[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659080":3},{"organization":4,"outcomesModule":7,"designInfo":97,"detailedDescription":105,"studyPopulation":102,"armGroups":106,"interventions":126,"overallOfficials":141,"centralContacts":150,"locations":157,"responsibleParty":175,"collaborators":177,"id":185,"slug":186,"hasResults":187,"nctId":188,"briefTitle":189,"officialTitle":190,"acronym":191,"eligibilityCriteria":192,"healthyVolunteers":193,"sex":194,"minAge":195,"maxAge":196,"enrollmentInfo":197,"targetDuration":102,"studyType":200,"phases":201,"briefSummary":203,"conditions":204,"keywords":213,"overallStatus":222,"whyStopped":102,"lastUpdateSubmitDate":223,"lastUpdatePostDateStruct":224,"startDateStruct":227,"completionDateStruct":229,"leadSponsor":231,"locationsCount":232},{"fullName":5,"class":6},"Guttmacher Institute","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":23,"otherOutcomes":84},[9,13,16,19],{"measure":10,"description":11,"timeFrame":12},"Proportion of Adolescent Girls and Young Women (AGYW) Using (or Whose Partner Uses) a Modern Contraceptive Method (mCPR)","Proportion of female respondents who use, or whose partners use, modern contraceptive methods (female\u002Fmale sterilization, IUD, implant, injectable, pill, emergency contraception, male\u002Ffemale condom, and modern fertility-awareness-based methods). Aggregated as a proportion at each round; between-arm effect estimated via difference-in-differences.","Baseline; Month 6 of intervention; Month 12 of intervention; Month 18 of intervention; Month 24 of intervention; Month 30 of intervention; Month 36 of intervention; Month 42 of intervention; Endline (month 48 of intervention)",{"measure":14,"description":15,"timeFrame":12},"Proportion of AGYW Whose Contraceptive Use or Non-Use Is Concordant with Their Fertility Preferences (Preference-Aligned Fertility Management)","Proportion of female respondents classified as preference-concordant by the Preference-Aligned Fertility Management (PFM) indicator: using contraception and wanting to be, or not using and not wanting to be.",{"measure":17,"description":18,"timeFrame":12},"Proportion of AGYW with Decision-Making Autonomy over Family Planning","Proportion of female respondents who report being able to make their own decisions regarding the use of family planning, as opposed to needing permission from a parent, partner, healthcare provider, or other household authority figure.",{"measure":20,"description":21,"timeFrame":22},"Proportion of AGYW and Adolescent Boys and Young Men (ABYM) Who Have Dropped Out of School","Proportion of the baseline (JSS1-enrolled) cohort of female and male respondents no longer enrolled in \u002F attending school at a given follow-up round. Baseline enrollment is universal by eligibility, so dropout is measured longitudinally across rounds.","Month 6 of intervention; Month 12 of intervention; Month 18 of intervention; Month 24 of intervention; Month 30 of intervention; Month 36 of intervention; Month 42 of intervention; Endline (month 48 of intervention)",[24,27,30,33,36,39,42,45,48,51,54,57,60,63,66,69,72,75,78,81],{"measure":25,"description":26,"timeFrame":12},"Unintended Pregnancy Incidence Rate Among AGYW","Proportion of female respondents who reported a new pregnancy that was unwanted or mistimed since the previous round, based on pregnancy history and retrospective wantedness.",{"measure":28,"description":29,"timeFrame":12},"Proportion of Sexually Active AGYW and ABYM Who Used a Condom at Last Sexual Intercourse","Among female and male respondents who report having had sex in last 6 months, proportion who report that a condom was used at last intercourse.",{"measure":31,"description":32,"timeFrame":12},"Proportion of AGYW with Unmet Need for Modern Contraception","Modified unmet-need indicator: Proportion of sexually active non-pregnant female respondents who wish to delay or avoid pregnancy but are not using a modern contraceptive method.",{"measure":34,"description":35,"timeFrame":12},"Proportion of Female Contraceptive Users Who Are Satisfied With Their Method","Proportion of female contraceptive users who are satisfied with their method",{"measure":37,"description":38,"timeFrame":12},"Incidence of Contraceptive Method Discontinuation Among AGYW","Among female respondents using a method, proportion who discontinue (stop or have removed) their method between consecutive rounds.",{"measure":40,"description":41,"timeFrame":12},"Marriage\u002FCohabitation Incidence Rate for AGYW and ABYM","Proportion of female and male respondents who got married or started cohabiting between two consecutive rounds.",{"measure":43,"description":44,"timeFrame":12},"Mean Score on an Index of SRH Knowledge for AGYW and ABYM","Mean score on an index of 5 SRH knowledge items among female and male respondents, including potential side effects, infertility, postpartum fertility, and the fertile window.",{"measure":46,"description":47,"timeFrame":12},"Mean Score on the 4-Item Desire to Avoid Pregnancy Scale (DAP-4) for AGYW","Mean score on the 4-item DAP scale for female respondents. Items include to what extent: 1) becoming pregnant in the next 3 months makes me feel excited, 2) it would be a positive addition to my life to have a baby in the next year, 3) thinking about having a baby within the next year makes me feel stressed out, and 4) if I had a baby in the next year, it would be hard for me to manage raising the child.\n\nEach DAP item has response options that range from 0-4. For negatively worded items, 4 is \"strongly agree;\" for positively worded items, 4 is \"strongly disagree.\" Sum raw item scores and divide by 14 to obtain an average pregnancy preferences score (final range: 0-4). Higher scores reflect a higher desire to avoid pregnancy. The DAP is intended to be used as a continuous measure.",{"measure":49,"description":50,"timeFrame":12},"Mean Score on the Short 5-item Reproductive Coercion Scale for AGYW","Proportion of partnered female respondents reporting any of the five reproductive-coercion behaviors on the validated 5-item short-form validated Reproductive Coercion Scale (or the mean item count).",{"measure":52,"description":53,"timeFrame":12},"Mean Score on the Contraceptive Self-Efficacy Among Women in Sub-Saharan Africa (CSESSA) Scale for AGYW","Mean score on the validated 10-item CSESSA for female respondents. The score is calculated by summing all item values, creating a total score ranging from 0 to 100 across the partner-communication, provider-communication, and choosing\u002Fmanaging-a-method subscales.",{"measure":55,"description":56,"timeFrame":12},"Mean Score on Gender Attitudes and Beliefs for AGYW and ABYM","Mean score out of 15 items measuring beliefs and attitudes about gender and gender norms, for female and male respondents",{"measure":58,"description":59,"timeFrame":12},"Proportion of AGYW and ABYM Reporting Very Good or Excellent Self-Rated Health","Proportion of female and male respondents who rated their health as very good or excellent (or mean on the ordinal scale).",{"measure":61,"description":62,"timeFrame":12},"Mean Score on Cantril Life Satisfaction Ladder (Present and Future) for AGYW and ABYM","Mean score on validated Cantril Self-Anchoring Ladder (present and anticipated 4-year rungs, 0-10), for female and male respondents",{"measure":64,"description":65,"timeFrame":12},"Mean score on PHQ-4 Mental Health Scale (and Proportion Screening Positive for Anxiety or Depression) for AGYW and ABYM","Mean score on validated 4-item PHQ-4 mental health scale, for female and male respondents (range 0-12). Report the mean total score and the proportion screening positive (subscale total \\>=3 for anxiety and for depression).Total score is determined by adding together the scores of each of the four items. Scores are rated as normal (0-2), mild (3-5), moderate (6-8), and severe (9-12).",{"measure":67,"description":68,"timeFrame":12},"Mean Score on the Child and Youth Resilience Measure (CYRM-11) for AGYW and ABYM","Mean score on the validated 11-item CYRM for female and male respondents (simple sum of all 11 items, no reverse-scored items)",{"measure":70,"description":71,"timeFrame":12},"Mean Score on the Global Early Adolescent Study (GEAS) Empowerment Scale for AGYW and ABYM","Mean score on validated GEAS empowerment scale and 3 subscales (5-item freedom of movement, 7-item voice and 5-item decision-making\u002Fbehavioral control), for female and male respondents. Mean scores are calculated based on each set of scaled items, ranging from 1 to 4.",{"measure":73,"description":74,"timeFrame":12},"Mean Desired Educational Attainment for AGYW and ABYM","Mean highest school level that female and male respondents aspire to complete",{"measure":76,"description":77,"timeFrame":12},"Proportion of AGYW and ABYM Who Support the Continuation of Female Genital Cutting","Proportion of female and male respondents expressing both: 1) support for the continuation of female circumcision, and 2) intention to have a future daughter circumcised (or for boys, desire that their future wife be circumcised).",{"measure":79,"description":80,"timeFrame":12},"Proportion of Partnered AGYW Reporting Intimate Partner Violence in the Past 12 Months","Among ever-partnered female respondents, proportion reporting any controlling, emotional, physical, sexual, or economic abuse by a current\u002Fmost-recent partner, using standard DHS\u002FWHO-style items. Reportable overall and by subdomain.",{"measure":82,"description":83,"timeFrame":12},"Proportion of ABYM Able to Challenge Violence","Proportion of male respondents who have witnessed physical violence by another man who would do something about it",[85,88,91,94],{"measure":86,"description":87,"timeFrame":12},"Average Number of Comprehensive Sexuality Education Topics Reported by AGYW and ABYM as Covered in Class","Average number of CSE topics covered in class during the current school year as reported by female and male respondents",{"measure":89,"description":90,"timeFrame":12},"Proportion of AGYW and ABYM Reporting That Comprehensive Sexuality Education Classes Have Been Useful","Proportion of female and male respondents who report that CSE classes have been useful or very useful in helping them in their personal life, by trial arm",{"measure":92,"description":93,"timeFrame":12},"Proportion AGYW and ABYM Who Received School-Based Mobile SRH services","Proportion of female and male respondents who report having attended mobile SRH services at their school or a neighboring school during the current school year",{"measure":95,"description":96,"timeFrame":12},"Mean Score on Person-Centered Contraceptive Counseling (PCCC) Scale for AGYW","Mean score on validated PCCC scale for female respondents who attended mobile SRH services at their school or a neighboring school during the current school year, based on 4 items",{"allocation":98,"interventionModel":99,"interventionModelDescription":100,"primaryPurpose":101,"observationalModel":102,"timePerspective":102,"maskingInfo":103},"RANDOMIZED","FACTORIAL","This is a randomized controlled trial with factorial design consisting of 4 arms, as follows:\n\nArm 1. Control schools: No additional services Arm 2. Only CSE Arm 3. Only mobile SRHR services Arm 4. CSE + mobile SRHR services\n\n240 randomly selected junior secondary schools in Kenema and Kambia districts will be randomized to one of the 4 arms (60 schools per arm), stratified by urban\u002Frural status. All arms will start the study simultaneously and run in parallel for the same duration.","HEALTH_SERVICES_RESEARCH",null,{"masking":104,"maskingDescription":102,"whoMasked":102},"NONE","This study aims to evaluate the short- and long-term health, social and economic impacts of a school-based comprehensive sexuality education (CSE) program and improved access to sexual and reproductive health and rights (SRHR) services via mobile outreach to schools, both separately and in combination. This study is part of the Family Planning Impact Lab (FPIL), a five-year research initiative to generate new experimental evidence of the longer-term health, wellbeing, and development outcomes and on the cost-effectiveness of family planning interventions, which includes three randomized controlled trials evaluating family planning interventions in underserved settings in sub-Saharan Africa (RCT1: Sierra Leone; RCT2: Somalia and South Sudan; RCT3: Chad).\n\nEarly marriage is common in Sierra Leone, with 13% of young girls marrying before age 15 and 30% before 18, meaning that many girls begin sexual activity and childbearing in adolescence. Married adolescents aged 15-19 have the highest unmet need for family planning (27.8%) of any age group, limiting their ability to delay or space pregnancies. Unmarried adolescents face social barriers to accessing contraception, such as social stigma and male partner disapproval of contraceptive use. Forty percent of young people (15-24) in Sierra Leone did not use a method of contraception at their last sexual intercourse, even though they did not want to become pregnant. Sierra Leone ranks among the top ten countries with the highest teenage pregnancy rates globally, estimated to range between 28.3% and 34%. At the same time, inequitable gender norms leave young women and girls vulnerable to transactional sex, sexual abuse, and other forms of sexual exploitation. Together, these factors reinforce a cycle of limited reproductive autonomy, early and unintended pregnancies, and heightened maternal health risks among adolescent girls.\n\nCSE is an evidence-based approach to improve adolescent SRHR and wellbeing outcomes, including reducing early and unintended pregnancy, HIV, and gender-based violence, as well as building skills for greater autonomy. In Sierra Leone, CSE is being implemented through the Child and Adolescent Health and Life Skills (CAHLS) curriculum, integrated into the national curriculum in 2020. However, rollout has been limited due to resource and training constraints. The effectiveness of CSE also depends on the availability and accessibility of youth-friendly SRHR services, which in Sierra Leone remains weak. A 2018 UNFPA assessment found that only one-third of the facilities had adequate space to provide youth-friendly services. These limitations restrict adolescents' ability to translate knowledge gained from CSE into safer behaviors or timely care-seeking. There is an urgent need for evidence that assesses the impact of linking school-based CSE with accessible, youth-friendly SRH services on SRHR outcomes for adolescents. Despite recent policy commitments and the ongoing rollout of the CAHLS curriculum, no robust studies have examined the impact of such integrated approaches in Sierra Leone. This study aims to fill that gap by generating evidence on the effectiveness of CSE programs that connect learning with health service access, to inform the ongoing national efforts to strengthen adolescent SRHR.\n\nResearchers will use a randomized controlled trial (RCT) design with four arms to evaluate the effectiveness of the two study interventions (CSE and mobile SRHR services) to impact a specific set of reproductive and sexual health, empowerment and well-being outcomes among adolescents in two provinces in Sierra Leone. The four arms, each with 60 schools, will consist of: 1) no intervention (control schools), 2) CSE only, 3) mobile SRHR services only, and 4) CSE and mobile SRHR services. Additionally, researchers will assess the cost-effectiveness of the two primary interventions and the extent to which the interventions are delivered with planned fidelity.\n\nThe two study interventions can be envisioned within the context of programs to address both supply and demand within a rights-based framework. As part of the demand-side intervention, the implementing partner Marie Stopes Sierra Leone (MSSL) will train teachers in intervention schools to teach CSE, and will organize necessary equipment, materials and oversight of the CSE program in each school. To address the key supply-side gaps that most affect youth, mobile SRH services will be provided directly on school premises by trained MSSL providers. MSSL has been providing high-quality and affordable SRH services to the most vulnerable and difficult-to-reach populations across all districts of Sierra Leone since 1986, and has also played an integral role in developing the overall CSE strategy and piloting initial CAHLS rollout in schools in collaboration with the Ministry of Basic and Senior Secondary Education.",[107,111,117,122],{"label":108,"type":109,"description":110,"interventionNames":102},"Control schools","NO_INTERVENTION","The 60 schools in this arm are the control group. They will continue providing their standard services and functions. They will not implement the Comprehensive Sexuality Education curriculum nor will they receive mobile SRH services.",{"label":112,"type":113,"description":114,"interventionNames":115},"CSE only","EXPERIMENTAL","The 60 schools in this arm will implement the Comprehensive Sexuality Education (CSE) curriculum and offer a safe space for menstrual hygiene and care.",[116],"Behavioral: Comprehensive Sexuality Education",{"label":118,"type":113,"description":119,"interventionNames":120},"Mobile SRH services only","The 60 schools in this arm will receive MSSL-provided mobile sexual and reproductive health (SRH) outreach services on the school premises 3 times per school year.",[121],"Behavioral: Mobile SRH services",{"label":123,"type":113,"description":124,"interventionNames":125},"CSE + mobile SRH services","The 60 schools in this arm will receive both interventions: they will implement the CSE curriculum (and space spaces) and will also receive MSSL-provided mobile SRH outreach services on the school premises 3 times per school year.",[116,121],[127,135],{"type":128,"name":129,"description":130,"armGroupLabels":131,"otherNames":132},"BEHAVIORAL","Comprehensive Sexuality Education","For junior secondary schools in the \"CSE only\" and \"CSE+mobile SRH services\" intervention arms, at baseline at the start of the school year, MSSL will train teachers who teach subjects in which CSE topics are included, using a standard teaching training curriculum to help mitigate the risk of variability in the quality of CSE implementation across schools. Teachers will then implement the CSE curriculum in their classes throughout the duration of the study. MSSL will provide yearly refresher teacher training throughout the study. In each school, guidance counselors will be tasked with monitoring implementation of the intervention. MSSL will provide all materials and equipment needed to teach CSE. Each school will create a \"safe space\" where students can go for menstrual hygiene and care.",[123,112],[133,134],"CSE","Child and Adolescent Health and Life Skills (CAHLS) - name used by the Ministry of Education to refer to the CSE curriculum",{"type":128,"name":136,"description":137,"armGroupLabels":138,"otherNames":139},"Mobile SRH services","For junior secondary schools in the \"Mobile SRH services only\" and \"CSE+mobile SRH services\" intervention arms, MSSL will utilize three mobile clinical teams to provide direct, comprehensive SRHR services on-site at schools. Each team will be composed of two service providers trained to provide youth-friendly services, one data imputer, and a transport assistant. The team will visit each school once per quarter (3 times during the school year). A comprehensive range of youth-friendly SRH services, including contraceptive counseling, provision of LARC (implants and IUDs), short-term methods (pills, injectables and emergency contraception), condom promotion, STI services, and referrals to health facilities if needed, will be available to all students through the mobile visits.",[123,118],[140],"Mobile outreach clinics",[142,145,147],{"name":143,"affiliation":5,"role":144},"Hannah Olson, PhD","PRINCIPAL_INVESTIGATOR",{"name":146,"affiliation":5,"role":144},"Margaret Giorgio, PhD",{"name":148,"affiliation":5,"role":149},"Onikepe Owolabi, PhD","STUDY_DIRECTOR",[151,155],{"name":143,"role":152,"phone":153,"phoneExt":102,"email":154},"CONTACT","800-355-0244","holson@guttmacher.org",{"name":146,"role":152,"phone":153,"phoneExt":102,"email":156},"mgiorgio@guttmacher.org",[158],{"facility":159,"status":102,"city":160,"state":102,"zip":102,"country":161,"countryCode":162,"cosmosGeoPoint":163,"geoPoint":168,"contacts":169},"240 schools in Kambia and Kenema districts (confidential, cannot be disclosed)","Freetown","Sierra Leone","SL",{"type":164,"coordinates":165},"Point",[166,167],-13.2356,8.48714,{"lat":167,"lon":166},[170,174],{"name":171,"role":152,"phone":172,"phoneExt":102,"email":173},"Francis Moses","+232 76 460 440","fmoses@mohs.gov.sl",{"name":171,"role":144,"phone":102,"phoneExt":102,"email":102},{"type":176,"investigatorFullName":102,"investigatorTitle":102,"investigatorAffiliation":102,"oldNameTitle":102,"oldOrganization":102},"SPONSOR",[178,180,183],{"name":179,"class":6},"Innovations for Poverty Action",{"name":181,"class":182},"Marie Stopes Sierra Leone","UNKNOWN",{"name":184,"class":182},"MSI Reproductive Choices","100659080","estimating-the-impact-of-sexuality-education-and-mobile-health-services-on-reproductive-health-and-empowerment-among-adolescents-in-sierra-leone-for-the-family-planning-impact-lab-100659080",false,"NCT07860723","Estimating the Impact of Sexuality Education and Mobile Health Services on Reproductive Health and Empowerment Among Adolescents in Sierra Leone for the Family Planning Impact Lab","REACH Study: Reproductive Empowerment for Adolescents Through CAHLS and Health Services (FPIL Sierra Leone Component)","REACH","Inclusion Criteria:\n\n* Aged 12 to 17 at baseline\n* Enrolled in the lowest grade (JSS1) of one of the junior secondary schools selected for the study in September 2026\n* Provided assent to participate in the research\n\nExclusion Criteria:\n\n* Individuals unable to provide assent due to cognitive impairment or severe mental illness\n* Individuals whose guardians opted them out",true,"ALL","12 Years","17 Years",{"count":198,"type":199},5300,"ESTIMATED","INTERVENTIONAL",[202],"NA","The goal of this randomized controlled trial is to learn if comprehensive sexuality education (CSE) and access to mobile sexual and reproductive health (SRH) services in secondary schools can improve short- and long-term health, well-being, social and economic outcomes among adolescents and young people in two districts of Sierra Leone. The main questions it aims to answer are:\n\n1. How do CSE and mobile SRH services (individually and combined) change adolescent SRHR, well-being and socioeconomic outcomes in the short term and in the longer term (over 3 years)?\n2. What are the economic costs of providing CSE and mobile SRH services?\n3. How cost-effective is the provision of CSE and mobile SRH services, given its potential impact on health, socioeconomic, and well-being outcomes?\n4. To what extent are CSE and mobile SRH services being implemented according to the original plan and timeline?\n\nResearchers will compare schools receiving CSE and mobile SRH services to schools not receiving these services, to see if adolescent SRHR, well-being and socioeconomic outcomes are better in those schools that received the services. The trial will compare four groups of schools, each with 60 participating schools:\n\n1. No additional services (control schools)\n2. Only CSE\n3. Only mobile SRH services\n4. CSE and mobile SRH services\n\nThe implementation of these services will be led by Marie Stopes Sierra Leone (MSSL) in collaboration with the Ministry of Education. MSSL will ensure that participating schools:\n\n* Attend teacher training on the CSE curriculum before the study starts, followed by yearly refresher training during the study\n* Have sufficient time allocated to CSE in the weekly school schedule\n* Have adequate teaching materials \\& equipment to teach CSE\n* Have guidance counsellors in each school who will monitor the implementation of CSE\n* Have a designated \"safe space\" which adolescents can access for menstrual products and care.\n* Have access to mobile SRH services (provided by MSSL staff) on the school premises 3 times per school year",[205,206,207,208,209,210,211,212],"Reproductive Health","Sexual Health","Contraception Behavior","Pregnancy (Unwanted)","Empowerment","Agency","School Dropouts","Marriage",[214,215,216,129,217,218,219,161,220,205,206,207,209,210,221],"Family Planning Impact Lab","Randomized Controlled Trial","Sex Education","Mobile Health Units","Schools, secondary","Adolescent","Family Planning","School Dropout","NOT_YET_RECRUITING","2026-09-30",{"date":225,"type":226},"2026-10-06","ACTUAL",{"date":228,"type":199},"2026-10-05",{"date":230,"type":199},"2029-10",{"name":5,"class":6},1]