Adolescent DevelopmentY-CheckNCT06090006
An Adolescent Health and Wellbeing Check-up Programme in Three African Cities (Y-Check)
A study testing Screening package, Psychosocial and mental health disorder screening and Alcohol, tobacco and substance use screening in people with Adolescent Development and Adolescent Behavior, run by World Health Organization at 3 sites in 3 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 10 to 19 yearsHealthy volunteers can take part
- Conditions the study is for
- Adolescent Development, Adolescent Behavior, Health-Related Behavior
- What is being tested?
- Screening package, Psychosocial and mental health disorder screening and Alcohol, tobacco and substance use screening
- Type of treatment
- Vaccines, Pill or oral medicine, Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6,000 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 1 Mar 2023to 30 Jun 2024
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 19 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- To be included in the study, adolescents aged 10-19 must fall into one of the first three categories below and fulfil category 4.
- Be attending selected classes of Year 5 of primary school in Mwanza (median age 11 years); Grade 5/6 of primary school in Chitungwiza (median age 11 years); or Year 1 of Junior Secondary School in Cape Coast (median age 12 years) OR
- Be attending selected classes in Year 3 of Secondary School in Mwanza (median age 17 years), Form 3/4 in Chitungwiza (median age 17 years), or Year 2 of Senior Secondary School in Cape Coast (median age 16 years) OR
- Be resident in a selected community during the time of the Y-Check intervention, and be aged 16-19 years AND
- Have a completed and signed Informed Consent and have a signed Informed Assent Form if the adolescent is below the national age of consent or is seen in a school, irrespective of their age.
Who cannot join
- Not meeting above inclusion criteria
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
Ghana1 site, 1 recruiting
- Not yet recruiting
Schools and Community Centers
Cape Coast
Benedict Weobong
Tanzania1 site, 1 recruiting
- Not yet recruiting
Schools and community centers
Mwanza
Saidi Kapiga, MD
Zimbabwe1 site, 1 recruiting
- Recruiting
Schools and community centers
Chitungwiza
Aoife Doyle, PhD
About this study
Official title: An Adolescent Health and Wellbeing Check-up Programme in Three African Cities (Y-Check): Protocol for a Multimethod, Prospective, Hybrid Implementation-effectiveness Study
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).
Read the detailed description
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.
- Conditions
- Adolescent Development, Adolescent Behavior, Health-Related Behavior, Health Care Seeking Behavior
- Being tested
- Screening package, Psychosocial and mental health disorder screening, Alcohol, tobacco and substance use screening, Diet and physical activity screening, Underweight and overweight screening
- Medical subject headings
- Adolescent Behavior, Health Behavior, Patient Acceptance of Health Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Screening packageOther
Also called Check ups
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).
Psychosocial and mental health disorder screeningDiagnostic test
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
Alcohol, tobacco and substance use screeningDiagnostic test
World Health Organization (WHO) ASSIST-Y tool (Humeniuk, 2016) and referral where indicated
Diet and physical activity screeningBehavioural
HEEADSSS (Klein et al., 2014) and counselling and advice
Underweight and overweight screeningDiagnostic test
MUAC (Middle Upper Arm Circumference), BMI (Body Mass Index) followed by Counselling and advice +/- referral where indicated
AnemiaDiagnostic test
Hemocue. Iron and folic-acid supplementation (3 months supply) if anaemic. If severely anaemic (<8g/dl) refer to health facility.
Oral health screeningBehavioural
Questions on oral health and visual inspection followed by advice, gift of toothpaste and toothbrush, fluoride varnish application +/- Silver Diamine Fluoride application +/- referral
Circumcision screeningBehavioural
Question on circumcision status. Visual inspection. Referral for Voluntary Medical Male Circumcision) where uncircumcised (males only)
Risky behavioursBehavioural
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 testingDiagnostic test
HIV oral mucosal self-test +/- confirmatory blood-based rapid diagnostic test followed by Counselling + referral to treatment where indicated
STI (CT, NG, TV) testingDiagnostic test
Chlamydia Trachomatic (CT) /Neisseria Gonorrhea (NG) test on urine sample, Trichomoniasis Vaginalis (TV) test and treatment where indicated
Immunization screeningBehavioural
Question on Human Papilloma Virus (HPV) immunisation history. Review of vaccination card. Followed by referral to immunization
Visual impairment screeningDiagnostic test
Peek Acuity or Snellen Tumbling-E and Refer to specialist if indicated
Hearing screeningDiagnostic test
HearScreen smartphone app +/- HearTest plus Inspection for presence of wax and wax removal.
Refer to specialist if indicated
Physical impairment screeningDiagnostic test
Questions on physical impairment. Jump or squat test Functional reach test Referral to specialist if indicated
Uncontrolled epilepsy screeningDiagnostic test
Questions on experience of convulsions followed by referral to specialist if indicated
Pre-hypertension screeningDiagnostic test
Blood pressure measured using digital sphygmomanometer followed by counselling and advice if indicated
| Study group | Role | What they receive |
|---|---|---|
| No comparison group | Other | 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 Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 16 weeks (4 months)
Secondary outcomes (9)
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.
Measured: 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.
Measured: 16 weeks (4 months)
Qualitative assessment of adolescents who find the intervention acceptable
Qualitative assessment tool for acceptability of adolescent wellbeing interventions
Measured: 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
Measured: 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
Measured: 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.
Measured: 16 weeks (4 months)
Proportion of Y-Check visits completed
Intervention feasibility (actual fit, practicability): Y-Check visits completed
Measured: 16 weeks (4 months)
Proportion of referrals completed
Intervention feasibility (actual fit, practicability): Referrals completed
Measured: 16 weeks (4 months)
Proportion of youth reporting youth friendly health services received with quality
youth-friendly health services quality assessment.
Measured: 16 weeks (4 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2023
- Study start1 Mar 2023
- Primary completion30 Jun 2024 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Adolescent DevelopmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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
- Masking
- None (open label)
- Enrolment
- 6,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- World Health Organization
- Sponsor type
- University, hospital or other
- Collaborators
- London School of Hygiene and Tropical Medicine, University of Ghana, Mwanza Intervention Trials Unit, Biomedical Research and Training Institute
- Responsible party
- Principal investigator, Prerna Banati, World Health Organization
- Investigators
- Prerna Banati, PhD, Principal investigator, World Health OrganizationBaltag Valentina, MD, Principal investigator, World Health OrganizationAoife Doyl, PhD, Principal investigator, Biomedical Training and Research InstituteSaidi Kapiga, MD, Principal investigator, Mwanza Intervention Trials UnitBenedict Weobong, PhD, Principal investigator, University of Ghana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06090006
- Sponsor's protocol ID
- WHO ERC.0003778
- Acronym
- Y-Check
- Status last verified
- Oct 2023
- First submitted
- 16 May 2023
- Last updated
- 19 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Banati P, Ross DA, Weobong B, Kapiga S, Weiss HA, Baltag V, Nzvere F, Glozah F, Nsanya MK, Greco G, Ferrand R, Doyle AM; Y-Check Research Programme Team. Adolescent health and well-being check-up programme in three African cities (Y-Check): protocol for a multimethod, prospective, hybrid implementation-effectiveness study. BMJ Open. 2024 Jun 21;14(6):e077533. doi: 10.1136/bmjopen-2023-077533.
PubMed 38908843