An interventional study of Screening package and Psychosocial and mental health disorder screening in Adolescent Development, Adolescent Behavior and Health-Related Behavior, sponsored by World Health Organization. Recruiting at 3 sites in 3 countries. Open to participants aged 10 Years to 19 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-10-19.
Sponsored by World Health Organization · Not applicable, Interventional, and Screening
This is a multi-country prospective intervention study, with a mixed-method process evaluation to assess the implementation, effects and short-term cost-effectiveness of Y-Check. The intervention involves screening, on-the-spot care and, if needed, referral of adolescents through health and wellbeing check-up visits in early adolescence (10-14 years) and older adolescence (15-19 years old). In each city, the intervention will be delivered to 2000 adolescents recruited in schools (both age groups) or community venues (older adolescents only).
Background: During adolescence, behaviours are initiated that will have substantial positive or negative impacts on the individual's short- and long-term health and wellbeing, educational attainment and employment prospects. However, adolescents rarely have regular contact with health services, especially for health promotion and disease prevention, and services are not always appropriate for their needs. The investigators co-developed with adolescents a health and wellbeing check-up programme, to improve adolescent health and wellbeing (Y-Check). This paper describes the methods to evaluate the feasibility, acceptability, short-term effects, and cost-effectiveness of Y-Check in three African cities: Cape Coast in Ghana, Mwanza in Tanzania and Chitungwiza in Zimbabwe.
Method: This is a multi-country prospective intervention study, with a mixed-method process evaluation to assess the implementation, effects and short-term cost-effectiveness of Y-Check. The intervention involves screening, on-the-spot care and, if needed, referral of adolescents through health and wellbeing check-up visits in early adolescence (10-14 years) and older adolescence (15-19 years old). In each city, the intervention will be delivered to 2000 adolescents recruited in schools (both age groups) or community venues (older adolescents only). The adolescents will be followed-up at 4 months (all sites) and 12 months (Zimbabwe only). The study will assess the effects of Y-Check on knowledge and behaviours, as well as clinical outcomes and costs. The primary outcome will be the proportion of those screening positive for at least one condition who receive appropriate on-the-spot care or complete appropriate referral for all identified conditions within four months. Secondary outcomes include yield of untreated conditions, reported health-related risk and protective behaviours, engagement with health services, wellbeing, clinical and educational outcomes. A process evaluation will understand acceptability, feasibility, uptake, and fidelity, and an economic evaluation will explore cost effectiveness.
Discussion: This study is innovative in evaluating a comprehensive adolescent health and wellbeing check-up intervention which addresses both health conditions that impact on wellbeing during adolescence, and risk factors for non-communicable diseases in three African cities. Evidence of the intervention´s feasibility, acceptability, and short-term positive effects and costs will support larger scale intervention implementation and rigorous evaluation.
305 studies on the registry are indexed under Adolescent Behavior; 47 are open to participants now.
This study's planned enrollment of 6,000 is above the median of 172 across 256 interventional studies indexed under Adolescent Behavior.
Browse Adolescent Behavior studies →World Health Organization is the lead sponsor of 10 studies on the registry; 3 are open to participants now.
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To be included in the study, adolescents aged 10-19 must fall into one of the first three categories below and fulfil category 4.
Exclusion Criteria:
Not meeting above inclusion criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
In our study sites, a contemporaneous comparison group is not required since no routine screening is currently taking place, and as a result, assessments at baseline will serve as the counterfactual for internal comparisons
Other: Screening package · Diagnostic Test: Psychosocial and mental health disorder screening · Diagnostic Test: Alcohol, tobacco and substance use screening · Behavioral: Diet and physical activity screening · Diagnostic Test: Underweight and overweight screening · Diagnostic Test: Anemia · Behavioral: Oral health screening · Behavioral: Circumcision screening · Behavioral: Risky behaviours · Diagnostic Test: HIV testing · Diagnostic Test: STI (CT, NG, TV) testing · Behavioral: Immunization screening · Diagnostic Test: Visual impairment screening · Diagnostic Test: Hearing screening · Diagnostic Test: Physical impairment screening · Diagnostic Test: Uncontrolled epilepsy screening · Diagnostic Test: Pre-hypertension screening
Y-Check is a novel intervention delivering a health check-up and where indicated will provide on-the-spot care and referral for common conditions on two occasions in adolescence (in young adolescents (10-14 year-olds) - soon after the onset of puberty - and again in older adolescents (15-19 year-olds) - when many adolescents become, or are soon to become, sexually active). It will also provide health promotion information and materials to support positive behaviours and healthy lifestyles during adolescence and beyond. Adolescents will only be screened for conditions that have an accurate, low-cost, acceptable screening test and a locally accessible, effective intervention. The conditions selected for screening will be chosen to reflect the local epidemiological contexts (e.g. screening for malaria will only take place in high malaria endemic areas).
Also known as: Check ups
HEEADSSS stands for Home, Education/Employment, Eating, Activities, Drugs, Sexuality, Suicide/Depression, and Safety (Klein et al., 2014) and Patients´ Health Questionnaire - Adolescent (PHQ-A), Generalised Anxiety Disorder (GAD-9) and counselling and referral where indicated
World Health Organization (WHO) ASSIST-Y tool (Humeniuk, 2016) and referral where indicated
HEEADSSS (Klein et al., 2014) and counselling and advice
MUAC (Middle Upper Arm Circumference), BMI (Body Mass Index) followed by Counselling and advice +/- referral where indicated
Hemocue. Iron and folic-acid supplementation (3 months supply) if anaemic. If severely anaemic (\<8g/dl) refer to health facility.
Questions on oral health and visual inspection followed by advice, gift of toothpaste and toothbrush, fluoride varnish application +/- Silver Diamine Fluoride application +/- referral
Question on circumcision status. Visual inspection. Referral for Voluntary Medical Male Circumcision) where uncircumcised (males only)
Question (s) on sexual activity and other risky behaviours, followed by Risk reduction counselling, Provision of condoms, Provision of modern contraceptives (emergency contraception, depot injections, oral contraceptive pill) (females only) PreExposure Prophylaxis (PrEP) (females only)
HIV oral mucosal self-test +/- confirmatory blood-based rapid diagnostic test followed by Counselling + referral to treatment where indicated
Chlamydia Trachomatic (CT) /Neisseria Gonorrhea (NG) test on urine sample, Trichomoniasis Vaginalis (TV) test and treatment where indicated
Question on Human Papilloma Virus (HPV) immunisation history. Review of vaccination card. Followed by referral to immunization
Peek Acuity or Snellen Tumbling-E and Refer to specialist if indicated
HearScreen smartphone app +/- HearTest plus Inspection for presence of wax and wax removal. Refer to specialist if indicated
Questions on physical impairment. Jump or squat test Functional reach test Referral to specialist if indicated
Questions on experience of convulsions followed by referral to specialist if indicated
Blood pressure measured using digital sphygmomanometer followed by counselling and advice if indicated
Y-Check Screening outcome
Proportion of those screening positive for at least one condition who receive appropriate on-the-spot care or complete appropriate referral for all identified conditions within 4 months (i.e. they attend a provider for referral care who has been accredited by the study team and has been shown to be capable of providing appropriate referral care).
Time frame: 16 weeks (4 months)
Condition Screening outcome
Proportion of those screening positive for each condition who receive appropriate on-the-spot care or complete appropriate referral for that condition within 4 months.
Time frame: 16 weeks (4 months)
Previously untreated conditions identified (yield)
This will be measured as: Numerator: number of individuals identified with a condition that is not currently being treated and requires counselling and/or treatment Denominator: number of individuals who were screened for the condition.
Time frame: 16 weeks (4 months)
Qualitative assessment of adolescents who find the intervention acceptable
Qualitative assessment tool for acceptability of adolescent wellbeing interventions
Time frame: 16 weeks (4 months)
Qualitative assessment of teachers, parents and health workers who find the intervention acceptable
Qualitative assessment tool for acceptability of adolescent wellbeing interventions
Time frame: 16 weeks (4 months)
Proportion of adolescents who take up and use Y-Check services and referrals
Proportion of young people invited who complete the screening program; proportion of young people invited who complete referrals. Qualitative assessment tool will also be used to assess intervention adoption
Time frame: 16 weeks (4 months)
Qualitative assessment of perceived value of the intervention to adolescents and to other stakeholders.
Intervention appropriateness (perceived fit, perceived relevance, perceived usefulness): perceived value of the intervention to adolescents and to other stakeholders.
Time frame: 16 weeks (4 months)
Proportion of Y-Check visits completed
Intervention feasibility (actual fit, practicability): Y-Check visits completed
Time frame: 16 weeks (4 months)
Proportion of referrals completed
Intervention feasibility (actual fit, practicability): Referrals completed
Time frame: 16 weeks (4 months)
Proportion of youth reporting youth friendly health services received with quality
youth-friendly health services quality assessment.
Time frame: 16 weeks (4 months)
Plan to share: No
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