Behavioral, Epidemiological and Clinical Sciences Division, Durham, NC, FHI 360, USA.
AVAC, New York, NY, USA.
AIDS Behav. 2024 Nov;28(11):3850-3872. doi: 10.1007/s10461-024-04459-z. Epub 2024 Aug 17.
Historically, pregnant and lactating populations (PLP) have been excluded or disenrolled from biomedical HIV prevention trials, despite being more likely to acquire HIV during pregnancy and the post-partum period. We conducted a meta-analysis of pregnancy events in biomedical HIV prevention trials in sub-Saharan Africa to support trialists moving toward more inclusive clinical and implementation studies. We searched peer-reviewed literature reporting pregnancy events and contraceptive requirements in HIV prevention trials between 2001 and 2022. We hypothesized four variables to explain variation: contraceptive requirements, study start year, study product, and sub-region. We fit a meta-analytic model to estimate individual effect sizes and sampling variances, then conducted sub-group analyses to assess moderating effects. We identified 38 references for inclusion, across which the proportion of pregnancy events was 8% (95% confidence interval [CI]: 6-10%) with high heterogeneity (I = 99%). Studies not requiring contraceptives (21%, 95%CI: 7-48%) reported a significantly higher proportion of pregnancy events than studies requiring two methods (5%, 95%CI: 2-10%). Studies launched between 2001 and 2007 (11%, 95%CI: 8-16%), microbicide gel trials (12%, 95%CI: 8-18%), and studies conducted in Western Africa (28%, 95%CI: 13-51%) reported higher proportions of pregnancy events than reference groups. Together, these variables have a moderating effect on pregnancy events (p < 0.0001), explaining 63% of heterogeneity in trials. Results describe how, over time, more stringent contraceptive requirements reduced pregnancy events, which ensured necessary statistical power but limited reproductive choice by participants. With the move toward continuing PLP on experimental products, trialists can utilize estimated pregnancy events reported here to inform strategies that accommodate participants' changing fertility preferences.
从历史上看，尽管怀孕和哺乳期人群（PLP）在怀孕期间和产后更有可能感染 HIV，但她们被排除在生物医学 HIV 预防试验之外或被取消参与资格。我们对撒哈拉以南非洲地区的生物医学 HIV 预防试验中的妊娠事件进行了荟萃分析，以支持试验人员开展更具包容性的临床和实施研究。我们检索了 2001 年至 2022 年间发表的报告 HIV 预防试验中妊娠事件和避孕需求的同行评议文献。我们假设了四个变量来解释变异：避孕需求、研究开始年份、研究产品和次区域。我们拟合了一个荟萃分析模型来估计个体效应量和抽样方差，然后进行了亚组分析以评估调节效应。我们确定了 38 篇参考文献，其中妊娠事件的比例为 8%（95%置信区间 [CI]：6-10%），异质性很高（I=99%）。不需要避孕措施的研究（21%，95%CI：7-48%）报告的妊娠事件比例明显高于需要两种方法的研究（5%，95%CI：2-10%）。2001 年至 2007 年启动的研究（11%，95%CI：8-16%）、杀微生物凝胶试验（12%，95%CI：8-18%）和在西非进行的研究（28%，95%CI：13-51%）报告的妊娠事件比例高于参考组。这些变量共同对妊娠事件产生了调节作用（p<0.0001），解释了试验中 63%的异质性。结果描述了随着时间的推移，更严格的避孕需求如何降低了妊娠事件的发生，这确保了必要的统计效力，但限制了参与者的生殖选择。随着继续在实验产品上对 PLP 进行研究，试验人员可以利用这里报告的估计妊娠事件来为适应参与者不断变化的生育偏好的策略提供信息。
