Predicting PrEP Uptake and Adherence Among Adolescent Girls and Young Women in Sub-Saharan Africa: Leveraging Programmatic and Clinical Trials Data - Administrative Supplement

摘要 尽管艾滋病毒护理和治疗举措以及预防活动的扩大显著地 撒哈拉以南非洲(SSA)大部分地区艾滋病毒感染率下降，那里的年轻女性在 世界上艾滋病毒发病率最高的国家。已经推出了几个计划来应对持续的高水平 SSA中AGYW人群中的HIV风险。其中最雄心勃勃的是梦想倡议。这是分层的 一揽子干预措施侧重于四个领域：增强AGYW的能力并降低其风险，降低其 性伴侣，巩固家庭，动员社区进行变革。该方案还包括 获得关键生物医学干预组件暴露前预防(PrEP)。 口服抗逆转录病毒药物预防HIV性感染(PrEP)的潜在有效性 在安慰剂对照、随机临床试验和开放标签研究中得到了很好的证实。在这些试验中， 药物疗效取决于依从性。在几项研究中，在女性中没有看到疗效 对这种药物的依从性很低。现有的监测PrEP依从性的工具包括自我报告、药片计数、 电子药瓶和PBMC的。目前，DREAMS计划依赖于健康提供者的评估 记录不一致，并且基于自我报告、药片计数或PrEP计划持久性。一种药物 浓度是依从性的更客观的衡量标准，并与临床结果密切相关 准备好了。在这项研究中，我们建议用指棒采集干血斑标本来测量PrEP的粘附性 通过细胞内替诺福韦-二磷酸水平和评价目标药物水平之间的一致性，自身 报告遵守情况，并研究坚持措施。

ABSTRACT Although HIV care and treatment initiatives, as well as scale-up of prevention activities, have dramatically reduced HIV infection rates in much of sub-Saharan Africa (SSA), young women there experience among the highest HIV incidence rates in the world. Several programs have been launched to address the ongoing high HIV risk among AGYW in SSA. The most ambitious among them is the DREAMS initiative. This layered intervention package focuses on four areas: empowering AGYW and reducing their risk, reducing risk in their sexual partners, strengthening families, and mobilizing communities for change. The package also includes access to the critical biomedical intervention component Pre-Exposure Prophylaxis (PrEP). The potential effectiveness of oral antiretroviral medications to prevent the sexual acquisition of HIV (PrEP) has been well established in placebo-controlled, randomized clinical trials and open-label studies. In these trials, drug efficacy is dependent on adherence. No efficacy was seen in several studies among women where adherence to the drug was low. The existing tools to monitor PrEP adherence include self-report, pill count, electronic pill bottles, and PBMC’s. Currently the DREAMS program relies on health provider assessment which is inconsistently recorded and based on either self-report, pill count, or PrEP program persistence. A drug concentration is a more objective measure of adherence and closely correlates with the clinical outcomes of PrEP. In this study, we propose to collect dried blood spot specimens via finger stick to measure PrEP adherence by intracellular tenofovir-diphosphate level and evaluate concordance between the objective drug levels, self- reported adherence, and study persistence measures.