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

NCT06090006 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 6000

Last updated 2023-10-19

No results posted yet for this study

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).

Conditions

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

Interventions

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

Sponsors & Collaborators

  • London School of Hygiene and Tropical Medicine

    collaborator OTHER
  • University of Ghana

    collaborator OTHER
  • Mwanza Intervention Trials Unit

    collaborator OTHER
  • Biomedical Research and Training Institute

    collaborator OTHER
  • World Health Organization

    lead OTHER

Principal Investigators

  • Prerna Banati, PhD · World Health Organization

  • Baltag Valentina, MD · World Health Organization

  • Aoife Doyl, PhD · Biomedical Training and Research Institute

  • Saidi Kapiga, MD · Mwanza Intervention Trials Unit

  • Benedict Weobong, PhD · University of Ghana

Study Design

Allocation
NA
Purpose
SCREENING
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
10 Years
Max Age
19 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-03-01
Primary Completion
2024-06-30
Completion
2024-06-30

Countries

  • Ghana
  • Tanzania
  • Zimbabwe

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06090006 on ClinicalTrials.gov