Mobile Health Intervention for Depression in Youth with HIV

Recruiting at 2 trial locations

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Washington University School of Medicine

Must be taking: Antiretrovirals

Disqualifiers: Cognitive impairment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

278 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a mobile health app called Suubi-Mhealth, designed to assist Ugandan teens with both HIV and depression. The app applies cognitive-behavioral therapy principles (a type of talk therapy) to enhance mood and help teens adhere to their HIV medication schedules. Participants living with HIV, prescribed antiretroviral therapy, and experiencing depression may be suitable for this study. Some participants will begin using the app immediately, while others will receive it later. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance mental health and medication adherence for teens with HIV.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications. However, since participants must be on antiretroviral therapy, it seems you will continue with those medications.

What prior data suggests that this mHealth intervention is safe for youth with HIV and depression?

Research shows that mobile health tools like Suubi-Mhealth are generally safe for users. Studies of similar digital treatments suggest they are well-tolerated, with few reports of side effects. Suubi-Mhealth employs cognitive-behavioral therapy (CBT), a common and typically safe method for treating depression.

Specific safety data for Suubi-Mhealth is not yet available, but the technology has been safely applied in other areas. This study focuses on developing the app, so early-phase studies like this one usually assess how the treatment works rather than identifying rare side effects. If the treatment had already been approved for other uses, safety would be less of a concern. However, since this is a new treatment in development, researchers will continue to monitor it to ensure safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Suubi-Mhealth intervention because it leverages mobile technology to address depression in youth with HIV. Unlike traditional treatments that often involve therapy sessions or medication, Suubi-Mhealth delivers support through a smartphone app, making it more accessible and less stigmatizing for young users. This app-based approach allows for continuous, real-time support and engagement with mental health resources, which could lead to better adherence and outcomes compared to conventional methods. Plus, the intervention is designed to be culturally relevant and engaging, which could enhance its effectiveness in this specific population.

What evidence suggests that the Suubi-Mhealth intervention could be effective for depression in youth with HIV?

Research has shown that mobile health (mHealth) tools can help young people with depression feel better and improve their overall health. Studies have found that cognitive-behavioral therapy (CBT), used by the Suubi-Mhealth app, can reduce symptoms of depression. In this trial, participants in the experimental arm will receive the Suubi-Mhealth app, designed specifically for Ugandan youth with both HIV and depression. Although specific data on Suubi-Mhealth's effectiveness is still being gathered, it is based on proven methods like CBT. Early signs suggest that digital tools like this can improve mental health and help young people adhere to their HIV treatment, which is crucial for managing the condition. ^{2 3 6 7 8}

Are You a Good Fit for This Trial?

This trial is for Ugandan youth aged 14-17 who are HIV positive, aware of their status, on antiretroviral therapy, and living with family. Health care providers at participating clinics can also join. It's not for those with cognitive impairments that affect understanding consent or commitment to the study.

Inclusion Criteria

Living within a family, including with extended family members (not in institutions)

Health care providers who work with youth at participating clinics who agree to participate in the study

HIV positive and aware of their status i.e., disclosed to

Exclusion Criteria

I understand the study and am willing to complete it.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Development and Refinement

Develop and iteratively refine an intervention protocol for Suubi-Mhealth based on formative work to understand needs of youth living with HIV (YLHIV). Conduct focus groups for feedback on intervention content and methods.

Not specified

Feasibility and Acceptability Testing

Explore the feasibility and acceptability of Suubi-Mhealth on a small scale (N=30) to inform subsequent refinement for the larger R33 phase.

Not specified

Preliminary Impact Testing

Test the preliminary impact of Suubi-Mhealth versus a waitlist control group (N=200) on youth outcomes such as depression, ART adherence, mental health functioning, quality of life, and stigma.

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Suubi-Mhealth

Trial Overview The Suubi-Mhealth intervention is being tested; it's a mobile app-based digital therapy using cognitive-behavioral principles aimed at improving depression and medication adherence in young people with both HIV and depression.

How Is the Trial Designed?

Group I: Waitlist Control Experimental Treatment 1 Intervention

Participants in this condition will receive the Suubi-Mhealth intervention after the active treatment group. They will also receive a smart phone without the Suubi-Mhealth app at the same time as the intervention group.

Group II: Suubi-Mhealth Experimental Treatment 1 Intervention

Participants in this condition will receive the Suubi-Mhealth intervention delivered via a smart phone app.

Who Is Running the Clinical Trial?

Washington University School of Medicine

Lead Sponsor

Trials

2,027

Recruited

2,353,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Citations

1. reporter.nih.gov reporter.nih.gov/project-details/10950383

Suubi-Mhealth - NIH RePORTER The overall goal of this proposed R21/33 study is to develop an mHealth intervention (Suubi-mhealth) for use among Ugandan youth (14-17 years) with comorbid HIV ...

2. ichad.wustl.edu ichad.wustl.edu/suubi-mhealth/

Suubi-Mhealth This study will generate data-driven knowledge to address depression and ART adherence and will ultimately improve HIV-related health outcomes for youth living ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10960218/

An mHealth Intervention to Address Depression and Improve ... This protocol paper presents the Suubi-Mhealth study, which proposed to develop a mobile health (mHealth) intervention for use among Ugandan youths (14-17 ...

4. withpower.com withpower.com/trial/phase-depressive-disorder-10-2022-a9299

Mobile Health Intervention for Depression in Youth with HIV The overall goal of this study is to develop an mHealth intervention (Suubi-Mhealth) for use among Ugandan youth (14-17 years) with comorbid HIV and ...

5. app.dimensions.ai app.dimensions.ai/details/grant/grant.14351841

Suubi-Mhealth: A mobile health intervention to address ... The overall goal of this proposed R21/33 study is to develop an mHealth intervention (Suubi-mhealth) for use among Ugandan youth (14-17 years) with comorbid HIV ...

6. ichad.wustl.edu ichad.wustl.edu/2025/10/suubi-mhealth-study-achieves-recruitment-milestone/

Suubi-Mhealth Study Achieves Recruitment Milestone - ICHAD The overall goal of the Suubi-Mhealth study (2022-2027) is to develop a mobile health intervention (Suubi-Mhealth) for use among Ugandan youth ...

7. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05965245/suubi-mhealth-a-mobile-health-intervention-to-address-depression-among-youth

Suubi-Mhealth: A Mobile Health Intervention to Address ... The overall goal of this study is to develop an mHealth intervention (Suubi-Mhealth) for use among Ugandan youth (14-17 years) with comorbid ...

8. researchprotocols.org researchprotocols.org/2023/1/e49352/

Mobile Phone Technology for Preventing HIV and Related ... Suubi-Mhealth: A mobile health intervention to address depression and improve ART adherence among Youth living with HIV in Uganda. A protocol ...