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
Year: 2018
Type: article
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.
Source: AIDS and Behavior
Language: English
Subfield: Infectious Diseases
Field: Medicine
Domain: Health Sciences
Open Access status: hybrid
Estimated APC paid: $4,590
Funders: United States Agency for International Development, Bill and Melinda Gates Foundation, Wellcome Trust, National Institutes of Health, Medical Research Council, National Institute of Mental Health, National Institute of Allergy and Infectious Diseases, Eunice Kennedy Shriver National Institute of Child Health and Human Development
Awards: Delivery of integrated PrEP and ART for HIV prevention for couples in Kenya, In Their Own Voices: Vulnerabilities & Abilities of Women, Children, & Families in Health Research, Antiretroviral periconception HIV prevention for HIV discordant couples, 'The Global Health Bioethics Network: a programme to carry out ethics research and build ethics capacity across the Wellcome Trust's Major Overseas Programmes.', 'The Global Health Bioethics Network: a programme to carry out ethics research and build ethics capacity across the Wellcome Trust's Major Overseas Programmes.', Optimizing Delivery of ART/PrEP for HIV Prevention through Qualitative Research, Antiretroviral periconception HIV prevention for HIV discordant couples, PrEP EXPOSURE DURING HIV-1 INFECTION AND THE RISK OF LOW-FREQUENCY ARV RESISTANCE, In Their Own Voices: Vulnerabilities & Abilities of Women, Children, & Families in Health Research, APP - AAD 936-3090, University of Washington Foundation - to conduct a placebo-controlled proof-of-concept phase III trial of the safety and efficacy of TDF and FTC/TDF in reducing HIV acquisition among HI..., Development of Real-Time Antiretroviral Therapy Adherence Intervention in Uganda, G7965387109, University of Washington/Fred Hutch Center for AIDS Research
OpenAlex ID: W2903568614