Ending the evidence gap for pregnancy, HIV and co-infections: ethics guidance from the PHASES project.

INTRODUCTION: While pregnant people have been an important focus for HIV research, critical evidence gaps remain regarding prevention, co-infection, and safety and efficacy of new antiretroviral therapies in pregnancy. Such gaps can result in harm: without safety data, drugs used may carry unacceptable risks to the foetus or pregnant person; without pregnancy-specific dosing data, pregnant people face risks of both toxicity and undertreatment; and delays in gathering evidence can limit access to beneficial next-generation drugs. Despite recognition of the need, numerous barriers and ethical complexities have limited progress. We describe the process, ethical foundations, recommendations and applications of guidance for advancing responsible inclusion of pregnant people in HIV/co-infections research. DISCUSSION: The 26-member international and interdisciplinary Pregnancy and HIV/AIDS: Seeking Equitable Study (PHASES) Working Group was convened to develop ethics-centred guidance for advancing timely, responsible HIV/co-infections research with pregnant people. Deliberations over 3 years drew on extensive qualitative research, stakeholder engagement, expert consultation and a series of workshops. The guidance, initially issued in July 2020, highlights conceptual shifts needed in framing research with pregnant people, and articulates three ethical foundations to ground recommendations: equitable protection from drug-related risks, timely access to biomedical advances and equitable respect for pregnant people's health interests. The guidance advances 12 specific recommendations, actionable within the current regulatory environment, addressing multiple stakeholders across drug development and post-approval research, and organized around four themes: building capacity, supporting inclusion, achieving priority research and ensuring respect. The recommendations describe strategies towards ethically redressing the evidence gap for pregnant people around HIV and co-infections. The guidance has informed key efforts of leading organizations working to advance needed research, and identifies further opportunities for impact by a range of stakeholder groups. CONCLUSIONS: There are clear pathways towards ethical inclusion of pregnant people in the biomedical research agenda, and strong agreement across the HIV research community about the need for - and the promise of - advancing them. Those who fund, conduct, oversee and advocate for research can use the PHASES guidance to facilitate more, better and earlier evidence to optimize the health and wellbeing of pregnant people and their children.

An analysis of funding patterns in development assistance for mental health: who, when, what, and where.

BACKGROUND: Mental health has recently gained increasing attention on global health and development agendas, including calls for an increase in international funding. Few studies have previously characterized official development assistance for mental health (DAMH) in a nuanced and differentiated manner in order to support future funding efforts. METHODS: Data from the Organisation for Economic Cooperation and Development Creditor Reporting System were obtained through keyword searches. Projects were manually reviewed and categorized into projects dedicated entirely to mental health and projects that mention mental health (as one of many aims). Analysis of donor, recipient, and sector characteristics within and between categories was undertaken cumulatively and yearly. FINDINGS: Between the two categories of official DAMH defined, characteristics differed in terms of largest donors, largest recipient countries and territories, and sector classification. However, across both categories there were clear and consistent findings: the top donors accounted for over 80% of all funding identified; the top recipients were predominantly conflict-affected countries and territories, or were receiving nations for conflict-affect refugees; and sector classification demonstrated shifting international development priorities and political drivers. CONCLUSION: Across DAMH, significant amounts of funding are directed toward conflict settings and relevant emergency response by a small majority of donors. Our analysis demonstrated that, within minimal international assistance for mental health overall, patterns of donor, recipient, and sector characteristics favor emergency conflict-affected settings. Calls for increased funding should be grounded in understanding of funding drivers and directed toward both emergency and general health settings.