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

W

World Health Organization (WHO)

Status

Enrolling

Conditions

Adolescent Development
Health Care Seeking Behavior
Adolescent Behavior
Health-Related Behavior

Treatments

Behavioral: Oral health screening
Diagnostic Test: Psychosocial and mental health disorder screening
Diagnostic Test: STI (CT, NG, TV) testing
Diagnostic Test: Alcohol, tobacco and substance use screening
Diagnostic Test: Underweight and overweight screening
Behavioral: Immunization screening
Diagnostic Test: Physical impairment screening
Behavioral: Circumcision screening
Behavioral: Diet and physical activity screening
Diagnostic Test: Anemia
Other: Screening package
Behavioral: Risky behaviours
Diagnostic Test: HIV testing
Diagnostic Test: Uncontrolled epilepsy screening
Diagnostic Test: Pre-hypertension screening
Diagnostic Test: Hearing screening
Diagnostic Test: Visual impairment screening

Study type

Interventional

Funder types

Other

Identifiers

NCT06090006
WHO ERC.0003778

Details and patient eligibility

About

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).

Full 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.

Enrollment

6,000 estimated patients

Sex

All

Ages

10 to 19 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Screening

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

6,000 participants in 1 patient group

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

Trial contacts and locations

3

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Central trial contact

Baltag Valentina, MD; Prerna Banati, PhD

Data sourced from clinicaltrials.gov

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