Clinical trial NCT06389565: Pilot Randomized Clinical Trial of Change My Story
Official title: Change My Story: Pilot Randomized Clinical Trial of Change My Story Among Young Persons Living With HIV and Depression
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Hiv
Depression
Psychological Distress
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: University of Ibadan
First posted: 2024-04-29
Enrollment: 80
Sex: ALL
Minimum age (years): 16
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: Young people living with HIV (Y-PLWH) have poor adherence to antiretroviral therapy and engagement in HIV care, making HIV the leading cause of death for African adolescents. Depression and psychological distress are much more common among Y-PLWH than in the general population, and are associated with significantly worse adherence to care and treatment when compared to Y-PLWH without these co-morbid conditions. Thus, untreated depression and severe psychological distress are important contributors to poor HIV outcomes in this population. Nigeria is home to the 4th largest HIV population globally and 10% of Y-PLWH, but mental health screening is not routinely conducted in this setting, and less than 10% of those diagnosed have access to evidence-based care. Despite this treatment gap, few interventions have targeted the mental health needs of Y-PLWH in Africa. The World Health Organization recommends that caregivers of Y-PLWH adopt youth-friendly strategies and incorporate psychosocial services to meet their needs, and that task shifting to non-specialized health workers be used to overcome the dearth of trained professionals in low and middle-income countries. Task-shifted problem Solving Therapy (PST) has been effectively used to treat both depression and psychological distress using a task-shifted approach. However, PST is an intensive strategy (typically 6-15 weekly sessions) often delivered in-person and poor completion rates are associated with less effectiveness -- a concern further magnified during the current COVID-19 climate. Mobile health technologies may be uniquely suited to surmount some of the obstacles for effective A theory-grounded game, Change My Story, has been developed which allows players navigate difficult experiences based on drivers of psychological distress and interact with a virtual environment this research aims to 1) conduct a hybrid implementation-effectiveness pilot RCT for 80 Y-PLWH with depression or psychological distress, and compare feasibility, acceptability, engagement, satisfaction and preliminary effectiveness among individuals receiving PST alone or PST with Change My Story, and 2) use the Consolidated Framework for Implementation Research (CFIR) to assess factors influencing engagement, acceptability, and satisfaction along with facilitators and barriers to implementation delivery.

Eligibility criteria: 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.

Primary outcomes:
measure: Engagement
timeFrame: 3 months
measure: Satisfaction
timeFrame: 3 months
measure: Feasibility 1
timeFrame: 3 months
measure: Feasibility 2
timeFrame: 3 months
measure: Feasibility 3
timeFrame: 3 months
measure: Feasibility 4
timeFrame: 3 months
measure: Feasibility 5
timeFrame: Baseline
measure: Feasibility 6
timeFrame: 3 months
measure: Feasibility 7
timeFrame: 3 months
measure: Acceptability 1
timeFrame: Once
measure: Acceptability 2
timeFrame: up to 3 months
measure: Acceptability 3
timeFrame: up to 3 months
measure: Acceptability 4
timeFrame: 3 months
measure: Acceptability 5
timeFrame: 3 months
Secondary outcomes:
measure: Remission of depression.
timeFrame: 3 and 6 months
measure: Remission of psychological distress.
timeFrame: 3 and 6 months
measure: ART adherence
timeFrame: 3 and 6 months
measure: Viral suppression
timeFrame: 3 and 6 months
Other outcomes:
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