ERIC Number: EJ1331289
Record Type: Journal
Publication Date: 2022-Apr
Pages: 19
Abstractor: As Provided
ISBN: N/A
ISSN: ISSN-1747-0161
EISSN: N/A
Motives and Risk Perceptions of Participants in a Phase 1 Trial for Hepatitis C Virus Investigational Therapy in Pregnancy
Kislovskiy, Yasaswi; Chappell, Catherine; Flaherty, Emily; Hamm, Megan E.; de Abril Cameron, Flor; Krans, Elizabeth; Chang, Judy C.
Research Ethics, v18 n2 p132-150 Apr 2022
Limited research has been done among pregnant people participating in investigational drug trials. To enhance the ethical understanding of pregnant people's perspectives on research participation, we sought to describe motives and risk perceptions of participants in a phase 1 trial of ledipasvir/sofosbuvir (LDV/SOF) treatment for chronic Hepatitis C virus (HCV) during pregnancy. Pregnant people with chronic HCV infection enrolled in an open-label, phase 1 study of LDV/SOF participated in semi-structured, in-depth interviews to explore their reasons for participation and experiences within the study. Pregnant people took 12 weeks of LDV/SOF and were interviewed at enrollment and at the end of study. We recorded the interviews, transcribed them verbatim, coded them using NVivo software, and performed inductive thematic analysis. Nine women completed the study yielding 18 interview transcripts. We identified two themes regarding motives and one regarding risk perception. Motives--(1) Women conceptualized study participation as part of the caregiving role they associate with motherhood; participating was viewed as an act of caregiving for their infants, their families, themselves, and other pregnant women with chronic HCV. (2) Women also noted that they faced multiple barriers to treatment prior to pregnancy that created a desire to receive therapy through trial participation. Risk perception--(3) Women acknowledged personal and fetal risk associated with participation. Acceptance of risk was influenced by women's concepts of motherhood, preexisting knowledge of HCV and medical research, family members, intimate partners, or by the study design. Women enrolled in a phase 1 trial for chronic HCV therapy during pregnancy acknowledged risks of participation and were motivated by hopes for fetal and personal benefit and by lack of prenatal access to treatment. Ethical inclusion of pregnant people in research should acknowledge structural factors that contribute to vulnerability and data deficiencies for treatment in pregnancy.
Descriptors: Communicable Diseases, Pregnancy, Drug Therapy, Participation, Research, Motivation, Risk, Chronic Illness, Females
SAGE Publications. 2455 Teller Road, Thousand Oaks, CA 91320. Tel: 800-818-7243; Tel: 805-499-9774; Fax: 800-583-2665; e-mail: journals@sagepub.com; Web site: http://bibliotheek.ehb.be:2814
Publication Type: Journal Articles; Reports - Research
Education Level: N/A
Audience: N/A
Language: English
Sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) (DHHS/NIH); National Institutes of Health (DHHS), Office of Research on Women's Health (ORWH)
Authoring Institution: N/A
Identifiers - Location: Pennsylvania (Pittsburgh)
Grant or Contract Numbers: 1R21HD08945601; 5K12HD4344114