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.: PACTR201811565085019 Date of Approval: 14/11/2018
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Influence of School Based Sexual Risk Avoidance Education on Sexual Behavior Among Adolescent Girls In Homabay County, Kenya
Official scientific title Influence of School Based Sexual Risk Avoidance Education on Sexual Behavior Among Adolescent Girls In Homabay County, Kenya
Brief summary describing the background and objectives of the trial Adolescent sexual and reproductive health is a primacy in global agenda because of its associated negative reproductive health indices. It is estimated that Homabay County contributes 11.5% of adolescent aged 10-19 years living with HIV in Kenya and has an overall HIV prevalence of 26.0% which 4.5 times higher than the national prevalence. Fertility rate among girls aged 15-19 is also highest in Homabay at 33% pregnancy rate and age specific fertility rate 178 births per 1000 girls as compared to the National figure on pregnancy rate of 18% and specific fertility rate of 96 births per 1000 girls. The broad objective for this study is to determine the effectiveness of school based Sexual Risk Avoidance Education on sexual behavior in Homabay County. Using Randomized Control Trial study design, 14 schools will be enrolled for Sexual Risk Avoidance education (intervention group) while 14 will be enrolled as comparison group for a period of 12 months. The individual respondents sample size for the baseline, midterm and end term surveys will be 244 per group. Two stage stratified random sampling and simple random sampling will be used in selection of schools for the study and individual respondents for the surveys respectively. The Baseline, Midterm and End term intervention data collection will be done through self-administered questionnaire for quantitative data, Focused group discussion and key informant interview for qualitative data. Quantitative data will be managed in SPSS while qualitative will be analyzed by thematic content analysis. Logistic regression analysis will be conducted to determine factors associated with risky sexual behavior and effects of the intervention. The results will be presented in tables, bar graphs and pie charts. The level of significance for the study will at p≤0.05 and the Minimum Detectable Effect Size will be 0.1.Research permit will be obtained from NACOSTI, ethical clearance from Kenyatta University Ethics Committee and permission will be obtained from Ministry of Education while the participants will be asked for verbal informed consent and voluntary participation in the study. Confidentiality will be ensured throughout the study period. The study will also adhere to the WHO guidelines on adolescent sexual health studies.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Education /Training
Anticipated trial start date 01/09/2018
Actual trial start date 03/09/2018
Anticipated date of last follow up 30/06/2019
Actual Last follow-up date 30/06/2019
Anticipated target sample size (number of participants) 488
Actual target sample size (number of participants) 512
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
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 Numbered containers Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group School Based Sexual Risk Avoidance Education 14 Indoor lessons and 5 outdoor activities. Nine months This involve baseline followed by Class based Sexual Risk Avoidance Education for a period of nine months and final end term data collection on sexual behavior to measure intervention effect. 244
Control Group No Training 9 months No intervention 244 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
All girls’ day school which have completed at least one cycle of secondary education will be legible for selection. All unmarried adolescent girls aged 15-19 years enrolled in the sampled schools irrespective of their sexual activity and pregnancy status and who will voluntarily consent to participate will be included in the Baseline, Midterm and End term surveys. Both boys and girls will be exposed to SRAE program in the case of mixed schools. Adolescent with terminal conditions will not participate in the any of the three surveys in the study. Schools in island with unreliable means of transport will be eliminated from the sampling frame. Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year 19 Year(s) 19 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 28/06/2018 KENYATTA UNIVERSITY ETHICS REVIEW COMMETTEE
Ethics Committee Address
Street address City Postal code Country
23844 NAIEOBI 0100 Kenya
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Risky sexual behaviour Baseline and End term
Secondary Outcome Knowledge,perception of Risk,Self Efficacy , Baeline and Endtem
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
HOMABAY COUNTY DHIWA AND RACHUONYO NORTH HOMABAY 23844 Kenya
FUNDING SOURCES
Name of source Street address City Postal code Country
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Isaac Owaka KENYATTA UNIVERSITY NAIROBI 43844 Kenya Individual
COLLABORATORS
Name Street address City Postal code Country
MINISTRY OF EDUCATION HOMABAY HOMABAY 0100 Kenya
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator OWAKA ISAAC owaka.isaac@ku.ac.ke +254725870089 KENYATTA UNIVERSITY
City Postal code Country Position/Affiliation
NAIROBI 23844 Kenya TUTORIAL FELLOW
Role Name Email Phone Street address
Scientific Enquiries GEORGE OCHIENG OTIENO.GEORGE@ku.ac.ke +254719506770 KENYATTA UNIVERSITY
City Postal code Country Position/Affiliation
NAIROBI 0100 Kenya SENIOR LECTURER
Role Name Email Phone Street address
Public Enquiries MARGARET KERAKA margaret.keraka@ku.ac.ke +254721817521 KENYATTA UNIVERSITY
City Postal code Country Position/Affiliation
NAIROBI 23844 Kenya Proffesor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Study result Informed Consent Form,Statistical Analysis Plan,Study Protocol 12 months after the study Open access journal
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