Validating Sexual Behavior by Y-chromosome PCR

通过 Y 染色体 PCR 验证性行为

基本信息

批准号：
7026612
负责人：
Jonathan M Zenilman
金额：
$ 0.81万
依托单位：
JOHNS HOPKINS UNIVERSITY
依托单位国家：
美国
项目类别：
财政年份：
2003
资助国家：
美国
起止时间：
2003-04-15 至 2006-03-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/7026612
关键词：
biomarker clinical research communicable disease control condoms contraceptives enzyme linked immunosorbent assay female human subject polymerase chain reaction sex behavior sex chromosomes sexually transmitted diseases women&apos s health young adult human (21-34)

项目摘要

DESCRIPTION (provided by applicant): Estimating reporting bias and validity of self-reports are a major issue in sexual behavior and condom use research. Incident STDs as biomarkers are expensive, and not useful in low-incident populations. We have developed a highly sensitive polymerase chain reaction (PCR) assay for semen Y-chromosome (Yc) sequences in vaginal fluid as a potential biomarker of sexual behavior and/or condom efficacy. The assay is highly sensitive and can be performed on a self-administered vaginal swab. Pilot data found that after unprotected intercourse followed by an abstinence period, Yc was detectable for 15 days, and the half-life was 3.4 days. In this proposal, we will further characterize the assay by enrolling 50 women in a clinical study to demonstrate "proof of concept", i.e. that after condom-protected intercourse no Yc is detectable in the post-coital vagina. 2). To define assay sensitivity under different conditions, we propose further research to evaluate characteristics of the vaginal microenvironment, which could affect Yc clearance. We hypothesize that menses and douching would shorten Yc clearance times. First we will evaluate the presence/absence of menses on Yc clearance by evaluating Yc clearance over a carefully monitored 2 week post-coital period in 120 women who will participate as their own control-they will participate twice (for a total of 224 cycles), comparing the effect of having their menstrual period during the measurement interval Yc clearance time compared to a time interval where menses did not occur. We will evaluate the effect of douching, a common practice in women in Baltimore at risk for STD, by comparing Yc clearance in 120 women after douching, compared to a repeated study interval in the same subject where they did not douche (a total of 224 study cycles). From our 1990-92 studies of condom use, we have archived cervicovaginal lavage fluid from 82 women reporting sex within 2 weeks and 100% condom use, and 322 who did not use condoms. These samples will be assayed for Yc and compared with demographic and behavioral data, and concomitant markers of cervical inflammation and STDs at time of visit. The outcomes will be compared to the findings from a previously published study that used STD incidence as the biomarker variable. Since Yc sampling requires only a vaginal swab, and is stable under field conditions, this test promises to be a practical and easily used biomarker for sexual behavior research.

描述（由申请人提供）：自我报告的估计报告偏见和有效性是性行为和避孕套使用研究的主要问题。作为生物标志物的事件性传播疾病很昂贵，在低收入人群中没有用。我们已经开发了高度敏感的聚合酶链反应（PCR）测定，用于阴道液中的精液Y染色体（YC）序列，作为性行为和/或避孕套疗效的潜在生物标志物。该测定很灵敏，可以在自我管理的阴道拭子上进行。飞行员数据发现，在未受保护的性交之后，随后是节制期，可以检测到YC 15天，而半衰期为3.4天。在此提案中，我们将通过将50名女性参加临床研究来证明“概念证明”，即在避孕套保护后的性交中未发现YC在医生后阴道中，在临床研究中，我们将进一步表征该测定法。 2）。为了在不同条件下定义测定敏感性，我们提出了进一步的研究来评估阴道微环境的特征，这可能会影响YC清除率。我们假设月经和冲洗将缩短YC的清除时间。首先，我们将通过评估YC间隙的存在/不存在YC在YC间隙中的存在/不存在，这是在120名妇女中经过经过仔细监控的2周后期的监测，这些妇女将参加自己的控制，她们将参与两次（共224个周期），从而比较了在测量间隔时间间隔间隔间隔间隔间隔间隔间隔间隔间隔间隔时间为MENS的效果。我们将通过比较120名女性在巴尔的摩的YC清除率进行比较，这是在巴尔的摩的妇女中的普遍做法，这是一种在灌肠后的YC清除率，与同一受试者的重复研究间隔（共224个研究周期）进行了比较。从1990 - 92年的避孕套研究研究中，我们已经归档了来自82名妇女在2周内报告性行为和100％避孕套的宫颈阴道灌洗液，还有322名不使用避孕套的女性。这些样本将用于YC，并将其与人口统计学和行为数据以及访问时宫颈炎症和性病的伴随标记进行比较。结果将与以前发表的研究的发现相提并论，该研究将STD发病率用作生物标志物变量。由于YC采样仅需要阴道拭子，并且在田间条件下是稳定的，因此该测试有望成为一种实用且易于使用的生物标志物进行性行为研究。