Promoting Condom Use among Women in Established Relationships

 描述（由申请人提供）：在全球范围内，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。在越南，拟议研究的所在地，未满足的避孕需求很大，这反映在该国的高堕胎率上。在越南，已婚妇女约占艾滋病毒病例的三分之一，在这一群体中，大多数人通过与丈夫的性活动接触到病毒。尽管最近在预防艾滋病毒的生物医学干预措施方面取得了进展，但在今后一段时间内，避孕套仍将是生殖健康干预措施的一个重要组成部分。然而，众所周知，持续使用避孕套很难实现。持续使用避孕套的一个关键障碍是它们对性快感的影响。虽然性快感是性行为的主要动机，也是整体性健康的一个组成部分，但大多数改善性健康的计划都是在怀孕和疾病预防的模式下运作的。一种新的避孕套，CSD 500，含有勃起药物，被开发用于健康的夫妇，通过增加阴茎的硬度，大小和勃起时间来改善性快感。拟议的两组随机试验的总体目标是测试推广新型避孕套CSD 500是否会改善性快感，从而减少无保护阴道性行为的发生。我们将通过检测女性阴道液中前列腺特异性抗原（PSA）的存在来测量无保护阴道性行为的发生率，PSA是近期精液暴露的客观生物标志物。该项目有三个具体目标：目标1。评估与标准避孕套相比，提供CSD 500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。目标2.确定CSD 500的提供是否增加了男性和女性的性快感报告，使用经验证的量表进行测量。目标3：通过PSA阳性来确定精液暴露的相关性，这可以为未能持续使用避孕套的女性亚组提供深入了解。为了实现这些目标，我们将在越南清和省随机抽取500对成年异性恋一夫一妻制夫妇，接受CSD 500的性快感或目前仅在常规护理期间为患者提供的用于妊娠和疾病预防的标准避孕套。我们将在入组时以及2、4和6个月后对女性受试者进行访谈，并在6个月访视时对其男性伴侣进行访谈。我们将在所有访视时采集女性受试者的阴道液样本，以检测PSA的存在。拟定研究 这项研究意义重大，因为研究结果可以支持一种促进性快感安全套的变革性方法，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.