NCT06389565 Change My Story Task Shifted Mental Health Intervention
| NCT ID | NCT06389565 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Massachusetts General Hospital |
| Condition | Hiv |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2026-01-09 |
| Primary Completion | 2026-08-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 80 participants in total. It began in 2026-01-09 with a primary completion date of 2026-08-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06389565 clinical trial?
This trial is open to participants of all sexes, aged 16 Years or older, up to 29 Years, studying Hiv. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06389565 currently recruiting?
Yes, NCT06389565 is actively recruiting participants. Contact the research team at AAHONKHAI@mgh.harvard.edu for enrollment information.
Where is the NCT06389565 trial being conducted?
This trial is being conducted at Ibadan, Nigeria.
Who is sponsoring the NCT06389565 clinical trial?
NCT06389565 is sponsored by Massachusetts General Hospital. The trial plans to enroll 80 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.