A Mobile Game Intervention for Young Persons Living With HIV and Depression in Nigeria: Protocol for a Pilot Randomized Controlled Trial.
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.
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.
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.
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.
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.
ClinicalTrials.gov NCT06389565; https://clinicaltrials.gov/study/NCT06389565.
PRR1-10.2196/74199.
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.
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.
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.
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.
ClinicalTrials.gov NCT06389565; https://clinicaltrials.gov/study/NCT06389565.
PRR1-10.2196/74199.
Authors
Eliazer Eliazer, Omotosho Omotosho, Kuti Kuti, Pierce Pierce, Gray Gray, Audet Audet, Awolude Awolude, Gureje Gureje, Oladeji Oladeji, Ahonkhai Ahonkhai
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