A Mobile Game Intervention for Young Persons Living With HIV and Depression in Nigeria: Protocol for a Pilot Randomized Controlled Trial.
Caleb Eliazer, Temitope Omotosho, Kehinde M Kuti...
https://pubmed.ncbi.nlm.nih.gov/41337738Actively Recruiting
Phase Not Applicable
Age: 16Years - 24Years
All Genders
ID06389565
Change My Story: Pilot Randomized Clinical Trial of Change My Story Among Young Persons Living With HIV and Depression
Led by Massachusetts General Hospital · Updated on 2026-05-28
80
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
M
Massachusetts General Hospital
Lead Sponsor
U
University of Ibadan
Collaborating Sponsor
AI-Summary
What this Trial Is About
Young people living with HIV (Y-PLWH) often face psychological distress and depression, which can lead to poor medication adherence and worse HIV outcomes. This challenge is especially significant in low- and middle-income countries like Nigeria, where mental health services are limited and frequent clinic visits can cause inconvenience and stigma. Researchers are evaluating an interactive narrative game called Change My Story, combined with problem-solving therapy (PST), to address depression and psychological distress among Y-PLWH. This pilot randomized controlled trial compares this combined approach to PST alone in 80 young people aged 16 to 24 living with HIV and experiencing depression or psychological distress. Participants are randomly assigned to one of two groups: PST alone or PST combined with the Change My Story game. PST is a cognitive-behavioral therapy delivered through several sessions using a stepped-care approach, with further care determined by depression scores at week 6. Those in the combined group download the game on their phones, receive instructions, and are encouraged to play weekly narratives alongside their therapy sessions. Participants with ongoing severe symptoms or suicidality receive additional psychiatric consultation as needed. During the study, researchers assess engagement, satisfaction, feasibility, and acceptability of the interventions at baseline and up to three months. They also measure remission of depression and psychological distress, antiretroviral therapy adherence, and viral suppression at three and six months. Participants undergo regular evaluations including mental health screenings and risk assessments. The trial aims to improve mental health care access and outcomes for young people living with HIV by integrating innovative digital tools with established therapy methods.
CONDITIONS
Brief Title
Change My Story Task Shifted Mental Health Intervention
Who Can Participate
Age: 16Years - 24Years
All Genders
Eligibility Criteria
You may qualify if you...
- HIV-positive
- Age between 16 and 24 years
- Able to read and understand English
- PHQ-9 score between 8 and 17 with impairment in functioning consistent with clinical depression
You will not qualify if you...
- Pregnant or nursing
- In HIV care and on antiretroviral therapy for less than 6 months
- History of or positive assessment for bipolar or psychotic disorder
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Outpatient Treatment
Duration - 6 to 12 weeks
Participants receive Problem Solving Therapy (PST), a cognitive-behavioral therapy delivered in weekly sessions. Participants in the experimental arm also use the Change My Story narrative game alongside PST to support mental health.
Weekly visits for up to 12 weeks
Follow-up
Duration - Up to 6 months
Participants are evaluated at 3 and 6 months to assess remission of depression and psychological distress, adherence to antiretroviral therapy, and viral suppression.
Visits at 3 and 6 months
Trial Site Locations
Total: 1 location
1
University of Ibadan
Ibadan, Oyo State, Nigeria
Actively Recruiting
Loading map...
Research Team
A
Aima a Ahonkhai, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here