Adolescent health and well-being check-up programme in three African cities (Y-Check): protocol for a multimethod, prospective, hybrid implementation-effectiveness study

The Y-Check intervention

Y-Check is a novel intervention delivering a health and well-being check-up and, where indicated, will provide on-the-spot care and/or referral for common conditions on two occasions in adolescence (in young adolescents (10–14 year olds)—soon after the onset of puberty—and 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. The intention is that in the context of a future routinely delivered programme, every adolescent will have two guaranteed contacts with the healthcare system. 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 (eg, screening for malaria will only take place in malaria endemic areas). Respecting specific requests from the Ministries of Education in all three cities, the study will only include SRH screening and services at the community sites (which only include older adolescents).

Figures 1 and 2 present the Theory of Change and description of the intervention. Table 1 applies the Template for Intervention Description and Replication (TIDieR) checklist18 to describe details of the intervention.

Figure 1

Theory of Change for Y-Check, an adolescent health and well-being check-up.

Figure 2

The Y-Check intervention package. *The intervention package may vary according to setting.

Locally accessible services will be identified and assessed in terms of their ability to provide the services recommended by local and WHO guidelines, willingness to accept referred adolescents, and the fees charged to the project will be negotiated by the research team for services provided to referred adolescents (where adequate services are not covered by national health insurance schemes, free NGO services or free public healthcare).

Aims

The aim of the study is to develop and implement in three African cities a potentially sustainable adolescent health check-up programme, and evaluate the acceptability, feasibility, short-term effects and cost-effectiveness of the programme to improve health and well-being. The study was launched in September 2021 and will run until June 2025.

Objectives

1. To develop and pilot test a check-up programme for adolescents that screens for important preventable and treatable health conditions using accurate and acceptable screening tests and provides locally accessible effective interventions.

2. Through a prospective intervention study in selected schools and communities to:

   • Estimate short-term impacts on adolescent health and well-being outcomes: clinical outcomes, health-related knowledge and behaviours, intentions, agency and perceived social support for behaviour change; engagement with health services.

   • Understand, through process evaluation, the feasibility and fidelity of implementation, the acceptability and uptake and the influence of context.

   • Estimate the cost-effectiveness of the programme in reducing overall disease burden and improving adolescent well-being

3. Obtain information on key parameters needed for the planning of an evaluation study: prevalence of health conditions and behaviours, acceptability of referral, feasibility of following-up programme participants and delivering quality follow-up care, initial estimates of the impact of the programme on longer term health, educational and well-being outcomes based on the short-term implementation and effectiveness outcomes observed in this phase of the research programme, and factors related to the optimal implementation of the Y-Check intervention.

4. To refine the programme and its Theory of Change, and finalise optimal methods for the measurement of the impact of the programme in future studies.

Patient and public involvement

The intervention was designed following formative research conducted in three African countries between 2019 and 2020.19–21 This formative research revealed that the proposed adolescent health and well-being check-ups are likely to be feasible to implement and acceptable to stakeholders in Ghana, Tanzania and Zimbabwe, and are likely to meet the perceived needs of key stakeholders including adolescents, their parents and key policy makers in the health and education sectors.22 Further, we showed that the programme is likely to produce a substantial yield of important, previously untreated, treatable conditions. Human-centred design techniques were used alongside desk review to define elements of objective and subjective importance to the health and well-being of adolescents, identify facilitators and barriers to adolescent health seeking, preferences for delivery of routine health check-ups, and potential effects of interventions to select the content and method of delivery of the Y-Check intervention. Interviews and participatory workshops with adolescents, parents of adolescents and key stakeholders from the ministries of health and education, non-governmental organisations, healthcare workers and teachers found that there was overall support for the introduction of routine health check-ups.19–21 To navigate potential barriers, stakeholders suggested clear messaging, awareness building and sensitisation campaigns to overcome disinterest in preventative healthcare and, in some contexts, mitigate cultural or religious messaging against healthcare engagement.19

Theory of Change

We hypothesise that a routine health and well-being check-up visit for adolescents that screens for multiple conditions and risk behaviours will have an immediate and long-term positive impact on health and well-being outcomes (figure 1).

Health seeking and promotion behaviours among adolescents operate in complex environments and across ecological levels,10 with determinants at individual, interpersonal institutional/organisational, community and public policy levels. Drawing from the health promotion literature,23 24 the Theory of Change for Y-Check (figure 1) draws on thinking that recognises predisposing, enabling and reinforcing factors as capacities to be strengthened in order to achieve adolescent well-being at the individual level; that responsive parenting can support adolescents to meet their own health and well-being goals; that systems-based approaches (including stronger linkages between health and education systems) can improve outcomes for adolescents, especially reaching the most vulnerable and those in need and that an enabling environment (especially in schools and communities) can support adolescents to take action towards improving their health.

Study setting

Our study will be undertaken in three African cities: Cape Coast in Ghana, Mwanza in Tanzania and Chitungwiza in Zimbabwe. These cities are described in table 2.

Study design

In this prospective hybrid implementation-effectiveness study, 2000 adolescents per city who receive the Y-Check intervention will be followed up at 4 months, and at 12 months (Zimbabwe only).

Stakeholder engagement

In each city, the research study is undertaken in partnership with both the national and municipal Ministries of Health and Education. Each country has a policy framework that provides encouragement for the introduction of health and nutrition education and promotion among adolescents, including screening for communicable and non-communicable diseases, immunisation, growth monitoring and assessments and nutritional services.25–27

This study will build on stakeholder engagement, the process for which was established in each research setting during the formative phase. In each city, a Community Advisory Committee (CAC) comprising key community leaders and stakeholders will be reinforced or set up to facilitate input from, and feedback to, participating communities and a Youth Advisory Group (YAG) will provide a forum for adolescents to input into the programme. The YAG will meet with research staff at least four times per year, be active participants in programme design and dissemination workshops and help to ensure that the programme meets the needs of adolescents. Community engagement will be an ongoing process through regular contacts with the CAC, the YAG and other stakeholders, such as teachers, health workers, Community-Based Organisations (CBOs), Non-Governmental Organisations (NGOs) and religious leaders. In addition, a key aspect for building confidence within communities is the knowledge that the study has the support of the government.

Intervention development and pilot testing

Prior to implementation, preparatory activities will include community engagement, participatory co-design, negotiating referral arrangements and pretesting of screening tools, procedures and referral protocols. Pilot studies in each setting will provide initial estimates of the frequency of health and behavioural outcomes, and help to refine the intervention model.

Pilot testing will involve the implementation of the screening tools and procedures with approximately 200 adolescents in each of the three cities with revisions and repeat pilot testing where required. Adolescents who participate in the pilot study will be excluded from the main study if the procedures change following the pilot. There will be an opportunity for young people and stakeholders to suggest additional client-centred outcomes that may reflect some of their priority concerns or intentions that should be captured.

Intervention implementation

The intervention will be delivered over a period of 2–6 months in each of the settings. The follow-up visits will take place at the same school or community setting as the initial check-up. In addition to covering all clinical costs, the equivalent of US$5 will be given to each participant who attends the follow-up to cover any transport costs that they might have incurred. Additionally, health and hygiene related items will also be provided for adolescents to take home, including tooth cleaning kit (toothbrush and toothpaste), fruit, bottle of water, two pairs of underpants and pack of reusable sanitary pads (girls only).

Composition and training of Y-Check team

The Y-Check team will be trained to deliver adolescent-responsive and age-appropriate services according to national and WHO guidelines, recognising also the needs for privacy and confidentiality.28 This includes providing services that are attractive to adolescents, meet their needs comfortably and responsively and that are attentive to their privacy. These principles and approaches will be embedded into each part of the Y-Check intervention. Visual and auditory privacy will be prioritised, through the use of separate tents, rooms or screens. Health workers will employ standard gowning and draping for clinical procedures.

For infection prevention and control, all study procedures including interviews, physical examinations and blood tests will take place in well-aerated tents or outdoors, and will follow relevant nationally approved protocols for all staff and participants.

The Y-Check team will be trained in good clinical practice, data protection and confidentiality and clinical staff will be trained in counselling for participants testing positive for any of the conditions being screened for within Y-Check as well as in general counselling skills.

Inclusion and exclusion criteria

To be included in the study, adolescents aged 10–19 years 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

1. Have a completed and signed Informed Consent form, or a signed Informed Assent Form and signed Parental/Guardian Informed Consent Form if the adolescent is seen in the community and is below the national age of consent or is seen in a school, irrespective of their age.

Consent and assent procedures

Before the visit of the implementation team, information on the Y-Check programme will be distributed to parents/guardians through the schools and to community members through an active communication campaign in collaboration with the CAC and the YAG. School and community meetings will allow parents and community members to ask questions about the programme and give their feedback.

In schools, adolescents will have a short introductory meeting with a member of the Y-Check team typically in a class or group setting. Parent meetings will then be held in each of the schools, to which all the parents and guardians of eligible learners will be invited. During these sessions, information will be provided about the study, its objectives and procedures, possible risks and procedures that will be used to maintain confidentiality. These meetings will provide an opportunity for the adolescents, parents and guardians of eligible adolescents to learn more about the Y-Check intervention and the research linked to it and to have their questions answered.

No participants will be screened, receive care or be counselled or interviewed without their informed consent (community participants who are above the national age of consent), or, for minors, their assent and parental consent, unless they are determined to be emancipated minors.29 Following advice from Ministries of Education in all three countries, all adolescents seen in schools will be considered to be minors and require parental consent, irrespective of their age.

Minor adolescents’ assent will be ascertained and documented in an assent form. Parents or guardians who would like their adolescent to receive the check-up will be asked to provide their written consent. On the day of the check-up visit, a verbal confirmation of their previous written assent will be requested from the adolescent. In Ghana and Tanzania, where the minimum age for providing consent to medical and health-related research is 18 years, clients of all ages under 18 will provide completed parental consent forms and provide written assent before proceeding through the check-up visit regardless of whether the check-up is in schools or communities. In Zimbabwe, a waiver of parental consent has been given by the Medical Research Council of Zimbabwe (MRC-Zimbabwe) so that participants aged 16 and 17 years who attend the check-ups in the community venues will be allowed to provide written consent for themselves.

The intervention will be conducted in private and not in the presence of the parent or guardian. Contact details of the study team will be shared with participants in case they have questions at a later stage. All participants will be reminded that participation is entirely voluntary and will be told that they can opt out of the research or services at any time.

Data collection

Study outcomes

Outcomes will be ascertained during the check-up screening visit and through collection of referral vouchers from the referral health facilities, and, for outcomes related to health and well-being impacts, through data from the 4 month and, in Zimbabwe only, 12 month follow-up visits. Outcomes related to completed referrals will be triangulated against participants’ self-reports at the 4 month and in Zimbabwe only, 12 month follow-up visits. Review of school and health service registers will be used to see whether attendance has increased during the period when Y-Check is being implemented.

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 4 months. This will be measured using data collected at the initial check-up visit and through recovery of referral vouchers given to participants to allow them to access referral services for free during the 4 months after the Y-Check screening. Completed referral is defined as attending at least the first referral appointment.

Secondary implementation outcomes will include the 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, the yield of previously untreated conditions, clinical outcomes at 4 months among those who had originally screened positive for each condition, and intervention acceptability, adoption, appropriateness, feasibility, fidelity and cost. Secondary effectiveness outcomes will include knowledge about health services and health behaviours, self-reported agency and self-efficacy to make decisions about their health, self-reported health-related risk and protective behaviours, reported engagement with health services, well-being, self-esteem and quality of life, clinical outcomes and educational outcomes, which will be collected within the Y-Check and follow-up visits. The short-term cost-effectiveness of the intervention will be estimated (calculated by a comparison of the costs of the intervention against the primary and secondary outcomes and including short-term changes in self-reported quality of life). All outcomes for the study are described in table 3.

Sample size

In each city, the intervention will be implemented for 10–14 year olds in up to six government primary schools (n=500 for young adolescent girls, and n=500 for young adolescent boys), and for 15–19 year-olds in up to eight secondary schools and up to three community venues (n=500 for older adolescent girls, and n=500 for older adolescent boys), giving a total sample size of 2000 adolescents (10–19 y).

The sample size provides specified precision around the primary outcome. For example, for the primary outcome, within each age group and gender, if 150 (30%) of 500 participants screen positive for at least one condition, and 75% of those who screen positive are correctly managed (n=112), the 95% CI for correct management will be ±7%. The primary outcome used data from the initial check-up visit and referrals and did not require the 4 month follow-up data.

Statistical analysis

All primary analyses will be conducted separately by study city; Cape Coast, Chitungwiza and Mwanza. Where comparable, secondary analyses will be conducted with the data from all three cities combined.

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. Similarly, since there is no routine screening and treatment provided to adolescents of the target ages in the study population, a before–after comparison is appropriate since it is plausible to assume that reductions in the prevalence of the chronic conditions between the original Y-Check visit and the follow-up at 4 months will be due to the interventions provided through Y-Check.

We will follow Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) guidelines for the reporting of cohort studies. Descriptive analyses will be used to compare the community-level and school-level characteristics of the study communities and schools.

Quantitative programmatic data, including screening test results, services delivered and referrals made and completed will be reported by age, sex and city. The primary outcome is a single proportion which will be presented with a 95% CI for each of the four target groups: 10–14 year-old males, 10–14 year-old females, 15–19 year-old males 15–19 year-old females.

Secondary outcomes which are measured at a single-time point will be presented in a similar way to the primary outcome. For outcomes which are measured at two or more time points, a before–after analysis will be conducted comparing differences in measures between the time points. The unit of analysis will be the individual. For clinical outcomes which are measured at two or more time-points, the initial check-up visit (baseline) will give the prevalence of untreated conditions which will represent the counterfactual. The prevalence of conditions at the 4 month follow-up visit will be formally compared with this counterfactual to estimate the short-term effects of the intervention in improving these clinical outcomes. For analysis of outcomes measured at two timepoints, we will use mixed-effects logistic regression (binary outcomes) or linear regression (continuous outcomes) adjusting for individual-level clustering as a random effect and school/community as a fixed effect. Health service and client determinants of correct management of conditions at 4 months will be analysed using multivariable regression.

Ethics and dissemination

Ethics clearance has been received from WHO (WHO/ERC.0003778) and from all country national ethics bodies. Protocol modifications will be shared with the WHO Ethics Review Committee and relevant national ethics boards. Results will be published in at least three country-specific peer-reviewed journal publications and one multicountry publication. There will also be videos, briefs, webinars and meetings to disseminate results. All data will be placed into an open access repository after deidentification and anonymisation to ensure confidentiality and participant privacy.