Fertility Decision-Making and Reproductive Health Outcomes in the Era of Antiretr

反退休时代的生育决策和生殖健康结果

基本信息

批准号：
7769403
负责人：
Sheree Renae Schwartz
金额：
$ 3.78万
依托单位：
JOHNS HOPKINS UNIVERSITY
依托单位国家：
美国
项目类别：
财政年份：
2009
资助国家：
美国
起止时间：
2009-09-30 至 2010-09-29
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/7769403
关键词：
Fertility Decision Making Reproductive Health

项目摘要

DESCRIPTION (provided by investigator): Thirty-three million people worldwide are estimated to be living with HIV, half of which are women. Significant attention is being given to researching the effectiveness of antiretroviral therapy (ART) and its overall impact on lifetime survival. Improving the health of persons living with HIV, however, must also include securing the reproductive and sexual health needs of these individuals. As access to ART expands and the population of HIV-positives experiencing long-term survival multiplies, we are likely to see a growing class of persons who are aware of their serostatus and who want to live their lives as normally as possible, which may include having children. Increased fecundity and fertility have been documented in HIV-positive women after initiation of ART, but there remains little evidence or knowledge of whether or not these pregnancies are intended and how the reproductive decision making process is being managed in the treatment era. An inadequate understanding of how women are making reproductive decisions limits the ability of providers to deliver either the reproductive health care or ART care most appropriate to their patients' needs. The overall objective of this study is to further our understanding of fertility desires, reproductive decision making processes and reproductive health outcomes in HIV-positive women on ART. SPECIFIC AIMS: (1) to characterize reproductive decision-making processes in a clinical cohort of non- pregnant, HIV-positive women with access to antiretroviral therapy in South Africa; (2) to compare incidence rates of pregnancy between women on ART regimens that use the drug efavirenz versus nevirapine as a non- nucleoside reverse transcriptase inhibitor (NNRTI). METHODS: By aim: (1) We will conduct a prospective clinical cohort study of 800 HIV-positive, non-pregnant women who are currently receiving ART in South Africa. In-depth, structured surveys will be given to the women at baseline regarding their reproductive history, relationship status and intentions to become pregnant in the future. Pregnancy status and therapy regimens will be collected monthly over one year of follow-up during routine clinic visits. A decision analysis approach will be used to determine the clinical, behavioral and environmental factors that best predict pregnancy in HIV-positive women. The predictive accuracy of these findings will be compared to the sensitivity of simply asking about fertility intentions. (2) Pregnancy and ART data will be collected monthly over one year to compare differences in pregnancy incidence rates between efavirenz and nevirapine treatment groups. Cox proportional hazards models will compare pregnancy risk between the two treatment groups, controlling for time-varying CD4 count and contraceptive use. Early pregnancy loss will be reported as a secondary outcome of interest. PUBLIC HEALTH RELEVANCE: Drug treatment for HIV-positive individuals is expanding worldwide and is allowing for longer survival as well as increased fertility for women on treatment. There is currently little knowledge about the intentions of HIV positive women, nor how to manage reproductive decision making in this new era of treatment. The overall objective of this study is to further our understanding of fertility desires, reproductive decision making processes and reproductive health outcomes in HIV-positive women on treatment.

描述（调查员提供）：据估计，全世界有300万人患有艾滋病毒，其中一半是女性。人们对研究抗逆转录病毒疗法（ART）的有效性及其对终生生存的总体影响。但是，改善艾滋病毒患者的健康还必须包括确保这些人的生殖和性健康需求。随着艺术的机会扩大，经历了长期生存的艾滋病毒兴趣赋予人群，我们很可能会看到成长中的一类人，他们意识到自己的血清，他们希望尽可能正常地过着正常的生活，其中包括生孩子。启动艺术后，艾滋病毒阳性妇女已经记录了繁殖力和生育能力的提高，但是几乎没有证据或了解这些怀孕是否是打算的，以及如何在治疗时代管理生殖决策过程。对妇女做出生殖决定的理解不足，限制了提供者提供最适合患者需求的生殖医疗保健或艺术护理的能力。这项研究的总体目的是进一步了解艾滋病毒阳性女性艺术的欲望，生殖决策过程以及生殖健康结果。具体目的：（1）在南非的非怀孕，艾滋病毒阳性妇女的临床队列中表征生殖决策过程；（2）比较女性对使用Efavirenz药物与奈韦拉平的ART方案的妊娠发生率，作为非核苷逆转录酶抑制剂（NNRTI）。方法：通过目标：（1）我们将对目前正在南非接受艺术的800名HIV阳性，非怀孕妇女进行前瞻性临床队列研究。深入的，在基准的妇女的生殖历史，人际关系状况和未来怀孕的意图将对妇女进行结构化调查。在常规诊所就诊期间，将在一年的随访中每月收集怀孕状况和治疗方案。决策分析方法将用于确定最能预测HIV阳性女性妊娠的临床，行为和环境因素。这些发现的预测准确性将与简单询问生育意图的灵敏度进行比较。（2）将在一年内每月收集妊娠和ART数据，以比较Efavirenz和Nevirapine治疗组之间妊娠发生率的差异。 COX比例危害模型将比较两个治疗组之间的妊娠风险，从而控制了随时间变化的CD4计数和避孕药的使用。提早怀孕丧失将被报告为感兴趣的次要结果。公共卫生相关性：艾滋病毒阳性个体的药物治疗在全球范围内正在扩大，允许更长的生存以及女性接受治疗的生育能力。目前对艾滋病毒阳性妇女的意图的了解很少，也没有如何在这个新的治疗时代管理生殖决策。这项研究的总体目的是进一步了解艾滋病毒阳性妇女治疗的生殖欲望，生殖决策过程以及生殖健康结果。