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

NCT ID: NCT06090006

Last Updated: 2023-10-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 6000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-01
• Study Completion Date: 2024-06-30

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

No comparison group

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

Group Type: OTHER

Screening package

Intervention Type: OTHER

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).

Psychosocial and mental health disorder screening

Intervention Type: DIAGNOSTIC_TEST

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

Intervention Type: DIAGNOSTIC_TEST

World Health Organization (WHO) ASSIST-Y tool (Humeniuk, 2016) and referral where indicated

Diet and physical activity screening

Intervention Type: BEHAVIORAL

HEEADSSS (Klein et al., 2014) and counselling and advice

Underweight and overweight screening

Intervention Type: DIAGNOSTIC_TEST

MUAC (Middle Upper Arm Circumference), BMI (Body Mass Index) followed by Counselling and advice +/- referral where indicated

Anemia

Intervention Type: DIAGNOSTIC_TEST

Hemocue. Iron and folic-acid supplementation (3 months supply) if anaemic. If severely anaemic (\<8g/dl) refer to health facility.

Oral health screening

Intervention Type: BEHAVIORAL

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

Intervention Type: BEHAVIORAL

Question on circumcision status. Visual inspection. Referral for Voluntary Medical Male Circumcision) where uncircumcised (males only)

Risky behaviours

Intervention Type: BEHAVIORAL

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)

HIV testing

Intervention Type: DIAGNOSTIC_TEST

HIV oral mucosal self-test +/- confirmatory blood-based rapid diagnostic test followed by Counselling + referral to treatment where indicated

STI (CT, NG, TV) testing

Intervention Type: DIAGNOSTIC_TEST

Chlamydia Trachomatic (CT) /Neisseria Gonorrhea (NG) test on urine sample, Trichomoniasis Vaginalis (TV) test and treatment where indicated

Immunization screening

Intervention Type: BEHAVIORAL

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

Visual impairment screening

Intervention Type: DIAGNOSTIC_TEST

Peek Acuity or Snellen Tumbling-E and Refer to specialist if indicated

Hearing screening

Intervention Type: DIAGNOSTIC_TEST

HearScreen smartphone app +/- HearTest plus Inspection for presence of wax and wax removal.

Refer to specialist if indicated

Physical impairment screening

Intervention Type: DIAGNOSTIC_TEST

Questions on physical impairment. Jump or squat test Functional reach test Referral to specialist if indicated

Uncontrolled epilepsy screening

Intervention Type: DIAGNOSTIC_TEST

Questions on experience of convulsions followed by referral to specialist if indicated

Pre-hypertension screening

Intervention Type: DIAGNOSTIC_TEST

Blood pressure measured using digital sphygmomanometer followed by counselling and advice if indicated

Interventions

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).

Intervention Type: OTHER

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

Intervention Type: DIAGNOSTIC_TEST

Alcohol, tobacco and substance use screening

World Health Organization (WHO) ASSIST-Y tool (Humeniuk, 2016) and referral where indicated

Intervention Type: DIAGNOSTIC_TEST

Diet and physical activity screening

HEEADSSS (Klein et al., 2014) and counselling and advice

Intervention Type: BEHAVIORAL

Underweight and overweight screening

MUAC (Middle Upper Arm Circumference), BMI (Body Mass Index) followed by Counselling and advice +/- referral where indicated

Intervention Type: DIAGNOSTIC_TEST

Anemia

Hemocue. Iron and folic-acid supplementation (3 months supply) if anaemic. If severely anaemic (\<8g/dl) refer to health facility.

Intervention Type: DIAGNOSTIC_TEST

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

Intervention Type: BEHAVIORAL

Circumcision screening

Question on circumcision status. Visual inspection. Referral for Voluntary Medical Male Circumcision) where uncircumcised (males only)

Intervention Type: 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)

Intervention Type: BEHAVIORAL

HIV testing

HIV oral mucosal self-test +/- confirmatory blood-based rapid diagnostic test followed by Counselling + referral to treatment where indicated

Intervention Type: 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

Intervention Type: DIAGNOSTIC_TEST

Immunization screening

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

Intervention Type: BEHAVIORAL

Visual impairment screening

Peek Acuity or Snellen Tumbling-E and Refer to specialist if indicated

Intervention Type: DIAGNOSTIC_TEST

Hearing screening

HearScreen smartphone app +/- HearTest plus Inspection for presence of wax and wax removal.

Refer to specialist if indicated

Intervention Type: DIAGNOSTIC_TEST

Physical impairment screening

Questions on physical impairment. Jump or squat test Functional reach test Referral to specialist if indicated

Intervention Type: DIAGNOSTIC_TEST

Uncontrolled epilepsy screening

Questions on experience of convulsions followed by referral to specialist if indicated

Intervention Type: DIAGNOSTIC_TEST

Pre-hypertension screening

Blood pressure measured using digital sphygmomanometer followed by counselling and advice if indicated

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

Check ups

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.

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

London School of Hygiene and Tropical Medicine

OTHER

Sponsor Role: collaborator

University of Ghana

OTHER

Sponsor Role: collaborator

Mwanza Intervention Trials Unit

OTHER

Sponsor Role: collaborator

Biomedical Research and Training Institute

OTHER

Sponsor Role: collaborator

World Health Organization

OTHER

Sponsor Role: lead

Responsible Party

Prerna Banati

Scientist, Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Prerna Banati, PhD

Role: PRINCIPAL_INVESTIGATOR

World Health Organization

Baltag Valentina, MD

Role: PRINCIPAL_INVESTIGATOR

World Health Organization

Aoife Doyl, PhD

Role: PRINCIPAL_INVESTIGATOR

Biomedical Training and Research Institute

Saidi Kapiga, MD

Role: PRINCIPAL_INVESTIGATOR

Mwanza Intervention Trials Unit

Benedict Weobong, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Ghana

Locations

Schools and Community Centers

Cape Coast, , Ghana

Site Status: NOT_YET_RECRUITING

Schools and community centers

Mwanza, , Tanzania

Site Status: NOT_YET_RECRUITING

Schools and community centers

Chitungwiza, , Zimbabwe

Site Status: RECRUITING

Countries

Ghana; Tanzania; Zimbabwe

Central Contacts

Prerna Banati, PhD

Role: CONTACT

banatip@who.int

+41793003948

Baltag Valentina, MD

Role: CONTACT

baltagv@who.int

+41799633136

References

Banati P, Ross DA, Weobong B, Kapiga S, Weiss HA, Baltag V, Nzvere F, Glozah F, Nsanya MK, Greco G, Ferrand R, Doyle AM; Y-Check Research Programme Team. Adolescent health and well-being check-up programme in three African cities (Y-Check): protocol for a multimethod, prospective, hybrid implementation-effectiveness study. BMJ Open. 2024 Jun 21;14(6):e077533. doi: 10.1136/bmjopen-2023-077533.

Reference Type: DERIVED

PMID: 38908843 (View on PubMed)

Related Links

https://www.who.int/publications/m/item/ycheck-phase-2-the-effectiveness-and-cost-effectiveness-of-adolescent-health-and-well-being-in-three-african-cities

Summary of Y-Check Phase 2

Other Identifiers

WHO ERC.0003778

Identifier Type: -

Identifier Source: org_study_id