An mHealth Intervention to Address Depression and Improve Antiretroviral Therapy Adherence Among Youths Living With HIV in Uganda: Protocol for a Pilot Randomized Controlled Trial

BackgroundPeople living with HIV often struggle with mental health comorbidities that lower their antiretroviral therapy (ART) 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 underequipped 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, which proposed to develop a mobile health (mHealth) intervention for use among Ugandan youths (14-17 years) with comorbid HIV and depression, taking into account their unique contextual, cultural, and developmental needs. ObjectiveThe proposed study is guided by the following objectives: (1) to develop and iteratively refine an intervention protocol for Suubi-Mhealth based on formative work to understand the needs of youths living with HIV; (2) to explore the feasibility and acceptability of Suubi-Mhealth on a small scale to inform subsequent refinement; (3) to test the preliminary impact of Suubi-Mhealth versus a waitlist control group on youths’ outcomes, including depression and treatment adherence; and (4) to examine barriers and facilitators for integrating Suubi-Mhealth into health care settings. MethodsYouths will be eligible to participate in the study if they are (1) 14-17 years of age, (2) HIV-positive and aware of their status, (3) receiving care and ART from one of the participating clinics, and (4) living within a family. The study will be conducted in 2 phases. In phase 1, we will conduct focus group discussions with youths and health care providers, for feedback on the proposed intervention content and methods, and explore the 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. ResultsParticipant recruitment for phase 1 is completed. Youths and health care 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 have been completed. The team is currently developing Suubi-Mhealth content based on participants’ feedback. ConclusionsThis study will lay important groundwork for several initiatives at the intersection of digital therapeutics, HIV treatment, and mental health, especially among sub-Saharan African youths, as they transition through adolescence and into adult HIV care settings. Trial RegistrationClinicalTrials.gov NCT05965245; https://clinicaltrials.gov/study/NCT05965245 International Registered Report Identifier (IRRID)DERR1-10.2196/5463

Mobile Phone Technology for Preventing HIV and Related Youth Health Problems, Sexual Health, Mental Health, and Substance Use Problems in Southwest Uganda (Youth Health SMS): Protocol for a Pilot Randomized Controlled Trial

BackgroundEast and Southern Africa have the highest HIV incidence and prevalence in the world, with adolescents and young adults being at the greatest risk. Despite effective combination prevention tools, including the recently available pre-exposure prophylaxis (PrEP), HIV incidence among adolescents and young adults in Uganda remains high, and PrEP use remains low. Mental health and substance use (behavioral health) play a role in sexual behavior and decision-making, contributing to an increase in the risk for acquiring HIV. Interventions that target multiple HIV risk factors, including sexual and mental health and problematic substance use, are crucial to ending the HIV epidemic. Yet few interventions addressing HIV related health disparities and comorbidities among adolescents and young adults in East and Southern Africa currently exist. ObjectiveThis study aims to evaluate the acceptability and feasibility of Kirabo, an SMS text message intervention informed by the information, motivation, and behavior model and to be disseminated through secondary schools. The study will gather preliminary estimates of Kirabo’s effectiveness in increasing HIV testing and linking users to mental health counselors. MethodsWe identified Mobile 4 Reproductive Health for adaptation using the assessment, decision, administration, production, topical experts, integration, training, testing (ADAPT-ITT) framework. Mobile 4 Reproductive Health is an evidence-based automated 2-way SMS text messaging and interactive voice response platform that offers sexual and reproductive health information and links users to HIV clinics in East Africa. Through ADAPT-ITT we refined our approach and created Kirabo, an SMS text message–based intervention for linking adolescents and young adults to health services, including HIV testing and mental health counseling. We will conduct a 2-arm randomized controlled trial in Masaka, Uganda. Adolescents (N=200) will be recruited from local schools. Baseline sociodemographic characteristics, HIV test history, and behavioral health symptoms will be assessed. We will evaluate acceptability and feasibility using surveys, interviews, and mobile phone data. The preliminary efficacy of Kirabo in increasing HIV testing and linking users to mental health counselors will be evaluated immediately after the intervention and at the 3-month follow-up. We will also assess the intervention’s impact on self-efficacy in testing for HIV, adopting PrEP, and contacting a mental health counselor. ResultsIntervention adaptation began in 2019. A pretest was conducted in 2021. The randomized controlled trial, including usability and feasibility assessments and effectiveness measurements, commenced in August 2023. ConclusionsKirabo is a tool that assists in the efforts to end the HIV epidemic by targeting the health disparities and comorbidities among adolescents in Uganda. The intervention includes local HIV clinic information, PrEP information, and behavioral health screening, with referrals as needed. Increasing access to prevention strategies and mitigating factors that make adolescents and young adults susceptible to HIV acquisition can contribute to global efforts to end the HIV epidemic. Trial RegistrationClinicalTrials.gov NCT05130151; https://clinicaltrials.gov/study/NCT05130151 International Registered Report Identifier (IRRID)DERR1-10.2196/4935