TY - JOUR
T1 - Integration of a task strengthening strategy for hypertension management into HIV care in Nigeria
T2 - a cluster randomized controlled trial study protocol
AU - Aifah, Angela A.
AU - Odubela, Oluwatosin
AU - Rakhra, Ashlin
AU - Onakomaiya, Deborah
AU - Hu, Jiyuan
AU - Nwaozuru, Ucheoma
AU - Oladele, David A.
AU - Odusola, Aina Olufemi
AU - Idigbe, Ifeoma
AU - Musa, Adesola Z.
AU - Akere, Ayodeji
AU - Tayo, Bamidele
AU - Ogedegbe, Gbenga
AU - Iwelunmor, Juliet
AU - Ezechi, Oliver
N1 - Funding Information:
This study is supported by a grant from the National Heart, Lung, and Blood Institute (NHLBI), 1R01HL147811-01A1 (PI: Ogedegbe, Ezechi, Iwelunmor). The funding agency played no role in the design of the study and in writing the manuscript.
Publisher Copyright:
© 2021, The Author(s).
PY - 2021/12
Y1 - 2021/12
N2 - Background: In 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, Nigeria. Design: Guided 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. Discussion: This study is one of few, if any trials, 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, system-level hypertension control intervention into HIV care and treatment. Trial registration: ClinicalTrials.gov (NCT04704336). Registered on 11 January 2021.
AB - Background: In 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, Nigeria. Design: Guided 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. Discussion: This study is one of few, if any trials, 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, system-level hypertension control intervention into HIV care and treatment. Trial registration: ClinicalTrials.gov (NCT04704336). Registered on 11 January 2021.
KW - HIV-Hypertension integration
KW - Implementation strategy tailoring
KW - Practice facilitation
UR - http://www.scopus.com/inward/record.url?scp=85119446220&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85119446220&partnerID=8YFLogxK
U2 - 10.1186/s13012-021-01167-3
DO - 10.1186/s13012-021-01167-3
M3 - Article
C2 - 34789277
AN - SCOPUS:85119446220
SN - 1748-5908
VL - 16
JO - Implementation Science
JF - Implementation Science
IS - 1
M1 - 96
ER -