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

Adolescent Behavior Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06090006
• Other study ID #: WHO ERC.0003778
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2023
• Est. completion date: June 30, 2024

Study information

• Verified date: October 2023
• Source: World Health Organization
• Contact: Prerna Banati, PhD
• Phone: +41793003948
• Email: banatip[@]who.int
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 6000
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 10 Years to 19 Years

Eligibility

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

Related Conditions & MeSH terms

• Adolescent Behavior
• Adolescent Development
• Health Care Seeking Behavior

Intervention

Other:
• Screening package
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).

Diagnostic Test:
• Psychosocial and mental health disorder screening
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 screening
World Health Organization (WHO) ASSIST-Y tool (Humeniuk, 2016) and referral where indicated

Behavioral:
• Diet and physical activity screening
HEEADSSS (Klein et al., 2014) and counselling and advice

Diagnostic Test:
• Underweight and overweight screening
MUAC (Middle Upper Arm Circumference), BMI (Body Mass Index) followed by Counselling and advice +/- referral where indicated
• Anemia
Hemocue. Iron and folic-acid supplementation (3 months supply) if anaemic. If severely anaemic (<8g/dl) refer to health facility.

Behavioral:
• Oral health screening
Questions on oral health and visual inspection followed by advice, gift of toothpaste and toothbrush, fluoride varnish application +/- Silver Diamine Fluoride application +/- referral
• Circumcision screening
Question on circumcision status. Visual inspection. Referral for Voluntary Medical Male Circumcision) where uncircumcised (males only)
• Risky behaviours
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)

Diagnostic Test:
• HIV testing
HIV oral mucosal self-test +/- confirmatory blood-based rapid diagnostic test followed by Counselling + referral to treatment where indicated
• STI (CT, NG, TV) testing
Chlamydia Trachomatic (CT) /Neisseria Gonorrhea (NG) test on urine sample, Trichomoniasis Vaginalis (TV) test and treatment where indicated

Behavioral:
• Immunization screening
Question on Human Papilloma Virus (HPV) immunisation history. Review of vaccination card. Followed by referral to immunization

Diagnostic Test:
• Visual impairment screening
Peek Acuity or Snellen Tumbling-E and Refer to specialist if indicated
• Hearing screening
HearScreen smartphone app +/- HearTest plus Inspection for presence of wax and wax removal. Refer to specialist if indicated
• Physical impairment screening
Questions on physical impairment. Jump or squat test Functional reach test Referral to specialist if indicated
• Uncontrolled epilepsy screening
Questions on experience of convulsions followed by referral to specialist if indicated
• Pre-hypertension screening
Blood pressure measured using digital sphygmomanometer followed by counselling and advice if indicated

Locations

Country	Name	City	State
Ghana	Schools and Community Centers	Cape Coast
Tanzania	Schools and community centers	Mwanza
Zimbabwe	Schools and community centers	Chitungwiza

Sponsors (5)

Lead Sponsor	Collaborator
World Health Organization	Biomedical Research and Training Institute, London School of Hygiene and Tropical Medicine, Mwanza Intervention Trials Unit, University of Ghana

Countries where clinical trial is conducted

Ghana,  Tanzania,  Zimbabwe, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	16 weeks (4 months)
Secondary	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.	16 weeks (4 months)
Secondary	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.	16 weeks (4 months)
Secondary	Qualitative assessment of adolescents who find the intervention acceptable	Qualitative assessment tool for acceptability of adolescent wellbeing interventions	16 weeks (4 months)
Secondary	Qualitative assessment of teachers, parents and health workers who find the intervention acceptable	Qualitative assessment tool for acceptability of adolescent wellbeing interventions	16 weeks (4 months)
Secondary	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	16 weeks (4 months)
Secondary	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.	16 weeks (4 months)
Secondary	Proportion of Y-Check visits completed	Intervention feasibility (actual fit, practicability): Y-Check visits completed	16 weeks (4 months)
Secondary	Proportion of referrals completed	Intervention feasibility (actual fit, practicability): Referrals completed	16 weeks (4 months)
Secondary	Proportion of youth reporting youth friendly health services received with quality	youth-friendly health services quality assessment.	16 weeks (4 months)

External Links

•   Summary of Y-Check Phase 2