HivNCT06389565
Change My Story Task Shifted Mental Health Intervention
A study testing Problem Solving Therapy and Change My Story in people with Hiv and Depression, run by Massachusetts General Hospital at 1 site in Nigeria.
Trial 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… Read more about this study
- Who is it for?
- Ages 16 to 29 years
- Conditions the study is for
- Hiv, Depression, Psychological Distress
- What is being tested?
- Problem Solving Therapy and Change My Story
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteNigeria
- Study dates
- 9 Jan 2026to 30 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 29 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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)
Who cannot join
- pregnant or nursing
- in care and on ART for <6 months
- history of- or positive assessment for- bipolar or psychotic disorder.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Nigeria1 site, 1 recruiting
- Recruiting
University of Ibadan
Ibadan, Oyo State
Bibilola Oladeji, MBBS, 234 02-2914-130, bibideji@yahoo.com
About this study
Official title: Change My Story: Pilot Randomized Clinical Trial of Change My Story Among Young Persons Living With HIV and Depression
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.
Read the 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. 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.
- Conditions
- Hiv, Depression, Psychological Distress
- Being tested
- Problem Solving Therapy, Change My Story
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Problem Solving TherapyBehavioural
Problem solving therapy (PST) is a cognitive-behavioral therapy (CBT)-based intervention that uses seven basic steps to teach problem solving orientation and skills to equip individuals to manage the impact of stressful life events on their mental health.
Change My StoryOther
Change My Story is a narrative game with a choose-your-own-adventure format in which players navigate emotionally difficult experiences along with the character(s) and interact with the virtual environment to choose a narrative path toward the story's conclusion. It will used to address important obstacles in the mental health treatment gap for Y-PLWH.
| Study group | Role | What they receive |
|---|---|---|
| PST alone | Active comparator | Patients randomized to PST alone will receive PST delivered using a stepped-care approach. Subsequent care will be determined based on participant PHQ-9 score at the week 6 evaluation. All participants who do not achieve remission (PHQ-9 <12) after completion of the additional six-week therapy sessions, will be required to have a referral to either the general MD or psychiatrist at the clinic to determine need for pharmacologic treatment or additional intervention based on local clinical practice guidelines. During each PST session, the HIV counselor will ask the participant structured questions to identify those at risk of suicide, or with adverse reactions to prescribed antidepressants. Participants who indicate suicidality (plan/attempt) during PST sessions, or ongoing refractory disease (at reassessment points) will require immediate consultation by the psychiatry clinic. Receives: Behavioral: Problem Solving Therapy |
| PST with Change My Story | Experimental | In addition to all activities described in the PST alone arm, at enrollment, participants in the arm with Change My Story, will download the game onto their phones, receive instructions about the game and receive recommendations on how to play the game (at least one narrative for one of the three characters) each week within 48 hours of the PST session. Participants will be encouraged to set a weekly reminder alarm for their game play session. Participants will have an opportunity to explore the game at will according to these loose parameters prior to the first PST session. Receives: Behavioral: Problem Solving Therapy; Other: Change My Story |
What is being measured
The primary outcome is the main question the study is designed to answer.
Engagement
The percentage of recommended problem solving therapy sessions attended.
Measured: 3 months
Patient Satisfaction with Interventionn
Based on an adapted version of the client satisfaction questionnaire (CSQ-8). Total scores range from 8 to 32, with the higher number indicating greater satisfaction.
Measured: 3 months
Feasibility 1
Weiner's feasibility of an intervention (FIM). Scales can be created for each measure by averaging responses. Scale values range from 1 to 5.
Measured: 3 months
Feasibility 2
Proportion of consented patients enrolled
Measured: 3 months
Feasibility 3
Proportion of game play sessions interrupted by technical problems
Measured: 3 months
Feasibility 4
Proportion of users requiring mobile phone (at baseline) or requiring a replacement phone (due to loss or theft)
Measured: 3 months
Feasibility 5
Proportion of users requiring mobile phone
Measured: Baseline
Feasibility 6
Proportion of users requiring mobile phone replacement due to loss or theft
Measured: 3 months
Feasibility 7
Proportion in need for additional data bundles
Measured: 3 months
Acceptability 1
Weiner's acceptability of an intervention. Scales can be created for each measure by averaging responses. Scale values range from 1 to 5.
Measured: Once
Acceptability 2
Number of minutes of total game play per month
Measured: up to 3 months
Acceptability 3
Number of days of total game play per month
Measured: up to 3 months
Acceptability 4
Percentage of recommended game play minutes completed
Measured: 3 months
Acceptability 5
Proportion of narratives completed assessed from aggregated game play metrics
Measured: 3 months
Secondary outcomes (4)
Remission of depression.
Patient health questionnaire-9. For this research, a PHQ-9 score < 6 will be considered in remission.
Measured: 3 and 6 months
Remission of psychological distress.
Self reporting questionnaire-20. For this research, a SRQ-20 < 5 will be considered in remission.
Measured: 3 and 6 months
ART adherence
Based on % pharmacy refill
Measured: 3 and 6 months
Viral suppression
VL < 200 copies/mL
Measured: 3 to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2024
- Study start9 Jan 2026
- Primary completion30 Aug 2026 (estimated)
- Study completion30 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HivStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Ibadan
- Responsible party
- Principal investigator, Aimalohi Ahonkhai, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06389565
- Sponsor's protocol ID
- 2024p000857
- Status last verified
- Jul 2026
- First submitted
- 9 Apr 2024
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Eliazer C, Omotosho T, Kuti KM, Pierce LJ, Gray D, Audet CM, Awolude O, Gureje O, Oladeji B, Ahonkhai AA. 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 Dec 3;14:e74199. doi: 10.2196/74199.
PubMed 41337738
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Change My Story: Pilot Randomized Clinical Trial of Change My Story Among Young Persons Living With HIV and Depression
- ClinicalTrials.gov ID
- NCT06389565
- Acronym / sponsor ID
- 2024p000857
- Conditions
- Hiv, Depression, Psychological Distress
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- University of Ibadan
- Study start
- 9 Jan 2026 (actual)
- Primary completion
- 30 Aug 2026 (estimated)
- Study completion
- 30 Aug 2026 (estimated)
- First posted
- 29 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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. 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PST alone | Active comparator | Behavioral: Problem Solving TherapyPatients randomized to PST alone will receive PST delivered using a stepped-care approach. Subsequent care will be determined based on participant PHQ-9 score at the week 6 evaluation. All participants who do not achieve remission (PHQ-9 <12) after completion of the additional six-week therapy sessions, will be required to have a referral to either the general MD or psychiatrist at the clinic to determine need for pharmacologic treatment or additional intervention based on local clinical practice guidelines. During each PST session, the HIV counselor will ask the participant structured questions to identify those at risk of suicide, or with adverse reactions to prescribed antidepressants. Participants who indicate suicidality (plan/attempt) during PST sessions, or ongoing refractory disease (at reassessment points) will require immediate consultation by the psychiatry clinic. |
| PST with Change My Story | Experimental | Behavioral: Problem Solving Therapy, Other: Change My StoryIn addition to all activities described in the PST alone arm, at enrollment, participants in the arm with Change My Story, will download the game onto their phones, receive instructions about the game and receive recommendations on how to play the game (at least one narrative for one of the three characters) each week within 48 hours of the PST session. Participants will be encouraged to set a weekly reminder alarm for their game play session. Participants will have an opportunity to explore the game at will according to these loose parameters prior to the first PST session. |
Who may qualify
- Ages
- 16 to 29 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (3 listed)
- pregnant or nursing
- in care and on ART for <6 months
- history of- or positive assessment for- bipolar or psychotic disorder.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Problem Solving TherapyProblem solving therapy (PST) is a cognitive-behavioral therapy (CBT)-based intervention that uses seven basic steps to teach problem solving orientation and skills to equip individuals to manage the impact of stressful life events on their mental health. | Behavioural | PST alone, PST with Change My Story |
| Change My StoryChange My Story is a narrative game with a choose-your-own-adventure format in which players navigate emotionally difficult experiences along with the character(s) and interact with the virtual environment to choose a narrative path toward the story's conclusion. It will used to address important obstacles in the mental health treatment gap for Y-PLWH. | Other | PST with Change My Story |
Primary outcome
Engagement
Time frame: 3 months
The percentage of recommended problem solving therapy sessions attended.
Patient Satisfaction with Interventionn
Time frame: 3 months
Based on an adapted version of the client satisfaction questionnaire (CSQ-8). Total scores range from 8 to 32, with the higher number indicating greater satisfaction.
Feasibility 1
Time frame: 3 months
Weiner's feasibility of an intervention (FIM). Scales can be created for each measure by averaging responses. Scale values range from 1 to 5.
Feasibility 2
Time frame: 3 months
Proportion of consented patients enrolled
Feasibility 3
Time frame: 3 months
Proportion of game play sessions interrupted by technical problems
Feasibility 4
Time frame: 3 months
Proportion of users requiring mobile phone (at baseline) or requiring a replacement phone (due to loss or theft)
Feasibility 5
Time frame: Baseline
Proportion of users requiring mobile phone
Feasibility 6
Time frame: 3 months
Proportion of users requiring mobile phone replacement due to loss or theft
Feasibility 7
Time frame: 3 months
Proportion in need for additional data bundles
Acceptability 1
Time frame: Once
Weiner's acceptability of an intervention. Scales can be created for each measure by averaging responses. Scale values range from 1 to 5.
Acceptability 2
Time frame: up to 3 months
Number of minutes of total game play per month
Acceptability 3
Time frame: up to 3 months
Number of days of total game play per month
Acceptability 4
Time frame: 3 months
Percentage of recommended game play minutes completed
Acceptability 5
Time frame: 3 months
Proportion of narratives completed assessed from aggregated game play metrics
4 secondary outcomes
Remission of depression.
Time frame: 3 and 6 months
Remission of psychological distress.
Time frame: 3 and 6 months
ART adherence
Time frame: 3 and 6 months
Viral suppression
Time frame: 3 to 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
- Derived from this study: PubMed 41337738Eliazer C, Omotosho T, Kuti KM, Pierce LJ, Gray D, Audet CM, Awolude O, Gureje O, Oladeji B, Ahonkhai AA. 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 Dec 3;14:e74199. doi: 10.2196/74199.
Related trials for Hiv
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Problem Solving Therapy and Change My Story in people with Hiv and Depression, run by Massachusetts General Hospital at 1 site in Nigeria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Nigeria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aima a Ahonkhai, MD (617-726-3906, AAHONKHAI@mgh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Engagement (time frame: 3 months). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06389565, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2026.