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.

Objective: Describe the experiences and perspectives among pregnant people with chronic HCV infection receiving ledipasvir/sofosbuvir (LDV/SOF) therapy during pregnancy. Methods: We conducted semi-structured, in-depth interviews within an open-label, phase 1 study of LDV/SOF therapy among pregnant people with chronic HCV infection. Participants took 12 weeks of LDV/SOF and were interviewed at enrollment and again at the end of treatment. We transcribed the interviews verbatim and coded them with NVivo software for subsequent inductive thematic analysis. Results: Nine pregnant people completed the study, leading to 18 interview transcripts. All participants identified as women. Eight women acquired HCV through injection drug use, and 1 through perinatal transmission. We identified 3 themes. (1) Treatment for HCV during pregnancy with LDV/SOF was tolerable and convenient. (2) Women described that taking investigational LDV/SOF increased their self-esteem and sense of well-being due to possible cure from HCV, and they felt that the experience of working hard to achieve cure may potentially prevent return to drug abuse in the future. (3) Women appreciated researchers and providers that gave non-judgmental care and communicated honestly, and preferred person-centered care that acknowledges women’s individual needs. Conclusions: Women stated that cure from HCV would be “life-changing,” and described antepartum treatment for HCV with LDV/SOF as tolerable and desired, when provided by non-judgmental providers. Antepartum treatment was found to be acceptable by study participants and should be further evaluated to combat the increasing HCV epidemic among young persons, including pregnant people.

Background People who exchange sex for money, favors, goods or services, combat higher risk of acquiring sexually transmitted diseases (STDs) and human immunodeficiency virus (HIV). Understanding barriers to STD and HIV related healthcare from the perspective of this stigmatized and marginalized community may improve access to sexual health services including pre-exposure prophylaxis (PrEP).  Methods We used community-partnered participatory and qualitative methods to conduct anonymous one-on-one interviews with people who exchange sex to understand their perspectives and experiences related to pre-exposure prophylaxis (PrEP) to prevent HIV acquisition. We conducted twenty-two interviews and coded them to perform thematic analysis.  Results We identified five themes: (1) Appreciation of HIV risk and prevention strategies grew from information accumulated over time. (2) PrEP information came from a variety of sources with mixed messages and uncertain credibility. (3) Decision-making about use of PrEP was relative to other behavioral decisions regarding exchange sex. (4) The multi-step process of obtaining PrEP presented multiple potential barriers. (5) Healthcare providers were seen as powerful facilitators to PrEP utilization. Conclusions Our findings suggest that PrEP education and care needs to be made more relevant and accessible to individuals who exchange sex.