Clinical trial NCT05965245: Suubi-Mhealth: A Mobile Health Intervention to Address Depression Among Youth
Official title: Suubi-Mhealth: A Mobile Health Intervention to Address Depression and Improve ART Adherence Among Youth Living With HIV (YLHIV) in Uganda
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Depression
HIV Infection
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2023-07-28
Enrollment: 278
Sex: ALL
Minimum age (years): 14
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Patient Health Questionnaire (PHQ-9) Health Questionnaire (PHQ-9)
timeFrame: Baseline, 1 month, 2 months, 6 months
Secondary outcomes:
measure: ART Treatment Adherence
timeFrame: Baseline, 1 month, 2 months, 6 months
measure: Brief Symptoms Index (BSI)
timeFrame: Baseline, 1 month, 2 months, 6 months
measure: Pediatric Quality of Life Inventory (PedsQL)
timeFrame: Baseline, 1 month, 2 months, 6 months
measure: Medical Outcomes Study HIV Health Survey (MOSHIV)
timeFrame: Baseline, 1 month, 2 months, 6 months
measure: HIV/AIDS Stigma and Discrimination Scale
timeFrame: Baseline, 1 month, 2 months, 6 months
measure: Shame Questionnaire
timeFrame: Baseline, 1 month, 2 months, 6 months
measure: Multidimensional Scale of Perceived Social Support
timeFrame: Baseline, 1 month, 2 months, 6 months
measure: Social Support Behavioral Scale (SS-B)
timeFrame: Baseline, 1 month, 2 months, 6 months
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University in St. Louis
state: Missouri
city: Masaka
country: Uganda
facility: International Center for Child Health and Development (ICHAD)
Study officials:
References: