Clinical trial NCT06090006: An Adolescent Health and Wellbeing Check-up Programme in Three African Cities (Y-Check)
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Adolescent Development
Adolescent Behavior
Health-Related Behavior
Health Care Seeking Behavior
Lead sponsor: World Health Organization
Sponsor class: OTHER
Collaborators: name: London School of Hygiene and Tropical Medicine
name: University of Ghana
name: Mwanza Intervention Trials Unit
name: Biomedical Research and Training Institute
First posted: 2023-10-19
Enrollment: 6000
Sex: ALL
Minimum age (years): 10
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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
Primary purpose: SCREENING

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.

Eligibility criteria: 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

Primary outcomes:
measure: Y-Check Screening outcome
timeFrame: 16 weeks (4 months)
Secondary outcomes:
measure: Condition Screening outcome
timeFrame: 16 weeks (4 months)
measure: Previously untreated conditions identified (yield)
timeFrame: 16 weeks (4 months)
measure: Qualitative assessment of adolescents who find the intervention acceptable
timeFrame: 16 weeks (4 months)
measure: Qualitative assessment of teachers, parents and health workers who find the intervention acceptable
timeFrame: 16 weeks (4 months)
measure: Proportion of adolescents who take up and use Y-Check services and referrals
timeFrame: 16 weeks (4 months)
measure: Qualitative assessment of perceived value of the intervention to adolescents and to other stakeholders.
timeFrame: 16 weeks (4 months)
measure: Proportion of Y-Check visits completed
timeFrame: 16 weeks (4 months)
measure: Proportion of referrals completed
timeFrame: 16 weeks (4 months)
measure: Proportion of youth reporting youth friendly health services received with quality
timeFrame: 16 weeks (4 months)
Other outcomes:
Locations:
city: Cape Coast
country: Ghana
facility: Schools and Community Centers
city: Mwanza
country: Tanzania
facility: Schools and community centers
city: Chitungwiza
country: Zimbabwe
facility: Schools and community centers
Study officials:
affiliation: World Health Organization
name: Prerna Banati, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: World Health Organization
name: Baltag Valentina, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Biomedical Training and Research Institute
name: Aoife Doyl, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Mwanza Intervention Trials Unit
name: Saidi Kapiga, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Ghana
name: Benedict Weobong, PhD
role: PRINCIPAL_INVESTIGATOR
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