Actively Recruiting

Phase Not Applicable
Age: 16Years - 24Years
All Genders
NCT06389565

Change My Story Task Shifted Mental Health Intervention

Led by Massachusetts General Hospital · Updated on 2025-07-14

80

Participants Needed

1

Research Sites

56 weeks

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

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.

CONDITIONS

Official Title

Change My Story Task Shifted Mental Health Intervention

Who Can Participate

Age: 16Years - 24Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • HIV-positive
  • Age between 16 and 24 years
  • Able to read and understand English
  • PHQ9 score between 8 and 17 with impaired functioning consistent with clinical depression
Not Eligible

You will not qualify if you...

  • Pregnant or nursing
  • On antiretroviral therapy for less than 6 months
  • History of or positive assessment for bipolar or psychotic disorder

AI-Screening

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Trial Site Locations

Total: 1 location

1

University of Ibadan

Ibadan, Oyo State, Nigeria

Actively Recruiting

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Research Team

A

Aima a Ahonkhai, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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