Ethical, Regulatory and Market related aspects of Deploying Triple Artemisinin-Based Combination Therapies for Malaria treatment in Africa: A study protocol.

Abstract

Introduction: According to the World Malaria Report 2019, Africa accounts for 94% of the global malaria deaths. While malaria prevalence and mortality have declined over the years, recent reports suggest that these gains may stand the risk of being reversed if resistance to Artemisinin Combination Therapies (ACTs) spreads from Southeast Asia to Africa. Efforts are being made to develop new treatments that will address the looming threat of ACT resistance, including the development of triple artemisinin combination therapies (TACTs). The proposed study seeks to explore the views of stakeholders on the key ethical, regulatory and market-related issues that should be considered in the potential introduction of triple artemisinin combination therapies (TACTs) in Africa. Methods: The study employed qualitative research methods involving in-depth interviews and focus group discussions (FGDs) with stakeholders, who will be directly affected by the potential deployment of triple artemisinin combination treatments, as regulators, suppliers and end-users. Participants will be purposively selected and will include national regulatory authorities, national malaria control programs, clinicians, distributors and retailers as well as community members in selected districts in Burkina Faso and Nigeria. Discussion: The proposed study is unique in being one of the first studies that seeks to understand the ethical, social, regulatory and market position issues prior to the development of a prospective antimalarial medicine.

A framework for stakeholder engagement in the adoption of new anti-malarial treatments in Africa: a case study of Nigeria

“…This study is based on two approaches. An analysis of stakeholders’ perspectives extracted from a qualitative study conducted in Nigeria between December 2019 and June 2020 involving 33 in-depth interviews (IDI) and 6 focus group discussions (FGDs) [ 31 ]. An analysis of programme, and policy documents and two further interviews conducted in December 2021 to include historical accounts with key informants immersed in the malaria elimination program in Nigeria.…”

Ethical considerations in deploying triple artemisinin-based combination therapies for malaria: An analysis of stakeholders’ perspectives in Burkina Faso and Nigeria

“…This study was an exploratory qualitative research study conducted as part of the Development of Triple Artemisinin-based Combination Therapies (DeTACT) project [16]. It involved the collection and analysis of stakeholders' perspectives obtained through in-depth interviews (IDIs) and focus group discussions (FGDs) [27]. The study design was selected to elicit perspectives of diverse stakeholder groups within the healthcare service delivery.…”

“…If the public health goal of TACTs is to mitigate the risk of drug resistance and protect the therapeutic efficacy of ACTs, thereby preventing malaria morbidity and mortality across Africa and the rest of the world, is it justifiable to ask patients to carry an additional burden associated with TACT treatments for the sake of public good? Beyond justifying the public health benefits of deploying TACTs in Africa, given previous experiences with the slow change of national malaria policies in the early 2000s, it is crucial that important ethical issues are addressed before the deployment of TACTs, and that these are informed by the perspectives of stakeholders such as policy makers, implementers, prescribers and end-users [27].…”

A framework for stakeholder engagement in the adoption of new antimalarial treatments in Africa: a case study of Nigeria

“…1. An analysis of stakeholders' perspectives extracted from a qualitative study conducted in Nigeria between December 2019 and June 2020 involving 33 in-depth interviews (IDI) and 6 focus group discussions (FGDs) [30].…”

“…The qualitative phase of the study conducted with purposively selected respondents in both the federal capital city of Nigeria, Abuja and in a Northcentral State, Kwara, has been described previously, [25,26,30]. For this case study, we extracted information from the 33 IDIs and 6 FGDs with key stakeholders (Table 1).…”