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.: PACTR201810882140200 Date of Approval: 16/10/2018
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title School Based Sexual and Reproductive Health services for Prevention of Adolescent Pregnancy in Hoima District, Uganda: Cluster Randomized Controlled Trial.
Official scientific title School Based Sexual and Reproductive Health services for Prevention of Adolescent Pregnancy in Hoima District, Uganda: Cluster Randomized Controlled Trial.
Brief summary describing the background and objectives of the trial Uganda has persistently had unacceptably high adolescent pregnancy prevalence of 25% compared to 16% globally for the last 10 years (UBOS, 2006; UBOS and ICF, 2012; UBOS and ACF, 2017). This means that one in every four (25%) adolescent girls between 15 and 19 years in Uganda is pregnant or has had their first child. The adolescent pregnancy rate in Bunyoro region where Hoima District is found has an adolescent pregnancy rate of 29% higher than the national average of 25% (UBOS and ACF, 2017). According to the UDHS 2016 report, the complications due to adolescent pregnancy account for approximately 13% of all pregnancy related maternal deaths in Uganda. Access (5km or more) to a public health facility by the population including adolescent girls is limited and it is estimated that approximately 39.5% of the population in Hoima District live outside the catchment area (5km or more) of the public health facilities. This contributes significantly to inaccessibility and low utilization of SRH care among the adolescents who largely depend on financial support from the parents or guardians. This implies that the adolescent girls may not have the need for ASRH services met due to this hindrance. This study therefore seeks to determine the effect of providing School Based Sexual and Reproductive Health information and services on the prevention of adolescent pregnancy among girls in school aged 15 to 19 years in Hoima District, Uganda. The provision of SRH services on the school grounds is aimed at removing the barriers to access of these services among sexually active adolescents and youths so as to enable timely access to and utilization of SRH services. The study will also seek to advance a suitable school based SRH model for use in adolescent pregnancy prevention programs in Uganda and other developing countries specific objectives are; 1. To investigate the effect of School Based SRH services on occurrence of adolescent pregnancy among school girls aged 15-19 years in Hoima District, Uganda. 2. To evaluate the effect of School Based SRH services on sexual behavioral change for prevention of adolescent pregnancy among school girls aged 15-19 years in Hoima District, Uganda. 3. To analyze the effect of School Based SRH services on utilization of SRH services among school girls aged 15-19 years in Hoima District, Uganda
Type of trial RCT
Acronym (If the trial has an acronym then please provide) SBSRH
Disease(s) or condition(s) being studied Adolescent pregnancy,Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 01/11/2018
Actual trial start date
Anticipated date of last follow up 22/04/2019
Actual Last follow-up date 18/11/2019
Anticipated target sample size (number of participants) 1186
Actual target sample size (number of participants) 1182
Recruitment status Completed
Publication URL https://www.mdpi.com/2409-9279/2/1/21
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 by using procedures such as coin-tossing or dice-rolling Sealed opaque envelopes Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Sexual and Reproductive Health education sessions The SRH education sessions will be conducted for 1 hour, once a week during the school term 12 months SRH education session will be based on the SRH policy guidelines of Uganda and will include topics on sexuality and prevention of pregnancy 540 Active-Treatment of Control Group
Experimental Group School Based Sexual and Reproductive Health services SBSRH services will be provided once a week for 8 hours 12 months SBSRH services will be 3 tier ie 1. SRH information, education and counselling using the stepping stones methodology 2. SRH services on school premises 3. Referral for advanced care that are not offered as part of the package 540
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Girls aged 15 to 19 completed years at the time of the study Currently in secondary school in Hoima District Schools enrolling both sexes or girls only single sex schools will be included Ability to read and write English language Formal informed consent form signed by the parent or guardian Formal informed assent form signed by student herself Girls below 15 years or above 19 completed years at the time of study Girls who are unable to read and write English language Girls with no formal informed consent from parent/guardian and herself Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year 15 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 26/09/2018 Clarke International University Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Kampala Kampala 7782 Uganda
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome reduction in occurrence of adolescent pregnancy 6 months and 12 months
Secondary Outcome Utilization of SRH services, sexual behavioural change 6 months and 12 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Buhimba Senior Secondary School Kyabatalya, Buhimba Hoima Uganda
Bugambe Secondary School Bugambe Hoima Uganda
Duhaga Secondary School Western ward-Kahoora Hoima Uganda
Strive Secondary School Western ward-Kahoora Hoima Uganda
Mandela Senior Secondary SchoolAnnex Central ward-Kahoora Hoima Uganda
St. Peters High School Western ward-Kahoora Hoima Uganda
St. Andrews Kitoba High School Kiryangobe-Kitoba Hoima Uganda
Bwikya secondary school Mparo division Hoima Uganda
Mandela Annex secondary school central ward Hoima Uganda
Kitara secondary school central ward- kahoora Hoima Uganda
Day star secondary school Hoima municipality Hoima Uganda
St. James Secondary schools Butema Hoima Uganda
Premier secondary school Western ward Hoima Uganda
Buhanika Secondary School Nyakambugu ward-Mparo Hoima Uganda
St Cyprians secondary school Butema Hoima Uganda
Kings High School Kibingo parish Hoima Uganda
Bwikya muslim secondary school Mparo-Bwikya ward Hoima Uganda
Buseruka secondary school Nyakibingo Hoima Uganda
Morning star Secondary School Bwikya ward Hoima Uganda
Destiny Secondary School Hoima municipality Hoima Uganda
FUNDING SOURCES
Name of source Street address City Postal code Country
self Nakasero Kampala Uganda
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Gloria Kirungi Kasozi P.O.Box 5319, Kampala Kampala 5319 Uganda Individual
COLLABORATORS
Name Street address City Postal code Country
Brenda Katusiime Kahoora Hoima Uganda
Dr. Ruyonga Joseph Western ward-Kahoora Hoima Uganda
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Gloria Kirungi Kasozi gkirungi@gmail.com +256782264292 5319
City Postal code Country Position/Affiliation
Kampala Uganda PhD student
Role Name Email Phone Street address
Scientific Enquiries Frank Pio Kiyingi kfrankpio@yahoo.com +256703203391 Entebbe
City Postal code Country Position/Affiliation
Entebbe Uganda Supervisor
Role Name Email Phone Street address
Public Enquiries Miph Musoke ar@nkumbauniversity.ac.ug +256772997963 Entebbe
City Postal code Country Position/Affiliation
Entebbe Uganda Senior Supervisor
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, nd appendices) Clinical Study Report,Informed Consent Form,Study Protocol Beginning 9 months and ending 36 months following article publication Investigators whose proposed use of the data has been approved by an independent review committee (“learned intermediary”) identified for this purpose
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes 20/11/2020 30/05/2020
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 20/11/2020
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks https://www.mdpi.com/2409-9279/2/1/21
Changes to trial information