JMIR Publications

ABSTRACT

Background:

Young people living with HIV (Y-PWH) bear a disproportionate burden of depression, which has been associated with poor HIV outcomes. Cognitive-behavioral therapy (CBT) interventions, such as Problem-Solving Therapy (PST), have been shown to be effective for individuals with depression and can be delivered with fidelity by non-specialist frontline health providers, especially in resource-limited settings. PST is designed to teach problem solving orientation and skills 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 engagement with PST for Y-PWH in Nigeria.

Objective:

This pilot randomized clinical trial will evaluate the impact of PST alone or PST integrated with Change my Story (a digital narrative game on HIV) on mental health outcomes among Y-PWH in Nigeria.

Methods:

We will conduct a pilot hybrid implementation-effectiveness randomized controlled trial (RCT) with 80 Y-PWH (16-24 years) in Nigeria with depression (PHQ-9 9). Participants will be randomized to receive PST either with or without the Change My Story game. All participants will engage in weekly PST sessions for six weeks delivered by trained non-specialists (clinic HIV adherence counselors). PHQ-9 (at 6-weeks and 10-12 weeks) will determine the frequency of subsequent PST sessions over a total intervention period of three months. Primary implementation outcomes including engagement, satisfaction, feasibility, acceptability and appropriateness from the perspective of study participants, will be assessed using validated scales, programmatic data, and focus group discussions at 3 months. Secondary, clinical outcomes will assess participant changes in depressive symptoms, psychological distress, functional disability, adherence to antiretroviral therapy (ART) at 3 and 6 months, and HIV viral suppression (3 to 6 months) after intervention initiation. Pre-implementation and implementation outcomes (all but engagement and satisfaction) will be additionally assessed through surveys and focus group discussions from the perspective of program implementers at baseline and 6 months.

Results:

This study is funded by the United States National Institutes of Health. Participant recruitment and data collection are expected to begin early 2025. Through this study we will assess our hypothesis that participants who receive PST integrated with Change My Story will have improved implementation and effectiveness outcomes compared to those receiving PST alone.

Conclusions:

This pilot randomized clinical trial attempts to establish preliminary data on the feasibility, acceptability, and efficacy of task-shifted PST and supplementary mHealth technology on improving HIV and mental health outcomes among Y-PWH in Nigeria. These findings may serve as a basis for future large-scale interventions. Clinical Trial: This randomized clinical trial is registered with ClinicalTrials.gov (Trial Registration: NCT06389565).