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

预测撒哈拉以南非洲地区青春期女孩和年轻女性的 PrEP 采用率和依从性：利用计划和临床试验数据 - 行政补充

• 批准号: 9753587
• 负责人: Ying Qing Chen
• 金额: $ 26.75万
• 依托单位: FRED HUTCHINSON CANCER RESEARCH CENTER
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-08-01 至 2022-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9753587
• 关键词: AIDS prevention; Acquired Immunodeficiency Syndrome; Address; Adherence; Administrative Supplement; Adolescent HIV risk; Africa South of the Sahara; African; Anti-Retroviral Agents; Area; Bedside Testings; Biological Assay; Blood; Caring; Categories; Clinical; Clinical Trials; Communities; Country; Data; Diphosphates; Dreams; Effectiveness; Failure; Family; Female Adolescents; Fingers; Funding; Funding Opportunities; HIV; HIV Infections; Hair; Health Personnel; Heterosexuals; High Risk Woman; Incidence; Individual; Industry; Infection; Intervention; Interview; Kenya; Measurement; Measures; Mentors; Monitor; Oral; Outcome; Parents; Participant; Patient Self-Report; Peripheral Blood Mononuclear Cell; Pharmaceutical Preparations; Placebos; Population; Prevention; Prevention strategy; Privatization; Provider; Randomized Clinical Trials; Research; Research Personnel; Risk; Risk Factors; Sexual Partners; Specimen; Spottings; Standardization; Student Dropouts; Tenofovir; Testing; Time; Universities; Washington; Woman; aged; base; compliance behavior; cost; design; drug efficacy; empowered; experience; girls; health assessment; liquid chromatography mass spectrometry; medication compliance; men; men who have sex with men; open label; parent grant; pill; pre-exposure prophylaxis; prevent; programs; research study; scale up; success; tool; transgender women; unintended pregnancy; uptake; young woman

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.

摘要 尽管艾滋病毒护理和治疗举措以及预防活动的扩大， 在撒哈拉以南非洲的大部分地区，艾滋病毒感染率下降，那里的年轻妇女在艾滋病毒感染者中经历了 世界上艾滋病发病率最高的国家。已经启动了几个方案，以解决持续的高 撒南非洲青年女青年中的艾滋病毒风险。其中最雄心勃勃的是梦想计划。这种分层 干预方案侧重于四个领域：增强青年妇女的权能并减少其风险， 性伙伴、巩固家庭和动员社区进行变革。该包装还包括 获得关键的生物医学干预成分-接触前预防。 口服抗逆转录病毒药物预防艾滋病毒性感染（PrEP）的潜在有效性 已在安慰剂对照、随机临床试验和开放标签研究中得到充分确立。在这些试验中， 药物功效取决于依从性。在几项针对女性的研究中， 对药物的依从性很低。现有的监测PrEP依从性的工具包括自我报告，药丸计数， 电子药瓶和PBMC。目前，DREAMS计划依赖于健康提供者的评估， 不一致的记录和基于自我报告，药丸计数，或PrEP程序的持久性。药物 浓度是依从性的更客观的衡量标准，与临床结局密切相关。 制备型在这项研究中，我们建议通过手指针刺收集干燥的血斑标本，以测量PrEP粘附 通过细胞内替诺福韦-二磷酸水平，并评估客观药物水平、自身 报告的依从性和研究持续性指标。