A Mobile Game Intervention for Young Persons Living With HIV and Depression in Nigeria: Protocol for a Pilot Randomized Controlled Trial
Bibliographic record
Abstract
BACKGROUND: Young people living with HIV bear a disproportionate burden of depression, which is associated with poor HIV outcomes. Problem-solving therapy (PST) has been shown to be effective for depression management and can be delivered with fidelity by nonspecialists, especially in resource-limited settings. PST is designed to equip individuals to manage the impact of stressful life events on their mental health. Change My Story is a narrative digital game designed to improve PST engagement among young people living with HIV in Nigeria. OBJECTIVE: This trial will evaluate the impact of PST alone or PST with Change My Story on mental health outcomes among young people living with HIV in Nigeria. METHODS: We will conduct a pilot hybrid implementation-effectiveness randomized controlled trial with 80 young people living with HIV (aged 16-24 years) in Nigeria with depression (9-item Patient Health Questionnaire [PHQ-9] ≥9) over 3 months. Participants will be randomized to receive PST with or without Change My Story. All participants will engage in weekly PST sessions for 6 weeks delivered by trained nonspecialists (clinic HIV adherence counselors). At 6 and 10-12 weeks, scores on PHQ-9 will determine the frequency of PST sessions during the remaining intervention period. Primary implementation outcomes, including engagement, satisfaction, feasibility, acceptability, and appropriateness from the participant perspective, will be assessed using validated scales, programmatic data, and focus group discussions at 3 months. Secondary clinical outcomes will assess changes in depressive symptoms, psychological distress, functional disability, antiretroviral therapy adherence, and HIV viral suppression at 3 and 6 months. Implementation outcomes (all but engagement and satisfaction) will be assessed through validated scales and focus group discussions from the implementer perspective at baseline and 6 months. RESULTS: This study is funded by the US National Institutes of Health (funding commenced on March 8, 2024), institutional review board approval was received on April 15, 2024, and recruitment and data collection began in June 2025. Thus far, we have screened 103 youths and enrolled 23 participants. Among enrolled participants, 15 (65%) were male; 1 (4%) had a PHQ-9 score ≥17, and 6 (26%) had suicidal thoughts. We anticipate recruitment will be completed by January 2026 and follow-up by June 2026. We will assess our hypotheses that PST with Change My Story is feasible, acceptable, and appropriate and that individuals receiving PST integrated with Change My Story will have greater engagement, satisfaction, and depression remission compared to those receiving PST alone. CONCLUSIONS: This pilot randomized controlled trial attempts to establish preliminary data on the feasibility, acceptability, appropriateness, and efficacy of task-shifted PST and supplementary mobile health technology on improving HIV and mental health outcomes among young people living with HIV in Nigeria. These findings may serve as a basis for future large-scale interventions. TRIAL REGISTRATION: ClinicalTrials.gov NCT06389565; https://clinicaltrials.gov/study/NCT06389565. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/74199.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.021 | 0.016 |
| Meta-epidemiology (narrow) | 0.005 | 0.003 |
| Meta-epidemiology (broad) | 0.010 | 0.005 |
| Bibliometrics | 0.003 | 0.003 |
| Science and technology studies | 0.003 | 0.003 |
| Scholarly communication | 0.004 | 0.003 |
| Open science | 0.004 | 0.002 |
| Research integrity | 0.006 | 0.008 |
| Insufficient payload (model declined to judge) | 0.068 | 0.008 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".