• Generating evidence for health policy in challenging settings: Lessons learned from four prevention of mother-to-child transmission of HIV implementation research studies in Nigeria

      Sam-Agudu, N.A.; Aliyu, M.H.; Adeyemi, O.A. (BioMed Central Ltd., 2018)
      Background: Implementation research (IR) facilitates health systems strengthening and optimal patient outcomes by generating evidence for scale-up of efficacious strategies in context. Thus, difficulties in generating IR evidence, particularly in limited-resource settings with wide disease prevention and treatment gaps, need to be anticipated and addressed. Nigeria is a priority country for the prevention of mother-to-child transmission of HIV (PMTCT). This paper analyses the experiences of four PMTCT IR studies in Nigeria, and proffers solutions to major challenges encountered during implementation. Studies included and findings: Multicentre PMTCT IR studies conducted in Nigeria during the Global Plan's assessment period (2011 to 2015) were included. Four studies were identified, namely The Baby Shower Trial, Optimizing PMTCT, MoMent and Lafiyan Jikin Mata. Major common challenges encountered were categorised as 'External' (beyond the control of study teams) and 'Internal' (amenable to rectification by study teams). External challenges included healthcare worker strikes and turnover, acts and threats of ethnic and political violence and terrorism, and multiplicity of required local ethical reviews. Internal challenges included limited research capacity among study staff, research staff turnover and travel restrictions hindering study site visits. Deliberate research capacity-building was provided to study staff through multiple opportunities before and during study implementation. Post-study employment opportunities and pathways for further research career-building are suggested as incentives for study staff retention. Engagement of study community-resident personnel minimised research staff turnover in violence-prone areas. Conclusions: The IR environment in Nigeria is extremely diverse and challenging, yet, with local experience and anticipatory planning, innovative solutions can be implemented to modulate internal challenges. Issues still remain with healthcare worker strikes and often unpredictable insecurity. There is a dire need for cooperation between institutional review boards across Nigeria in order to minimise the multiplicity of reviews for multicentre studies. External challenges need to be addressed by high-level stakeholders, given Nigeria's crucial regional and global position in the fight against the HIV epidemic. Copyright 2018 The Author(s).
    • Variation in research designs used to test the effectiveness of dissemination and implementation strategies: A review

      Mazzucca, S.; Tabak, R.G.; Pilar, M. (Frontiers Media S. A, 2018)
      Background: The need for optimal study designs in dissemination and implementation (D & I) research is increasingly recognized. Despite the wide range of study designs available for D & I research, we lack understanding of the types of designs and methodologies that are routinely used in the field. This review assesses the designs and methodologies in recently proposed D & I studies and provides resources to guide design decisions. Methods: We reviewed 404 study protocols published in the journal Implementation Science from 2/2006 to 9/2017. Eligible studies tested the efficacy or effectiveness of D & I strategies (i.e., not effectiveness of the underlying clinical or public health intervention); had a comparison by group and/or time; and used ≥1 quantitative measure. Several design elements were extracted: design category (e.g., randomized); design type [e.g., cluster randomized controlled trial (RCT)]; data type (e.g., quantitative); D & I theoretical framework; levels of treatment assignment, intervention, and measurement; and country in which the research was conducted. Each protocol was double-coded, and discrepancies were resolved through discussion. Results: Of the 404 protocols reviewed, 212 (52%) studies tested one or more implementation strategy across 208 manuscripts, therefore meeting inclusion criteria. Of the included studies, 77% utilized randomized designs, primarily cluster RCTs. The use of alternative designs (e.g., stepped wedge) increased over time. Fewer studies were quasi-experimental (17%) or observational (6%). Many study design categories (e.g., controlled pre-post, matched pair cluster design) were represented by only one or two studies. Most articles proposed quantitative and qualitative methods (61%), with the remaining 39% proposing only quantitative. Half of protocols (52%) reported using a theoretical framework to guide the study. The four most frequently reported frameworks were Consolidated Framework for Implementing Research and RE-AIM (n = 16 each), followed by Promoting Action on Research Implementation in Health Services and Theoretical Domains Framework (n = 12 each). Conclusion: While several novel designs for D & I research have been proposed (e.g., stepped wedge, adaptive designs), the majority of the studies in our sample employed RCT designs. Alternative study designs are increasing in use but may be underutilized for a variety of reasons, including preference of funders or lack of awareness of these designs. Promisingly, the prevalent use of quantitative and qualitative methods together reflects methodological innovation in newer D & I research. Copyright 2018 Mazzucca, Tabak, Pilar, Ramsey, Baumann, Kryzer, Lewis, Padek, Powell and Brownson.