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

Lead Research Organisation: London Sch of Hygiene and Trop Medicine
Department Name: Epidemiology and Population Health

Abstract

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.

Technical Summary

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.

Planned Impact

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.

Publications

10 25 50

 
Description SHAPING UP: A stakeholder workshop to facilitate translation of research findings into HIV policy in three African countries
Geographic Reach Africa 
Policy Influence Type Gave evidence to a government review
 
Description Teaching postgraduate researchers to improve research methods in Tanzania
Geographic Reach Local/Municipal/Regional 
Policy Influence Type Influenced training of practitioners or researchers
Impact The inputs of Dr. Renju have impacted on the quality of postgraduate training and research projects at Kilimanjaro Christian Medical University College in Northern Tanzania. The improvements have been made across many aspects of postgraduate education, and also specifically include the development of a 9 week foundation course for all postgraduate students (+120 each year) and an advanced two week study design module (+15 students each year).
 
Title Capturing costing data for the implementation of Option B+ and/or test and treat 
Description We have developed a comprehensive costing tool to capture the different elements to cost out PMTCT provision in different countries (Malawi and Tanzania) 
Type Of Material Physiological assessment or outcome measure 
Year Produced 2017 
Provided To Others? No  
Impact Once completed this tool will be made available for other to use, it builds on current methods and should provide increased rigour to costing studies in the future. 
 
Title Facility survey 
Description I designed a facility survey to be administered in to health facilities offering HIV services in African HIV cohort studies that are members of the ALPHA network. The data could then be compared with national HIV policies in the same countries as a means of assessing and comparing whether HIV policies translate into practice in each setting. Under the SHAPE study we have updated this tool (2016) for an additional survey round. 
Type Of Material Physiological assessment or outcome measure 
Year Produced 2013 
Provided To Others? Yes  
Impact Data currently being analysed and have been collected again in 2015 and 2016/7 
 
Title HIV policy tool 
Description development (in collaboration with a colleague) of a policy analysis tool to collect, synethesise and compare HIV policies across 6 sub-Saharan African countries participating in the ALPHA network - updated this took in 2016 
Type Of Material Physiological assessment or outcome measure 
Year Produced 2013 
Provided To Others? Yes  
Impact Paper (on which I am a co-author) submitted for publication. The results from the policy analysis will also be used to carry out site specific comparisons of HIV policy and facility implementation. The tool has been updated for subsequent years and additional abstracts have been prepared. 
 
Title Qualitative data collection tools 
Description Co-developed (with project partners) a handbook of tools to assess the health systems impacts of Option B+, in each country have conducted detailed training for the qualitative researchers on the study aims, protocol and tools. 
Type Of Material Physiological assessment or outcome measure 
Year Produced 2017 
Provided To Others? No  
Impact The tool has and is still being used to guide the interviews of approximately 25 women and 5-8 men, 5-10 key informants and 3-5 health care workers per country. 
 
Title Linked HIV community cohort dataset and clinic records 
Description Creation of a dataset that links routinely collected patient data from health facilities (including referral, HIV counseling and testing and antiretroviral therapy clinic data) with HIV cohort data - uses specially developed anonymous linking techniques 
Type Of Material Database/Collection of data 
Provided To Others? No  
Impact Linking methods shared with other demographic surveillance sites with the potential to link patient clinic records; papers published using generated data (eg/ uptake and coverage with HIV services in Tanzania in comparison with other sites from the ALPHA network) 
 
Title Repeated cross sectional facility survey dataset 2013-2017 
Description Between 2013 and 2017 our project has conducted a health facility survey at three time points. The facility survey includes multiple indicators in three/four modules (fourth added in round 3); namely HIV testing, ART initiation and delivery, PMTCT and ANC services. As part of SHAPE UTT we have created a compiled data set in excel and STATA that includes all the data points and allows for longitudinal analysis of multiple indicators over time. 
Type Of Material Database/Collection of data 
Year Produced 2019 
Provided To Others? Yes  
Impact We are currently preparing 9 research papers using this data-set and have an additional two students from LSHTM (both African scholars) who will/may use this data set in their MSc research projects. 
 
Title Tanzanian HIV Care and Treatment dataset 
Description Creation of a dataset containing patient-level data from 101 HIV care and treatment clinics across Tanzania 
Type Of Material Database/Collection of data 
Year Produced 2010 
Provided To Others? Yes  
Impact 3 analyses undertaken on : i) survival after antiretroviral therapy initiation; ii) estimations of need for antiretroviral therapy; iii) failure of first-line antiretroviral therapy and switching rates to 2nd line therapy 
 
Description AHRI - South Africa 
Organisation Africa Health Research Institute
Country South Africa 
Sector Charity/Non Profit 
PI Contribution Support AHRI to recruit, train and manage the SHAPE research team to collect and analyse the SHAPE data. Regular/weekly skype calls, involvement in week-long analysis workshop, support in preparing AIDS2018 abstracts (AHRI researcher lead author on 1).
Collaborator Contribution AHRI are responsible for all the data collection, analysis and reporting of the data from South Africa. They have and will continue to also collaborate with the other sites to ensure lessons are learned as we go along and input into the multip-country comparative analyses.
Impact 8 abstracts submitted to AIDS 2018, policy review updated, qualitative data collection underway, facility survey underway.
Start Year 2016
 
Description Alpha Network 
Organisation London School of Hygiene and Tropical Medicine (LSHTM)
Department Alpha Network
Country United Kingdom 
Sector Charity/Non Profit 
PI Contribution Definition of research topics, comparative analyses of HIV cohort data from up to 6 sites in sub-Saharan Africa, technical support and capacity building for African demographers and epidemiologists, organisation of analysis workshops
Collaborator Contribution Provision of HIV cohort data for analysis, analysis of data
Impact See publications list
 
Description Building capacity in PMTCT research and programming in Tanzania 
Organisation Kilimanjaro Christian Medical University College
Country Tanzania, United Republic of 
Sector Academic/University 
PI Contribution Supported the continued development of the Reproductive health research group with a specific focus on PMTCT. Jenny Renju (SHAPE Co-PI) has coordinated the collaboration, attended meetings, supervised three Masters students and two PhD students in their work around PMTCT.
Collaborator Contribution Inputs into the SHAPE study design, listen to the initial analysis plans and provided technical support.
Impact 1 x manuscript submitted to TMIH, 1 x manuscript in preparation, Phd students both in their first year and will soon prepare for their upgrading. This partnership is multi-disciplinary and includes epidemiology, bio-statistics and health systems research
Start Year 2017
 
Description Ifakara Health Institute 
Organisation Ifakara Health Institute
Country Tanzania, United Republic of 
Sector Charity/Non Profit 
PI Contribution We have supported IHI in the recruitment and training of project staff. We have conducted a series of workshops prior to (x2) and during (x1) data collection to support the process and ensures lessons learned across sites are shared. We have made two field visits to support data collection.
Collaborator Contribution IHI are partners on the SHAPE study and coordinating all study activities within Tanzania. This includes the recruitment and management of field and office teams, data collection, analysis and reporting.
Impact See publications - also submission of abstracts to AIDS2018 and HSR Global 2018
Start Year 2016
 
Description Improving the implementation of Option B+ in Tanzania 
Organisation Duke University
Country United States 
Sector Academic/University 
PI Contribution Jointly supported the development of the PMTCT research group in Kilimanjaro, have co-supervised two Masters students (one at KCMCo and one at Duke) to conduct their research project. We have co-submitted an additional grant application to NIH to continue to develop interventions to strengthen health systems to implement PMTCT (stigma reduction intervention). We co-hosted a workshop to explore avenues for collaboration (report available on request).
Collaborator Contribution Joint supervision of projects, scientific inputs into SHAPE data collection plans and initial interpretations. Sharing of relevant policy documents and updates from the Ministry level.
Impact symposium held bringing together researchers who are working on PMTCT, joint publication of a secondary data analysis, submission of a research proposal to NIH. This is multi-disciplinary as includes epidemiology, bio-statistics, clinical research, implementation science, health systems research.
Start Year 2017
 
Description Malawi Epidemiology and Intervention Research Unit (MEIRU). 
Organisation London School of Hygiene and Tropical Medicine (LSHTM)
Department Faculty of Epidemiology and Population Health
Country United Kingdom 
Sector Academic/University 
PI Contribution Preparations are currently underway to carry out qualitative research investigating delayed progression through the treatment continuum for HIV-infected persons in the study population
Collaborator Contribution The partner manages the study site (ongoing community cohort study including demographic, behavioural and HIV surveillance)
Impact Outcomes will include peer-reviewed publications and policy briefs Disciplines: demography, anthropology
Start Year 2014
 
Description Ministry of Health - Malawi 
Organisation Ministry of Health Malawi
PI Contribution Regular meetings, skype calls, involvement in research planning, conduct and interpretation. Involvement in the week long virtual preliminary analysis workshop. Joint authorship on 8 abstracts submitted to AIDS2018
Collaborator Contribution Regular meetings, skype calls, involvement in research planning, conduct and interpretation.
Impact Submission of 8 abstracts to AIDS2018
Start Year 2016
 
Description Ministry of Health - South Africa 
Organisation KwaZulu-Natal Department of Health
PI Contribution Regular communication and project updates, invitation to be part of the steering committee.
Collaborator Contribution Input into the research design, committed to be involved in the analysis of the findings.
Impact Research work still in progress
Start Year 2016
 
Description Ministry of Health - Tanzania 
Organisation Ministry of Community Development, Gender and Children
PI Contribution Work closely the prevention of mother to child transmission programme within the National AIDS control programme to ensure SHAPE addresses their programme needs. Have regular meetings and skype calls to keep active communication. We have supported a programme member to attend IAS Paris and to support him to present. Jenny Renju is a PhD supervisor for three NACP employees, one who is within the PMTCT programme.
Collaborator Contribution MoH through the PMTCT programme provided input into the study design, data collection and preliminary data analysis. One team member has presented SHAPE data at IAS 2017.
Impact Poster presentation at IAS 2017. Research and analysis on going.
Start Year 2016
 
Description HIV conference 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Policymakers/politicians
Results and Impact Presented a series of ~15 poster presentations and oral presentations at the Durban AIDS Conference on qualitative findings relating to my research
Year(s) Of Engagement Activity 2016
 
Description Presentation at IAS 2017 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Other audiences
Results and Impact Attended and presented SHAPE study results at the IAS2017 - the paper is available online
Year(s) Of Engagement Activity 2017
URL http://www.ias2017.org/Portals/1/Files/IAS2017_LO.compressed.pdf?ver=2017-07-27-211231-197
 
Description Presentation to the Malawi College of Medicine (November 2018) 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach Regional
Primary Audience Undergraduate students
Results and Impact John Songo presented his work to the college of medicine, this has prompted further discussions about the challenges within the health system as to how to strengthen the workforce.
Year(s) Of Engagement Activity 2018
 
Description Presentation to the National Aids Commission (NAC) at the Best Practices Dissemination Conference (October 2018) 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Policymakers/politicians
Results and Impact John Songo presented his paper: Understanding the impact of policies for delivering universal antiretroviral therapy on the health workforce in Tanzania and Malawi: Evidence from repeated health facility surveys from 2013 to 2017 and qualitative interviews
Year(s) Of Engagement Activity 2018
 
Description SHAPE findings presented at IAS2018 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact At AIDS2018 the four of the SHAPE UTT study team traveled to Amsterdam to present 5 abstracts. We also received two scholarships enabling us to travel to this event. The sessions were attended by numerous people and the inputs from the audience have helped to shape the future direction of the work.
Year(s) Of Engagement Activity 2018
 
Description Symposium with PMTCT implementers in Tanzania 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Professional Practitioners
Results and Impact The symposium brought together a range of stakeholders to discuss how research might best inform the implementation of the national PMTCT guidelines in Tanzania. Panels included updates on PMTCT policy guidelines, training and routine data collection, implementation science research on PMTCT care delivery, and presentations of ongoing research by KCMC students and trainees. Representatives from the Ministry of Health, Elizabeth Glaser Pediatric AIDS Foundation and local health facilities participated.
Year(s) Of Engagement Activity 2017