Promoting Condom Use among Women in Established Relationships

促进已建立关系的女性使用安全套

基本信息

批准号：
9925822
负责人：
Maria F Gallo
金额：
$ 29.36万
依托单位：
OHIO STATE UNIVERSITY
依托单位国家：
美国
项目类别：
财政年份：
2016
资助国家：
美国
起止时间：
2016-06-01 至 2022-03-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9925822
关键词：
AIDS prevention Abortion Rates Address Adherence Adoption Adult Biological Markers Coitus Contraceptive methods Couples Data Reporting Development Disease Early identification Ejaculation Enrollment Eroticism Esthesia Excision Exposure to Face Failure Female Future HIV HIV Infections HIV risk Health Heterosexuals Hormonal Husband Impairment Infection Control Intervention Interview Lead Length Location Logistics Male Circumcision Male Condoms Marriage Measures Mediation Medical Methodology Methods Motivation PSA screening Participant Patient Self-Report Patients Pharmaceutical Preparations Prostate-Specific Antigen Province Public Health Randomized Regimen Reporting Research Risk Risk Factors Safe Sex Sampling Seminal fluid Sex Behavior Sexual Health Sexuality Sexually Transmitted Diseases Southeastern Asia Subgroup Swab Testing Time Unsafe Sex Vagina Vietnam Virus Visit Woman World Health Organization abortion arm base condoms consistent condom use design disability disorder prevention erection experience follow-up hormonal contraception improved insight intimate behavior male men mortality novel penis pleasure pre-exposure prophylaxis pregnancy prevention prevent programs public health relevance randomized trial reproductive health intervention routine care sex sexual HIV transmission sexual health intervention sexual relationship side effect treatment arm unintended pregnancy vaginal fluid

项目摘要

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.

描述（由申请人提供）：在全球范围内，既定关系中的妇女仍然有意外怀孕和性传播感染（STIS）（包括艾滋病毒）的风险。在越南，拟议的研究的位置，未满足的避孕需求在国家的高流产比例中反映出。已婚妇女约占越南艾滋病毒的三分之一，在这一群体中，大多数人通过与丈夫的性活动接触了病毒。尽管最近在生物医学预防的生物医学干预措施方面取得了进步，但避孕套仍将是生殖健康干预措施的关键组成部分。然而，众所周知，持续的避孕套使用很难实现。持续使用避孕套的关键障碍是它们对性愉悦的影响。尽管性愉悦是从事性行为的主要动机，并且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在怀孕和预防疾病范式内运作。开发了一种新的避孕套CSD500，其中包含勃起药物，用于在健康夫妇中使用，以增加阴茎牢固，大小和勃起持续时间来改善性乐趣。拟议的两臂随机试验的总体目标是测试是否促进新型的避孕套CSD500以改善性愉悦感，从而导致没有保护性的阴道性别较少的夫妻。我们将通过测试女性的阴道液来衡量未受保护的阴道性别的发生，以便存在前列腺特异性抗原（PSA），这是最近精液暴露的客观生物学标记。该项目具有三个特定的目标：目标1。评估与标准避孕套相比，是否提供CSD500来改善性愉悦感，导致妇女在既定关系中的精液暴露较少。目的2。确定CSD500的规定是否增加了使用经过验证的量表来衡量的男女性愉悦报告。目标3。确定通过PSA阳性衡量的精液暴露的相关性，这可以洞悉未能始终使用避孕套的女性亚组。为了实现这些目标，我们将在越南塔省省的500名成年人，异性恋，一夫一妻夫妇随机，以接受CSD500以进行性愉悦或目前仅用于预防妊娠和预防疾病的标准避孕套，以预防常规护理期间患者。我们将在入学人数和2、4和6个月后采访女性参与者，并在6个月的访问中采访男性伴侣。我们将在所有访问中采样来自女性参与者的阴道流体，以测试PSA的存在。拟议的研究很重要，因为结果可以支持促进性愉悦避孕套的变革性方法，以防止意外怀孕和艾滋病毒/性传播感染。

项目成果

期刊论文数量（4）

专著数量（0）

科研奖励数量（0）

会议论文数量（0）

专利数量（0）

Changes in the use of effective and long-acting reversible contraception in Vietnam.

越南有效和长效可逆避孕方法使用的变化。

DOI：
10.1016/j.contraception.2018.11.014
发表时间：
2019
期刊：
Contraception
影响因子：
2.9
作者：
Asad,Sarah;Hebert,Courtney;Andridge,Rebecca;Nguyen,Nghia;Gallo,MariaF
通讯作者：
Gallo,MariaF

Effects of a Novel Erectogenic Condom on Men and Women's Sexual Pleasure: Randomized Controlled Trial.

DOI：
10.1080/00224499.2021.2024790
发表时间：
2022-11
期刊：
JOURNAL OF SEX RESEARCH
影响因子：
3.6
作者：
Gallo, M. F.;Nguyen, N. C.;Luff, A.;Luong, T. N.;Le, V. T.;Casterline, J.;Andridge, R.
通讯作者：
Andridge, R.

Effectiveness of erectogenic condom against semen exposure among women in Vietnam: Randomized controlled trial.