Integrating hypertension detection and management in HIV care in South Africa: protocol for a stepped-wedged cluster randomized effectiveness-implementation hybrid trial
Authors: Galaviz Karla I. , Patel Shivani A. , Siedner Mark J. , Goss Charles W. , Gumede Siphamandla B. , Johnson Leslie C. , Ordóñez Claudia E. , Laxy Michael , Klipstein-Grobusch Kerstin , Heine Martin , Masterson Mary , Mody Aaloke , Venter W. D. Francois , Marconi Vincent C. , Ali Mohammed K. , Lalla-Edward Samanta T. 
Published: October 2024

Abstract
Background
HIV clinical guidelines recommend hypertension detection and management to lower cardiovascular disease risk, but these have not been effectively implemented for people living with HIV (PWH). Addressing this implementation gap requires community-engaged implementation studies focused on addressing implementation barriers specific to the HIV care context.

Methods
This protocol describes a type 2 effectiveness-implementation hybrid study conducted in nine primary care clinics in Johannesburg. The study will evaluate the effect of implementation strategies on guideline-recommended blood pressure assessment and management in HIV clinics and the effects of assessment/management on patient blood pressure. A stepped-wedge, cluster randomized study design was used to randomize clinics to the time at which they receive the implementation strategies and patient intervention. The implementation strategies tested include identifying and preparing care champions, changing record systems, conducting ongoing training, providing audit and feedback, and changing the physical structure/equipment. The patient intervention tested includes detection of elevated blood pressure, educational materials, lifestyle modification advice, and medication where needed. Implementation outcomes include adoption, fidelity (co-primary outcome), cost, and maintenance of the blood pressure assessment protocol in participating clinics, while patient outcomes include reach, effectiveness (co-primary outcome), and long-term effects of the intervention on patient blood pressure. These will be assessed via direct observation, study records, staff logs, medical chart reviews, and patient and healthcare worker surveys. To examine effects on the implementation (intervention fidelity) and effectiveness (patient blood pressure changes) co-primary outcomes, we will use the standard Hussey and Hughes model for analysis of stepped-wedge designs which includes fixed effects for both interventions and time periods, and a random effect for sites. Finally, we will examine the costs for the implementation strategies, healthcare worker time, and patient-facing intervention materials, as well as the cost-effectiveness and cost-utility of the intervention using study records, patient surveys, and a time and motion assessment.

Discussion
This study will address knowledge gaps around implementation of cardiovascular disease preventive practices in HIV care in South Africa. In doing so, it will provide a dual opportunity to promote evidence-based care in the South African HIV care context and help refine implementation research methods to better serve HIV populations globally.

Trial registration
ClinicalTrials.gov: NCT05846503. Registered on May 6, 2023. https://classic.clinicaltrials.gov/ct2/show/NCT05846503.