Assessing policy implementation and health systems impacts of Option B+ in three African countries to inform the delivery of Universal Test and Treat.

In 2013, the World Health Organisation (WHO) recommended initiation of lifelong antiretroviral therapy (ART) for all HIV-positive pregnant women, regardless of disease stage, in order to minimise transmission risks to their index offspring and offspring of later pregnancies. HIV-exposed infants should receive antiretroviral (ARV) prophylaxis, be tested and receive ART if HIV-positive. In 2015, WHO extended their guidance to recommend immediate ART initiation for all adults diagnosed with HIV (universal Test and Treat (UTT)), following evidence from randomised control trials demonstrating that it reduced sexual transmission and provided individual health benefits for HIV-positive adults.

Although few sub-Saharan African countries have introduced UTT policies, many have rolled out Option B+, despite ongoing debates over its cost-effectiveness and health systems impacts, particularly in settings with weak infrastructure. Despite its potential to eliminate HIV in infants and improve maternal health, some argue that poor delivery could lead to resources being channelled away from adult HIV services, detrimentally affecting their quality and health outcomes.

There is widespread agreement that research is needed to understand how Option B+ has been implemented in different settings and its corresponding impacts on health systems. Furthermore, there is a key window of opportunity to use the evidence generated by such research to assess how best to prepare these health systems for further expansion of ART services as UTT policies are rolled out.

Our study will take place in three HIV community cohort (HCC) sites in rural Malawi, Tanzania and South Africa, representing early, mid-term and late adopters of Option B+ in 2011, 2013 and 2015 respectively, and where UTT policies were being drafted in 2016, in order to answer 4 key research questions:

1) What are the Option B+ policy implementation gaps in each setting and how do the actors, policy content, context and processes explain these gaps?

2) Have underlying economic and epidemiological assumptions in economic evaluations that demonstrated the anticipated cost-effectiveness of Option B+ been met in each site?

3) What are the health systems impacts of Option B+ in each setting?

4) What strategies can be developed with policymakers to ensure that health systems are ready for effective delivery of UTT?

We will use a comparative, longitudinal approach with mixed methods that include secondary analysis of existing policy reviews, health facility survey data and routine HIV clinic data linked to HCC data. We will also collect new data through an updated review of national HIV policies, a further round of facility surveys, key informant interviews with policymakers and programmers, in-depth interviews with health workers and PMTCT service users, and costing estimates.

We will draw on existing frameworks to identify gaps in Option B+ implementation and to explore the policy processes and contexts underlying them. We will then assess whether the costs of implementing Option B+ in purposively sampled health facilities correspond with pre-implementation estimates, and whether epidemiological parameters used for economic evaluations prior to Option B+ implementation align with local estimates derived from the HCC. We will also adapt existing indicators to assess the impacts of Option B+ on governance, financing, service delivery, workforce, information, medical supplies, and use qualitative and HCC data to consider impacts on health systems processes commonly defined as those relating to access, quality and coverage. Using our findings, we will work with key stakeholders to develop tools to assess health systems readiness for UTT, and to monitor health systems impacts through its implementation.

The research questions and methods were developed in collaboration with policymakers to support the uptake of the findings into UTT policies in each country and beyond.

This project addresses a critical evidence gap in assessments of health systems preparedness for Universal Test and Treat (UTT) for HIV by drawing on lessons from Option B+ policy implementation, widely viewed as its precursor. We will conduct a longitudinal mixed methods study in HIV community cohort (HCC) sites in Malawi, South Africa and Tanzania, underpinned by a conceptual framework that incorporates elements from Walt and Gilson's "policy triangle" and the WHO health systems "Building Blocks" model to explore the link between Option B+ implementation and subsequent impacts on health systems within which they are delivered. Our analysis will be informed by a political economy and "systems thinking" approach that recognises the dynamic relationship between the policy and implementation environments and the role of economic considerations in policy-making processes.

We will draw on HCC data, health facility survey data, policy reviews collected in 2013, 2015 and updated with a further round in 2017, as well as data from key informant interviews with policymakers, in-depth interviews with patients and healthcare providers, and economic costing data to:

1) Identify Option B+ policy implementation gaps in each setting and consider how the actors, policy content, context and processes explain these gaps
2) Assess whether underlying costing and epidemiological assumptions in economic evaluations that demonstrate cost-effectiveness of Option B+ been met in each site
3) Describe the health systems impacts of Option B+ in each site
4) Develop strategies with policymakers to assess and promote health systems readiness for effective UTT delivery

Strengths of the study include its multi-country and longitudinal perspective and the ability to triangulate findings from multiple data sources. The results will generate evidence that will help prioritise areas for health systems strengthening to achieve the intended cost-effectiveness and health outcomes of UTT.

Modelling studies suggest that adoption of the 2015 World Health Organisation (WHO) treatment guidelines, coupled with high rates of testing and retention in care, could end AIDS by 2030. However, there is widespread concern that these models are unlikely to be replicated in African settings without investments in health systems research to guide its delivery. Our study leverages a unique opportunity to assess health systems readiness for UTT delivery by investigating the impacts of Option B+ for the prevention of mother-to-child transmission (PMTCT) of HIV on the health systems in Malawi, Tanzania and South Africa, where it was introduced in 2011, 2013 and 2015 respectively.

The results of the study are expected to have impacts at multiple levels. Firstly, the study was conceived and designed in collaboration with policymakers in Tanzania, Malawi and South Africa, building on relationships that were developed through previous HIV-related health systems research undertaken by the co-investigators and Ministries of Health. The research questions were identified from concerns raised by the policymakers in relation to the ability of existing health systems to deliver ART to larger populations through Option B+ and UTT policies.

The study will be the first to respond to demands from policymakers as well as other researchers for rigorous multi-country evidence of the health systems impacts of Option B+ and subsequently the potential impacts of UTT policies. It will also respond to calls for empirical data to verify the underlying economic and epidemiological assumptions that have thus far guided analyses of Option B+ cost-effectiveness. These results will also be of interest to policymakers in other African countries as they refine, update and enhance guidelines and recommendations for PMTCT and ART programmes, and consider health systems readiness for UTT.

The WHO has emphasised the need for implementation research to accompany Option B+ roll out and representatives from their HIV/AIDS department, who collaborated in our earlier HIV policy analyses, have repeatedly indicated their enthusiasm for the proposed study, and their need for the results that it would generate.

The findings will also impact on funding policies for donors of national HIV programmes, including the Bill and Melinda Gates Foundation and the Clinton Health Access Initiative. Representatives from both institutions have indicated that the findings from the proposed research could inform their future funding priorities, particularly where the results dovetail with demographic data on the impacts of Option B+ on the survival status of HIV-infected mothers and children, which are available from the HIV community cohort studies in the three countries where our research will be conducted.

Ultimately, the results are expected to improve the conditions for health workers delivering HIV services and positively impact the lives of HIV-positive adults and children in Tanzania, Malawi and South Africa, and beyond, as they will be better served by the health facilities that deliver HIV care and treatment.

The research will provide an excellent opportunity for developing the skills of talented African health systems researchers in each site, as well as providing capacity-building opportunities for junior African researchers through mentoring and nested PhD studies within each site.

In terms of timing, this study has a unique window of opportunity, and the findings are expected to have immediate impacts as donors and policymakers across Africa start implementing the 2015 WHO recommendations on ART initiation. Our earlier research has indicated that policymakers, programme implementers and health workers are hesitant to embrace the 2015 guidance from WHO without drawing on the lessons learned from the Option B+ experience.