FHI 360, Durham, North Carolina, United States of America.
UNC-Project Malawi, Malawi Clinical Research Site, Lilongwe, Malawi.
PLoS One. 2024 Oct 23;19(10):e0309811. doi: 10.1371/journal.pone.0309811. eCollection 2024.
HPTN 084 compared the safety and efficacy of long-acting injectable cabotegravir (CAB) to daily oral TDF/FTC for prevention of HIV-1 in uninfected African women. Like a similar trial in MSM/TGW (HPTN 083), the trial was stopped early for efficacy, expediting the need to consider introduction strategies for different populations. We examine survey and qualitative data from a four-country sub-study to examine oral and injectable PrEP acceptability and considerations for CAB access among African women.
Participants completed baseline and follow-up surveys on HIV risk perception, sexual behavior. product acceptability and adherence during the blinded trial. Additionally, up to two in-depth interviews each with 73 sub-study participants explored product use and trial-related experiences, during the blinded and unblinded study periods. Using survey data, we classified participants as: engaged in female sex work (FSW), having multiple non-transactional partners, or monogamous. A study statistician identified participants' assigned study arm. We followed a thematic analysis process to read transcripts, develop a codebook and apply codes in NVivo to transcripts with intermittent intercoder reliability checks; using Excel matrices to explore differences across risk categories and study arms.
Participants overwhelmingly preferred injections to pills, appreciating the ease, convenience, and privacy of a long-acting formulation. Many participants described challenges with contraceptive and/or study pill adherence, impeded by late night work, unexpected travel, or heavy drinking. Women in the TDF/FTC arm were more likely to describe side effects, compared to those in the CAB arm. Pain also varied widely by study arm. When considering post-trial access to CAB, limited PrEP knowledge, cost and concerns around stigma and poor service quality were potential access barriers.
Women's desire for privacy and ease of use outweighed injectable concerns, resulting in a strong preference for CAB. Cost and accessibility will need to be addressed by implementation programs.
HPTN 084 比较了长效注射用卡替拉韦（CAB）与每日口服 TDF/FTC 在预防未感染的非洲女性中 HIV-1 的安全性和有效性。与在男男性行为者/跨性别女性（HPTN 083）中的类似试验一样，该试验因疗效而提前终止，这加速了需要考虑为不同人群制定引入策略。我们通过四国子研究中的调查和定性数据，研究了非洲女性对口服和注射用 PrEP 的可接受性以及获得 CAB 的考虑因素。
参与者在盲法试验期间完成了关于 HIV 风险感知、性行为、产品可接受性和依从性的基线和随访调查。此外，在盲法和非盲法研究期间，对 73 名子研究参与者中的每一位进行了最多两次深入访谈，以探讨产品使用和与试验相关的经验。使用调查数据，我们将参与者分为：从事女性性工作者（FSW）、有多个非交易性伴侣或一夫一妻制。一位研究统计学家确定了参与者的研究分组。我们遵循主题分析流程，阅读转录本，制定代码本，并在 NVivo 中应用代码，同时进行间歇性的编码员间可靠性检查；使用 Excel 矩阵探索不同风险类别和研究分组之间的差异。
参与者压倒性地更喜欢注射而不是片剂，赞赏长效制剂的易用性、便利性和隐私性。许多参与者描述了在遵守避孕措施和/或研究药物方面的挑战，这些挑战受到深夜工作、意外旅行或大量饮酒的阻碍。与 CAB 组相比，接受 TDF/FTC 治疗的女性更有可能描述副作用。疼痛也因研究分组而差异很大。在考虑试验后获得 CAB 的机会时，有限的 PrEP 知识、成本以及对污名和服务质量差的担忧可能是获得途径的障碍。
女性对隐私和易用性的需求超过了对注射的担忧，因此强烈倾向于使用 CAB。成本和可及性将需要由实施项目来解决。
