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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

278 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-23

Study Completion Date

2027-08-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Depression HIV Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Suubi-Mhealth

Participants in this condition will receive the Suubi-Mhealth intervention delivered via a smart phone app.

Group Type EXPERIMENTAL

Suubi-Mhealth

Intervention Type BEHAVIORAL

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.

Waitlist Control

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 Type OTHER

Suubi-Mhealth

Intervention Type BEHAVIORAL

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.

Interventions

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Suubi-Mhealth

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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 to participate in the study.

Exclusion Criteria

* 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

Minimum Eligible Age

14 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No