Mobile Health Intervention for Depression in Youth with HIV

Recruiting at 1 trial location

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

Trial Summary

What is the purpose of this trial?

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 depression, taking into account their unique contextual, cultural, and developmental needs. This digital therapy intervention delivered via a mobile application, will utilize the core tenets of cognitive-behavioral therapy (CBT) found to improve depression and ART adherence.

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 data supports the effectiveness of the treatment Suubi-Mhealth for depression in youth with HIV?

Research shows that mobile health interventions can help reduce depression in people living with HIV. A study on a similar treatment, Health and Wellness Cognitive Behavioral Therapy, showed improvement in depression symptoms among youth with HIV, suggesting that Suubi-Mhealth might also be effective. ^{1 2 3 4 5}

How is the Suubi-Mhealth treatment different from other treatments for depression in youth with HIV?

The Suubi-Mhealth treatment is unique because it uses a mobile health intervention, which may offer more accessible and personalized support compared to traditional in-person therapies. This approach can be particularly beneficial for youth with HIV, who may face barriers to accessing regular mental health care. ^{5 6 7 8 9}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

References

1. United States pubmed.ncbi.nlm.nih.gov

Development and Implementation of Health and Wellness CBT for Individuals with Depression and HIV. [2021]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Validity of an interviewer-administered patient health questionnaire-9 to screen for depression in HIV-infected patients in Cameroon. [2022]

3. Canada pubmed.ncbi.nlm.nih.gov

Long-term Effects of a Social Media-Based Intervention (Run4Love) on Depressive Symptoms of People Living With HIV: 3-Year Follow-up of a Randomized Controlled Trial. [2022]

4. England pubmed.ncbi.nlm.nih.gov

A non-specialist depression care pathway for adolescents living with HIV and transitioning into adult care in Peru: a nested, proof of concept pilot study. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Screening for depression among youth with HIV in an integrated care setting. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

Site-Randomized Controlled Trial of a Combined Cognitive Behavioral Therapy and a Medication Management Algorithm for Treatment of Depression Among Youth Living With HIV in the United States. [2023]

7. Germany pubmed.ncbi.nlm.nih.gov

Which HIV-infected youth are at risk of developing depression and what treatments help? A systematic review focusing on Southern Africa. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Prevalence of Depressive Symptoms and Associated Factors among HIV-Positive Youth Attending ART Follow-Up in Addis Ababa, Ethiopia. [2020]

9. England pubmed.ncbi.nlm.nih.gov

Development and validation of a 20-item screening scale to detect major depressive disorder among adolescents with HIV in rural Uganda: A mixed-methods study. [2022]