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
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 trea...
| Main Authors: | , , , , , , , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
BMC
2023-05-01
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| Series: | Implementation Science |
| Subjects: | |
| Online Access: | https://doi.org/10.1186/s13012-023-01272-5 |
| _version_ | 1797827435787452416 |
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| author | Angela A. Aifah Erinn M. Hade Calvin Colvin Daniel Henry Shivani Mishra Ashlin Rakhra Deborah Onakomaiya Anyiekere Ekanem Gabriel Shedul Geetha P. Bansal Daphne Lew Nafesa Kanneh Samuel Osagie Ememobong Udoh Esther Okon Juliet Iwelunmor Angela Attah Gbenga Ogedegbe Dike Ojji |
| author_facet | Angela A. Aifah Erinn M. Hade Calvin Colvin Daniel Henry Shivani Mishra Ashlin Rakhra Deborah Onakomaiya Anyiekere Ekanem Gabriel Shedul Geetha P. Bansal Daphne Lew Nafesa Kanneh Samuel Osagie Ememobong Udoh Esther Okon Juliet Iwelunmor Angela Attah Gbenga Ogedegbe Dike Ojji |
| author_sort | Angela A. Aifah |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-04-09T12:48:15Z |
| format | Article |
| id | doaj.art-4b19808f2f2543aeae1a771932a473a5 |
| institution | Directory Open Access Journal |
| issn | 1748-5908 |
| language | English |
| last_indexed | 2024-04-09T12:48:15Z |
| publishDate | 2023-05-01 |
| publisher | BMC |
| record_format | Article |
| series | Implementation Science |
| spelling | doaj.art-4b19808f2f2543aeae1a771932a473a52023-05-14T11:23:22ZengBMCImplementation Science1748-59082023-05-0118111210.1186/s13012-023-01272-5Study 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 trialAngela A. Aifah0Erinn M. Hade1Calvin Colvin2Daniel Henry3Shivani Mishra4Ashlin Rakhra5Deborah Onakomaiya6Anyiekere Ekanem7Gabriel Shedul8Geetha P. Bansal9Daphne Lew10Nafesa Kanneh11Samuel Osagie12Ememobong Udoh13Esther Okon14Juliet Iwelunmor15Angela Attah16Gbenga Ogedegbe17Dike Ojji18 Institute for Excellence in Health Equity, New York University (NYU) Grossman School of MedicineDepartment of Population Health, New York University (NYU) Grossman School of Medicine Institute for Excellence in Health Equity, New York University (NYU) Grossman School of MedicineCardiovascular Research Unit, University of Abuja Teaching Hospital, University of Abuja Institute for Excellence in Health Equity, New York University (NYU) Grossman School of MedicineDepartment of Population Health, New York University (NYU) Grossman School of MedicineDepartment of Population Health, New York University (NYU) Grossman School of MedicineDepartment of Community Medicine, Faculty of Clinical Sciences, University of UyoCardiovascular Research Unit, University of Abuja Teaching Hospital, University of AbujaFogarty International Center, NIHWashington University in St. Louis School of Medicine Institute for Excellence in Health Equity, New York University (NYU) Grossman School of MedicineCardiovascular Research Unit, University of Abuja Teaching Hospital, University of AbujaCardiovascular Research Unit, University of Abuja Teaching Hospital, University of AbujaCardiovascular Research Unit, University of Abuja Teaching Hospital, University of AbujaDepartment of Behavioral Science and Health Education, College for Public Health and Social Justice, Saint Louis UniversityAkwa Ibom Primary Healthcare Development Board, State Primary Health Care Development Board Institute for Excellence in Health Equity, New York University (NYU) Grossman School of MedicineDepartment of Internal Medicine, Faculty of Clinical Sciences, College of Health Sciences, University of AbujaAbstract 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.https://doi.org/10.1186/s13012-023-01272-5Implementation strategyIntegrated modelsNCD-HIV care |
| spellingShingle | Angela A. Aifah Erinn M. Hade Calvin Colvin Daniel Henry Shivani Mishra Ashlin Rakhra Deborah Onakomaiya Anyiekere Ekanem Gabriel Shedul Geetha P. Bansal Daphne Lew Nafesa Kanneh Samuel Osagie Ememobong Udoh Esther Okon Juliet Iwelunmor Angela Attah Gbenga Ogedegbe Dike Ojji 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 Implementation Science Implementation strategy Integrated models NCD-HIV care |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| topic | Implementation strategy Integrated models NCD-HIV care |
| url | https://doi.org/10.1186/s13012-023-01272-5 |
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