) works with the Department of Health to support and scale up VMMC services in multiple districts across South Africa through VMMC demand creation and direct services, including the facilitation of site appointment bookings or on-site support and coordination. Through these activities several barriers to reaching men for VMMC have been identified, including fear of pain related to the procedure, loss of income as a result of missed work, stigma around HIV testing, low perception of HIV risk, concerns around the abstinence period post VVMC, and the belief that it is not appropriate for older males. Communication campaigns channeled through social media, television, interpersonal communication, community engagement and educational material are used to create demand for VMMC. Novel, innovative, low-cost demand creation strategies that are easily accessible to the public are needed to increase the reach of VMMC services by addressing behavioural barriers related to the procedure. Moya, a data free mobile phone application which is widely available in South Africa, is being used by RTC to host a form that can be used by men to register for a medical circumcision. Objective: Using behavioural insights to modify the the existing Moya VMMC registration form to increase the number of men that complete the registration process and book a VMMC at RTC facilities.
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 Prevention
Anticipated trial start date 01/01/2022
Actual trial start date
Anticipated date of last follow up 30/06/2022
Actual Last follow-up date
Anticipated target sample size (number of participants) 141000
Actual target sample size (number of participants)
Recruitment status Not yet 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
Crossover: all participants receive all interventions in different sequence during study 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 Moya Behavioural Insights Test The study will have four arms, with one comparison group (receiving the standard of care) and three intervention groups. The comparison group will receive the standard (current) VMMC registration form. Each intervention group will receive a different, modified version of the VMMC registration form. Behavioural economics principles will be used to design each of the three different registration forms. We will compare the primary outcome of the number of registrations submitted for VMMC bookings between the standard of care form and the three intervention forms. 12 weeks A non-randomised group design will be used to assess the impact of the study interventions compared to the comparison group. A data free link is currently embedded within the Moya app for passive VMMC recruitment and includes a booking registration form through which people can submit their details to receive a call back to book a VMMC appointment. The study will have four arms, with one comparison group (receiving the standard of care) and three intervention groups. The comparison group will receive the standard (current) VMMC registration form. Each intervention group will receive a different, modified version of the VMMC registration form. Behavioural economics principles will be used to design each of the three different registration forms. We will compare the primary outcome of the number of registrations submitted for VMMC bookings between the standard of care form and the three intervention forms. 35250
Control Group Moya Behavioural Insights Test The comparison group will receive the standard (current) VMMC registration form. 12 weeks The study will have four arms, with one comparison group (receiving the standard of care) and three intervention groups. The comparison group will receive the standard (current) VMMC registration form. Each intervention group will receive a different, modified version of the VMMC registration form. Behavioural economics principles will be used to design each of the three different registration forms. We will compare the primary outcome of the number of registrations submitted for VMMC bookings between the standard of care form and the three intervention forms. 35250 Uncontrolled
Experimental Group Moya Behavioural Insights Test The study will have four arms, with one comparison group (receiving the standard of care) and three intervention groups. The comparison group will receive the standard (current) VMMC registration form. Each intervention group will receive a different, modified version of the VMMC registration form. Behavioural economics principles will be used to design each of the three different registration forms. We will compare the primary outcome of the number of registrations submitted for VMMC bookings between the standard of care form and the three intervention forms. 12 weeks A non-randomised group design will be used to assess the impact of the study interventions compared to the comparison group. A data free link is currently embedded within the Moya app for passive VMMC recruitment and includes a booking registration form through which people can submit their details to receive a call back to book a VMMC appointment. The study will have four arms, with one comparison group (receiving the standard of care) and three intervention groups. The comparison group will receive the standard (current) VMMC registration form. Each intervention group will receive a different, modified version of the VMMC registration form. Behavioural economics principles will be used to design each of the three different registration forms. We will compare the primary outcome of the number of registrations submitted for VMMC bookings between the standard of care form and the three intervention forms. 35250
Experimental Group Moya Behavioural Insights Test The study will have four arms, with one comparison group (receiving the standard of care) and three intervention groups. The comparison group will receive the standard (current) VMMC registration form. Each intervention group will receive a different, modified version of the VMMC registration form. Behavioural economics principles will be used to design each of the three different registration forms. We will compare the primary outcome of the number of registrations submitted for VMMC bookings between the standard of care form and the three intervention forms. 12 weeks A non-randomised group design will be used to assess the impact of the study interventions compared to the comparison group. A data free link is currently embedded within the Moya app for passive VMMC recruitment and includes a booking registration form through which people can submit their details to receive a call back to book a VMMC appointment. The study will have four arms, with one comparison group (receiving the standard of care) and three intervention groups. The comparison group will receive the standard (current) VMMC registration form. Each intervention group will receive a different, modified version of the VMMC registration form. Behavioural economics principles will be used to design each of the three different registration forms. We will compare the primary outcome of the number of registrations submitted for VMMC bookings between the standard of care form and the three intervention forms. 35250
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Males 15 and older Registered Moya app user Parents/Guardians registering on behalf of their sons All females not registering as a guardian 80 and over: 80+ Year,Adolescent: 13 Year(s)-17 Year(s),Adult: 18 Year(s)-44 Year(s),Aged: 65 Year(s)-79 Year(s),Middle Aged: 45 Year(s)-64 Year(s) 15 Year(s) 100 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
No 08/11/2021 Wits Health Consortium Human Research Ethics Committee Medical
Ethics Committee Address
Street address City Postal code Country
31 Princess of Wales Terrace, Parktown, 2193 Johannesburg 2193 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The primary outcome is the total number of completed registrations for VMMC on the Moya application At the end of the 12 week study duration
Secondary Outcome Secondary outcomes include: Successful contact of registered users by the RTC call centre agents Confirmed VMMC appointments booked at RTC call-centre supported sites Appointments attended for VMMCs at RTC supported sites At the end of the 12 week study duration
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Right to Care Unit 05A, 1006 Lenchen Avenue North Centurion 1057 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
University of Pennsylvania 3451 Walnut Street University of Pennsylvania 19104 United States of America
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor University of Pennsylvania 3451 Walnut Street Philadelphia 19104 South Africa University
COLLABORATORS
Name Street address City Postal code Country
HERO Indlela 39 Empire Road, Parktown Johannesburg 2193 South Africa
University of Pennsylvania 3451 Walnut Street Philadelphia 19104 United States of America
Boston University 801 Massachusetts Avenue Boston MA 02118 United States of America
University of Cape Town Southern Africa Labour Development Research Unit, Level 3 School of Economics Building, Main Campus, Rondebosch Cape Town 7700 South Africa
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Pedro Pisa Pedro.pisa@righttocare.org +27112768850 Unit 05A, 1006 Lenchen Avenue
City Postal code Country Position/Affiliation
North Centurion 1057 South Africa Head of Strategic Information Right to Care
Role Name Email Phone Street address
Public Enquiries Thomas Crompton thomas.crompton@righttocare.org +27127868850 Unit 05A, 1006 Lenchen Avenue
City Postal code Country Position/Affiliation
North Centurion 1057 South Africa Head of Department Strategic Information Analytics Right to Care
Role Name Email Phone Street address
Scientific Enquiries Brendan Maughan Brown Brendan.maughan-brown@uct.ac.za +27216505695 Rm 302 Lev 3 Schl of Economics Blgd Middle Campus
City Postal code Country Position/Affiliation
Rondebosch Cape Town 7700 South Africa Chief Research Officer
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Confidentiality measures will apply to all aspects of the study process from the time of VMMC registration form submission through data collection. All study-related information will be stored securely on RTC user access controlled databases. Data will be de-identified by using a unique StudyID to maintain participant confidentiality prior to being transferred to the study team outside of RTC. Personal identifiers will not be shared with anyone outside of RTC. Any linking or identifiable information will only be available to RTC staff who have access to this information on a routine basis. Call centre data, RightMax-Lynx data, and facility level data are stored and secured as per programme standards and are in line with POPIA compliance. The study will be implemented by the RTC study team. Only designated collaborators from University of Pennsylvania, Boston University, University of Cape Town and Health Economics and Epidemiology Research Office (HE2RO) will take part in the design and the analysis of aggregate de-identified data. Therefore, all study administration, data handling, and record keeping, will be managed by RTC including all data sources which contain identifiable information (according to standards aligning with POPI). Right to Care data is stored on user access controlled OneDrive for Business and secure password protected Right to Care databases. Identifiable information used by Right to Care employees will be handled in-line with standard company IT policies. No identifiable data will be shared with study team members outside of the RTC organisation. Study Protocol 15 months De-identified aggregate data
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