An Adolescent Health and Wellbeing Check-up Programme in Three African Cities (Y-Check)

Not Applicable

Recruiting

• Conditions: Health Care Seeking Behavior; Adolescent Behavior; Health-Related Behavior; Adolescent Development
• Interventions: 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

• Registration Number: NCT06090006
• Lead Sponsor: World Health Organization

Brief 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. 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).

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.

Study Timeline

• Study Start: 2023-03-01
• Study First Submitted: 2023-05-16
• Status Verified: 2023-10
• Study First Submitted QC: 2023-10-12
• Last Update Submitted: 2023-10-12
• Study First Posted: 2023-10-19
• Last Update Posted: 2023-10-19
• Primary Completion: 2024-06-30
• Study Completion: 2024-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 6000

Inclusion Criteria

To be included in the study, adolescents aged 10-19 must fall into one of the first three categories below and fulfil category 4.

1. 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
2. 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
3. Be resident in a selected community during the time of the Y-Check intervention, and be aged 16-19 years AND
4. 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.

Exclusion Criteria

Not meeting above inclusion criteria

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
No comparison group	Alcohol, tobacco and substance use screening	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
No comparison group	Hearing screening	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
No comparison group	Physical impairment screening	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
No comparison group	Oral health screening	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
No comparison group	STI (CT, NG, TV) testing	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
No comparison group	Screening package	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
No comparison group	Diet and physical activity screening	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
No comparison group	Immunization screening	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
No comparison group	Visual impairment screening	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
No comparison group	Psychosocial and mental health disorder screening	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
No comparison group	Underweight and overweight screening	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
No comparison group	Risky behaviours	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
No comparison group	HIV testing	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
No comparison group	Anemia	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
No comparison group	Circumcision screening	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
No comparison group	Uncontrolled epilepsy screening	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
No comparison group	Pre-hypertension screening	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

Primary Outcome Measures

Name	Time	Method
Y-Check Screening outcome	16 weeks (4 months)	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).

Secondary Outcome Measures

Name	Time	Method
Proportion of youth reporting youth friendly health services received with quality	16 weeks (4 months)	youth-friendly health services quality assessment.
Previously untreated conditions identified (yield)	16 weeks (4 months)	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.
Qualitative assessment of adolescents who find the intervention acceptable	16 weeks (4 months)	Qualitative assessment tool for acceptability of adolescent wellbeing interventions
Qualitative assessment of teachers, parents and health workers who find the intervention acceptable	16 weeks (4 months)	Qualitative assessment tool for acceptability of adolescent wellbeing interventions
Condition Screening outcome	16 weeks (4 months)	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.
Proportion of adolescents who take up and use Y-Check services and referrals	16 weeks (4 months)	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
Qualitative assessment of perceived value of the intervention to adolescents and to other stakeholders.	16 weeks (4 months)	Intervention appropriateness (perceived fit, perceived relevance, perceived usefulness): perceived value of the intervention to adolescents and to other stakeholders.
Proportion of Y-Check visits completed	16 weeks (4 months)	Intervention feasibility (actual fit, practicability): Y-Check visits completed
Proportion of referrals completed	16 weeks (4 months)	Intervention feasibility (actual fit, practicability): Referrals completed

Trial Locations

Locations (2)

Schools and Community Centers; 🇬🇭 Cape Coast, Ghana

Schools and community centers; 🇿🇼 Chitungwiza, Zimbabwe