Mental health disorders are a significant global health challenge, with a disproportionate burden in low- and middle-income countries (LMICs), particularly sub-Saharan Africa (SSA), where resource limitations and unmet needs are profound [1]. These challenges have intensified in recent years, with the COVID-19 pandemic disrupting already fragile mental health systems and exacerbating psychosocial stressors, particularly among adolescents and young adults [1].

Young people in SSA face a convergence of structural and environmental risks, including poverty, exposure to violence and armed conflict, the enduring impact of the HIV/AIDS pandemic, and the disruption of education due to the COVID-19 pandemic restrictions, that heighten their vulnerability to a range of mental health conditions [2-4]. Systematic reviews have documented high prevalence rates of emotional, behavioral, and psychological difficulties among children and adolescents in the region [5-7]. These challenges are often exacerbated by experiences such as bullying, gender-based violence, substance misuse, and academic pressures.

Adolescents and young adults constitute a critical period for mental health development, necessitating timely access to effective mental health and psychosocial support (PSS) services [8]. Despite this well-documented need, access to professional mental health services in LMICs remains severely constrained, with many countries having fewer than one specialist per 100,000 population [9]. Persistent barriers such as entrenched stigma, reliance on traditional healing practices, mistrust of school-based counseling, and chronic shortages in mental health resources further exacerbate these challenges [10-12].

These persistent gaps underscore the urgency for innovative, scalable, and culturally attuned interventions. Task-shifting strategies, whereby nonspecialists such as teachers, community health workers, and peer counselors are trained to deliver evidence-based psychosocial interventions, have shown promise in mitigating workforce shortages [12,13]. Embedding such interventions within schools and community structures offers potential to reduce treatment gaps; however, there remains a paucity of systematic evidence comparing their effectiveness, implementation strategies, and adaptability across diverse SSA contexts [14]. Schools provide an important platform for delivering health interventions to adolescents and young adults broadly, and mental health services and PSS are key components of this provision [15,16]. Generating robust evidence on which interventions are most effective, for whom, and under what conditions is critical for informing policy decisions and optimizing resource allocation in resource-limited settings.

In South Africa, the unmet need for mental health services among adolescents and young adults is particularly acute [17,18]. Results of the South African National Youth Risk Behavior Survey found that 24% of respondents between grades 8 and 11 had experienced feelings of depression, hopelessness, and sadness, and 21% had attempted suicide at least once [19]. Another study, among school learners aged 14-15 years in Cape Town, reported high prevalences of depression (41%), anxiety (16%), and posttraumatic stress disorder (21%) [20]. Policies and programs in South Africa, including the 2012 Integrated School Health Policy (ISHP) and the 2014 Screening, Identification, Assessment, and Support (SIAS) Policy, have been developed with the express aim of improving both health and education outcomes among children and youth in South African schools. These policies target children, adolescents, and young adults from grades 1 to 12, between the ages of 6 and 18 years.

The ISHP is a multisectoral policy that mandates the Department of Health (DoH), Department of Education (DoE), and the Department of Social Development (DSD) to include comprehensive health screening and mental health screening using the Strengths and Difficulties Questionnaire [21]. The mental health screening is targeted at learners in grades 1, 4, 8, and 10, and this is done once in each of these grades and repeated for any learner who repeats any of these grades. The ISHP further provides for on-site services and health education in the foundation phase (grades R-3), intermediate phase (grades 4‐6), senior phase (grades 7‐9), and further education and training phase (grades 10‐12) [21]. However, gaps and inconsistencies in implementation persist, driven by shortages of trained personnel, a lack of cross-sectoral collaboration between education and health ministries, and weak referral pathways [22,23].

The SIAS Policy aims to provide additional support to learners who have been identified in mainstream and special schools with special needs and difficulties in learning, such as poverty, language, family issues, disability, and learning difficulties [24]. The policy also outlines structural arrangements to support learner inclusion, including support staff within the education district, articulating the roles of the district-based support teams, the school-based support teams, and school management. Despite the presence of these policies, the provision of mental health and PSS services remains inconsistent and suboptimal [25], requiring urgent strengthening if the mental health needs of adolescents and young adults are to be effectively addressed.

To address these persistent service delivery gaps, innovative and participatory approaches are required. Human-centered design (HCD) offers a promising framework for codeveloping mental health implementation strategies that are contextually grounded and responsive to end user needs. HCD emphasizes collaboration with individuals who have lived experience of a problem, in this case, adolescents and young adults, as well as with caregivers and service providers, to ensure that resulting implementation strategies are both feasible and culturally resonant [26,27]. As a problem-solving approach, HCD is particularly suited to complex health system challenges like those found in perirural South Africa, where user engagement is critical for the uptake, acceptability, and sustainability of mental health implementation strategies. Given the convergence of poverty, high HIV prevalence, and structural inequality in KwaZulu-Natal (KZN), HCD is deployed here not only as a design method but also as a means of empirical inquiry into the contextual, systemic, and experiential factors shaping adolescents’ and young adults’ mental health needs.

Operationalizing this HCD approach, the Asenze Impilo project is nested within the Asenze longitudinal cohort study, now in its fifth wave, which has generated robust data on adolescent development, health, and mental health in KZN over a period of more than a decade [28-31]. Prior waves of Asenze illustrate the prevalence of the common mental health disorders (CMHDs), including depression, among adolescents in the cohort, with 36% of the wave 4 sample presenting with a CMHD and 4.9% screening positive for 2 or more CMHDs [31].

At the time of their wave 4 assessment, 79% of Asenze adolescents were in school, 13% had completed matric (the National Grade 12 certificate; equivalent of completing high school), 5% had dropped out of school, and 3% were in technical and vocational education and training colleges. Despite Asenze participants being over the age of 18 years in wave 5 (the current wave of the study), the education system is likely to remain a key factor in Asenze young people’s lives because some of these young adults continue their schooling beyond 18 years. Combined with the prevalence of mental health challenges in this population and the demonstrated influence of a sense of school belonging as protective of mental health, the education system presents an important opportunity to intervene to protect mental health [32].

The Asenze Impilo study will be an application of the observational-implementation hybrid approach. Observational-implementation hybrid studies integrate implementation science methods within observational research to generate evidence that informs the development, delivery, and evaluation of implementation strategies. This approach has the potential to increase public health impact by broadening traditional observational epidemiologic study designs to include the collection of data to inform the design, implementation, or evaluation of implementation strategies on implementation outcomes, including service delivery/health outcomes. The Asenze Impilo will achieve this by incorporating implementation science methods into the observational Asenze cohort study and will collect information that will inform implementation strategies to address CMHDs among adolescents and young adults [33]. The longitudinal Asenze cohort offers a unique opportunity to conduct this work, providing over a decade of rich, contextual data that allows for an in-depth understanding of how social determinants of health, including the impact of COVID-19, affect mental health among adolescents and young adults. The Asenze cohort also provides a ready and diverse group of young adults who have lived experiences with mental health challenges and caregivers who have been previously screened that can be recruited for HCD workshops. These participants can offer critical insights into barriers and opportunities in the current system to use findings from prior research.

The Asenze Impilo study will use an HCD approach to codevelop solutions with young adults and caregivers, aligning implementation strategies with real-world challenges and contextual needs in KZN. By bringing together insights from the Asenze study, prior ISHP evaluations, to which several members of the Asenze Impilo research team contributed [25], and community members, Asenze Impilo will integrate evidence and stakeholder perspectives to co-design a tailored, context-specific, and effective implementation strategy to help address a critical implementation gap.

The Asenze Impilo study aims to identify strategies for improving implementation of evidence-based mental health and PSS interventions for adolescents and young adults. This knowledge can be used to address implementation gaps and, in turn, improve mental health outcomes among adolescents and young adults in South Africa. This will be achieved by bringing together young adults from the Asenze cohort, their caregivers, stakeholders from the provincial district DoE, DoH, DSD, other implementation partners, and nongovernment organizations (NGOs) staff, to co-design a context-specific, adolescent and young adult–friendly, and culturally sensitive implementation strategy for evidence-based mental health and PSS interventions for adolescents and young adults in KZN and completing the following steps:

The implementation strategy that is codeveloped can then be evaluated for acceptability, feasibility, effectiveness, and cost-effectiveness.

This study is theoretically informed by the social ecological model (SEM) and operationalized through a HCD methodology [26,34,35]. The SEM provides a multilevel framework for understanding the determinants of mental health, while HCD offers a user-driven methodology for generating practical, context-specific implementation strategies. The SEM frames mental health as shaped by interrelated factors operating at 4 levels—individual, interpersonal, community, and policy—requiring multilevel strategies. At the individual level, factors such as personal experiences, mental health conditions, and coping strategies shape well-being [35]. The interpersonal level considers the influence of relationships with family, peers, and caregivers, which can either support or hinder mental health. At the community level, access to resources, social norms, stigma, and structural barriers impact the effectiveness of mental health implementation strategies. Lastly, the policy level encompasses broader systems such as government policies, health care structures, and legal frameworks that shape service availability and implementation.

The HCD approach complements this by engaging directly with individuals and stakeholders within each of these SEM levels to codevelop tailored solutions. HCD ensures that implementation strategies are culturally relevant, contextually appropriate, feasible, and sustainable for real-world application [27]. This is particularly crucial in mental health and PSS service provision, where solutions must align with local beliefs, values, and service delivery constraints to be effective. This integration ensures that implementation strategies are not only user-driven but also system-sensitive.

Each phase of the HCD process aligns with specific SEM levels (Table 1).

This structured alignment ensures that each phase of the implementation strategy development is responsive to both user needs and the broader system context. (Figure 1).

By integrating SEM and HCD, this study adopts a holistic and participatory approach to co-designing a context-specific mental health implementation strategy. Engaging diverse stakeholders, including adolescents and young adults, caregivers, government, and their implementing partners, is essential to navigating the multilayered challenges in mental health service delivery and fostering solutions that are both effective and intended to support future scale-up within the specific sociocultural and policy environment of KZN.

The study is taking place in KZN, one of South Africa’s 9 provinces, situated in the southeastern part of the country. The demographic composition of KZN is predominantly Black African, with many residents speaking isiZulu as their first language [47].

Administratively, KZN is structured into 10 district municipalities: Ugu, uMgungundlovu, uThukela, uMkhanyakude, King Cetshwayo, Harry Gwala, uMzinyathi, Amajuba, Zululand, and iLembe. Additionally, eThekwini functions as a metropolitan municipality, encompassing the province’s largest urban center, Durban. Within this administrative and demographic landscape, various regions face distinct socioeconomic and health-related challenges, shaping the context in which research and implementation strategies take place [47]. One such region is the Valley of a Thousand Hills, where the Asenze study cohort is conducted, a geographically diverse area characterized by a mix of periurban and rural settlements approximately 45 km northwest of Durban.

The data will be collected through journey maps, card sorting exercises, and FGDs, which are recorded, and audio recording will be transcribed and analyzed thematically. All recorded data are downloaded onto a secured laptop and stored in a secure office together with all paper-based data, and access will be restricted to authorized research personnel. All data collected digitally will be stored using encrypted electronic devices and on secure servers. Identifiable information will be anonymized during the analysis phase.

The data will be collected through qualitative methods, including journey mapping, card sorting exercises, and FGDs. These sessions will be audio-recorded and transcribed. Data collection will also include visual and textual documents generated by participants during co-design activities, such as journey maps, service knowledge, and ranked service preferences from card sorting. Each transcript and artifact will be assigned a unique identifier to ensure confidentiality and facilitate data tracking during analysis.

In the Discover phase, data collection will include participatory and interactive methods designed to elicit rich insights from both young adults and caregivers on their experiences with mental health challenges and service use. Tools will include semistructured workshop guides to facilitate group discussions (Multimedia Appendix 2), journey mapping templates, and service evaluation checklists. Facilitators will be guided by a structured set of questions to ensure consistency, safety, and openness, incorporating interactive elements such as flashcards to prompt discussion about emotional and physical well-being.

In the Design phase, co-design workshops with young adults and caregivers will translate phase 1 findings into context-specific, culturally relevant, and feasible mental health and PSS implementation strategies. Facilitators will begin by recapping phase 1 results and prompting participants to articulate their “biggest worry” and “biggest hope” before exploring ideal mental health services and perceived barriers (Multimedia Appendix 3). A central activity will be the card sorting exercise, where participants will review a set of implementation strategy feature cards, ranging from school-based counseling and peer support groups to mobile clinics and digital referral tools, and rank them by importance and preference. Small group discussions will then compare choices, explore reasoning, and reach consensus on priority features. These priorities will inform structured problem-solving discussions on practical implementation, considering delivery settings, responsible actors, required resources, and strategies for addressing stigma, gender-related barriers, and the needs of youth affected by HIV. Feedback sessions will capture participants’ views on the workshop process and the refined proposed implementation strategies.

In the Build phase, the focus will be on refining, testing, and planning the implementation of the co-designed mental health implementation strategies developed in earlier phases. Workshops with young adults and caregivers will present an opportunity to present 3 prototype co-designed implementation strategies, using interactive feedback stations and scenario-based role plays to explore their relevance, safety, and feasibility (Multimedia Appendices 4 and 5). Participants will be encouraged to interact with real-life scenarios to assess each model’s potential benefits, risks, and acceptability, including stigma considerations and suitability for youth affected by HIV, gender-based violence, or other vulnerabilities. This will be followed by group discussions to identify strengths, gaps, and suggestions for improvement, followed by voting activities to prioritize key features or preferred implementation strategies. Feedback will be documented through structured templates and reflection activities, while visual aids (posters) will be used to help communicate each implementation strategy’s purpose.

To ensure that these diverse stakeholder inputs are translated into concrete implementation strategy components, each workshop phase will use structured facilitation tools, including HCD techniques such as card sorting and preference ranking, to capture and prioritize feedback, preventing dominant voices from suppressing minority perspectives. Following each workshop, the research team will debrief and discuss the feedback, mapping each proposed strategy component against dimensions of acceptability, feasibility, safety, and cultural appropriateness, as shared by the participant group. Points of convergence across adolescents and young adults and caregiver groups will be incorporated as core design features, while points of divergence will be escalated to deliberative resolution in subsequent workshops.

In phase 3, refinement workshops with adolescents and young adults and caregivers will produce specific tangible outputs, including a finalized implementation strategy, suggested participant-validated implementation protocols, and documented design constraints reflecting features explicitly rejected by either group. Government and NGO stakeholder workshop will serve a distinct function, that is, stress-testing the draft implementation strategies against policy and resource realities, producing a policy alignment matrix and feasibility gap analysis that will together inform an integration planning process. Final synthesis will triangulate outputs across all stakeholder groups, ensuring that the final implementation strategy is simultaneously grounded in community lived experience, operationally feasible, and policy-coherent.

All audio files and scanned documents will be downloaded to encrypted, password-protected laptops and a USB and securely backed up on a university-approved cloud server. Physical documents, for example, workshop notes, participant feedback templates, and participant maps, will be stored in locked cabinets in a secure office accessible only to authorized research personnel. All identifying information will be removed or anonymized at the transcription stage to enhance safety, confidentiality, trustworthiness, and transparency, as recommended for qualitative research protocols [41,48].

This study has applied for ethical approval from 2 institutional ethics bodies, the University of KwaZulu-Natal’s Biomedical Research Ethics Committee (BREC/00006912/2024) and Columbia University’s Institutional Review Board (IRB-AAAU7173). Approval from both institutional ethics boards has been granted. All participants will be provided with a copy of an informed consent form, which they can keep. To collaborate with stakeholders from the DoH, DoE, DSD, and their implementing partners, letters of approval have been sought from the Head of Department of the 3 ministries, together with supporting letters from the participating NGOs.

All young adults will be aged 18 years or older when recruited to participate in the study. Young adults and caregivers’ interest in participating will initially be assessed via telephonic contact, followed by written consent on an informed consent form at the first workshop. Consent forms will be securely stored and transported to a secure location. Additionally, to avoid linking the new study numbers to the Asenze study numbers, both study identifiers were stored and locked separately.

The anticipated risks for participants are minimal. The primary concern is the potential loss of confidentiality and the possibility of emotional distress when discussing sensitive mental health topics. Workshops will be held in private venues accessible only to consenting participants and authorized staff. At the start of each session, participants will be reminded that while confidentiality is expected, it cannot be fully guaranteed in a group setting, and they will be encouraged to avoid sharing information they would not be comfortable disclosing. They will also be reminded not to share any information shared during the workshops outside of the study.

Given that the participant pool includes young adults with prior moderate to severe mental health symptoms, a robust protocol for managing distress and adverse events will be in place and will include:

Data collection materials will be translated into isiZulu and English, and workshops will be facilitated by researchers and research assistants familiar with community and cultural norms in KZN, ensuring participants can engage in their preferred language.

Qualitative data analysis will follow an inductive and iterative thematic analysis approach [40,48], guided by the principles of HCD and participatory research. The analysis will seek to identify key patterns, needs, and barriers related to mental health and PSS services among adolescents and young adults in KZN. The qualitative data from the service mapping exercise, journey mapping, FGDs, and card sorting workshops will be analyzed thematically using the latest NVivo software (version 15; Lumivero). The analytic process will follow the 6 phases of thematic analysis as outlined by Braun and Clarke [40], allowing for an inductive and iterative exploration of patterns, experiences, and concerns related to mental health and PSS services.

Phase 1 will involve familiarization with the data, during which the research team will read and reread transcripts, review visual outputs, and note initial observations to build a deep understanding of participants’ lived experiences. In phase 2, generating initial codes, both semantic and latent codes will be developed inductively, allowing insights to emerge directly from the data [49]. NVivo will be used to systematically apply these codes across the dataset. Phase 3, searching for themes, will involve grouping related codes into broader categories that capture important patterns. This will be followed by phase 4, reviewing themes, where potential themes will be refined, ensuring they accurately represent the data and are coherent both internally and in relation to the overall dataset.

In phase 5, defining and naming themes, the research team will articulate the essence of each theme and determine how it relates to the study objectives and the broader literature on mental health service access, acceptability, and quality. Finally, in phase 6, producing the report, the themes will be synthesized into a coherent narrative supported by illustrative quotes and visual materials from journey maps and card sorting outputs. This approach aligns with the participatory and user-centered principles guiding the study and ensures that the analysis remains grounded in the perspectives of young adults, caregivers, and service providers.

Data generated during the Build phase, including feedback on implementation strategy prototypes, feasibility and acceptability assessments, and service provider evaluations, will be analyzed using the same reflexive thematic analysis framework applied in the Discover and Design phases [40]. This will ensure analytic consistency across the study. However, rather than generating stand-alone thematic reports, the Build phase analysis will focus specifically on identifying merging and deviating feedback and themes established in earlier phases. The similar findings will be incorporated as finalized implementation strategy components, while the deviating findings will undergo review. Any quantifiable preference and rating data collected through structured feedback tools will be summarized descriptively to complement qualitative findings. The integrated output of this analysis will be a finalized, evidence-informed, and community-validated implementation strategy that reflects the cumulative analytical work across all 3 phases.

Expected outcomes of this study include the development of a context-specific implementation strategy for mental health and PSS with the possibility of integration within either the health or education system, enhanced collaboration among stakeholders for sustainable mental health service delivery, and policy recommendations for improving young people’s mental health care in South Africa. Although the study engages a purposively selected group of 15 mental health stakeholders, their inclusion from the DoH, DoE, and DSD ensures representation of key institutional perspectives central to service delivery [50]. This focused, cross-sectoral engagement allows for in-depth exploration of coordination challenges and facilitators within existing systems, providing insights that are intended to support future scale-up in similar provincial and national contexts.

Additionally, the study aims to strengthen the capacity of local service providers to provide youth-friendly mental health services, improve early identification and implementation mechanisms, and contribute to knowledge on best practices for co-designing mental health implementation strategies. The findings will also inform practical frameworks and tools that can be adapted by nonparticipating institutions, thereby supporting broader capacity-building beyond the immediate study sites.

The study has several strengths. By using an HCD approach, it ensures that implementation strategies are cocreated with direct input from young adults, caregivers, and government and their implementing partners, making them contextually relevant and user-friendly. The participatory, mixed methods design allows for a comprehensive understanding of mental health service gaps, leveraging both qualitative insights and quantitative data. Additionally, the study builds upon the robust longitudinal data from the Asenze study, providing a strong evidence base for implementation strategy development. Stakeholder collaboration with government departments and community organizations further strengthens the study’s potential for policy integration and long-term impact.

However, the study also has some limitations. The findings may be context-specific and may not be easily generalizable beyond KZN due to regional differences in service availability and sociocultural factors. In addition, the study relies on self-reported data from young adults and caregivers, which may be subject to recall bias or social desirability bias. The HCD process can be time-consuming, especially in this study, where the process was implemented by a research team who were both learning and executing the process as the project unfolded. Despite these limitations, the study’s participatory approach and stakeholder engagement strategies will enhance its potential for sustainable impact.

This protocol outlines a rigorous, participatory process for developing an implementation strategy for delivering evidence-based mental health and PSS tailored to the needs of adolescents and young adults in perirural KZN, South Africa. By combining the SEM and HCD, the study ensures that solutions address individual, interpersonal, community, and policy-level determinants of mental health while remaining grounded in lived experience. Through collaboration with young adults, caregivers, and government and NGO stakeholders throughout all phases, the study is expected to produce an implementation strategy that is culturally relevant, feasible within existing systems, and responsive to local priorities. Ultimately, the implementation strategy can be evaluated for effectiveness. Efforts like these are needed to strengthen mental health services in low-resource settings and support the well-being of South African adolescents and young adults.