RecruitingNot Applicable

Change My Story Task Shifted Mental Health Intervention

Nigeria80 participantsStarted 2025-06-01

Plain-language 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.

Who can participate

Age range

16 Years – 24 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * HIV-positive * age 16-24 years * self-reported proficiency in reading and understanding English. * PHQ9 score of 8-17 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Engagement

Timeframe: 3 months

Patient Satisfaction with Interventionn

Timeframe: 3 months

Feasibility 1

Timeframe: 3 months

Feasibility 2

Timeframe: 3 months

Feasibility 3

Timeframe: 3 months

Feasibility 4

Timeframe: 3 months

Feasibility 5

Timeframe: Baseline

Feasibility 6

Timeframe: 3 months

Trial details

NCT IDNCT06389565

SponsorMassachusetts General Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-06-30

Contact for this trial

Aima a Ahonkhai, MD

617-726-3906 AAHONKHAI@mgh.harvard.edu

View on ClinicalTrials.gov More Hiv trials

Plain-language summary

Who can participate

Age range

16 Years – 24 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.