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 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.

Moving forward: Scaling-up the integration of an HIV and hypertension program in Akwa Ibom State, Nigeria

“…[4] By promoting skilled, non-physician workers to perform key tasks including case identi cation, referrals, initiation of treatment, and routine physical examinations, the policy makes hypertension management integration into HIV care platforms attainable and sustainable. [3]…”

“…The community nurses are then mentored by trained and retired community who serve as practice facilitators. [3] As part of MAP-IT, we identi ed key stakeholders within the health system, solicited their feedback, and outlined policy recommendations on how to scale-up current resources needed to integrate hypertension management into HIV care. The key stakeholders engaged at multiple levels include policymakers, patient advocacy groups, and healthcare workers.…”

“…[2] There is an urgent need to leverage available HIV care systems and resources to address the rising burden of NCDs in PLWH. Our research study, Managing Hypertension Among People Living with HIV: an Integrated Model (MAP-IT), is designed to address this important problem, and its goal is to evaluate the adoption and sustainability of an integrated HIV and hypertension program among PLWH who receive care in primary care centers in Akwa Ibom State [3] -a state with one of the highest burden in Nigeria.…”

Implementing and evaluating integrated care models for non-communicable diseases in fragile and humanitarian settings

“…Use case study methodologies where comparison sites are not available or suitable to conduct comparative studies ( Beecroft et al, 2022 , Paparini et al, 2020 ). Explore alternative designs to randomised controlled trials (RCT) that might be more feasible in humanitarian settings such as before-after studies, interrupted time series analysis, propensity score analyses, regression discontinuity or stepped-wedge RCT design ( Kohrt et al, 2019 , Reeves et al, 2017 , Aifah et al, 2023 ). Conduct economic evaluations, with sensitivity analyses and costing components that can guide funders and policymakers in prioritizing interventions ( Bertone et al, 2019 , Makhani et al, 2020 ).…”

“…Explore alternative designs to randomised controlled trials (RCT) that might be more feasible in humanitarian settings such as before-after studies, interrupted time series analysis, propensity score analyses, regression discontinuity or stepped-wedge RCT design ( Kohrt et al, 2019 , Reeves et al, 2017 , Aifah et al, 2023 ).…”