JMIR Publications

ABSTRACT

Background:

Approximately 1.3 million people are living with HIV in Kenya. Despite advances in antiretroviral therapy (ART), men continue to experience disproportionately poor engagement in HIV care due to entrenched masculine norms, stigma, and lack of tailored interventions. Mobile health (mHealth) platforms offer a promising strategy to improve care engagement, but their effectiveness remains under-evaluated particularly among men. However, evidence on its implementation and impact among men living with HIV is limited.

Objective:

This study aims to assess the implementation and potential effects of the Nishauri mHealth intervention on HIV care and treatment outcomes among men in western Kenya. Specifically, it seeks to- (1) analyze its potential effects on HIV care and treatment outcomes; (2) explore the role of masculine identity in modifying its acceptability and uptake; and, (3) identify barriers and facilitators of its adoption, utilization and sustainment.

Methods:

We will use mixed-methods design with a stepped wedge and pre-post implementation approaches across four health facilities in Homa Bay County, Kenya—a region with the country’s highest HIV prevalence (16.2%). The study will enroll approximately 347 men receiving HIV treatment who own a smartphone. Surveys will collect socio-demographics, masculinity, intervention acceptability, uptake, and HIV clinical outcomes data using validated scales. The intervention will be sequentially introduced across the facilities over an eight-month period, and we will assess visit attendance and pharmacy refill data using clinical records. Focus group discussions (5-6) will be conducted with (approximately 6) application developers, healthcare providers, and men living with HIV who are on ART to explore barriers and facilitators to adoption, utilization, and sustainment. Audio-recorded FGDs will be transcribed, coded, and analyzed thematically using Dedoose. McNemar’s test will compare pre-post binary outcomes, and Generalized Estimating Equations (α= .05, β= .2, 95% CI) will be used to assess the intervention’s effect via the stepped wedge design, accounting for repeated measures and clustering.

Results:

This study received initial Institutional Review Board approval in July 2025, and was registered on ClinicalTrials.gov in August 2025. Recruitment began in September 2025 and is scheduled to conclude in November 2025. Preliminary findings will describe implementation outcomes and early effects on HIV care engagement.

Conclusions:

This trial will use a stepped wedge design to evaluate the implementation and effects of Nishauri mHealth intervention on ART adherence and clinic attendance among men living with HIV in Homa Bay County. By examining both clinical outcomes and the influence of masculine norms on intervention uptake, it will provide robust evidence on the effectiveness of mHealth strategies tailored for men in low-resource, high-burden settings. Findings from this study will inform the design and scalability of the trial by identifying key implementation barriers and facilitators critical to optimizing intervention delivery and impact. Clinical Trial: Clinical Trials.gov NCT07116538; https://clinicaltrials.gov/study/ NCT07116538