NCT06090006

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).

Trial Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
6,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2023

Geographic Reach
3 countries

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 16, 2023

Completed
5 months until next milestone

First Posted

Study publicly available on registry

October 19, 2023

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2024

Completed
Last Updated

October 19, 2023

Status Verified

October 1, 2023

Enrollment Period

1.3 years

First QC Date

May 16, 2023

Last Update Submit

October 12, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (9)

  • Condition Screening outcome

    16 weeks (4 months)

  • Previously untreated conditions identified (yield)

    16 weeks (4 months)

  • Qualitative assessment of adolescents who find the intervention acceptable

    16 weeks (4 months)

  • Qualitative assessment of teachers, parents and health workers who find the intervention acceptable

    16 weeks (4 months)

  • Proportion of adolescents who take up and use Y-Check services and referrals

    16 weeks (4 months)

  • +4 more secondary outcomes

Study Arms (1)

No comparison group

OTHER

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

Other: Screening packageDiagnostic Test: Psychosocial and mental health disorder screeningDiagnostic Test: Alcohol, tobacco and substance use screeningBehavioral: Diet and physical activity screeningDiagnostic Test: Underweight and overweight screeningDiagnostic Test: AnemiaBehavioral: Oral health screeningBehavioral: Circumcision screeningBehavioral: Risky behavioursDiagnostic Test: HIV testingDiagnostic Test: STI (CT, NG, TV) testingBehavioral: Immunization screeningDiagnostic Test: Visual impairment screeningDiagnostic Test: Hearing screeningDiagnostic Test: Physical impairment screeningDiagnostic Test: Uncontrolled epilepsy screeningDiagnostic Test: Pre-hypertension screening

Interventions

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).

Also known as: Check ups
No comparison group

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

No comparison group

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

No comparison group

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

No comparison group

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

No comparison group
AnemiaDIAGNOSTIC_TEST

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

No comparison group

Questions on oral health and visual inspection followed by advice, gift of toothpaste and toothbrush, fluoride varnish application +/- Silver Diamine Fluoride application +/- referral

No comparison group

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

No comparison group

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)

No comparison group
HIV testingDIAGNOSTIC_TEST

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

No comparison group

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

No comparison group

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

No comparison group

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

No comparison group
Hearing screeningDIAGNOSTIC_TEST

HearScreen smartphone app +/- HearTest plus Inspection for presence of wax and wax removal. Refer to specialist if indicated

No comparison group

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

No comparison group

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

No comparison group

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

No comparison group

Eligibility Criteria

Age10 Years - 19 Years
Sexall(Gender-based eligibility)
Gender Eligibility Details50% males and 50% females
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • To be included in the study, adolescents aged 10-19 must fall into one of the first three categories below and fulfil category 4.
  • 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
  • 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
  • Be resident in a selected community during the time of the Y-Check intervention, and be aged 16-19 years AND
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Schools and Community Centers

Cape Coast, Ghana

NOT YET RECRUITING

Schools and community centers

Mwanza, Tanzania

NOT YET RECRUITING

Schools and community centers

Chitungwiza, Zimbabwe

RECRUITING

Related Publications (1)

  • 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.

Related Links

MeSH Terms

Conditions

Adolescent BehaviorHealth BehaviorPatient Acceptance of Health Care

Interventions

DietMass ScreeningHIV Testing

Condition Hierarchy (Ancestors)

BehaviorTreatment Adherence and Compliance

Intervention Hierarchy (Ancestors)

Nutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological PhenomenaDiagnostic Techniques and ProceduresDiagnosisHealth SurveysSurveys and QuestionnairesData CollectionEpidemiologic MethodsInvestigative TechniquesDiagnostic ServicesPreventive Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public HealthPublic Health PracticeMicrobiological TechniquesClinical Laboratory Techniques

Study Officials

  • Prerna Banati, PhD

    World Health Organization

    PRINCIPAL INVESTIGATOR
  • Baltag Valentina, MD

    World Health Organization

    PRINCIPAL INVESTIGATOR
  • Aoife Doyl, PhD

    Biomedical Training and Research Institute

    PRINCIPAL INVESTIGATOR
  • Saidi Kapiga, MD

    Mwanza Intervention Trials Unit

    PRINCIPAL INVESTIGATOR
  • Benedict Weobong, PhD

    University of Ghana

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Prerna Banati, PhD

CONTACT

Baltag Valentina, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Model Details: 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
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Scientist, Principal Investigator

Study Record Dates

First Submitted

May 16, 2023

First Posted

October 19, 2023

Study Start

March 1, 2023

Primary Completion

June 30, 2024

Study Completion

June 30, 2024

Last Updated

October 19, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations