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.: PACTR202111835241282 Date of Approval: 08/11/2021
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effect of Sexuality Education Programme on Secondary School Students’ STI and HIV knowledge, Attitude and Risk Behaviors in Adamawa State
Official scientific title Effect of Sexuality Education Programme on Secondary School Students’ STI and HIV knowledge, Attitude and Risk Behaviors in Adamawa State
Brief summary describing the background and objectives of the trial The research evidence for the need to support adolescents’ knowledge and behaviors related to their health and sexual wellbeing remains compelling. In the absence of effective, affordable vaccines or cure for HIV, the knowledge of sexually transmitted infections/human immunodeficiency virus (STI/HIV), positive screening attitudes and risk behaviors prevention remains central to the public health efforts aimed at preventing the unprecedented spread of STI/HIV in adolescent and adult populations. The STI/HIV prevalence rates are high in Nigeria. Nigeria has the second-largest HIV and AIDS epidemic in the world (National Agency for the Control of AIDS [NACA], 2015). An estimated 3.4 percent (3,229,757 people) of the population were living with HIV by the end of 2013 (NACA, 2015). Although the rate of new infections has started to decline (283,589 in 2010, to 220,394 in 2013), the total number of new infections in females continues to surpass that of the males (Aboki, Folayan, Daniel & Ogunlayi, 2014; NACA, 2015). The estimated cases of new STI/HIV infections in adolescents and young persons aged 15 to 24years also show similar trends. The present study aims to implement school-based a sexuality education program. The school-based sexuality education program has the potential to improve adolescent sexual health outcomes, STI/HIV knowledge, attitudes, and STI/HIV risk behaviors prevention. However, many schooling adolescents do not receive high-quality sexuality education due to several reasons such as a lack of evidence-based sexuality education programme in the secondary school curriculum and the non-availability of qualified health education teachers to deliver high-quality sexuality education. The present study, therefore, seeks to determine whether SEP can improve in-school adolescents' STI and HIV knowledge, modify attitude towards STI and HIV testing, and prevention of sexual risk behaviors.
Type of trial CCT
Acronym (If the trial has an acronym then please provide) SEP
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 30/03/2021
Actual trial start date 05/04/2021
Anticipated date of last follow up 30/10/2021
Actual Last follow-up date 01/11/2021
Anticipated target sample size (number of participants) 400
Actual target sample size (number of participants) 384
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 Non-randomised Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Sexuality Education Programme one session of SEP for 40 to 60 minutes per week for eight weeks 8 weeks Sexuality education programme covers broad areas at various times. The sexuality education programme has a strong focus on STI/HIV prevention (UNAIDS, 2017). The school plays a vital role in providing support for access to services, supporting adherence to treatment, as well as including education about preventing re-infection, the onward transmission of HIV to others, living positive, healthy lives, and reducing stigma and discrimination (UNESCO, 2012). SEP has been recognized as an important component of adolescent health interventions (WHO, 2017). Fonner, Armstrong, Kennedy, O’Reilly, and Sweat (2014) asserted that the contents of sexuality education include information about family planning, reproduction (fertilization, conception, and development of the embryo and fetus, through to childbirth), plus information about all aspects of one's sexuality including body image, sexual orientation, sexual pleasure, values, decision making, communication, dating, relationships, sexually transmitted infections (STIs) and how to avoid them, and birth control methods and HIV prevention. 200
Control Group Conventional School Health Education One session of 40 to 70 minutes per week 8 weeks Traditional school health education provides information on personal hygiene, prevention of diseases such as HIV, mental and social health, first aid services, safety education, mental health, nutrition education, environmental sanitation, substance abuse, and family life education. 200 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Students aged 15 to 19 years. Students in a public secondary school in Adamawa State Students who enroll during the 2019/2020 academic session. Students who provide informed consent by self, a parent, or guardian before participation. Students below the age of 15 years. Students who do not provide informed consent either by self, a parent, or guardian. Sick students will be excluded from the study. Adolescent: 13 Year-18 Year 15 Year(s) 19 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 30/03/2021 Health and Ethics Research Committee State Ministry of Health Adamawa State
Ethics Committee Address
Street address City Postal code Country
Adamawa State Ministry of Health, State Secretariat, PMB 2078, Yola, Adamawa State. Yola 640001 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome HIV and STI knowledge, Attitude towards STI and HIV testing/screening Time 1-baseline and Time 2-post intervention
Secondary Outcome STI and HIV testing uptake and safe sex behaviors/practices Time 2-post intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Adamawa State secondary schools Yola Yola 640001 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Self Adamawa State College of Technology, Mubi Yola 640001 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Yohanna Wamanyi Adamawa State College of Health Technology, Mubi Yola 640001 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Yohanna Wamanyi wamanyiyohanna@gmail.com +2348067608748 Adamawa State College of Health Technology, Mubi
City Postal code Country Position/Affiliation
Yola 640001 Nigeria Lecturer
Role Name Email Phone Street address
Public Enquiries Osmond Ene osmond.ene@unn.edu.ng +2348033368643 Department of Human Kinetics and Health Education, Faculty of Education, University of Nigeria, Nsukka
City Postal code Country Position/Affiliation
Nsukka 410001 Nigeria Lecturer and health promotion consultant
Role Name Email Phone Street address
Scientific Enquiries Olaoluwa Samson Agbaje agbajesam@yahoo.com +2348068091290 Department of Human Kinetics and Health Education, Faculty of Education, University of Nigeria, Nsukka
City Postal code Country Position/Affiliation
Nsukka 410001 Nigeria Lecturer researcher and health promotion consultant
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices). Analytic Code,Clinical Study Report,Informed Consent Form,Statistical Analysis Plan Immediately following publication, No end date. Researchers who provide a methodologically sound proposal. The proposal should be directed to agbajesam@yahoo.com or samson.agbaje@unn.edu.ng. To gain access, data requestors will need to sign a data access agreement.
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