Assessing the Implementation and Effects of Nishauri m-Health Intervention on HIV Care and Treatment Outcomes Among Men Living With HIV in Homa Bay County, Kenya
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 347
- 主要终点
- Proportion of missed clinic appointments
研究概览
简要总结
About 1.3 million people in Kenya are living with HIV, and Homa Bay County has the highest rate in the country. Even though HIV treatment has improved, many men still face challenges staying in care, taking their medicine, and achieving good health. This is often because of stigma, male gender norms, and lack of support designed specifically for men.
Nishauri is a mobile health (mHealth) app created to help people living with HIV by sending reminders, health tips, and other support through their phones. It has already reached over 300,000 users in Kenya. However, it is not yet clear how well it works for men in improving care and treatment.
This study, led by Maseno University in Kenya and the University of California San Francisco in the U.S., will test how the Nishauri app affects men's HIV care. We will work with 347 men aged 18 to 55 who own a smartphone or tablet and are already receiving HIV treatment at four clinics in Homa Bay. We will collect information through surveys before and after using the app, and also conduct focus group discussions to better understand what helps or makes it hard for men to use the app.
We believe that using Nishauri will help improve men's treatment outcomes-like staying in care, taking medicine regularly, and having lower viral load.
详细描述
Introduction Background Globally, men are 27% less likely than women to seek HIV testing and often present to care at later stages of illness. In sub-Saharan Africa, men's participation in HIV care is further constrained by cultural expectations that prioritize economic provision and emotional suppression. Kenya continues to face significant challenges in the fight against HIV/AIDS, with an estimated 1.3 million people living with HIV. Despite advances in antiretroviral therapy (ART) and HIV care services, men experience persistent barriers to accessing and engaging with care. Masculine norms around strength, stoicism, and self-reliance often discourage men from seeking health services, including HIV testing and treatment, contributing to lower engagement and adherence among men living with HIV. The lack of male-targeted interventions compounds these challenges, making it critical to develop and evaluate strategies that effectively engage men in care to achieve the UNAIDS 95-95-95 targets by 2030.
Mobile health (mHealth) interventions have emerged as promising tools for improving healthcare delivery and patient engagement, particularly in resource-constrained settings. By leveraging mobile devices to deliver health-related information and services, mHealth strategies help bridge critical gaps in access, communication, and continuity of care. Evidence from low- and middle-income countries (LMICs) suggests that mHealth interventions can enhance antiretroviral therapy (ART) adherence, retention in care, and health literacy among people living with HIV.
Globally, tools such as SMS reminders and mobile applications have demonstrated significant potential to improve clinical outcomes, including ART adherence, retention, and viral suppression. In sub-Saharan Africa, where healthcare access is often limited, mHealth approaches have been effective in reducing loss to follow-up and improving engagement in care. For instance, studies in Uganda and South Africa show that mobile reminders and SMS-based counseling significantly improve adherence and retention among HIV-positive individuals. These tools facilitate behavior change through personalized messaging, medication reminders, and educational content. Critically, gender-sensitive and culturally adapted mHealth interventions are more effective among men, as they address stigma and align health-seeking behaviors with socially accepted masculine norms. However, there remains limited evidence on the implementation outcomes, service outcomes, and long-term sustainability of mHealth interventions specifically tailored for men in HIV care in Kenya.
While mHealth technologies have shown promise in improving HIV care outcomes, their adoption and sustained use face significant challenges. These include digital literacy gaps, inconsistent device ownership, limited infrastructure, and concerns around data privacy and confidentiality. In Kenya, mobile phone ownership and digital access vary by gender, education level, and socioeconomic status, with individuals who own smartphones and have higher education levels being more likely to engage with mHealth services. Moreover, the integration of mHealth tools into routine HIV care remains limited, particularly in rural, high-prevalence settings like Homa Bay County. Although urban and educated populations may benefit more readily from these tools, long-term adoption, utilization, and sustainability, especially among men living with HIV, are still poorly understood. These structural and behavioral challenges underscore the need to examine how mHealth can be more equitably implemented across diverse populations.
Despite their potential, many mHealth interventions are not adequately aligned with the gendered and socio-cultural realities that shape care-seeking behaviors, particularly among men. Programs often lack meaningful involvement of healthcare providers and fail to tailor their content or delivery to address male-specific barriers or local norms. Discreet and convenient by design, mHealth tools may still fall short if they do not resonate with prevailing masculine identities or reframe care-seeking in ways that affirm strength and responsibility. In high-burden regions like Homa Bay County, where HIV prevalence stands at 16.2%, men often disengage from care due to stigma and perceived threats to masculinity. Addressing these critical gaps in implementation, cultural alignment, and gender responsiveness is essential for developing effective, sustainable mHealth solutions that can improve HIV treatment outcomes for men.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years(Adult)
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male, own a smart phone or tablet, aged 18-55, willing and able to provide written informed consent.
排除标准
- •Any mental or serious chronic illness that may affect particiattion and credibility of data being collected for the study.
研究组 & 干预措施
Control
Participants accessing HIV treatment from the facilities during the control period for such facilities will receive standard of care.
Nishauri mHealth Intervention arm
when a health facility will eb in its intervention period, based on the sequential roll out of the stepped wedge design, men living with HIV accessing care and treatment for HIV from such a facility will be using the Nishauri mHealth app, as guided and supported by their respective peer educators.
干预措施: Nishauri mHealth Intervention (Other)
结局指标
主要结局
Proportion of missed clinic appointments
时间窗: From enrollment to the end of the intervention at 6 weeks.
Proportion of participants who miss any type of scheduled clinic appointment per study arm, during the intervention period.
次要结局
未报告次要终点
研究者
Dan Omollo
Junior Faculty & PhD Candidate, School of Public Health, Maseno University
Maseno University
