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.: PACTR202505482244956 Date of Registration: 14/05/2025
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Impact Evaluation of Ghana’s Promoting Adolescent Safe Spaces (PASS) Program
Official scientific title Impact Evaluation of Ghana’s Promoting Adolescent Safe Spaces (PASS) Program
Brief summary describing the background and objectives of the trial Child marriage is a widely recognized violation of children's rights, with significant health, social and economic consequences, including profound intergenerational effects. While child marriage rates have declined in recent decades, West and Central Africa has the highest prevalence of child marriage globally. The trial aims to rigorously assess the impact of the Promoting Adolescent Safe Spaces (PASS) Program (hereafter “the intervention”) in Ghana on child marriage and pregnancy rates. PASS focuses on the themes of adolescent empowerment, community engagement for social behaviour change and strengthening linkages to services. PASS was initiated as part of UNICEF and UNFPA commitment to implement interventions that provide intensive support to the most marginalized adolescent girls to make their own informed decisions and choices regarding marriage, education and sexual and reproductive health. It is also positioned under the UNICEF and UNFPA-led Global Program to End Child Marriage. The overall goal of PASS is: “to ensure that the adolescent girls at risk or affected by child marriage are empowered with the relevant knowledge, skills and networks to build confidence, make informed decisions, express their voices, and access services and community support to prevent and respond to child marriage”.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Obstetrics and Gynecology
Sub-Disease(s) or condition(s) being studied Child marriage (marriage before age of 18 years),Child pregnancy (pregnancy before age of 18)
Purpose of the trial Prevention
Anticipated trial start date 14/05/2025
Actual trial start date
Anticipated date of last follow up 30/01/2027
Actual Last follow-up date
Anticipated target sample size (number of participants) 3000
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
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 Randomised Stratified allocation where factors such as age, gender, center, or previous treatment are used in the stratification Central randomisation by phone/fax Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Promoting Adolescent Safe Spaces PASS 8-11 months The PASS program provides adolescents with essential support services, educational opportunities on sexual and reproductive health and rights (SRHR), and forums for discussing issues that impact their well-being. The core programming of PASS focuses on creating of safe spaces for adolescent girls aged 10 to 19. These adolescents’ girls receive at least 31 contact hours (48 in the Central region) of customizable life skills and reproductive health education (official term used in Ghana in place of “Comprehensive Sexuality Education”) sessions. Sessions are led by a mentor selected by adolescents themselves and typically held weekly. Sessions provide a platform for girls to have reflective dialogues about a wide range of topics, such as girls’ rights, gender, relationships, SRH, contraception, menstrual hygiene management, child marriage and other forms of gender-based violence (GBV) and mental health. The core safe spaces and training components are complemented by the following approaches: o Boys’ supportive programming, whereby boys are mobilized into groups of 20 to 35 boys that hold bi-weekly or monthly gender dialogue meetings for a minimum of 20 hours to garner support for issues affecting adolescent girls (e.g., ‘I am for girls’ groups). o Economic empowerment and vocational training, via collaboration with business advisory centres to train girls in non-traditional skills (started in 2021 based on the needs of the girls and being implemented at a small scale as pilot). o Community mobilization and engagement via various approaches called “Model Gender Households”, “Community Parent Networks” and “Community Breaking the Silence” with the use of the “Child Protection Community Facilitation Toolkits” and support of religious and traditional leaders to develop and enforce local community byelaws for child marriage bans; and o Linkages with services in partnership with the duty bearers. 1500
Control Group Not Applicable N/A N/A No PASS activities, business as usual. 1500 Historical
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Study participants include households residing in communities in Central, Northern, North East, and Savannah regions, which have not yet been exposed to the intervention. Target individuals for the study include caregivers (adult men and women) of young girls of ages 10-17 years old, as well as adolescent boys aged 10-17 years old, and girls aged 10 -17 years old who are unmarried at the time of the recruitment (at risk for future early marriage transitions). Communities already exposed to the intervention are excluded. In addition, adolescent girls who are already married or cohabiting alongside their households are excluded from study. Individuals who do not speak the dominant languages spoken in the village will be excluded. Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Child: 6 Year-12 Year,Middle Aged: 45 Year(s)-64 Year(s) 10 Year(s) 80 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 15/03/2025 University of Ghana
Ethics Committee Address
Street address City Postal code Country
N/A Accra LG 74 Ghana
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome 1. Girl child marriage (marriage or cohabitation before the age of 18 years) 2. Child pregnancy (pregnancy before the age of 18 years) 3. Childbirth (given birth before the age of 18 years) All outcomes will be measured at follow-up.
Secondary Outcome 1. Girls’ and boys’ educational attainment 2. Girls’ and boys’ mental health (symptoms of anxiety and depression) 3. Violence against girls (experienced any emotional, physical, sexual violence in the past 12 months) 4. Girls’ improved livelihood (has quality and age-appropriate paid work, apprenticeship, or training in the past 6 months) 5. Girls’ life skills (communication skills, social problem-solving skills) 6. Girls’ and boys’ knowledge on adolescent sexual reproductive health 7. Girls’ perceived social support 8. Girls’ aspirations on marriage and childbearing 9. Girls’ aspirations on education and professional occupation 10. Girls’ agency and self confidence 11. Girls’ and boys’ use of contraceptives 12. Girls’ and boys’ risky behaviours (drug, alcohol, and tobacco use in the past 12 months) 13. Girls,’ boys,’ and caregivers’ gender equitable attitudes and social norms including child marriage 14. Girls,’ boys,’ and caregivers’ access to and receipt of prevention and protection services 15. Caregivers’ and boys’ protective behaviours (willingness to speak out and take action to support girls) All outcomes will be measured at baseline and follow-up.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
University of Ghana School of Public Health N/A Accra LG 74 Ghana
FUNDING SOURCES
Name of source Street address City Postal code Country
UNICEF 3 United Nations Plaza New York 10017 United States of America
UNFPA N/A Accra Ghana
UNICEF Ghana N/A Accra Ghana
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor UNICEF 3 United Nations Plaza New York 10017 United States of America United Nations
COLLABORATORS
Name Street address City Postal code Country
Francesco Iacoella UNICEF Evaluation Office, 3 United Nations Plaza New York 10017 United States of America
Horace M. A. Gninafon 3 United Nations Plaza New York 10017 United States of America
Amber Peterman United Nations Office at Nairobi Block E Nairobi 44145 Kenya
Monica Lambon Quayefio University of Ghana Accra LG 13 Ghana
Deda Ogum University of Ghana Accra LG 13 Ghana
Nirav Shah UNICEF Ghana Country Office 4 8th Cantonments City Cl Accra Ghana
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Yasemin Kisbu ykisbu@unicef.org +12123267000 3 United Nations Plaza
City Postal code Country Position/Affiliation
New York 10017 United States of America Evaluation Consultant at UNICEF Evaluation Office New York HQ
Role Name Email Phone Street address
Public Enquiries Zlata Bruckauf zbruckauf@unicef.org +12123267000 3 United Nations Plaza
City Postal code Country Position/Affiliation
New York 10017 United States of America Senior Evaluation Specialist UNICEF Evaluation Office New York HQ
Role Name Email Phone Street address
Scientific Enquiries Francesco Iacoella fiacoella@unicef.org +12123267000 3 United Nations Plaza
City Postal code Country Position/Affiliation
New York 10017 United States of America Evaluation Specialist UNICEF Evaluation Office New York HQ
Role Name Email Phone Street address
Scientific Enquiries Horace Gninafon hgninafon@unicef.org +12123267000 3 United Nations Plaza
City Postal code Country Position/Affiliation
New York 10017 United States of America Consultant at UNICEF Evaluation Office
Role Name Email Phone Street address
Public Enquiries Nirav Shah nshah@unicef.org +233559806439 UNICEF Ghana Country Office 4 8th Cantonments City Cl
City Postal code Country Position/Affiliation
Accra Ghana Evaluation Manager
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Data from the trial will be owned by UNICEF Ghana and efforts will be made to share the deindentified data in a public repository. In addition, it is expected that de-identified replication files will be made publicly available upon the publication of any journal articles to allow the reproduction of all tables, figures and results, alongside statistical replication code. Informed Consent Form 24 months after the trial ends, or upon publication of the main trial results. It is expected that data will be accessible to all the scientific community via open repository.
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
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Inclusion criteria 09/05/2025 PACTR Admin Study participants include households residing in communities in Central, Northern, North East, and Savannah regions, which have not yet been exposed to the intervention. Target individuals for the study include caregivers (adult men and women) of young girls of ages 10-17 years old, as well as adolescent boys aged 10-17 years old, and girls aged 10 -17 years old who are unmarried at the time of the recruitment (at risk for future early marriage transitions). Study participants include households residing in communities in Central, Northern, North East, and Savannah regions, which have not yet been exposed to the intervention. Target individuals for the study include caregivers (adult men and women) of young girls of ages 10-17 years old, as well as adolescent boys aged 10-17 years old, and girls aged 10 -17 years old who are unmarried at the time of the recruitment (at risk for future early marriage transitions).
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Exclusion criteria 09/05/2025 PACTR Admin Communities already exposed to the intervention are excluded. In addition, adolescent girls who are already married or cohabiting alongside their households are excluded from study. Individuals who do not speak the dominant languages spoken in the village will be excluded. Communities already exposed to the intervention are excluded. In addition, adolescent girls who are already married or cohabiting alongside their households are excluded from study. Individuals who do not speak the dominant languages spoken in the village will be excluded.
Section Name Field Name Date Reason Old Value Updated Value
Contact People Contacs List 09/05/2025 Ghana contact is added. Public Enquiries, Nirav, Shah, Mr., nshah@unicef.org, , +233559806439, UNICEF Ghana Country Office 4 8th Cantonments City Cl, Accra, , Ghana, Evaluation Manager