Effects of Stakeholder’s Management and Engagement on the Success of Fixed Dose Combination (FDC) Tenofovir/Lamivudine/Dolutegravir (TLD) Introduction and Transition: Nigeria Experience

Adenike Adelanwa3 and Babatunji Odelola3

Nigeria

(GHSC-PSM) project, Abuja, Nigeria, Email: yarobee@gmail.com transition plan.

Opinion

Results: A total of twenty (20) Federal Ministry of Health staff, fifty (50) staff of technical and treatment partners and two thousand four hundred and eighty-three (2,483) healthcare workers (HCW) from one thousand and ninety (1,090) antiretroviral treatment sites across thirty-six (36) and FCT were reached during the dissemination meetings and were adequately trained prior to transition commencement. 12,000 jobs aids and 800,000 Information Education and Communication materials were distributed to health facilities to assist HCW improve their knowledge on the use of TLD.

Enhanced mentorship and on-the-job training were provided to not less than 462 healthcare workers during the Integrated National Monitoring and Supportive Visits (INMSV).

Conclusion: Engagement of and communication with broad range of stakeholders during the transition process was key to the success of TLD transition as it allowed large numbers of stakeholders at the national, state and health facility level to be reached with relevant information about the transition. This paper describes engagement activities and other practices that facilitated TLD introduction and transition in Nigeria.

Keywords: Stakeholder; Engagement; Integrated Monitoring and Supportive Visits; Dissemination Meeting; TLD Transition; Management Abbreviations: ART: Antiretroviral treatment; FDC: Fixed Dose Combination; TLD: Tenofovir/Lamivudine/Dolutegravir; NASCP: National AIDS and STIs Control Program.

Introduction

Antiretroviral treatment (ART) protocol has been changing considerably in recent years due to scientific innovations and increased evidence of newer antiretroviral drugs with modest clinical and cost advantages over existing ones [1, 2]. The newer ARV drugs commonly referred to as optimized products, such as those containing dolutegravir (DTG) are expected to bring about improved treatment outcomes and significant cost savings as they are introduced to country programs [2].

Dolutegravir (DTG) is an Integrase strand transfer inhibitors (INSTI) that was first approved by the United States Food and Drug Administration in 2013 [3, 1]. It has shown clinical superiority in comparison to Efavirenz (EFV) in multiple large phase III trials [3, 4, 5, 1]. Additional benefits of DTG include faster viral suppression ability, a high genetic barrier, lower risk of resistance from poor adherence, prolonged intracellular half-life that allows for once-daily fixed dosing, and low-dosing requirements [1, 3]. It has less toxicity profile and a smaller pill size that is treatment adherence-friendly [1, 3]. Nigeria processed an initial order for 4.9 million doses of TLD in September 2017 and additional 3.1 million doses in January 2018.

The cost per patient per annum based on the negotiated price is US$ 75 and additional price reductions are expected [3].

The Nigeria Federal Ministry of Health (FMoH) in December 2017 approved the use of TLD as preferred first-line regimen for ART. The Ministry issued a Rapid Advice in October 2018 announcing TLD as the preferred adult first line [6]. This was developed as an addendum to the recommendations of National Guideline for HIV/AIDS Prevention, Treatment and Care 2016. To maximize health and budgetary benefits from TLD, implementation and uptake of the regimen must be well planned and coordinated. As a result, the National HIV program adopted an innovative strategy that relied on engagement, management and communication with stakeholders for the transitioning of existing patients on non-optimized ARV drugs tenofovir/lamivudine/efavirenz (TLE) and zidovudine/lamivudine/nevirapine (LNZ) to TLD. This was to avoid the experience of past transitions to new first-line ARV regimens that was met with a variety of logistical and implementation challenges, while also yielding several good practices.

According to the Institute of Development Studies (IDS), the word ‘stakeholder’ is used to describe anyone who has a ‘stake’ or an ‘interest’ in an initiative [7]. Griffiths, et al. describe stakeholders as people who will be affected by a project, or who can influence it, but who are not directly involved in doing the work. In other words, stakeholders can have an interest in an organization, in a specific initiative or project, or in an overarching policy or objective to which specific initiatives contribute [8]. IDS also defined engagement as a set of activities that facilitate an exchange of knowledge between stakeholders. This may include one-off activities but is usually a longer-term process of mutual exchange of knowledge and learning [7].

Led by the Federal Ministry of Health, there were 3 phases during which the different stakeholders were engaged in the TLD transition process. They include planning (phase in/phase out plan and communication development); State and Service delivery support (dissemination meetings); and transition monitoring and visibility (patient transition monitoring, pharmacovigilance and feedback). The Stakeholders engagement activities in the different phases involved building relationship through constant communications and shared decision making about the transition activities.

Methodology

The first phase of the engagement activity commenced with meeting of seven representatives from National AIDS and STIs Control Program (NASCP)-2, Global Health Supply Chain Program-Procurement and Supply Management (GHSC-PSM)-3, and Clinton Health Access Initiative-2. These were group of champions that were highly motivated to drive forward the transition program within their respective organizations. During this meeting, the team developed a step-wise twelve (12) months plan for phase in of TLD and phase out of non- optimized ARVs drugs. The transition plan was presented at the joint meeting of the National Task Team on Antiretroviral Treatment (NTTA) and National Task Team on Prevention of Mother to Child Transmission of HIV (NTTPMTCT). The NTTA and NTTPMTCT are national advisory council on antiretroviral treatment program. Communication messages on TLD (job aids for the health care workers and information education and communication materials for the patient’s group) were developed at the joint meeting. The transition plan and the communication message were endorsed for implementation by the joint meeting.

The second phase of the engagement process started with stakeholder analysis. This phase was led by the champions but involved the entire stakeholders in HIV/AIDS program in the country. Key stakeholders involved in HIV/AIDS program were identified and prioritized based on their level of interest in and influence in the program. A database with details of the stakeholders and their potential role in the transition process was developed to guide communication during the transition process. The stakeholders comprised of Government Agencies, UN Agencies, funders, technical and treatment partners.

The stakeholders were invited to an inaugural meeting that was later referred to as the National Stakeholders meeting on TLD transition. At the meeting, treatment partners were mapped based on the states where they are playing lead role and the goals of the transition were set out. In the follow-on meetings, schedule for state level dissemination meetings and presentation deck were developed while funding for the state level dissemination meetings and printing of the communication materials were decided.

As part of the pre-activity for the state level dissemination meeting, federal ministry of health, technical and treatment partners’ staff were provided trainings to empower them with appropriate knowledge and guidance including how initiatives like viral load (VL) monitoring interface with changes to ARV regimens.

State level TLD transition dissemination meetings took place across thirty-six (36) of the federation and the federal capital territory with participants drawn from states ministry of health and health facilities with technical support from National AIDS and STIs Control Program, Clinton Health Access Initiative (CHAI), Global Health Supply Chain Program-Procurement and Supply Management (GHSC-PSM) project, AIDS Healthcare Foundation and PEPFAR and GF lead partners and funding support from PEPFAR, GF and CHAI. The dissemination’ involved formal communication and roll- out of the transition plan and programmes to states ministry of health and health facilities. Job aids and the IEC materials were distributed as part of the activities for the dissemination meeting.

The third phase consisted of exchange of information about the need and benefits of the transition programme. Central, regional and state level Procurement and Supply Management technical working group meetings (PSM TWG) were organized at federal, regional and state levels on a bimonthly, semiannually and monthly basis respectively to review implementation strategies, discuss barriers and way forward. All stakeholders involved in HIV/AIDS program at the national, regional and state level participated in the PSM TWG meetings. Government with funding support from PEPFAR organized meetings of all clinicians, pharmacist and laboratory focal persons from antiretroviral treatment sites to review implementation and address challenges hindering progress.

National TLD transition monitoring tool and adverse drug reaction summary form for the new drug were developed and deployed by the National program. Monthly reports from treatment partners were collated by NASCP to monitor transition progress and to track and ensure timely detection of adverse events and development of appropriate mitigation strategies. The data are analyzed and disseminated to all stakeholders on monthly basis.

As a way of obtaining feedbacks on TLD transition implementation, the national program conducted an Integrated National Monitoring and Supportive Visits (INMSV) to 154 health facilities supported by fifteen (15) implementing partners in 21 states of the federation. The exercise involved on-site practical hands on mentoring and correction of wrong practices and sensitization of staff members on guidelines and correct processes. Oral and documented feedback were obtained from both the clinicians, Pharmacist, laboratory scientist and the patients on specific key & quality issues as per structured checklists during the visits to monitor progress as well as identify challenges hampering transition implementation. The checklists contained a scoring system wherein different indicators were quantified on basis of their importance to rank health facilities between good, average and poor performing. The information collected during visits was entered in MS Excel based template, which generated ready analyzed feedback in info graphic and numerical forms, which was shared with stakeholders at different levels for corrective actions.

Table 1 below summarized key activities undertook by the program during TLD transition progress and the various stakeholders that played a role in implementation of the activities.

Activity Organization(s) that implemented the

NTTA and NTTPMTCT for adoption NASCP

Development of TLD introduction job aids and IEC materials CHAI/GHSC-PSM/NASCP Convening of first national level stakeholder’s engagement meeting NASCP/GHSC-PSM Updating of information systems (tools and registers etc.) with TLD NASCP/GHSC-PSM Approval of Communique and Rapid Advice for the roll out of TLD FMOH Printing of Communique and Rapid Advice for the roll out of TLD NASCP Printing of the Job Aids and IEC materials for the TLD roll out CHAI/GHSC-PSM Email dissemination of the Communique and Rapid Advice for the roll out of TLD to national and state stakeholders NASCP Convening of national planning meeting for TLD dissemination NASCP/GHSC-PSM Mapping of national and state level stakeholders NASCP/GHSC-PSM Development of budgets and schedules for State level TLD dissemination meetings NASCP/GHSC-PSM Mapping of national and state level stakeholders NASCP/GHSC-PSM Notification of State’s Ministry of Health leadership about State level TLD Dissemination meeting NASCP Development of presentation materials for the State level TLD Dissemination meeting CHAI/NASCP/GHSC-PSM/NACA/FHI360-GF Meeting of the state teams/structures to finalize arrangement for the State level TLD dissemination meeting SMOH and Implementing Partners Training and orientation for national team for the Dissemination Meeting CHAI/NASCP/GHSC-PSM Development of activity reporting template for the State level TLD Dissemination meeting NASCP/GHSC-PSM Orientation of national level stakeholders on the use activity reporting NASCP/GHSC-PSM

Twenty (20) Federal Ministry of Health staff, fifty (50) staff of technical and treatment partners were provided mentorship on national rollout of TLD. This was to ensure requisite knowledge and information among the staff thus preparing them to effectively support the health facilities in the transition process.

Two thousand four hundred and eighty-three (2,483) healthcare workers from one thousand and ninety (1,090) antiretroviral treatment sites across thirty-six (36) states of the federation and federal capital territory were reached in the dissemination meetings and were adequately trained at the time of the transition. 12,000 jobs aids and 800,000 IEC materials were distributed to the health facilities to assist health care worker improve their knowledge and skills on the use of TLD.

Enhanced mentorship and on-the-job training were provided to not less than 462 healthcare workers during the Integrated National Monitoring and Supportive Visits (INMSV). The INMSV revealed that 95.8% of the health facilities visited had commenced the use of TLD as the preferred first line ART; 91% had at least one trained

Conclusions

Effective engagement of and communication with broad range of stakeholders during the transition process allowed Nigeria to rapidly disseminate the transition plan across the country. Although, it was not without its challenges, the main being lack of flexibility in scheduling, logistical support and funding. Stakeholders may have had conflicts with each other and perceived or direct conflicts of interest, but well-developed mechanisms for managing these conflicts were deployed by NASCP.

The outcome of the national monitoring and supportive visits suggests that the success of the transition to TLD was strongly dependent on the amounts of information provided to the participants during the dissemination meeting. While healthcare worker training is typically an essential component of transitions, the NMSV also found that on-the-job mentoring and user- friendly job aids are more effective at supporting good practices during transition.

To maintain relationships among stakeholders, it is believed that uninterrupted engagement over the transition period is necessary.

Disclaimer

The findings and conclusions in this paper are those of the authors and do not necessarily represent the official position of the USAID or GHSC-PSM.

Competing Interest

The authors of this manuscript declare that they have no competing interests.

Acknowledgement

The authors would like to acknowledge all the stakeholders that participated in the state level TLD Dissemination meetings. We are also grateful to the leadership of NASCP for their support and efforts in the roll out of TLD.