Integration of a Task Strengthening Strategy for Hypertension Management into HIV Care in Nigeria: a Cluster Randomized Controlled Trial Study Protocol

Abstract

BackgroundIn regions with weak healthcare systems, critical shortages of the healthcare workforce, and increasing prevalence of dual disease burdens, there is an urgent need for the implementation of proven effective interventions and strategies to address these challenges. Our mixed-methods hybrid type II effectiveness-implementation study is designed to fill this evidence-to-practice gap. This study protocol describes a cluster randomized controlled trial which evaluates the effectiveness of an implementation strategy, practice facilitation (PF), on the integration, adoption, and sustainability of a task-strengthening strategy for hypertension control (TASSH) intervention within primary healthcare centers (PHCs) in Lagos State, NigeriaDesignGuided by the Consolidated Framework for Implementation Research (CFIR) and the Reach Effectiveness Adoption Implementation and Maintenance (RE-AIM), this study tests the impact of a proven effective implementation strategy to integrate hypertension management into the HIV care cascade, across 30 PHCs. The study will be conducted in three phases: 1) a pre-implementation phase that will use CFIR to develop a tailored PF intervention for integrating TASSH into HIV clinics; 2) an implementation phase that will use RE-AIM to compare the clinical effectiveness of PF vs. a self-directed condition (receipt of information on TASSH without PF) on BP reduction; and 3) a post-implementation phase that will use RE-AIM to evaluate the effect of PF vs. self-directed condition on adoption and sustainability of TASSH. The PF intervention components comprise: (a) an advisory board to provide leadership support for implementing TASSH in PHCs; (b) training of the HIV nurses on TASSH protocol; and (c) training of practice facilitators, who will serve as coaches, provide support, and performance feedback to the HIV nurses.DiscussionThis study is the first trial to evaluate the impact of an implementation strategy for integrating hypertension management into HIV care, on clinical and implementation outcomes. Findings from this study will advance implementation science research on the effectiveness of tailoring an implementation strategy for the integration of an evidence-based, systems level hypertention control intervention into HIV care and treatment.Trial registrationClinicalTrials.gov (NCT04704336). Registered on 11 January 2021.

Building Capacity of Community Nurses to Strengthen the Management of Uncomplicated Hypertension in Persons Living with HIV in Low- and Middle-Income Countries

“…Our training programme for the MAP-IT study is adapted from multiple sources or protocols for hypertension treatment at primary care levels (i.e., WHO PEN package and the Simplified Nigerian Hypertension Protocol for primary care) and well-known methods for delivering behaviour change programmes (i.e., 5As and the Train-the-Trainer model). Previous TASSH studies led by two of the principal investigators for this MAP-IT study have shown the benefits of the training approach for implementing and sustaining TASSH within primary care practices in LMICs [11]. The formation of the MAP-IT training programme from these different sources highlights its significance within the Nigerian context and potentially for other LMIC settings experience increasing prevalence of NCDs among PLWH.…”

“…PFs were also trained to observe and supervise (enhance) the CNs during monthly onsite visits and to evaluate the nurses through onsite supervision and the use of online learning communities. The 3E's were developed specifically for PFs who support nurses delivering TASSH and has been implemented in other TASSH studies [11,20].…”

“…These findings are of particular note as evidence suggests that lifestyle counseling provided by nurses is known to be effective in modifying patients' health behaviors [6,9]. Furthermore, the emphasis on health education and training of the healthcare workforce, including non-physician workers, will be essential in addressing the shortage of physicians, the increasing prevalence of NCDs among the general population, and targeting populations already burdened with chronic conditions such as PLWH [6,7,10,11].…”