Promoting Condom Use among Women in Established Relationships

描述(申请人提供)：在全球范围内，已建立关系的妇女仍然面临意外怀孕和性传播感染(STI)的风险，包括艾滋病毒。在这项研究的所在地越南，未得到满足的避孕需求很大，这反映在该国的高堕胎率上。在越南，已婚女性约占艾滋病毒病例的三分之一，其中大多数人是通过与丈夫的性行为接触到病毒的。尽管最近在预防艾滋病毒的生物医学干预方面取得了进展，但在未来一段时间内，避孕套仍将是生殖健康干预的重要组成部分。然而，持续使用避孕套是出了名的难以实现。持续使用避孕套的一个关键障碍是避孕套对性快感的影响。虽然性快感是性行为的主要动机，也是整体性健康不可或缺的一部分，但大多数改善性健康的计划都是在怀孕和疾病预防的范例下进行的。一种名为CSD500的新型避孕套被开发出来，它含有一种勃起药物，供健康夫妇使用，通过增加阴茎的坚固性、大小和勃起时间来提高性快感。这项拟议的双臂随机试验的总体目标是测试推广新型避孕套CSD500以改善性快感是否会对没有保护措施的阴道性行为较少的夫妇产生效果。我们将通过检测女性阴道液中前列腺特异性抗原(PSA)的存在来衡量无保护阴道性行为的发生，PSA是最近精液暴露的客观生物标志。该项目有三个具体目标：目标1.评估与标准避孕套相比，CSD500是否能改善性快感，从而减少已建立关系的女性的精液暴露。目的2.确定CSD500条款是否增加了男性和女性对性快感的报告，这是使用经过验证的量表来衡量的。目的3.确定精液暴露的相关性，通过PSA阳性来衡量，这可以为未能持续使用避孕套的女性亚群提供洞察。为了实现这些目标，我们将在越南清华省随机选择500对成年、异性恋、一夫一妻制的夫妇，让他们要么获得500加元的性快感，要么在常规护理期间为患者提供目前仅用于怀孕和疾病预防的标准避孕套。我们将在注册时、2个月、4个月和6个月后采访女性参与者及其男性伴侣，为期6个月。我们将在所有就诊时从女性参与者的阴道液中提取样本，以检测PSA的存在。这项拟议的研究意义重大，因为研究结果可能支持一种变革性的方法，即推广避孕套获得性快乐，以防止意外怀孕和艾滋病毒/性传播感染。

DESCRIPTION (provided by applicant): Globally, women in established relationships remain at risk for unintended pregnancy and sexually transmitted infections (STIs), including HIV. In Vietnam, the location of the proposed research, unmet need for contraception is substantial as reflected in the nation's high abortion ratio. Married women account for about one-third of HIV cases in Vietnam, and among this group, most were exposed to the virus through sexual activity with their husband. Despite recent advancements in biomedical interventions for HIV prevention, condoms will remain a crucial component of reproductive health interventions for some time to come. Sustained condom use, however, is notoriously difficult to achieve. A key barrier to the consistent use of condoms is their effect on sexual pleasure. Although sexual pleasure is a primary motivation for engaging in sex and is an integral part of overall sexual health, most programs to improve sexual health operate within a pregnancy and disease-prevention paradigm. A new condom, CSD500, containing an erectogenic drug was developed for use among healthy couples to improve sexual pleasure by increasing penile firmness, size and erection duration. The overall objective of the proposed two-arm randomized trial is to test whether promoting the novel condom CSD500 for improved sexual pleasure results in couples having less unprotected vaginal sex. We will measure the occurrence of unprotected vaginal sex by testing women's vaginal fluid for the presence of prostate-specific antigen (PSA), an objective, biological marker of recent semen exposure. The project has three specific aims: Aim 1. To evaluate whether CSD500 provided to improve sexual pleasure, as compared to the standard condom, results in less semen exposure among women in an established relationship. Aim 2. To determine whether CSD500 provision increases men and women's reports of sexual pleasure, as measured using a validated scale. Aim 3. To identify correlates of semen exposure, measured by PSA positivity, which could provide insight into subgroups of women who fail to use condoms consistently. To accomplish these aims, we will randomize 500 adult, heterosexual, monogamous couples in Thanh Hoa province, Vietnam to receive either CSD500 for sexual pleasure or the standard condom currently provided only for pregnancy and disease prevention to patients during routine care. We will interview female participants at enrollment and after 2, 4, and 6 months and their male partners at the 6-month visit. We will sample vaginal fluid from female participants at all visits to test for the presence of PSA. The proposed study is significant because the results could support a transformative approach of promoting condoms for sexual pleasure in order to prevent unintended pregnancy and HIV/STIs.