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Behavioral Intervention

Mobile Health Intervention for Depression in Youth with HIV

N/A
Recruiting
Research Sponsored by Washington University School of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 1 month, 2 months, 6 months
Awards & highlights

Study Summary

This trial will create a digital therapy tool to help Ugandan teens with HIV and depression, using CBT to improve mental health and ART adherence.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
As this is a psychological intervention delivered via an app focusing on cognitive-behavioral therapy techniques, there may be minimal physical side effects but could include increased anxiety or emotional distress initially.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 1 month, 2 months, 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 1 month, 2 months, 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Patient Health Questionnaire (PHQ-9) Health Questionnaire (PHQ-9)
Secondary outcome measures
ART Treatment Adherence
Brief Symptoms Index (BSI)
HIV/AIDS Stigma and Discrimination Scale
+5 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Waitlist ControlExperimental Treatment1 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-MhealthExperimental Treatment1 Intervention
Participants in this condition will receive the Suubi-Mhealth intervention delivered via a smart phone app.

Find a Location

Who is running the clinical trial?

National Institute of Mental Health (NIMH)NIH
2,786 Previous Clinical Trials
2,689,431 Total Patients Enrolled
Washington University School of MedicineLead Sponsor
1,937 Previous Clinical Trials
2,299,417 Total Patients Enrolled

Media Library

Suubi-Mhealth (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05965245 — N/A
HIV/AIDS Research Study Groups: Suubi-Mhealth, Waitlist Control
HIV/AIDS Clinical Trial 2023: Suubi-Mhealth Highlights & Side Effects. Trial Name: NCT05965245 — N/A
Suubi-Mhealth (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05965245 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is eligibility for this trial restricted to individuals under a certain age?

"In compliance with the enrolment criteria, those aged 14 to 17 can join this particular clinical trial."

Answered by AI

What are the eligibility requirements for enrolling in this research?

"Eligibility requirements for this clinical trial include a diagnosed depression and an age range of 14 to 17 years old. At present, the study is seeking 278 participants."

Answered by AI

Are there any additional participants required for this clinical investigation?

"Affirmative. The clinicaltrials.gov webpage reveals that this trial is immediately searching for able candidates, with the initial posting taking place on November 23rd of 2022 and last updated July 19th 2023. A total of 278 participants are needed to be recruited from 2 different medical facilities."

Answered by AI

How many participants are being invited to join this medical trial?

"Affirmative. Clinicaltrials.gov states that this medical trial, initially published on November 23rd 2022, is still open to new participants. Specifically, 278 patients must be sourced from 2 different healthcare providers."

Answered by AI
~53 spots leftby Aug 2024