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.: PACTR201811609257043 Date of Approval: 08/11/2018
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Sitakhela Likusasa Impact Evaluation in Eswatini
Official scientific title Sitakhela Likusasa Impact Evaluation: Evaluating the impact of incentives on HIV prevention amongst adolescent girls and young females in Swaziland
Brief summary describing the background and objectives of the trial The Sitakhela Likusasa Impact Evaluation is an initiative of the Government of Eswatini. It is an HIV prevention impact evaluation targeting adolescent girls and young women (AGYW) aged 15−22 (at the time of enrolment) into the study who currently attend school, or who have dropped out of school. o The aim of the study is to evaluate the impact of using incentives to reduce HIV infection among AGYW. o The study will enrol ~4,000 adolescent girls and young women who will be in enumerator areas that have been randomly assigned into the intervention arm or the control arm of the study. o The intervention being evaluated, consists of a financial incentive provided to AGYW in the intervention arm to enrol in and attend different types of education. 50% of AGYW in both arms will also be part of a raffle incentive, conditional on being trichomonas vaginalis and syphilis negative o A baseline, midline and endline survey will be done to assess demographics, behaviours and STI status (HIV, syphilis and trichomonas vaginalis): before enrolment into the study, halfway through the study, and at the end of the impact evaluation. o Because of the type of intervention being evaluated, the study will also collect data on enrolment into and attendance of different types of education, and the prevalence of sexual transmitted infection (STI) prevention at midline and endline.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) SL
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 15/11/2015
Actual trial start date 15/11/2015
Anticipated date of last follow up 30/09/2019
Actual Last follow-up date 31/10/2019
Anticipated target sample size (number of participants) 4300
Actual target sample size (number of participants) 4398
Recruitment status Closed to recruitment,follow-up continuing
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Stratified allocation where factors such as age, gender, center, or previous treatment are used in the stratification 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 Education Incentives sub arm 4 times per year, depending on type of schooling in which participant is enrolled in 3 school years: Jan to Dec 2016, Jan to Dec 2017, Jan to Dec 2018 The Sitakhela Likusasa Impact Evaluation aims to answer the following questions: a) Do education incentives paid to adolescent girls and young women (AGYW) aged 15 to 22 years contingent on school attendance or other forms of education engagement, reduce the incidence of HIV compared to adolescent girls and young women not receiving cash incentives? b) Do raffle prizes paid to adolescent girls and young women aged 15 to 22 contingent on being negative for curable STIs (Trichomonas vaginalis, syphilis) reduce the incidence of HIV compared to adolescent girls and young women not enrolled in a raffle? c) Do raffle incentives and education incentives act in an additive or multiplicative manner to reduce the incidence of HIV amongst adolescent girls and young women over time (acknowledging a possibly limited power to detect interaction)? d) Is the provision of incentives cost-effective as a method of HIV prevention in adolescent girls and young women in Swaziland? In order to investigate the impact of cash incentives paid to AGYW on HIV incidence, as well as the impact of a direct transfer of cash to girls via the raffle condition, the study employs a 2 X 2 factorial design, to allow a more efficient use of study resources by reducing the required sample size 1088
Experimental Group Raffle sub arm 8 raffle rounds over 2 years One raffle takes 4 weeks to be completed Every round, 400 participants are selected for the raffle. All participants negative for syphilis and trichomonas, are enrolled in a raffle, and 80 winners are selected every raffle round. A raffle winner is paid E1000. 1162
Control Group None Varied -- country's national efforts Varied -- country's national efforts Varied -- country's national efforts 1068 Uncontrolled
Experimental Group Education Incentive and Raffle sub arm Raffle intervention: 8 raffle rounds in 3 calendar years (2016, 2017 and 2018) Education intervention: Incentives paid at the start of the school year for enrolment and then throughout the school year for attendance (if in regular school) or completion (if enrolled in upgrading classes, tertiary education or a short course). Intervention was implemented over 3 calendar years (which are also regular education school years) - 2016, 2017 and 2018 Raffle intervention: 8 raffle rounds in 3 calendar years (2016, 2017 and 2018) Education intervention: Incentives paid at the start of the school year for enrolment and then throughout the school year for attendance (if in regular school) or completion (if enrolled in upgrading classes, tertiary education or a short course). Intervention was implemented over 3 calendar years (which are also regular education school years) - 2016, 2017 and 2018 As described for the education sub arm and for the raffle sub arm. These participants get both interventions. 1071
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. aged 15-22 at enrolment 2. Willingness to go back to some form of education 3. resident in Swaziland at the time of enrolment 4. Female HIV positive at enrolment Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year 15 Year(s) 22 Year(s) 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
Yes 08/08/2015 Swaziland National Health Research Review Board NHRRB
Ethics Committee Address
Street address City Postal code Country
Swaziland Christian University Building, Office F2, Makhosini Drive Mbabane 0000 Swaziland
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 18/12/2014 Western Institutional Review Board
Ethics Committee Address
Street address City Postal code Country
1019 39th Avenue SE Suite 120 Puyallup 98374 United States of America
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome HIV, syphilis and tricomonas incidence baselline 2015, midline 2017, endline 2019
Secondary Outcome High risk sexual behaviour baselline 2015, midline 2017, endline 2019
Secondary Outcome risk taking behaviour baselline 2015, midline 2017, endline 2019
Secondary Outcome education enrolment and attendance behaviour Every school term in 2016, 2017 and 2018
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Health facilities and community locations in Swaziland Health facilities and community locations in Swaziland - detailed list available on request Mbabane 0000 Swaziland
FUNDING SOURCES
Name of source Street address City Postal code Country
Department for International Development 22 Whitehall, Westminster, SW1A2EG London 0000 United Kingdom
The Global Fund to Fund AIDS TB and Malaria Chemin du Pommier 40 Geneva 0000 Switzerland
National Emergency Response Council on HIV and AIDS Swaziland Emajika Road Mbabane 0000 Swaziland
United Nations joint Program on HIVAIDS Avenue Appia Geneva Switzerland
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor The World Bank 1818 Street NW Washington DC 20433 United States of America Funding Agency
Primary Sponsor Department for Intenrational Development 22 Witehall, Westminster London 0000 United Kingdom Funding Agency
COLLABORATORS
Name Street address City Postal code Country
National Emergency Response Council on HIVAIDS Emajika Road Mbabane 0000 Swaziland
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Marelize Gorgens Prestidge mgorgens@worldbank.org 2025604741 1818 Street NW
City Postal code Country Position/Affiliation
Washington DC 22043 United States of America Senior Specialist
Role Name Email Phone Street address
Scientific Enquiries DAmien De Walque ddewalque@worldbank.org 2024730000 1818 H Street NW
City Postal code Country Position/Affiliation
Washington DC 20433 United States of America Senior Economist
Role Name Email Phone Street address
Public Enquiries Khanyakwezwe Mabuza kmabuza@nercha.org.sz 26824065000 Emajika Road
City Postal code Country Position/Affiliation
Mbabane 0000 Swaziland National Executive Director
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Anonymised patient data will be shared on the World Bank's Open Knowledge Repository one year after study results have been published. Swaziland's Central Statistics Office will also keep a final set of all data. Clinical Study Report,Informed Consent Form,Study Protocol one year after study results have been published Open access in line with World BAnk open data criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
okr.worldbank.org 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
Intervention Intervention List 07/11/2018 As per the reviewer's request, each of the 4 sub arms are added separately so that the total participants add up to 4389. Please keep in mind that this is a 2x2 factorial design where participants were first randomised (based on location) to the education treatment or education control arm. In each of these arms, 50% of the enrolled participants were also randomly selected and offered the opportunity to be part of the raffle. This results in 4 study sub arms. Experimental Group, Raffle sub arm , 8 raffle rounds over 2 years, One raffle takes 4 weeks to be completed, Every round, 400 participants are selected for the raffle. All participants negative for syphilis and trichomonas, are enrolled in a raffle, and 80 winners are selected every raffle round. A raffle winner is paid E1000., 1162,
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 07/11/2018 As requested by the reviewer, the 2 education treatment arms were separated so that all arms add up to 4389 in total. Experimental Group, Education Incentives sub arm and Education and Raffle sub arm, 4 times per year, depending on type of schooling in which participant is enrolled in, 3 school years: Jan to Dec 2016, Jan to Dec 2017, Jan to Dec 2018, The Sitakhela Likusasa Impact Evaluation aims to answer the following questions: a) Do education incentives paid to adolescent girls and young women (AGYW) aged 15 to 22 years contingent on school attendance or other forms of education engagement, reduce the incidence of HIV compared to adolescent girls and young women not receiving cash incentives? b) Do raffle prizes paid to adolescent girls and young women aged 15 to 22 contingent on being negative for curable STIs (Trichomonas vaginalis, syphilis) reduce the incidence of HIV compared to adolescent girls and young women not enrolled in a raffle? c) Do raffle incentives and education incentives act in an additive or multiplicative manner to reduce the incidence of HIV amongst adolescent girls and young women over time (acknowledging a possibly limited power to detect interaction)? d) Is the provision of incentives cost-effective as a method of HIV prevention in adolescent girls and young women in Swaziland? In order to investigate the impact of cash incentives paid to AGYW on HIV incidence, as well as the impact of a direct transfer of cash to girls via the raffle condition, the study employs a 2 X 2 factorial design, to allow a more efficient use of study resources by reducing the required sample size , 2159, Experimental Group, Education Incentives sub arm, 4 times per year, depending on type of schooling in which participant is enrolled in, 3 school years: Jan to Dec 2016, Jan to Dec 2017, Jan to Dec 2018, The Sitakhela Likusasa Impact Evaluation aims to answer the following questions: a) Do education incentives paid to adolescent girls and young women (AGYW) aged 15 to 22 years contingent on school attendance or other forms of education engagement, reduce the incidence of HIV compared to adolescent girls and young women not receiving cash incentives? b) Do raffle prizes paid to adolescent girls and young women aged 15 to 22 contingent on being negative for curable STIs (Trichomonas vaginalis, syphilis) reduce the incidence of HIV compared to adolescent girls and young women not enrolled in a raffle? c) Do raffle incentives and education incentives act in an additive or multiplicative manner to reduce the incidence of HIV amongst adolescent girls and young women over time (acknowledging a possibly limited power to detect interaction)? d) Is the provision of incentives cost-effective as a method of HIV prevention in adolescent girls and young women in Swaziland? In order to investigate the impact of cash incentives paid to AGYW on HIV incidence, as well as the impact of a direct transfer of cash to girls via the raffle condition, the study employs a 2 X 2 factorial design, to allow a more efficient use of study resources by reducing the required sample size , 1088,
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 07/11/2018 Please keep in mind that this is a 2x2 factorial design, with participants firstly in the education treatment or education control arm, and then within each of these 2 arms, 50% were randomised to the raffle. Experimental Group, Education Incentive and Raffle sub arm, Raffle intervention: 8 raffle rounds in 3 calendar years (2016, 2017 and 2018) Education intervention: Incentives paid at the start of the school year for enrolment and then throughout the school year for attendance (if in regular school) or completion (if enrolled in upgrading classes, tertiary education or a short course). Intervention was implemented over 3 calendar years (which are also regular education school years) - 2016, 2017 and 2018, Raffle intervention: 8 raffle rounds in 3 calendar years (2016, 2017 and 2018) Education intervention: Incentives paid at the start of the school year for enrolment and then throughout the school year for attendance (if in regular school) or completion (if enrolled in upgrading classes, tertiary education or a short course). Intervention was implemented over 3 calendar years (which are also regular education school years) - 2016, 2017 and 2018, As described for the education sub arm and for the raffle sub arm. These participants get both interventions. , 1071,
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 07/11/2018 PACTR review requested that the email address be added. Please see full contact information at http://www.shrswaziland.com/contact-us/ TRUE, Swaziland National Health Research Board, Ministry of Health headquarters, Mbabane, 0000, Swaziland, , 08 Aug 2015, 26824044905, babazileshongwe@gmail.com, 4685_3979_4737.pdf TRUE, Swaziland National Health Research Review Board NHRRB, Swaziland Christian University Building, Office F2, Makhosini Drive, Mbabane, 0000, Swaziland, , 08 Aug 2015, 26824044905, www.nhrdswaziland@gmail.com, 4685_3979_4737.pdf
Section Name Field Name Date Reason Old Value Updated Value
Funding Source FundingSources List 13/07/2022 This was incorrectly reported The World Bank, 1818 Street NW, Washington DC, 22043, United States of America, Other
Section Name Field Name Date Reason Old Value Updated Value
Funding Source FundingSources List 13/07/2022 This donor is reported for contributions after trial registration to the study and its findings dissemination United Nations joint Program on HIVAIDS, Avenue Appia, Geneva, , Switzerland, Other Collaborative Groups,