Suubi-Mhealth: A Mobile Health Intervention to Address Depression Among Youth

Last updated: March 24, 2025
Sponsor: Washington University School of Medicine
Overall Status: Active - Recruiting

Phase

N/A

Condition

Hiv/aids

Aids And Aids Related Infections

Depression

Treatment

Suubi-Mhealth

Clinical Study ID

NCT05965245
R21MH131044
  • Ages 14-17
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Ages 14-17 years

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

  • Prescribed antiretroviral therapy

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

  • Health care providers who work with youth at participating clinics who agree toparticipate in the study.

Exclusion

Exclusion Criteria:

  • A significant cognitive impairment that interferes with the participant'sunderstanding of the informed consent process, or inability/unwillingness to committo completing the study

Study Design

Total Participants: 278
Treatment Group(s): 1
Primary Treatment: Suubi-Mhealth
Phase:
Study Start date:
November 23, 2022
Estimated Completion Date:
August 31, 2027

Study Description

Approximately 1.7 million children under 15 years old were living with HIV in 2020; and most new HIV infections (85%) occurred in Sub-Saharan Africa (SSA). People living with HIV (PLHIV) often struggle with mental health comorbidities that lower their antiretroviral therapy (ART) adherence. However, 76% to 85% of PLHIV in SSA receive no treatment for serious mental health disorders, especially depression. Depression reduces ART adherence, which negatively impacts health and increases HIV transmission risks. Older adolescents (≥14 years) living with HIV are particularly vulnerable to these risks as caregivers withdraw or lessen their support during their transition to young adulthood. Moreover, older adolescents are also moving into larger and less accommodating adult HIV clinic settings and are at risk for dropping out of ART programs. Given that mental health services are severely under equipped in SSA, including in Uganda, and are inaccessible by many YLHIV, new solutions to increase access to mental health care and close the treatment gap are urgently needed. 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. The study will specifically: Phase 1. R21 Aim 1: Develop and iteratively refine an intervention protocol for Suubi-Mhealth based on formative work to understand needs of youth living with HIV (YLHIV). Four focus groups with youth and two focus groups with health care providers (6-8 youth each) will be conducted for feedback on intervention content and methods to increase participation and retention. R21 Aim 2: Based on results of Aim 1, explore the feasibility and acceptability of Suubi-Mhealth on a small scale (N=30), to inform subsequent refinement for the larger R33 phase. Phase 2. R33 Aim 1: Test the preliminary impact of Suubi-Mhealth versus a waitlist control group (N=200), on youth outcomes (depression, ART adherence, mental health functioning, quality of life, stigma). R33 Aim 2: Examine barriers and facilitators for integrating Suubi-Mhealth into health care settings for YLHIV. The study will be conducted in 10 health clinics in the greater Masaka region in Southern Uganda. Suubi-Mhealth is expected to be an acceptable and feasible mHealth tool to reduce depression, improve ART adherence and overall mental health functioning among YLHIV. If the results of this pilot are promising, then the next step is an R01 to rigorously test Suubi-Mhealth in a larger trial, spanning multiple sites across Uganda.

Connect with a study center

  • International Center for Child Health and Development (ICHAD)

    Masaka,
    Uganda

    Active - Recruiting

  • Washington University in St. Louis

    Saint Louis, Missouri 63130
    United States

    Site Not Available

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