Suubi-Mhealth: A study protocol for a mobile health intervention to address depression and improve ART adherence among Youth living with HIV in Uganda (Preprint)

Abstract

People living with HIV often struggle with mental health comorbidities that lower their antiretroviral therapy adherence. There is growing evidence that depression treatment may improve ART adherence and result in improved HIV outcomes. Given that mental health services are severely under equipped in low resource settings, including in Uganda, new solutions to increase access to mental health care and close the treatment gap are urgently needed. This protocol paper presents the Suubi-Mhealth study, proposed to develop an mHealth intervention for use among Ugandan youth (14-17 years) with comorbid HIV and depression, taking into account their unique contextual, cultural, and developmental needs.

The proposed study is guided by the following objectives: 1) develop and iteratively refine an intervention protocol for Suubi-Mhealth based on formative work to understand the needs of youth living with HIV, 2) explore the feasibility and acceptability of Suubi-Mhealth on a small scale to inform subsequent refinement, 3) test the preliminary impact of Suubi-Mhealth versus a waitlist control group on youth outcomes, including depression and treatment adherence, and 4) examine barriers and facilitators for integrating Suubi-Mhealth into health care settings.

Youth will be eligible to participate in the study if they are: 1) aged 14-17 years, 2) HIV positive and aware of their status, 3) receiving care and ART from one of the participating clinics, 4) and living within a family. The study will be conducted in two phases. In phase 1, we will conduct focus groups with youth and health care providers, for feedback on the proposed intervention content and methods, and explore feasibility and acceptability of the intervention. In phase II, we will pilot test the preliminary impact of the intervention on reducing depression and improving ART adherence. Assessments will be conducted at baseline, 1-, 2- and 6-months post- intervention completion.

Participant recruitment for Phase 1 is completed. Youth and healthcare providers participated in focus group discussions to share their feedback on the proposed Suubi-Mhealth intervention content, methods, design and format. Transcription and translation of focus group discussions has been completed. The team is currently developing Suubi-Mhealth content based on participants’ feedback.

This study will lay important groundwork for several initiatives at the intersection of digital therapeutics, HIV treatment, and mental illness, especially among sub–Saharan African youth, as they transition through adolescence and into adult HIV care settings.

https://clinicaltrials.gov/study/NCT05965245