Validating Sexual Behavior by Y-chromosome PCR

通过 Y 染色体 PCR 验证性行为

• 批准号: 6591172
• 负责人: Jonathan M Zenilman
• 金额: $ 17.94万
• 依托单位: JOHNS HOPKINS UNIVERSITY
• 依托单位国家: 美国
• 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/6591172
• 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's health; young adult human (21-34)

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）：估计自我报告的报告偏差和有效性是性行为和安全套使用研究中的一个主要问题。作为生物标志物的性传播疾病发病率昂贵，而且对于低发病率人群没有用处。我们开发了一种高灵敏度聚合酶链反应 (PCR) 检测方法，用于检测阴道液中精液 Y 染色体 (Yc) 序列，作为性行为和/或安全套功效的潜在生物标志物。该测定高度敏感，可以在自行施用的阴道拭子上进行。试验数据发现，在无保护性交和禁欲期后，15天内可检测到Yc，半衰期为3.4天。在本提案中，我们将通过招募 50 名女性参与临床研究来进一步描述该测定的特征，以证明“概念证明”，即在使用安全套保护性交后，在性交后阴道中检测不到 Yc。 2）。为了确定不同条件下的检测灵敏度，我们建议进一步研究评估可能影响 Yc 清除率的阴道微环境特征。我们假设月经和冲洗会缩短 Yc 清除时间。首先，我们将通过对 120 名女性进行仔细监测的性交后 2 周期间的 Yc 清除率来评估月经是否存在对 Yc 清除率的影响，这些女性将作为自己的对照参加，她们将参加两次（总共 224 个周期），比较在测量间隔 Yc 清除时间内月经期与月经未发生的时间间隔的影响。我们将通过比较 120 名女性冲洗后的 Yc 清除率与同一受试者未冲洗的重复研究间隔（总共 224 个研究周期），来评估冲洗的效果，这是巴尔的摩有 STD 风险的女性的一种常见做法。根据我们 1990-92 年的安全套使用研究，我们存档了 82 名报告在 2 周内发生性行为且 100% 使用安全套的女性以及 322 名未使用安全套的女性的子宫颈阴道灌洗液。这些样本将进行 Yc 检测，并与就诊时的人口统计和行为数据以及宫颈炎症和 STD 的伴随标记进行比较。结果将与之前发表的使用 STD 发病率作为生物标志变量的研究结果进行比较。由于 Yc 采样仅需要阴道拭子，并且在现场条件下稳定，因此该测试有望成为性行为研究中实用且易于使用的生物标志物。