Lessons from PrEP: A Qualitative Study Investigating How Clinical and Policy Experts Weigh Ethics and Evidence When Evaluating Preventive Medications for Use in Pregnant and Breastfeeding Women

Kristin M. Beima-Sofie, Susan Brown Trinidad, Kenneth Ngure, Renee Heffron, Jared M. Baeten, Grace C. John-Stewart, Maureen Kelley

Research output: Contribution to journalArticlepeer-review

3 Scopus citations

Abstract

This study explored how multinational HIV experts weigh clinical, evidential, and ethical considerations regarding pre-exposure prophylaxis in pregnant/breastfeeding women. Semi-structured interviews were conducted with experts in HIV policy, research, treatment, and implementation from three global regions. A constant comparative approach identified major themes. Experts noted that exclusion of pregnant women from research limits evidence regarding risks/benefits, emphasizing that underinclusion of pregnant women in RCTs shifts the onus of evidence-building to clinical care. Experts discussed approaches for weighing evidence to make decisions, including triangulating evidence from sources other than RCTs. Likelihood and severity of disease strongly influenced decisions. Less effective interventions with limited fetal risk were preferred over interventions of uncertain safety, unless the disease was serious. Experts resisted the dichotomous choice between protecting maternal and fetal interests, arguing that these interests are intertwined and that more holistic approaches to maternal–fetal balance support greater inclusion of pregnant women in research.

Original languageEnglish (US)
Pages (from-to)1858-1870
Number of pages13
JournalAIDS and Behavior
Volume23
Issue number7
DOIs
StatePublished - Jul 15 2019

Keywords

  • Decision-making
  • Ethics
  • PrEP
  • Pregnancy and HIV
  • Women

ASJC Scopus subject areas

  • Social Psychology
  • Public Health, Environmental and Occupational Health
  • Infectious Diseases

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