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. 2023 May 10;18(1):14.
doi: 10.1186/s13012-023-01272-5.

Study design and protocol of a stepped wedge cluster randomized trial using a practical implementation strategy as a model for hypertension-HIV integration - the MAP-IT trial

Angela A Aifah  1   2 , Erinn M Hade  3 , Calvin Colvin  4 , Daniel Henry  5 , Shivani Mishra  4 , Ashlin Rakhra  3 , Deborah Onakomaiya  3 , Anyiekere Ekanem  6 , Gabriel Shedul  5   7 , Geetha P Bansal  8 , Daphne Lew  9 , Nafesa Kanneh  4 , Samuel Osagie  5 , Ememobong Udoh  5 , Esther Okon  5 , Juliet Iwelunmor  10 , Angela Attah  11 , Gbenga Ogedegbe  4 , Dike Ojji  12
Affiliations

Study design and protocol of a stepped wedge cluster randomized trial using a practical implementation strategy as a model for hypertension-HIV integration - the MAP-IT trial

Angela A Aifah et al. Implement Sci. .

Abstract

Background: As people living with HIV (PLWH) experience earlier and more pronounced onset of noncommunicable diseases (NCDs), advancing integrated care networks and models in low-resource-high-need settings is critical. Leveraging current health system initiatives and addressing gaps in treatment for PLWH, we report our approach using a late-stage (T4) implementation research study to test the adoption and sustainability of a proven-effective implementation strategy which has been minimally applied in low-resource settings for the integration of hypertension control into HIV treatment. We detail our protocol for the Managing Hypertension Among People Living with HIV: an Integrated Model (MAP-IT) trial, which uses a stepped wedge cluster randomized trial (SW-CRT) design to evaluate the effectiveness of practice facilitation on the adoption of a hypertension treatment program for PLWH receiving care at primary healthcare centers (PHCs) in Akwa Ibom State, Nigeria.

Design: In partnership with the Nigerian Federal Ministry of Health (FMOH) and community organizations, the MAP-IT trial takes place in 30 PHCs. The i-PARiHS framework guided pre-implementation needs assessment. The RE-AIM framework will guide post-implementation activities to evaluate the effect of practice facilitation on the adoption, implementation fidelity, and sustainability of a hypertension program, as well as blood pressure (BP) control. Using a SW-CRT design, PHCs sequentially crossover from the hypertension program only (usual care) to hypertension plus practice facilitation (experimental condition). PHCs will recruit and enroll an average of 28-32 patients to reach a maximum of 960 PLWH participants with uncontrolled hypertension who will be followed longitudinally for BP outcomes.

Discussion: Given the need for integrated NCD-HIV care platforms in low-resource settings, MAP-IT will underscore the challenges and opportunities for integrating hypertension treatment into HIV care, particularly concerning adoption and sustainability. The evaluation of our integration approach will also highlight the potential impact of a health systems strengthening approach on BP control among PLWH.

Trial registration: Clinicaltrials.gov ( NCT05031819 ). Registered on 2nd September 2021.

Keywords: Implementation strategy; Integrated models; NCD-HIV care.

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Conflict of interest statement

The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
Overview of i-PARiHS and RE-AIM
Fig. 2
Fig. 2
Stepped wedge study design
Fig. 3
Fig. 3
Pre-implementation (UG3), implementation (UH3), and post-implementation phases
See this image and copyright information in PMC

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