Trials / Unknown
UnknownNCT06090006
An Adolescent Health and Wellbeing Check-up Programme in Three African Cities (Y-Check)
An Adolescent Health and Wellbeing Check-up Programme in Three African Cities (Y-Check): Protocol for a Multimethod, Prospective, Hybrid Implementation-effectiveness Study
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 6,000 (estimated)
- Sponsor
- World Health Organization · Academic / Other
- Sex
- All
- Age
- 10 Years – 19 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
| DIAGNOSTIC_TEST | 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 |
| DIAGNOSTIC_TEST | 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 |
| BEHAVIORAL | Circumcision screening | Question on circumcision status. Visual inspection. Referral for Voluntary Medical Male Circumcision) where uncircumcised (males only) |
| BEHAVIORAL | 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 |
| DIAGNOSTIC_TEST | 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 |
| DIAGNOSTIC_TEST | Hearing screening | HearScreen smartphone app +/- HearTest plus Inspection for presence of wax and wax removal. Refer to specialist if indicated |
| DIAGNOSTIC_TEST | Physical impairment screening | Questions on physical impairment. Jump or squat test Functional reach test Referral to specialist if indicated |
| DIAGNOSTIC_TEST | Uncontrolled epilepsy screening | Questions on experience of convulsions followed by referral to specialist if indicated |
| DIAGNOSTIC_TEST | Pre-hypertension screening | Blood pressure measured using digital sphygmomanometer followed by counselling and advice if indicated |
Timeline
- Start date
- 2023-03-01
- Primary completion
- 2024-06-30
- Completion
- 2024-06-30
- First posted
- 2023-10-19
- Last updated
- 2023-10-19
Locations
3 sites across 3 countries: Ghana, Tanzania, Zimbabwe
Source: ClinicalTrials.gov record NCT06090006. Inclusion in this directory is not an endorsement.