Implementation and Effects of Nishauri on HIV Treatment Outcomes Among Men
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18-55
SponsorMaseno University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Male, own a smart phone or tablet, aged 18-55, willing and able to provide written informed consent.
Disqualifiers
Any mental or serious chronic illness that may affect particiattion and credibility of data being collected for the study.
Trial design
Design model
Crossover
Treatments tested in this trial
Nishauri mHealth Intervention
Other interventionThe Nishauri mHealth intervention, developed by Palladium with Kenya's Ministry of Health and funded by PEPFAR/CDC, is a client-centered digital platform designed to enhance HIV care in Kenya. It supports appointment scheduling, ART referrals, and patient engagement through features such as automated medication and appointment reminders, tailored health education, two-way communication, and behavior-change strategies. Interoperable with national health systems like KenyaEMR and Ushauri, it enables real-time data exchange and continuity of care. Despite national scale-up, uptake remains low and varies across facilities, providers, and patients, particularly among men, who face unique sociocultural barriers. Addressing gender norms and contextual factors is key to improving implementation and achieving sustained engagement and better outcomes.
Treatment groups
347 Participants
are divided into 2 treatment groupsGroup A: ControlNo intervention 0 interventions
Group B: Nishauri mHealth Intervention armExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Proportion of missed clinic appointments
Proportion of participants who miss any type of scheduled clinic appointment per study arm, during the intervention period.
Time frame
From enrollment to the end of the intervention at 6 weeks.Locations
Sponsors and contacts
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Maseno University
Lead sponsor
Fogarty International Center of the National Institute of Health
Collaborator
Source ClinicalTrials.gov
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