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Uganda – PULESA

Uganda - Pulesa logo
Study titleStrengthening the Blood Pressure Care and Treatment Cascade for Ugandans Living with HIV–Implementation Strategies to SAve Lives (PULESA)
Study designComparative effectiveness stepped wedge cluster randomized trial of two implementation strategies (HTN-BASIC and HTN-PLUS)
Setting/locationKampala and Wakiso District, Uganda (16 HIV clinics)
Study participantsHIV-positive patients over 18 years of age who receiving care at a participating clinic and have been diagnosed with hypertension. Health care providers.
Principal investigatorFred C. Semitala, Infectious Diseases Research Collaboration (IDRC) and Makerere University (Uganda)
MPIsChris Longenecker, University of Washington (USA)
Co-InvestigatorsMoses R. Kamya, Infectious Diseases Research Collaboration (IDRC) and Makerere University (Uganda), Anne Ruhweza Katahoire, Makerere University; James Kayima, Makerere University; Martin Muddu, Makerere University; Jeremy Schwartz, Yale University (USA); Donna Spiegelman, Yale University; Rachel Nugent, RTI International (USA); Gerald Mutungi, Uganda Ministry of Health; Isaac Ssinabulya, Uganda Heart Institute
SummaryThe PULESA study team is working to improve blood pressure screening and control among people living with HIV (PLHIV) in Uganda in a scalable and sustainable manner. Guided by the Consolidated Framework for Implementation Research, the trial is testing the effectiveness, implementation, and cost-effectiveness of two different strategies to integrate evidence-based hypertension and HIV care in Kampala and Wakiso Districts: HTN-BASIC and HTN PLUS.

Study objectives are: 1) to determine the effectiveness of HTN-BASIC and HTN-PLUS strategies to improve hypertension cascade metrics; 2) to determine implementation outcomes of HTN-BASIC and HTN-PLUS strategies (the primary implementation outcome is scalability); and 3) to evaluate the economic and financial sustainability of the integrated care strategies.

The HTN-BASIC intervention will consist of providing consistent access to diagnostic equipment and evidence-based antihypertensive drugs at no cost to the hypertensive patients. A consistent supply of three anti-hypertensive drugs will be supplied to each clinic in the trial.

The HTN-PLUS intervention will have all the components of HTN-BASIC but will also include a more intensive package of activities for clinic staff, including training on hypertension management, differentiated service delivery, remote patient monitoring, and a performance improvement program. This enhanced intervention was developed by the team in consultation with clinicians and health administrators through a human-centered design process.

Sixteen clinics will be randomized to the order in which they will begin intervention, with two clinics initiating the intervention every two months after a run-in (introductory) period. Sites will be additionally randomized to receive the HTN-BASIC package only or the enhanced HTN-PLUS intervention. Clinic data will be collected during the control period, run-in period, and the intervention phase, and an additional longitudinal cohort study will continue for a few months after the intervention phase has concluded to gather more granular detail on how hypertension care is being implemented at the HTN-BASIC and HTN-PLUS sites.

Meet the Team

Fred Semitala (Contact PI)

Fred Semitala (Contact PI)

Makarere University
Chris Longenecker

Chris Longenecker

University of Washington