Approximately 10% of the world’s 4 million young people, aged 15-24 years, living with HIV reside in Nigeria—an African nation with the fourth largest global population of people living with HIV [1-3]. Young people living with HIV also bear a disproportionate burden of depression compared to the general population, which is a key driver of poor HIV outcomes such as higher rates of interruptions in care, medication nonadherence, virologic failure, and progression of HIV [4-7].

Cognitive behavioral therapy (CBT)–based interventions are highly effective in treating depression and have been successfully used across the age spectrum from adolescents to older people [8-10]. Problem-solving therapy (PST) is a CBT-based intervention that is typically administered face-to-face with a trained counselor in 6 to 15 sessions; session duration is typically 30 to 60 minutes. PST uses 7 basic steps to teach problem-solving orientation and skills to equip individuals to manage the impact of stressful life events on their mental health [11,12]. PST interventions are highly effective for the treatment of depression both among adults as well as among women during the perinatal period in Nigeria [13-16]. PST also offers advantages over pharmacologic treatment for mild to moderate depression for people living with HIV, as PST avoids concerns about increasing pill burden and potential drug-drug interactions. Further, PST can be delivered by nonspecialist health workers, which may serve to overcome the critical gap in providing mental health care in Nigeria and other settings with a limited mental health care workforce [17-21].

Completion of PST sessions is required for optimal mental health outcomes; therefore, strategies that maximize adherence to PST may lead to the greatest benefit [11,12,22-24]. Digital games deployed through mobile health (mHealth) technologies present a unique and innovative opportunity to support psychosocial interventions like PST in a youth-friendly manner. Youth-friendly health care is an important care strategy recommended by the World Health Organization (WHO) to address the specialized needs of young people and to promote their engagement in critical health services [23,25-27].

Digital games are played by youths worldwide, and an estimated 71% of adolescents and young adults are connected online [28]. Coupled with the rapid increase in ownership of mobile phones in low- and middle-income countries (LMICs; 90% in Nigeria), digital games provide a compelling format for intervention delivery [29]. A genre of games called serious games is developed specifically for a reason other than pure entertainment (ie, promotion of health behaviors or health outcomes) [30]. One subgenre, narrative digital games, tells stories in an immersive environment, and this appealing format has been leveraged to promote observational learning, cognitive and behavioral rehearsal, and problem-solving for HIV prevention among adolescents and young adults [31,32]. Emerging evidence suggests that interactive games are both feasible and potentially effective tools for supporting chronic disease management and mental health treatment among youths [33-35].

In this paper, we outline a pilot hybrid implementation-effectiveness randomized controlled trial (RCT; ClinicalTrials.gov NCT06389565) to compare Change My Story combined with PST to PST alone among 80 young people living with HIV with depression. We will use the Consolidated Framework for Implementation Research (CFIR) to explore factors influencing engagement, feasibility, acceptability, and satisfaction among young people living with HIV and facilitators and barriers to intervention delivery [36].

This 2-arm parallel hybrid implementation-effectiveness study will compare outcomes of PST alone to PST integrated with a novel digital game, Change My Story, for young people living with HIV. Implementation outcomes (primary outcomes) from the perspective of young people living with HIV (feasibility, acceptability, appropriateness, satisfaction, and engagement) will be compared across the 2 study groups. This study will also assess the effectiveness (secondary outcomes) of Change My Story in improving depression, psychological distress, and HIV viral suppression. In addition, we will assess the feasibility, acceptability, and appropriateness of the intervention from the perspective of implementers.

This trial is designed to assess 2 hypotheses. First, we hypothesize that pairing PST with Change My Story will provide a more comfortable entry point into mental health care and thus improve implementation outcomes including engagement, satisfaction, feasibility, acceptability, and appropriateness. It is through this mechanism that we believe PST integrated with Change My Story will have improved preliminary effectiveness on mental health and HIV outcomes compared to PST alone. Second, we hypothesize that integrating PST with Change My Story will be feasible, acceptable, and appropriate from the perspective of implementers.

Participants will be recruited in Nigeria from the HIV Clinic, Infectious Disease Institute, College of Medicine, University of Ibadan. The clinic has approximately 6600 patients active in care, with about 400 of these being young people living with HIV. The Infectious Disease Institute also runs a monthly youth clinic, whose activities include a support group and other youth-friendly activities in addition to clinical care for 15- to 24-year-old people. Participants for this study will be recruited from young people living with HIV attending the Infectious Disease Institute by direct outreach to the adolescent clinic with the guidance of our team’s peer champions.

We developed Change My Story, a theory-grounded, narrative-based serious game designed to enhance engagement with PST for young people living with HIV in Nigeria. Players of Change My Story navigate emotionally difficult experiences vicariously through the characters and choose a narrative path toward the story’s conclusion. Guided by the social cognitive theory, the game promotes observational learning and self-efficacy by allowing players to explore the consequences of player choice and build problem-solving skills [37,38]. The development process was guided by the Integrate, Design, Assess, and Share framework, a user-centered design approach for digital behavioral health tools [39]. We conducted formative research with young people living with HIV to identify core mental health stressors [40]. This early work highlighted high mobile phone use, frequent gameplay, and a strong preference for story-driven games. We used a user-centered design process that included youth cocreation through an interactive activity where participants developed compelling storylines informed by their lived experiences. Thematic analysis of these narratives informed the development of 3 choose-your-own-adventure style digital storylines focused on HIV disclosure, stigma, and health literacy created in collaboration with a professional game studio. The intervention package additionally includes the provision of PST (Table 1), task-shifted from clinical psychiatrists to HIV adherence counselors who are an integral part of the existing infrastructure of the study site’s HIV clinic (and many other HIV clinics in this environment). This component of the intervention is further described in the Provider Training section.

Arm 1 will receive the outlined PST intervention delivered by adherence counselors based in the HIV clinic. Arm 2 will receive the outlined PST intervention integrated with the Change My Story game. Both arms will offer phone-based PST for selected sessions to improve accessibility. We anticipate that both arms will show improvement in mental health outcomes assessed using the 9-item Patient Health Questionnaire (PHQ-9; secondary outcome). However, we hypothesize that integrating PST with Change My Story will improve implementation outcomes (primary outcomes) including satisfaction, feasibility, acceptability, and appropriateness (from the perspective of study participants). It is through these mechanisms that we believe individuals in arm 2 will have greater engagement (primary outcome) in the intervention and improved preliminary effectiveness on both participants’ PHQ-9 score and HIV viral load compared to those in arm 1.

Prior to recruitment, HIV adherence counselors and physicians will be trained in depression identification, documentation, and management, including support and referral protocols for patients with suicidal ideation or severe depression. HIV counselors will additionally receive training on the delivery of the manualized PST intervention package developed by Gureje et al [15]. Study physicians will receive further training on the appropriate risk assessment, treatment, and referral requirements for high-risk patients using a format that has been successfully used to train nonspecialists and to improve knowledge, attitudes toward mental illness, and competency in diagnosing and treating depression [15,41,42]. To effectively integrate Change My Story with PST delivery, the counselors in this arm will participate in a workshop where they have an opportunity to play the game, review key narratives and themes, identify how narrative themes may relate to important PST principles that can be highlighted in treatment sessions, and role-play PST sessions with and without Change My Story.

Trained study staff will approach consecutive attendees at the Infectious Disease Institute while they are waiting to see their health care providers or during youth club sessions. These staff will screen interested participants for eligibility by administering validated screening tools for depression (PHQ-9) as well as for bipolar and psychotic disorder (adapted from the World Mental Health Composite International Diagnostic Interview [WMH CIDI]) in a private area of the waiting room [43-46]. Patients will meet the inclusion criteria if they (1) are HIV seropositive, (2) are 16 to 24 years of age, (3) possess a self-reported proficiency in reading and understanding English, and (4) have depressive symptoms (defined as PHQ-9≥9) [45]. Patients will be excluded if they are pregnant or nursing, have been on antiretroviral therapy (ART) for 6 months, have been out of care for ≥6 months, or have a history of or positive assessment for bipolar or psychotic disorder (based on adapted WMH CIDI) [46]. Individuals who meet eligibility criteria will be invited to provide written informed consent. Consenting individuals with a PHQ-9 score between 9 and 17 will be randomized. Further, individuals with a score of 12-17 will be referred to a clinic physician to ensure that no further specialized psychological assessment is indicated. Those with a PHQ-9 score ≥18 or who are assessed to have serious suicidal risk (ie, indicate thoughts of suicidality) will be immediately referred to a psychiatrist to be evaluated for safety and treatment needs; in these 2 scenarios, if individuals are cleared by the clinic physician or psychiatrist, they may be reconsidered for study eligibility and randomized.

Participants with a PHQ-9 score ≥9 will be randomized 1:1 in a parallel group design by the study statistician to study arm 1, PST alone, or study arm 2, PST with Change My Story. Randomization will be stratified on 2 key baseline variables: age category (16-19 vs 20-24 years) and HIV mode of transmission (perinatal vs nonperinatal). Younger people living with HIV in LMICs may have more limited access to technology, which may impact the feasibility of the mHealth platform [47]. Perinatally and nonperinatally infected young people living with HIV often differ in psychosocial contexts and stigma experiences, which may influence both their engagement with the intervention and mental health outcomes [48]. The random allocation sequence will be generated centrally by the study statistician and implemented using sequentially numbered, opaque, sealed envelopes to ensure allocation concealment until the point of assignment.

Due to the nature of the intervention, it will not be possible to blind participants or implementers.

The study will use a type II hybrid design to assess both implementation and effectiveness outcomes across study arms. Outcome assessors will receive training on administering data collection instruments.

The primary outcomes for this study are implementation outcomes (engagement, satisfaction, feasibility, acceptability, and fidelity) and will be compared across participants in PST alone to PST with Change My Story arms. Engagement in the intervention is defined as the percentage of recommended PST sessions attended. Satisfaction with the intervention is based on an adapted version of the Client Satisfaction Questionnaire (CSQ-8) [51]. Feasibility and acceptability as well as facilitators and barriers to achieving implementation and clinical outcomes—from the patient’s perspective—will be assessed via focus group discussion (FGD) as well as via Weiner’s Feasibility of Intervention Measure (FIM) and Acceptability of Intervention Measure (AIM) [52]. For feasibility, programmatic data, including the proportion of consented patients enrolled, proportion of game play sessions interrupted by technical problems, proportion of users requiring a mobile phone (at baseline), a replacement phone (due to loss or theft), or data needs, will also be assessed. For acceptability, the number of minutes and number of days of total game play per month, the percentage of recommended game play minutes completed, and the proportion of narratives completed will also be assessed from aggregated game play metrics. We will assess fidelity by determining whether core components of the PST intervention are implemented as planned and as detailed in the intervention manual via direct observation of a random subset of 15% of PST sessions (2 and 5) rated on several dimensions according to a scale that has successfully been used by the study team in Nigeria [53].

Secondary outcomes are clinical outcomes (remission of depression or psychological distress, ART adherence, and viral suppression). Specifically, remission will be defined by a reduction in PHQ-9 from baseline to follow-up (PHQ-9 score <6) [43,44]. Functioning across 6 domains will be measured via the WHO Disability Assessment Schedule [54]. HIV outcomes, including ART adherence and viral suppression, will be, respectively, measured via pharmacy refills and laboratory values (HIV RNA <200 copies per milliliter) at baseline and 3 to 6 months after intervention completion. Laboratories will be drawn for this assessment if participants do not have a routine clinical viral load obtained within this window.

With a total sample size of 80 participants (40 per study arm), the study will have approximately 80% power to detect a difference between the intervention and control groups equivalent to 0.635 SDs in the outcome measure using a 2-sided t test with a significance level of .05.

The quality of the study outputs will be ensured by using validated data collection tools. In addition to the creation and implementation of operations manuals, data collectors and supervisors will be trained on all data collection tools and procedures. In total, 1 research assistant will manage the mobile app technology to ensure proper functioning, 2 Nigerian-based research assistants will coordinate the overall research, and 1 US-based research assistant and US-based program manager will provide continuous supervision throughout the entire follow-up. All case report form data will be stored on the University of Ibadan secure network drives and captured onto a secure, password-protected REDCap (Research Electronic Data Capture; Vanderbilt University) database. The encrypted REDCap data servers will be hosted by the University of Ibadan. Electronic mobile technology use data will be stored on a back-end storage system at the University of Ibadan that meets Health Normative Standards Framework guidelines, which call for restricted access and the separation of patient demographics and health data.

Recognizing that loss of privacy is a serious issue, especially for an mHealth-grounded intervention for youths, measures will be put in place to protect identifiable data. First, all investigators and research personnel will receive training on the protection of human participants. Second, identifiable information will only be made available to a few specific research personnel who will need access to the data purely for study purposes. All paper records will be stored in secure, locked cabinets only accessible to study personnel. Third, the mHealth app was developed with security as the top priority. The security features include early deidentification of data through the assignment of participant ID numbers, storage of data in an encrypted format, secure HTTPS-based data transmission between the mHealth app and a password-protected, Health Insurance Portability and Accountability Act (HIPAA)–compliant cloud-based storage system, robust user-level authentication to access the app, and automatic log-out after a period of inactivity. To minimize risk to confidentiality and privacy, the app will not include any explicit indications to its purpose as an HIV intervention. From an outside perspective, Change My Story will appear like other general apps, without obvious associations to mental health or HIV-related services. Fourth, participants will be counseled on the low risk of data breach with these safeguards, but also on how to further minimize data breach when phones are shared. Participants will additionally be taught to use the app and participate in remote PST sessions in ways that protect their privacy. These safeguards will be present in the demonstration session, introducing the participants to the app. Nonetheless, these risks will be explicitly discussed with participants at the time of enrollment and consent for study participation. Given the limited scale of the study, the research team will maintain direct oversight of all procedures and data collection; no additional monitoring processes are anticipated.

This study involves human participants and was reviewed and approved by the Mass General Brigham Institutional Review Board (IRB) in the United States (Protocol #: 2024P000857) and the University of Ibadan IRB in Nigeria (Protocol #: UI/EC/24/0484). Written informed consent will be obtained from all participants prior to enrollment. Individuals aged 16 years and older as well as emancipated youths can consent for research in compliance with Nigerian regulations and IRB requirements. The consent process will include a clear explanation of the study’s purpose, procedures, potential risks and benefits, voluntary nature of participation, and the right to withdraw at any time without penalty. All participants will receive due incentives and refreshments for in-person study visits (including outcome assessments) to account for their time and transportation needs. Participants randomized to the integrated PST and Change My Story arm will receive monthly mobile carrier bundles during the intervention period to ensure data access required for study activities. These reimbursements are intended solely to offset costs incurred as a result of participation and are not considered coercive. No performance-based or outcome-dependent incentives will be provided. All participant data will be deidentified through assignment of unique study identification numbers prior to storage or analysis. The Change My Story mobile app was developed with security as a priority, using encrypted data storage, secure HTTPS-based data transmission, robust user authentication, and automatic log-out.

The findings from this proposal will be shared as abstracts at international HIV conferences and submitted for publication in peer-reviewed journals. At the conclusion of the trial, we will consolidate findings and prepare a presentation oriented to an audience of trial participants and other young people living with HIV at the Infectious Disease Institute.

A Data Safety and Monitoring Board has been formed to safeguard the interests of participants. The Data Safety and Monitoring Board is an independent advisory group that will provide recommendations. The members have expertise in clinical psychiatry, HIV clinical trials, adolescent medicine, and biostatistics.

End users and key clinical and public health partners in the field of HIV have been integrally involved in the development of the Change My Story game. Throughout the data collection and follow-up period, the end users along with clinical and public health partners will provide key perspectives on outlined implementation outcomes in addition to how they can be overcome to maximize patient benefit.