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

Anne Drapkin Lyerly¹, Richard Beigi², Linda-Gail Bekker³, Benjamin H Chi⁴, Susan E Cohn⁵, Dázon Dixon Diallo^{6

7}, Joseph Eron⁸, Ruth Faden⁹, Elana Jaffe¹, Angela Kashuba¹⁰, Mary Kasule¹¹, Carleigh Krubiner¹², Maggie Little¹³, Joseph Mfustso-Bengo¹⁴, Lynne Mofenson¹⁵, Victor Mwapasa¹⁶, Lillian Mworeko¹⁷, Landon Myer¹⁸, Martina Penazzato¹⁹, Annette Rid²⁰, Roger Shapiro²¹, Jerome Amir Singh^{22

23}, Kristen Sullivan¹, Marissa Vicari²⁴, Jacque Wambui²⁵, Amina White⁴, Marisha Wickremsinhe²⁶, Leslie Wolf²⁷

Affiliations

¹ Department of Social Medicine and Center for Bioethics, University of North Carolina, Chapel Hill, North Carolina, USA.
² Department of Obstetrics, Gynecology & Reproductive Sciences, UPMC Magee-Women's Hospital, Pittsburgh, Pennsylvania, USA.
³ Desmond Tutu HIV Centre and Department of Medicine, University of Cape Town, Cape Town, South Africa.
⁴ Department of Obstetrics and Gynecology, University of North Carolina, Chapel Hill, North Carolina, USA.
⁵ Department of Medicine, Feinberg School of Medicine, Northwestern University, Chicago, Illinois, USA.
⁶ SisterLove, Inc, Atlanta, Georgia, USA.
⁷ SisterLove, Inc, Johannesburg, South Africa.
⁸ Department of Medicine and Center for AIDS Research, University of North Carolina, Chapel Hill, North Carolina, USA.
⁹ Johns Hopkins Berman Institute of Bioethics, Baltimore, Maryland, USA.
¹⁰ Eshelman School of Pharmacy and Department of Medicine, University of North Carolina, Chapel Hill, North Carolina, USA.
¹¹ Botswana-Baylor Centre for Clinical Excellence, Gabarone, Botswana.
¹² Center for Global Development, Washington, DC, USA.
¹³ Kennedy Institute for Ethics and Department of Philosophy, Georgetown University, Washington, DC, USA.
¹⁴ Center of Bioethics for Eastern & Southern Africa and Department of Health Systems and Policy, College of Medicine, University of Malawi, Zomba, Malawi.
¹⁵ Elizabeth Glaser Pediatric AIDS Foundation, Washington, DC, USA.
¹⁶ College of Medicine, University of Malawi, Zomba, Malawi.
¹⁷ International Community of Women Living with HIV Eastern Africa, Kampala, Uganda.
¹⁸ Division of Epidemiology and Biostatistics, School of Public Health and Family Medicine, University of Cape Town, Cape Town, South Africa.
¹⁹ HIV Department, World Health Organization, Geneva, Switzerland.
²⁰ Department of Bioethics, The Clinical Center, National Institutes of Health, Bethesda, Maryland, USA.
²¹ Department of Immunology and Infectious Diseases, Harvard T.H. Chan School of Public Health, Boston, Massachusetts, USA.
²² Howard College School of Law, University of KwaZulu-Natal, KwaZulu-Natal, South Africa.
²³ Dalla Lana School of Public Health Sciences, University of Toronto, Toronto, Ontario, Canada.
²⁴ International AIDS Society, Geneva, Switzerland.
²⁵ National Empowerment Network of People Living with HIV and AIDS in Kenya (NEPHAK), African Communities Advisory Board (AfroCAB), Lusaka, Zambia.
²⁶ Ethox Centre and Wellcome Centre for Ethics and Humanities, University of Oxford, Oxford, UK.
²⁷ Center for Law, Health & Society and College of Law and School of Public Health, Georgia State University, Atlanta, Georgia, USA.

PMID: 34910846
PMCID: PMC8673925
DOI: 10.1002/jia2.25846

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

Anne Drapkin Lyerly et al. J Int AIDS Soc. 2021 Dec.

. 2021 Dec;24(12):e25846.

doi: 10.1002/jia2.25846.

Authors

Affiliations

¹ Department of Social Medicine and Center for Bioethics, University of North Carolina, Chapel Hill, North Carolina, USA.
² Department of Obstetrics, Gynecology & Reproductive Sciences, UPMC Magee-Women's Hospital, Pittsburgh, Pennsylvania, USA.
³ Desmond Tutu HIV Centre and Department of Medicine, University of Cape Town, Cape Town, South Africa.
⁴ Department of Obstetrics and Gynecology, University of North Carolina, Chapel Hill, North Carolina, USA.
⁵ Department of Medicine, Feinberg School of Medicine, Northwestern University, Chicago, Illinois, USA.
⁶ SisterLove, Inc, Atlanta, Georgia, USA.
⁷ SisterLove, Inc, Johannesburg, South Africa.
⁸ Department of Medicine and Center for AIDS Research, University of North Carolina, Chapel Hill, North Carolina, USA.
⁹ Johns Hopkins Berman Institute of Bioethics, Baltimore, Maryland, USA.
¹⁰ Eshelman School of Pharmacy and Department of Medicine, University of North Carolina, Chapel Hill, North Carolina, USA.
¹¹ Botswana-Baylor Centre for Clinical Excellence, Gabarone, Botswana.
¹² Center for Global Development, Washington, DC, USA.
¹³ Kennedy Institute for Ethics and Department of Philosophy, Georgetown University, Washington, DC, USA.
¹⁴ Center of Bioethics for Eastern & Southern Africa and Department of Health Systems and Policy, College of Medicine, University of Malawi, Zomba, Malawi.
¹⁵ Elizabeth Glaser Pediatric AIDS Foundation, Washington, DC, USA.
¹⁶ College of Medicine, University of Malawi, Zomba, Malawi.
¹⁷ International Community of Women Living with HIV Eastern Africa, Kampala, Uganda.
¹⁸ Division of Epidemiology and Biostatistics, School of Public Health and Family Medicine, University of Cape Town, Cape Town, South Africa.
¹⁹ HIV Department, World Health Organization, Geneva, Switzerland.
²⁰ Department of Bioethics, The Clinical Center, National Institutes of Health, Bethesda, Maryland, USA.
²¹ Department of Immunology and Infectious Diseases, Harvard T.H. Chan School of Public Health, Boston, Massachusetts, USA.
²² Howard College School of Law, University of KwaZulu-Natal, KwaZulu-Natal, South Africa.
²³ Dalla Lana School of Public Health Sciences, University of Toronto, Toronto, Ontario, Canada.
²⁴ International AIDS Society, Geneva, Switzerland.
²⁵ National Empowerment Network of People Living with HIV and AIDS in Kenya (NEPHAK), African Communities Advisory Board (AfroCAB), Lusaka, Zambia.
²⁶ Ethox Centre and Wellcome Centre for Ethics and Humanities, University of Oxford, Oxford, UK.
²⁷ Center for Law, Health & Society and College of Law and School of Public Health, Georgia State University, Atlanta, Georgia, USA.

PMID: 34910846
PMCID: PMC8673925
DOI: 10.1002/jia2.25846

Abstract

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.

Keywords: HIV; co-infections; ethics; pregnancy; prevention; research.

PubMed Disclaimer

Conflict of interest statement

The authors declare no competing interests.

Figures

**Figure 1**
Recommendations of the PHASES guidance

See this image and copyright information in PMC

References

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

Affiliations

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

Authors

Affiliations

Abstract

Conflict of interest statement

Figures

References

Publication types

MeSH terms

Grants and funding

LinkOut - more resources

Full Text Sources

Medical

Miscellaneous