NIMH Multisite HIV/STD Prevention Trial for African-American Couples

NIMH 针对非裔美国夫妇的多地点 HIV/STD 预防试验

基本信息

批准号：
7546641
负责人：
GAIL E. WYATT
金额：
$ 14.62万
依托单位：
UNIVERSITY OF CALIFORNIA LOS ANGELES
依托单位国家：
美国
项目类别：
财政年份：
2002
资助国家：
美国
起止时间：
2002-04-01 至 2010-09-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/7546641
关键词：
AIDS/HIV problem Address African American Behavioral Biological California Chlamydia Clinic Coitus Collaborations Communities Computer Assisted Couples DNA amplification Data Data Analyses Data Collection Data Coordinating Center Decision Making Effect Modifiers (Epidemiology)Effectiveness Enrollment Epidemic Equation Feedback Female Funding Gender Gonorrhea Grant HIV Health Health Promotion Heterosexuals Incidence Individual Intervention Interview Learning Length Los Angeles Mediating Mediator of activation protein Medical Modality Modeling Names National Institute of Mental Health New York Outcome Participant Patient Self-Report Pennsylvania Phase Philadelphia Play Population Prevention approach Procedures Process Measure Progress Reports Protocols documentation Public Health Randomized Randomized Controlled Trials Recording of previous events Recruitment Activity Research Design Research Personnel Resources Risk Risk Reduction Role Safety Seminal Sex Behavior Sexual abuse Sexually Transmitted Diseases Site Social Work Specimen Substance abuse problem Testing Time Training Trichomonas Universities Urine Vagina Work base clinical research site condoms cultural values design disease transmission disorder prevention disorder risk efficacy testing follow up assessment follow-up health organization high risk innovation intervention effect male meetings outreach post intervention programs psychological distress quality assurance secondary outcome sex risk social cognitive theory solidarity success transmission process treatment effect

项目摘要

DESCRIPTION (provided by applicant): The HIV/AIDS epidemic continues to be a major public health concern that has hit African Americans particularly hard. Individual-level prevention approaches, although effective, are too narrowly focused and ignore the role relationships play in HIV/STD transmission. Couple-level interventions, especially with serodiscordant couples, redirect the focus to changing the relationship factors that influence sexual decision-making and increase the likelihood that sexual risk reduction will be stable over time. This U10 competing continuation application seeks four additional years of support to meet the original plan to enroll 800 African American HIV serodiscordant couples into Project Eban, the NIMH Multisite HIV/STD Prevention Trial for African American Couples, that is being conducted in four clinical sites-Atlanta, Los Angeles, New York, and Philadelphia-in collaboration with the NIMH and a Data Coordinating Center. Although attendance rates at intervention sessions and retention rates at follow-up assessments have been excellent, recruitment challenges have caused slower couple enrollment than was originally planned. Additional time is needed to implement new recruitment activities that are anticipated to recruit these hard-to-reach couples. As in the original trial, we will randomize couples to (1) an 8-session couples-focused HIV/STD Risk Reduction Intervention or (2) an 8-session individual-focused Health Promotion Intervention (the comparison condition) that addresses health issues unrelated to sexual behavior. Both interventions involve couple and group sessions led by trained male and female co-facilitators. The approach draws upon the social cognitive theory, an ecological framework, an Afro centric paradigm and the applicant teams' previous work with African American populations. The primary behavioral outcome is self-reported proportion of condom- protected sexual intercourse; the primary biological outcome is the incidence of STDs (i.e., chlamydia, gonorrhea, and trichomonas) assessed by DNA amplification tests on urine and vaginal specimens. Secondary outcomes include theoretically relevant variables hypothesized to mediate and moderate intervention effects. Audio computer-assisted self-interviewing (ACASI) will be used to collect data at baseline, immediately post-intervention, and at 6- and 12-month follow-up. Generalized estimating equations (GEE) and mixed-effects modeling (MEM) will be used to test (1) the effects of the intervention on STD incidence and condom use as well as on mediator variables of these outcomes and (2) whether the effects of the intervention differ depending on key moderator variables (e.g., gender of the seropositive partner, length of relationship, psychological distress, sexual abuse history, and substance abuse history. The findings will contribute significantly to an understanding of HIV/STD risk reduction among African American serodiscordant couples, a population at high risk of transmission.

描述（由申请人提供）：艾滋病毒/艾滋病的流行仍然是一个主要的公共卫生问题，对非裔美国人的影响特别严重。个体级的预防方法虽然有效，但过于狭窄地专注，而忽略了关系在HIV/STD传播中的作用。夫妻级干预措施，尤其是与塞里达夫妇的夫妻的干预措施，将重点重新定向，以改变影响性决策的关系因素，并增加随着时间的推移性风险稳定的可能性。 This U10 competing continuation application seeks four additional years of support to meet the original plan to enroll 800 African American HIV serodiscordant couples into Project Eban, the NIMH Multisite HIV/STD Prevention Trial for African American Couples, that is being conducted in four clinical sites-Atlanta, Los Angeles, New York, and Philadelphia-in collaboration with the NIMH and a Data Coordinating Center.尽管在干预会议上的出勤率和随访评估时的保留率非常出色，但招聘挑战导致夫妇入学率较慢。需要额外的时间来实施预计招募这些难以触及的夫妻的新招聘活动。与最初的试验一样，我们将将夫妻随机与（1）以8条夫妇为中心的艾滋病毒/性病风险降低干预措施或（2）8条经营的个人促进健康促进干预措施（比较状况），该干预措施解决了与性行为无关的健康问题。两种干预措施都涉及夫妇和由训练有素的男女共同领导者领导的小组会议。该方法借鉴了社会认知理论，一种生态框架，以非裔为中心的范式以及申请人团队以前与非裔美国人人口的合作。主要的行为结果是自我报告的性交的比例；主要的生物学结果是通过对尿液和阴道标本的DNA扩增测试评估的性病（即衣原体，淋病和毛毛虫）的发生率。次要结果包括理论上相关的变量，假设介导和中等干预效果。音频计算机辅助的自我浏览（ACASI）将用于在基线，干预后立即收集数据，并在6个月和12个月的随访中收集数据。广义估计方程（GEE）和混合效应建模（MEM）将用于测试（1）干预对性病发病率和避孕套使用以及这些结果的调解人变量的影响以及（2）干预的影响是否取决于关键调节变量的效果是否有所不同有助于了解非裔美国人血清夫妇的艾滋病毒/性病风险降低，该夫妇的传播风险很高。