Suubi-Mhealth: A Mobile Health Intervention to Address Depression Among Youth
2 other identifiers
interventional
248
2 countries
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable depression
Started Nov 2022
Longer than P75 for not_applicable depression
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 23, 2022
CompletedFirst Submitted
Initial submission to the registry
July 12, 2023
CompletedFirst Posted
Study publicly available on registry
July 28, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 31, 2027
May 12, 2026
May 1, 2026
4.8 years
July 12, 2023
May 11, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Patient Health Questionnaire (PHQ-9) Health Questionnaire (PHQ-9)
Depression will be assessed using the Patient Health Questionnaire (PHQ-9). Change in the mean score on the PHQ-9 over time will be assessed. The total score ranges between 0-27, with higher scores indicating higher levels of depressive symptoms.
Baseline, 1 month, 2 months, 6 months
Secondary Outcomes (8)
ART Treatment Adherence
Baseline, 1 month, 2 months, 6 months
Brief Symptoms Index (BSI)
Baseline, 1 month, 2 months, 6 months
Pediatric Quality of Life Inventory (PedsQL)
Baseline, 1 month, 2 months, 6 months
Medical Outcomes Study HIV Health Survey (MOSHIV)
Baseline, 1 month, 2 months, 6 months
HIV/AIDS Stigma and Discrimination Scale
Baseline, 1 month, 2 months, 6 months
- +3 more secondary outcomes
Study Arms (2)
Suubi-Mhealth
EXPERIMENTALParticipants in this condition will receive the Suubi-Mhealth intervention delivered via a smart phone app.
Waitlist Control
OTHERParticipants 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.
Interventions
Suubi-Mhealth is a theoretically-based digital therapeutics tool that aims to provide educational content on depression while considering the unique needs of SSA youth living with HIV. This educational content will be aligned with scientific recommendations for cognitive-behavioral therapy for adherence and depression as applied to HIV medication adherence. Core instruction will include psychoeducation on the interplay between HIV and depression; minimizing cognitive distortions related to ART adherence and stigma, as well as depression; challenging negative automatic thoughts; analysis and development of behavioral skills; reducing environmental stressors. Suubi-Mhealth will also have a social networking center in which patients can contact the research team, peers who are also taking part in this intervention, and other trusted individuals such as loved ones. Other features include tools for setting and monitoring goals, and a clinical management dashboard for the research team.
Eligibility Criteria
You may qualify if:
- 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 to participate in the study.
You may not qualify if:
- A significant cognitive impairment that interferes with the participant's understanding of the informed consent process, or inability/unwillingness to commit to completing the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Washington University in St. Louis
St Louis, Missouri, 63130, United States
International Center for Child Health and Development (ICHAD)
Masaka, Uganda
Related Publications (1)
Nabunya P, Cavazos-Rehg P, Mugisha J, Kasson E, Namuyaba OI, Najjuuko C, Nsubuga E, Filiatreau LM, Mwebembezi A, Ssewamala FM. An mHealth Intervention to Address Depression and Improve Antiretroviral Therapy Adherence Among Youths Living With HIV in Uganda: Protocol for a Pilot Randomized Controlled Trial. JMIR Res Protoc. 2024 Mar 8;13:e54635. doi: 10.2196/54635.
PMID: 38457202DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
July 12, 2023
First Posted
July 28, 2023
Study Start
November 23, 2022
Primary Completion (Estimated)
August 31, 2027
Study Completion (Estimated)
August 31, 2027
Last Updated
May 12, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ANALYTIC CODE
Once all of the data has been de-identified, cleaned, and validated, and main findings have been published, the Investigators expect to share data with the scientific community. The research team will make datasets available to any individual who makes a direct request to the PI and indicates the data will be used for the purposes of research (per Code of Federal Regulations Title 45 Part 46: "Research is defined as a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge."). In sharing participant data, the team will follow Washington University in St. Louis' Office of Sponsored Projects' data sharing agreement.