Clinical trial Recruiting at 1 site Interventional Ages 16 to 29

Change My Story: a narrative game plus task-shifted therapy for young people with HIV

Official title: Change My Story: Pilot Randomized Clinical Trial of Change My Story Among Young Persons Living With HIV and Depression

Run by Massachusetts General Hospital · NCT06389565 · Data updated 2026-11-12

This pilot will test whether the Change My Story interactive narrative game combined with task-shifted Problem Solving Therapy helps 16–24-year-olds living with HIV in Nigeria who have depression or psychological distress improve mood and medication adherence.

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Quick facts

Study typeInterventional
Ages16 Years to 29 Years
SexAll
Enrollment80 (estimated)
SponsorMassachusetts General Hospital
Academic / other
Locations1 site (Ibadan, Oyo State)
StatusRecruiting
StartedJanuary 9, 2026
Main results expectedAugust 30, 2026
Study endsAugust 30, 2026
Registry record updatedJuly 6, 2026
Trial IDNCT06389565 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are English-literate HIV-positive young people aged 16–24 in or near Ibadan, Nigeria, who have a PHQ-9 score between 8 and 17, are on ART for at least six months, and do not have bipolar disorder or psychosis.

Probably not a fit

People who are pregnant or nursing, those on ART for less than six months, those with bipolar disorder or psychosis, non-English readers, or those with more severe depression than the trial's eligibility range are unlikely to be eligible or to receive benefit from this intervention as tested here.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a pilot hybrid implementation-effectiveness randomized controlled trial enrolling 80 young people living with HIV (ages 16–24) with mild-to-moderate depression or psychological distress. Participants are randomized to receive the Change My Story interactive narrative game together with task-shifted Problem Solving Therapy (PST) or to receive PST alone. The intervention is delivered using non-specialized health workers to address limited mental health workforce capacity, with outcomes including depressive symptoms, functioning, and HIV treatment engagement. The trial is conducted at the University of Ibadan in Nigeria to test feasibility, acceptability, and preliminary clinical impact.

Why it matters

Potential benefit: If successful, this approach could give young people living with HIV an engaging, lower-cost way to reduce depression and improve adherence to HIV treatment through a scalable, task-shifted program.

How similar studies have gone: Task-shifted Problem Solving Therapy has shown effectiveness for depression in low- and middle-income countries, while the use of an interactive narrative game in this population is novel and has limited prior evidence.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* HIV-positive
* age 16-29 years
* self-reported proficiency in reading and understanding English.
* PHQ9 score of 9-17 and impairment in functioning (consistent with clinical depression)

Exclusion Criteria:

* pregnant or nursing
* in care and on ART for \<6 months
* history of- or positive assessment for- bipolar or psychotic disorder.

Where it's running

  • University of Ibadan
    Ibadan, Oyo State, Nigeria
    Recruiting

Study contacts

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.