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.: PACTR202209551216666 Date of Approval: 22/09/2022
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title I CAN WAIT: Assessing the effectiveness of using comprehensive sexuality education in improving uptake of HIV testing among adolescent and young people in secondary schools
Official scientific title I CAN WAIT: Assessing the effectiveness of using comprehensive sexuality education in improving uptake of HIV testing among adolescent and young people in secondary schools
Brief summary describing the background and objectives of the trial Kenya is one of the countries in Africa where the HIV/AIDS pandemic still poses huge challenges to social and economic development activities. The Kenya HIV estimates report by National AIDS and Control Council (NACC) indicates that the national HIV prevalence is at 4.9% (Kenya HIV estimates 2018 report); which translates to approximately 1.3 million adults living with HIV in Kenya (KENPHIA 2018). Among those aged 14-24 years, the HIV prevalence among females stood at 1.3%, while that of males was at 2.6% (KARPR 2018). These findings show that the adolescent and young people are more vulnerable to HIV infection. Some of the factors cited as driving the spread of the disease include early sexual debut, inconsistent condom use, lack of knowledge about HIV/AIDS, multiple sexual partners, and transactional sex (WHO 2006). Studies that have examined effects of interventions based on the social cognitive theory indicate that sexual and reproductive behavioral interventions among young people are effective, especially when targeting adolescent and young people before they become sexually active (Maticka-Tyndale et al. 2007). Primary Objective: To assess the effectiveness of using a CSE program to promote uptake of HIV testing among adolescent and young people in secondary schools. Secondary objectives: 1. To assess the effectiveness of using a CSE program in enhancing uptake of HIV testing services among adolescents and young people in secondary schools. 2. To assess the acceptability of using a CSE program to promote primary and secondary abstinence among adolescents and young people in secondary schools. 3. To measure the prevalence of self-reported risky sexual behaviours and practices among adolescents and young people in secondary schools. 4. To assess the feasibility of using a CSE program to promote primary and secondary abstinence among adolescents and young people in secondary schools to inform future scale up with an aim to inform future scale-up
Type of trial RCT
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,Sexually transmitted Infections/ Diseases
Purpose of the trial Improve uptake of HIV testing services among adolescent at selected Secondary Schools
Anticipated trial start date 01/04/2022
Actual trial start date 01/05/2022
Anticipated date of last follow up 31/10/2022
Actual Last follow-up date 30/11/2022
Anticipated target sample size (number of participants) 294
Actual target sample size (number of participants) 294
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
NON KEMRI 735 Kenya Medical Research Institute - Scientific Ethics Review Unit
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 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
Control Group No CSE Not applicable 3 months For the control arm (CSE), the pupils will continue with the status quo – learning experience being offered in the HIV/AIDS curriculum. A suggestion box will be placed at convenient sites within the school and the participants informed of it during enrolment. They will place in the suggestion box their requests for the type of HIV and other STIs services required and present any other issue related to the study. The information placed in the suggestion box will be treated with confidentiality. Access to the contents of the box will be limited to the principal investigator who will be the only person with the key(s). 147 Uncontrolled
Experimental Group Yes CSE Not applicable 3 months. For the intervention arm (CSE), the pupils will be engaged in peer-led lessons implemented over 24 weeks (once a week for 6 months), each session lasting 35 min. The sessions will be part of an after-school life skills training curriculum, designed to be interactive and teachers will be enlisted to offer support when needed. The CSE manual that will be used is thorough and contains scientifically accurate information about a range of interrelated sexual health and reproduction topics, has an explicit gender focus, and addresses gender norms and gender equality as stand-alone topics and across other CSE topics. A suggestion box will be placed at convenient sites within the schools and the participants informed of it during enrollment. They will place in the suggestion box their requests for the type of HIV and other STIs services required, submit opinions of their experiences with the CSE intervention and present any other issue related to the study. The information placed in the suggestion box will be treated with confidentiality. Access to the contents of the box will be limited to the principal investigator who will be the only person with the key(s). 147
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
 Students enrolled in the participating schools  Adolescents 18 years and below whose parents/ guardians give consent for participation  Adolescents 18 years and below who provide assent for participation  Young people 18 years and above who provide consent for participation  Students not enrolled in the participating schools  Adolescents 18 years and below whose parents/ guardians do not give consent for participation  Adolescents 18 years and below who do not provide assent for participation  Young people 18 years and above who do not provide consent for participation Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year 14 Year(s) 24 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 23/06/2021 Kenya Medical Research Institute Scientific Ethics Review Unit
Ethics Committee Address
Street address City Postal code Country
Raila Odinga way Nairobi 00200 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
Yes 26/08/2021 National Commission for Science Technology and Innovation
Ethics Committee Address
Street address City Postal code Country
Waiyaki Way, Nairobi Nairobi 00100 Kenya
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Uptake of HIV testing among adolescent and young people in secondary schools. Measured by assessing the proportion of AYP in schools demanding and accessing HIV and STIs testing and treatment services. Monthly for 6 months
Secondary Outcome 1. Reception of the intervention by the targeted population. Assessed by measuring the number of particpants reached and screened in the targeted population against those who are enrolled in the study. 2. Self-reported risky sexual behaviours and practices among adolescents and young people in secondary schools. Assessed by measuring the proportion of AYP reporting enhanced risk perception of HIV and enhanced bargaining power to determine the timing, nature and context of sex and proportion of sexually active AYP reporting practicing of safe sex and reduced number of sexual partners. 3. Identification of the barriers and facilitators of implementing the intervention. Assessed by evaluating feedback collected from study participants reached with the intervention. Acceptability of the intervention at baseline month 1, prevalence of risky sexual behaviours and practices monthly for 6 months and Feasibility of the intervention at endline month 6.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Nyamonye Girls Secondary School Bondo Sub-County, Siaya County, Kenya. Siaya 40632 Kenya
Wambasa girls secondary school Bondo Sub-County, Siaya County, Kenya. Siaya 40609 Kenya
Usenge Boys High School Bondo Sub-County, Siaya County, Kenya. Siaya 40609 Kenya
Got Agulu Boys Bondo Sub-County Siaya 40609 Kenya
Jusa Secondary school Bondo Sub-County Siaya 40609 Kenya
Majengo Mixed Secondary School Bondo Sub-County Siaya 40609 Kenya
FUNDING SOURCES
Name of source Street address City Postal code Country
Bill and Melinda Gates Foundation Seattle, WA98102, USA Seattle United States of America
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Impact Research and Development Organization Tuungane Hospital, Tom Mboya Estate Mito Jura Road, off Kisumu-Kakamega Highway Kisumu Kenya Grants management
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Gerald Owuor geraldochibo@gmail.com +254716108015 p.obox 9336
City Postal code Country Position/Affiliation
Kisumu 40141 Kenya Impact Research and Development Organization
Role Name Email Phone Street address
Public Enquiries Kawango Agot kawango@impact-rdo.org +254736505046 Tuungane Hospital, Tom Mboya Estate Mito Jura Road, off Kisumu-Kakamega Highway
City Postal code Country Position/Affiliation
Kisumu 40141 Kenya Impact Research and Development Organization
Role Name Email Phone Street address
Scientific Enquiries Charles Obonyo cobonyo@kemri.go.ke +254724993118 Rail way
City Postal code Country Position/Affiliation
Nairobi 00200 Kenya Kenya Medical Research Institute
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes We are committed to public dissemination of results of the study to participants, local stakeholders in Kenya, the global scientific community and global policymakers. Dissemination of study results will follow principles of good participatory practice. Study results will be disseminated through presentations to the relevant stakeholders, starting with the students and administration of schools that are participating, as well as the Ministry of Education officials in Siaya County and Bondo sub-County. Results will be published in conference abstracts and peer-reviewed journals. Statistical Analysis Plan,Study Protocol One year Upon completion of study analysis, the final dataset will be striped of identifiers prior to release for sharing. We will make the data and associated documentation available to users only under a data-sharing agreement that provides for: (1) a commitment to using the data only for research purposes and not to identify any individual participant; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying or returning the data after analyses are completed. Results from research conducted under this project will be shared in several ways. • Manuscripts will be submitted for publication in high-quality peer-reviewed journals • The MPI and Co-Investigator will also disseminate results from this research through presentations at public lectures, scientific institutions and meetings, as well as to the community in which the research took place as detailed in the enclosed.
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