One of the greatest public health successes in HIV research has been the development and implementation of interventions to prevent mother-to-child HIV transmission (PMTCT). Although initial PMTCT research and subsequent implementation were focused on prevention of in utero and intrapartum transmission in a formula-fed population in high resource countries, enormous strides have been made in the development and implementation of highly effective interventions in low- and middle-income countries. Indeed, new developments in clinical research, HIV programming and policy have made the goal of elimination of new pediatric HIV infections seem increasingly attainable. However, important challenges remain in resource-limited settings like Sub-Saharan Africa, where rates of transmission remain unacceptably high. In these settings, the benefits of proven interventions have not been fully realized because of enduring barriers to adoption and adaptation and limitations in health care infrastructure that have restricted scale-up and sustainability.
The field of implementation science holds promise for addressing these barriers. Representing a collective commitment to the goal of eliminating new pediatric infections by 2015,1 the National Institutes of Health (NIH) in collaboration with the Office of the Global AIDS Coordinator (OGAC) awarded several highly meritorious implementation science grants in 2013 through the NIH/PEPFAR Collaboration for Advancing Implementation Science in Prevention of Maternal-Child HIV Transmission Request for Applications.2 Premised on the idea that support for implementation science alone will have limited impact unless coupled with concerted efforts to bring researchers together with policy makers and program implementers, the NIH and OGAC also launched and hosted the NIH-PEPFAR PMTCT Implementation Science Alliance (the Alliance). The Alliance was developed as an innovative platform to enhance communication and catalyze collaboration among the funded implementation science researchers, policy makers, and program implementers to promote a cross-fertilization of ideas, insights, and experiences as the research progressed and the implementation environment evolved. It provided an exciting opportunity for synergy, cross-training, joint learning, and collaboration, and stands as a model that can inform future investments in implementation science. This introduction reflects on the collective learning of the Alliance and highlights some of the overarching and intersecting priorities for implementation science related to PMTCT.
THE CASE FOR THE IMPORTANCE OF IMPLEMENTATION SCIENCE FOR PMTCT
Elimination of pediatric HIV depends heavily on successful implementation of efficacious PMTCT interventions. With improved PMTCT strategies, new infections in infants have decreased worldwide.3 However, barriers to implementation of effective interventions persist disproportionately in low-income settings like Sub-Saharan Africa, where a substantial number of HIV-infected pregnant women remain unidentified and children still become infected at a rate that remains far from the global goal of less than 5% (resulting in fewer than 40,000 new infections globally per year).1 Implementation science offers a scientific strategy to address these barriers and is defined as the study of methods to promote the integration of research findings and evidence into health care policy and practice to achieve their potential public health impact.4 The intent of implementation science is to investigate and address major bottlenecks (eg, social, behavioral, economic, and management) that impede effective implementation, test new approaches to improve health programming, and determine a causal relationship between the intervention and its impact.
In 2014, the Alliance characterized the complexities of implementation science in the context of PMTCT by developing a framework made up of 4 interrelated components: (1) understanding the implementation environment; (2) studying the actual process of implementation; (3) testing innovative implementation science approaches; and (4) linking evidence from such research to policy making, program implementation, and scale-up.5 Notably, component 4 of this framework recognizes that support for implementation science alone will have limited impact unless it is coupled by efforts to catalyze interactions between researchers and users of scientific evidence, a fact embodied by the Alliance.6
Although we may all agree that enhanced interactions between researchers and users of scientific evidence (decision makers and program implementers) are important and necessary to tackle enduring barriers to implementation, how to effectively support these interactions is not altogether clear. When the Alliance was conceived in 2012, there were few models at NIH for implementation-oriented global health research that aimed to optimize synergies between those involved in research and program implementation and policy making on the ground. Given this, the Alliance was launched as a kind of “living laboratory,” providing an exciting opportunity to explore how enabling tools can help to effectively build, strengthen, and nurture interactions between researchers, program implementers, and policy makers and whether this type of model can catalyze positive results for implementation science and global health. Ultimately, what we learn from this model has the potential to inform and strengthen future implementation science–related initiatives and, in turn, improve the impact of these initiatives on programs and policies.
The Alliance was predicated on the idea that providing opportunities for enhanced communication and collaboration between implementation scientists and program implementers would facilitate better utilization of scientific evidence in programming while simultaneously helping to ensure that research is country driven and responsive to the local context. Building on important advances in the field and a growing portfolio of investment by NIH and OGAC (Table 1), the Alliance brought together a diverse set of experts working in the PMTCT field from both the United States and Sub-Saharan Africa with approximately 60 members. Specifically, the Alliance included (1) scientists receiving NIH PEPFAR RFA grant awards; (2) program implementers and policy makers from PEPFAR-supported countries; (3) representatives of multilateral institutions (eg, World Health Organization, United Nations Programme on HIV/AIDS, United Nations Children's Fund); (4) implementation science methodologists; and (5) key US government representatives and experts working in leading HIV/AIDS/PMTCT organizations. The Alliance was guided by a steering committee of experts from NIH and OGAC, the Elizabeth Glaser Pediatric AIDS Foundation, the Anova Health Institute (South Africa), and the World Health Organization. Through this steering committee, expertise in research, program implementation, and policy/advocacy was used to guide the Alliance's activities as well as the development and dissemination of deliverables informed from these activities.
Opportunities for interaction among Alliance members were operationalized through a series of 4 in-person meetings: March 2013 in the United States, January 2014 and January 2015 in South Africa, and May 2015 in the United States. Each meeting resulted in a number of critical questions and insights on the common challenges related to PMTCT implementation science and built on the dialog and learning from the network's previous gathering(s). Along with important research findings and critical insights, the Alliance also successfully catalyzed new collaborations, increased implementation science capacity, and seeded important sustainable activities to address implementation challenges related to PMTCT and beyond.
The Alliance successfully contributed to strengthening implementation science capacity, a need that has been identified repeatedly for multiple global health challenges.7–9 Specifically, a resounding consensus that emerged from the first 2 meetings of the Alliance was the need for enhanced capacity to use implementation science tools and methodologies for PMTCT among Alliance members. Acknowledging this need, the third meeting was designed to provide implementation science training and was dedicated to providing Alliance members with an in-depth learning opportunity on the critical elements of implementation science methods and approaches as well as the practical application of them to inform the work of Alliance members in their ongoing PMTCT research. The training brought together several implementation science experts as faculty and covered topics including (1) identifying levels of evidence, when to implement, evidence synthesis, and novel research methods; (2) assessing barriers in implementation science and developing/identifying facilitators for overcoming them; (3) selecting/tailoring the intervention; and (4) scaling, spreading, and sustainability of implementation.
The Alliance also catalyzed important new research successes, interactions, and formal collaborations between members as evidenced by coauthorship and collaborative grant submissions. One Alliance member reflected on the impact of the Alliance:
…. I was awarded a K24 focused on PMTCT implementation research a few weeks ago. In many ways, the work extends from our Alliance meetings and NIH-funded projects. Thank you for all your efforts in setting up this network of investigators and bringing people together. I think we're just starting to see the downstream impact.
Important spin-off activities were also catalyzed as a result of the Alliance. In March 2015, in response to the suboptimal PMTCT program outcomes in Nigeria, 20 local organizations that provide HIV care in Nigeria came together to form the Nigeria Implementation Science Alliance (NISA) in collaboration with Nigerian universities and state and federal government agencies. The initiative originated from a member of the Alliance, who describes it as being modeled after the NIH-PEPFAR Alliance.10 NISA represents an important and sustainable outgrowth of the Alliance and will focus on overcoming implementation challenges related to PMTCT in Nigeria.
KEY INSIGHTS ON COMMON CHALLENGES
The final article in this series describes a systematic concept mapping approach to address key important and adaptable barriers to PMTCT.11 Additional important and critical insights on common challenges in PMTCT implementation science emerged from the multiyear Alliance meetings related to stakeholder engagement, research and decision-making process tensions, capacity, and context. Select themes included are as follows:
- Relationships between scientists, implementers, and policy makers need to be fostered from the beginning of a research project (conceptualization) and maintained over the course of the project (implementation). Connecting research to practice involves multiple actors, competing policy agendas, and complex modes of communication.
- District- and local-level policy makers and implementers are critical (and sometimes nonconventional) partners for researchers and can provide input that ensures research is feasible, practical, and sustainable in the local context.
- A defined process for engagement between researchers, policy makers, and program implementers would help guide and enable a more fluid and effective dialog, thus supporting more useful collaboration.
- Multidisciplinary research teams are critical for effective and thoughtful implementation science.
Research and Decision-Making Process Tensions
- Important and critical differences between researchers and decision makers included are as follows:
- a. Researchers and policy makers ask different questions. Most researchers ask questions rooted in a quest for biomedical evidence, whereas policy makers are often looking for programmatic/public health insights to inform policy and program changes.
- b. Researchers and decision makers have different stakeholder audiences. Researchers often pursue broad scientific theory and work on a larger scale, whereas policy makers need answers to questions that are distinctly local.
- There is an important tension between the long gestation periods and rigorous requirements of research and the short time frames and need for quick information from policy makers and implementers. These differential time frames pose significant challenges and strategies to help reconcile these time frames are critical.
- Efforts should be made to develop new implementation science methodologies that enable research to more rapidly inform programming and policy development, perhaps using interim research results that have sufficient scientific rigor to meet the needs of decision makers. What would such interim goals be? And could these work for both researchers and decision makers?
- To support collaboration and communication, innovative research evidence dissemination strategies, such as short technical briefs or stakeholder meetings, are critical for producing effective results that can inform policy decisions.
- There are limited capacity and resources in many national ministries of health to effectively and sustainably collaborate with researchers and systemic barriers to harmonizing research efforts with major policy decision-making moments such as national budget cycles. More support for the bridge between this divide is necessary (and increasingly being developed through individuals who are performing dual roles as researcher and implementer, thereby allowing for deep engagement in both domains).
- An important and critical need exists to build capacity in implementation science among academic researchers as well as program implementers and policy makers.
- Policy guidance (due to shifting national and international policy guidelines) and environment (on the ground implementation) in low- and middle-income countries are not static. These changes have important impacts on the feasibility of ongoing research projects.
- Scaling up data/evidence from local specific context to national level is challenging. There is an important tension between locally relevant and generalizable findings. Understanding what type of evidence is sufficient to scale an innovation from one context to another is critical. Researchers may need to embrace applicability over generalizability.
DESCRIPTION OF SELECT RESULTS FROM THE RESEARCH
Ultimately, although the success of the Alliance relied on the multidisciplinary group of engaged individuals, the Alliance was built on a platform of research projects addressing a wide range of approaches to PMTCT implementation (Table 2). These approaches included optimizing integrated PMTCT and maternal/child health services; increasing uptake of and retention in PMTCT services; facilitating HIV testing and education of male partners; examining the effect of “buddy” systems to help mothers adhere to feeding guidelines; comparing cost effectiveness of faith-based and clinic-based approaches; increasing efficiency in early infant HIV diagnosis; and measuring the impact of PMTCT programs on maternal and infant health outcomes. These studies linked directly to local programs, researchers, and institutions in 7 countries (Cote D'Ivoire, Democratic Republic of Congo, Kenya, Mozambique, Nigeria, South Africa, and Zambia) receiving PEPFAR support and will support PEPFAR's focus on using scientific evidence to inform policy and programs. The projects represent a body of research that addresses unique and different points along the PMTCT cascade (Fig. 1), and data gathered through these implementation science studies provide important scientific insights described in the articles included in this supplement. Ultimately, the results from these studies will help maximize the impact of investments in curbing the HIV epidemic globally, contributing to the goal of achieving an AIDS-free generation.
Important and promising approaches for PMTCT were identified in the findings of Alliance researchers. The research findings illustrate the fact that the PMTCT cascade is inherently complex, and although uptake of services has improved, common and enduring challenges exist. These include the complexity of the components of the PMTCT cascade and that retaining women and infants in care after delivery is difficult yet critical to achieve the prevention objective. The results of these projects have important implications that can inform future efforts to address PMTCT. For example, one study found that cost-effective testing of male partners can decrease HIV morbidity/mortality. Another study found that workflow modification to redefine nurse tasks and shift tasks to community health workers had positive implications for improved retention and may increase affordability of interventions. More broadly, however, research included in this supplement suggests that implementation science frameworks are a valuable tool to understand which elements of an intervention are adaptable and why implementation of evidence is heterogeneous. These findings suggest that future studies could use evidence-based implementation science frameworks to provide salient data to inform scale-up and implementation in other settings. Findings also suggest that combining observational and experimental research approaches in the context of implementation science to address PMTCT presents a potentially novel and important approach to understanding the optimization of antiretroviral therapy delivery for maternal and child health.
The Alliance collectively identified priority research areas for the future including are as follows:
- Optimization of linkage of infants identified as HIV infected to HIV care and early initiation of antiretroviral therapy.
- Optimal models for maintaining retention and adherence of children in care and on treatment.
- Prioritizing locally driven research questions and research processes that engage the end users from the beginning of the research process.
Despite enormous successes in PMTCT, important challenges remain. The research findings included in this supplement make critical contributions to moving us closer to the goal of elimination of new pediatric HIV infections and maintaining maternal health. However, continuing to find innovative ways to foster collaboration of implementation science researchers with decision makers and program implementers will be critical to speed the translation of effective PMTCT interventions into the local context and health system programs. Ultimately, the Alliance provides a successful model for enhancing interaction and demonstrates that such efforts can catalyze positive results for implementation science and global health. What we have learned from this model has the potential to inform and strengthen future implementation science–related initiatives and, in turn, improve the impact of these initiatives on programs and policies.
1. Joint United Nations Programme on HIV/AIDS
. Global Plan Towards the Elimination of New HIV Infections Among Children by 2015 and Keeping Their Mothers Alive: 2011–2015. Geneva, Switzerland: UNAIDS; 2011. Available at: http://http://www.unaids.org
/sites/default/files/media_asset/20110609_JC2137_Global-Plan-Elimination-HIV-Children_en_1.pdf. Accessed March 24, 2016.
2. Funding Opportunity: NIH/PEPFAR
Collaboration for Advancing Implementation Science
in Prevention of Maternal-Child HIV Transmission (PMTCT
) (R01). National Institutes of Health, Bethesda, Maryland; 2011. Available at: http://grants.nih.gov/grants/guide/rfa-files/RFA-HD-12-210.html. Accessed March 24, 2016.
3. Joint United Nations Programme on HIV/AIDS
. 2014 Progress Report on the Global Plan Towards the Elimination of the New HIV Infections Among Children by 2015 and Keeping Their Mothers Alive. Geneva, Switzerland: UNAIDS; 2011. Available at: http://http://www.unaids.org
/sites/default/files/documents/JC2681_2014-Global-Plan-progress_en.pdf. Accessed March 24, 2016.
4. Implementation Science
Information and Resources. Fogarty International Center, 2016. Available at: http://http://www.fic.nih.gov
/researchtopics/pages/implementationscience.aspx. Accessed March 24, 2016.
5. Sturke R, Harmston C, Simonds RJ, et al A multi-disciplinary approach to implementation science
: the NIH-PEPFAR PMTCT implementation science
alliance. J Acquir Immune Defic Syndr. 2014;67(suppl 2):S163–S167.
6. Fogarty International Center. Strategic Plan: Advancing Science for Global Health. Bethesda, MD: NIH; 2014. Available at: http://http://www.fic.nih.gov
/About/Documents/fogarty-international-center-nih-strategic-plan.pdf. Accessed March 24, 2016.
7. Glasgow RE, Eckstein ET, Elzarrad MK. Implementation science
perspectives and opportunities for HIV/AIDS
research: integrating science, practice, and policy. J Acquir Immune Defic Syndr. 2013;63(suppl 1):S26–S31.
8. Madon T, Hofman KJ, Kupfer L, et al Public health. Implementation science
. Science. 2007;318:1728–1729.
9. Padian NS, Holmes CB, McCoy SI, et al Implementation science
for the us President's Emergency plan for AIDS Relief (PEPFAR
). J Acquir Immune Defic Syndr. 2011;56:199–203.
10. Ezeanolue EE, Powell BJ, Patel D, et al Identifying and Prioritizing implementation barriers, gaps, and strategies through the Nigeria implementation science
alliance: getting to zero in the prevention of mother to child transmission of HIV. J Acquir Immune Defic Syndr. 2016;72(suppl 2):S161–S166.
11. Aarons GA, Sommerfeld DH, Chi BH, et al Concept mapping of PMTCT
implementation challenges and solutions across Six sub-Saharan Africa countries in the NIH-PEPFAR PMTCT implementation science
alliance. J Acquir Immune Defic Syndr. 2016;72(suppl 2):S202–S206.
Keywords:Copyright © 2016 Wolters Kluwer Health, Inc. All rights reserved.
HIV/AIDS; implementation science; PMTCT; PEPFAR