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.

中文翻译：

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马拉维妇女对怀孕时参加艾滋病毒预防临床试验的看法。

人们越来越认识到，迫切需要扩大妊娠期间艾滋病毒预防的生物医学证据基础。妇女对参与此类试验和怀孕期间启动 PrEP 的看法对于不断发展的政策和最佳实践至关重要，这些政策和最佳实践旨在负责任地扩大该人群的循证服务机会。我们使用当地语言奇切瓦语对马拉维育龄妇女进行了 35 次半结构化访谈。参与者均为艾滋病毒阴性，并有目的地进行抽样，以获取怀孕期间的一系列研究经验。探讨了妇女对怀孕期间参加三个假设的艾滋病毒预防试验小插曲的看法，测试：（1）口服 PrEP（特鲁瓦达）（2）阴道环（达匹韦林），以及（3）比较两者的随机试验。向参与者大声朗读这些小插图，并提供简单的视觉效果。使用 NVivo 11 对访谈进行录音、转录、翻译和编码。主题分析为分析方法提供了依据。大多数女性接受参加所有试验。妇女对参与研究的看法在很大程度上取决于她们对参与或不参与是否能最好地保护自己及其后代健康的评估。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接触艾滋病毒的担忧，并强调了参与的健康益处——主要是艾滋病毒保护和获得检测/治疗和辅助护理，并认为小插曲的潜在风险较低。不感兴趣参与的女性强调了该试验潜在的孕产妇和胎儿健康风险、向其伴侣证明预防使用合理性的挑战，并提出了一些特定方式的担忧。女性还描述了她们的社交网络、利他主义意识和遵守要求如何影响参与决策。大多数参与者对参与怀孕期间艾滋病毒生物医学预防研究表现出浓厚的兴趣，主要是出于保护自己和后代的愿望。我们的结果与其他研究一致，这些研究发现怀孕期间艾滋病毒预防产品的接受度很高，并支持当前艾滋病毒研究政策和实践的方向，这些政策和实践越来越旨在通过负责任的研究来保护孕妇及其后代的健康，而不是默认将他们排除在外。