Sullivan Kristen, Mtande Tiwonge, Jaffe Elana, Rosenberg Nora, Zimba Chifundo, Hoffman Irving, Little Maggie, Faden Ruth, Lyerly Anne Drapkin
Center for Bioethics and Department of Social Medicine, University of North Carolina at Chapel Hill, 333 S. Columbia Street, Campus Box 7240, Chapel Hill, NC, 27599, USA.
UNC Project Malawi, Tidziwe Centre, Private Bag A-104, Lilongwe, Malawi.
AIDS Res Ther. 2020 May 27;17(1):27. doi: 10.1186/s12981-020-00271-6.
The pressing need to expand the biomedical HIV prevention evidence base during pregnancy is now increasingly recognized. Women's views regarding participation in such trials and initiating PrEP while pregnant are critical to inform evolving policy and best practices aimed at responsibly expanding evidence-based access for this population.
We conducted 35 semi-structured interviews with reproductive-aged women in Malawi in the local language, Chichewa. Participants were HIV-negative and purposively sampled to capture a range of experience with research during pregnancy. Women's perspectives on enrolling in three hypothetical HIV prevention trial vignettes while pregnant were explored, testing: (1) oral PrEP (Truvada) (2) a vaginal ring (dapivirine), and (3) a randomized trial comparing the two. The vignettes were read aloud to participants and a simple visual was provided. Interviews were audio-recorded, transcribed, translated, and coded using NVivo 11. Thematic analysis informed the analytic approach.
A majority of women accepted participation in all trials. Women's views on research participation varied largely based on their assessment of whether participation or nonparticipation would best protect their own health and that of their offspring. Women interested in participating described power dynamics with their partner as fueling their HIV exposure concerns and highlighted health benefits of participation-principally, HIV protection and access to testing/treatment and ancillary care, and perceived potential risks of the vignettes as low. Women who were uninterested in participating highlighted potential maternal and fetal health risks of the trial, challenges of justifying prevention use to their partner, and raised some modality-specific concerns. Women also described ways their social networks, sense of altruism and adherence requirements would influence participation decisions.
The majority of participants conveyed strong interest in participating in biomedical HIV prevention research during pregnancy, largely motivated by a desire to protect themselves and their offspring. Our results are consistent with other studies that found high acceptance of HIV prevention products during pregnancy, and support the current direction of HIV research policies and practices that are increasingly aimed at protecting the health of pregnant women and their offspring through responsible research, rather than defaulting to their exclusion.
孕期扩大生物医学艾滋病毒预防证据基础的迫切需求如今日益得到认可。女性对于参与此类试验以及孕期开始服用暴露前预防药物（PrEP）的看法，对于为不断发展的政策和最佳实践提供信息至关重要，这些政策和实践旨在负责任地扩大该人群基于证据的获取途径。
我们用当地语言奇契瓦语对马拉维的育龄女性进行了35次半结构化访谈。参与者为艾滋病毒阴性，通过目的抽样以获取一系列孕期研究经历。探讨了女性对于在孕期参与三个假设的艾滋病毒预防试验案例的看法，试验内容包括：（1）口服PrEP（特鲁瓦达）；（2）阴道环（达匹韦林）；（3）比较前两者的随机试验。向参与者大声朗读案例并提供简单的视觉辅助。访谈进行了录音、转录、翻译，并使用NVivo 11进行编码。主题分析为分析方法提供了依据。
大多数女性接受参与所有试验。女性对于研究参与的看法在很大程度上取决于她们对参与或不参与是否最能保护自身及后代健康的评估。有兴趣参与的女性将与伴侣的权力动态描述为加剧了她们对艾滋病毒暴露的担忧，并强调了参与的健康益处——主要是艾滋病毒防护以及获得检测/治疗和辅助护理的机会，且认为案例中的潜在风险较低。对参与不感兴趣的女性则强调了试验对母婴健康的潜在风险、向伴侣说明预防用途的挑战，并提出了一些与具体方式相关的担忧。女性还描述了她们的社交网络、利他意识和依从性要求会如何影响参与决策。
大多数参与者表达了对孕期参与生物医学艾滋病毒预防研究的强烈兴趣，主要动机是保护自己和后代。我们的结果与其他研究一致，这些研究发现孕期对艾滋病毒预防产品的接受度很高，并支持艾滋病毒研究政策和实践的当前方向，即越来越多地旨在通过负责任的研究保护孕妇及其后代的健康，而不是默认将她们排除在外。
