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临床试验/NCT05965245
NCT05965245进行中(未招募)不适用

Suubi-Mhealth: A Mobile Health Intervention to Address Depression and Improve ART Adherence Among Youth Living With HIV (YLHIV) in Uganda

Washington University School of Medicine4 个研究点 分布在 2 个国家目标入组 248 人开始时间: 2022年11月23日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
248
试验地点
4
主要终点
Patient Health Questionnaire (PHQ-9) Health Questionnaire (PHQ-9)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
14 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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

研究组 & 干预措施

Suubi-Mhealth

Experimental

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

干预措施: Suubi-Mhealth (Behavioral)

Waitlist Control

Other

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.

干预措施: Suubi-Mhealth (Behavioral)

结局指标

主要结局

Patient Health Questionnaire (PHQ-9) Health Questionnaire (PHQ-9)

时间窗: Baseline, 1 month, 2 months, 6 months

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.

次要结局

  • Social Support Behavioral Scale (SS-B)(Baseline, 1 month, 2 months, 6 months)
  • Medical Outcomes Study HIV Health Survey (MOSHIV)(Baseline, 1 month, 2 months, 6 months)
  • Multidimensional Scale of Perceived Social Support(Baseline, 1 month, 2 months, 6 months)
  • Pediatric Quality of Life Inventory (PedsQL)(Baseline, 1 month, 2 months, 6 months)
  • Shame Questionnaire(Baseline, 1 month, 2 months, 6 months)
  • ART Treatment Adherence(Baseline, 1 month, 2 months, 6 months)
  • Brief Symptoms Index (BSI)(Baseline, 1 month, 2 months, 6 months)
  • HIV/AIDS Stigma and Discrimination Scale(Baseline, 1 month, 2 months, 6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Proscovia Nabunya

Assistant Professor

Washington University School of Medicine

研究点 (4)

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