Implementation and Effects of Nishauri on HIV Treatment Outcomes Among Men

NCT07116538 | Not Yet Recruiting

• 2 other identifiers: MSU/DRPI/MUSERC/01502/25D43TW011306
• Study Type: interventional
• Target: 347
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

HIV Antiretroviral Therapy (ART) Adherence

Outcome Measures

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.

  From enrollment to the end of the intervention at 6 weeks.

Study Arms (2)

Control

NO INTERVENTION

Participants accessing HIV treatment from the facilities during the control period for such facilities will receive standard of care.

Nishauri mHealth Intervention arm

EXPERIMENTAL

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.

Other: Nishauri mHealth Intervention

Interventions

Nishauri mHealth Intervention OTHER

The 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.

Nishauri mHealth Intervention arm

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Male, own a smart phone or tablet, aged 18-55, willing and able to provide written informed consent.

You may not qualify if:

• Any mental or serious chronic illness that may affect particiattion and credibility of data being collected for the study.

Sponsors & Collaborators

• Maseno University: lead
• Fogarty International Center of the National Institute of Health: collaborator

Central Study Contacts

Dan Omollo, MPH

CONTACT

+254724734312; danodomany@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Junior Faculty & PhD Candidate, School of Public Health, Maseno University

Model Details: The study will use an explanatory sequential mixed methods design- with a cluster randomized stepped-wedge trial across four health facilities. The stepped-wedge component consists of 6 steps, each lasting 2 months, with an intervention period of 6 months. At the beginning , all facilities will be in the control condition. The intervention will then be rolled out sequentially in a randomized order at each step until all facilities have received the intervention. Each facility will serve as its own control before implementation. Quantitative data will be collected at baseline and six months time point using structured surveys, chart reviews, and app analytics to measure acceptability, uptake, retention in care, and VLS. Thereafter, qualitative data will be collected through FGD with men living with HIV, healthcare providers, and app developers to explore barriers and facilitators of adoption, utilization, and sustainment of the intervention.

Study Record Dates

• First Submitted: August 7, 2025
• First Posted: August 11, 2025
• Study Start: August 20, 2025
• Primary Completion: April 20, 2026
• Study Completion (Estimated): July 17, 2026
• Last Updated: August 11, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: The IPD will eb available as from May 2026 until July 2026 (or further depending on approval of study period renewal).
• Access Criteria: De-identified individual participant data (IPD) and supporting documents will be accessible to qualified researchers upon reasonable request, following approval by the study team, via secure, password-protected data transfer.