NCT06389565Recruiting
Change My Story Task Shifted Mental Health Intervention
Change My Story: Pilot Randomized Clinical Trial of Change My Story Among Young Persons Living With HIV and Depression
Source: ClinicalTrials.gov · Last updated 6 Jul 2026
Brief summary (registry, in English)
Psychological distress and depression are common among young people living with HIV (Y-PLWH) and negatively impact medication adherence and disease control. In low- and middle-income countries, this problem is compounded by the lack of trained mental health professionals on the provider side and the requirement of frequent clinic-based visits imposing greater cost, inconvenience, and stigma for patients. Change My Story, is a theory-grounded, interactive narrative game designed to address the key drivers of depression and psychological distress among Y-PLWH in Nigeria. This pilot hybrid implementation-effectiveness randomized controlled trial (RCT) will compare Change My Story combined with PST to PST alone among 80 Y-PLWH with depression or psychological distress.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 80 (estimated)
- First submitted
- 9 Apr 2024
- Start date
- 9 Jan 2026
- Primary completion date
- 30 Aug 2026
- Lead sponsor
- Massachusetts General Hospital
- Diseases
- HIV
- NCT number
- NCT06389565
What you commit to
- Study type: Interventional
- Planned participants: 80
- From 9 Jan 2026 to the primary completion date, 30 Aug 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- history of- or positive assessment for- bipolar or psychotic disorder.
Other
- pregnant or nursing
- in care and on ART for \<6 months
Who the study is looking for
- 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)
Age in the registry: 16 years to 29 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Ibadan Coordinator of this site? Confirm its status | Ibadan | Nigeria | Recruiting |
Related publications
- A Mobile Game Intervention for Young Persons Living With HIV and Depression in Nigeria: Protocol for a Pilot Randomized Controlled Trial.JMIR Res Protoc · 2025 · PMID 41337738
This page is information, not medical advice. Discuss any trial with your doctor.