Ignite Creation Date:
2024-05-06 @ 7:18 PM
Last Modification Date:
2025-12-17 @ 5:12 PM
Study NCT ID:
NCT05965245
Status:
None
Last Update Posted:
2025-03-28 00:00:00
First Post:
2023-07-12 00:00:00
Brief Title:
Suubi-Mhealth: A Mobile Health Intervention to Address Depression Among Youth
Sponsor:
Washington University School of Medicine
Organization:
Washington University School of Medicine
Study Overview
Official Title:
Suubi-Mhealth: A Mobile Health Intervention to Address Depression and Improve ART Adherence Among Youth Living With HIV (YLHIV) in Uganda
Status:
None
Status Verified Date:
2025-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
Detailed Description:
Approximately 17 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 N30 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 N200 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None