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：
9412385
负责人：
Maria F Gallo
金额：
$ 28.64万
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 2021-03-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9412385
关键词：
AIDS prevention Abortion Rates Address Adherence Adoption Adult Adverse effects 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 Participant Patient Self-Report Patients Pharmaceutical Preparations Pregnancy 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 pleasure pre-exposure prophylaxis pregnancy prevention prevent programs public health relevance randomized trial reproductive health intervention routine care sex sexual health intervention sexual relationship 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，已建立的妇女仍处于意外的预期和性传播的风险。关于越南的Hib Casses的三分之一，尽管与丈夫进行性行为，但在该群体中，避孕套仍将成为生殖时间的关键组成部分避孕套的持续使用的关键障碍是他们的性愉悦感。在健康的夫妇中，可以通过提高阴茎的牢固性，大小和勃起时间通过测试女性的阴道液在前列腺特异性抗原（PSA）的存在中。该项目具有三个特定的目的：目标1。评估是否提供CSD500来改善性愉悦，与标准避孕套相比在既定的关系和妇女的性愉悦报告中，都使用验证的量表来确定精液曝光的相关性，以PSA的阳性来衡量，这可能会成为500名成年人的女性。，异性恋，一夫一妻制，越南，越南获得CSD500的性愉悦感或目前仅用于怀孕和常规期间提供的标准。。重要的结果很难支持促进性愉悦避孕套的变革性方法，以使其成为抗辩和艾滋病毒/性传播疾病。