Assessing the Implementation and Potential Effects of the Nishauri mHealth Intervention on HIV Care Among Men in Homa Bay County, Kenya: Protocol for a Mixed Methods Study.

BACKGROUND

About 2.4% of Kenyan people (approximately 1.3 million people) are living with HIV. Despite advances in antiretroviral therapy, 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 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 effects on HIV care engagement and treatment outcomes, (2) explore the role of masculine identity in modifying acceptability and uptake, and (3) identify barriers and facilitators of adoption, use, and sustainment.

METHODS

We will use a mixed methods design combining a stepped-wedge cluster approach and a pre- and postimplementation assessment across 4 health facilities in Homa Bay County, Kenya. Approximately 347 men receiving HIV treatment who own a smartphone will be enrolled. The stepped-wedge design will sequentially introduce the intervention across the 4 facilities in 2-month intervals following baseline assessments, allowing each site to serve as its own control. Surveys will collect data on sociodemographics, masculinity, intervention acceptability and uptake, and HIV clinical outcomes using validated measures. Intervention effects on pre- and postbinary outcomes will be assessed using the McNemar test, while generalized estimating equations (α=.05; β=.2; 95% CI) will account for clustering and repeated measures in the stepped-wedge analysis. Focus group discussions (n=5-6) will be conducted with men living with HIV, health care providers, and app developers to explore barriers and facilitators of implementation and adoption. Focus group discussions will be audio-recorded, transcribed, coded, and analyzed thematically.

RESULTS

This study received institutional review board approval in July 2025 and was registered on ClinicalTrials.gov in August 2025. Recruitment began in September 2025 and concluded in November 2025. A total of 307 men living with HIV were recruited across the 4 clinics for the pre- and postquantitative assessment. 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 the Nishauri mHealth intervention on antiretroviral therapy adherence and clinic attendance among men 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-HIV-burden settings. Findings will inform the design, scalability, and optimization of similar interventions by identifying key implementation barriers and facilitators.