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（由研究者提供）：估计全世界有 3300 万人感染艾滋病毒，其中一半是女性。人们非常重视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。然而，改善艾滋病毒感染者的健康还必须包括确保这些人的生殖和性健康需求。随着抗逆转录病毒治疗的普及和长期生存的艾滋病毒阳性者人数成倍增加，我们可能会看到越来越多的人意识到自己的血清状况并希望尽可能正常地生活，其中可能包括有孩子。据记录，在开始抗逆转录病毒治疗后，艾滋病毒呈阳性的女性的生育能力和生育能力有所提高，但对于这些怀孕是否是有意的以及在治疗时代如何管理生殖决策过程，仍然没有任何证据或了解。对妇女如何做出生殖决定的了解不足，限制了提供者提供最适合患者需求的生殖保健或辅助生殖技术护理的能力。本研究的总体目标是进一步了解接受 ART 的 HIV 阳性女性的生育愿望、生殖决策过程和生殖健康结果。具体目标： (1) 描述南非接受抗逆转录病毒治疗的非怀孕、艾滋病毒阳性女性临床队列的生殖决策过程特征； (2) 比较采用依非韦伦药物与奈韦拉平作为非核苷逆转录酶抑制剂 (NNRTI) 的 ART 治疗方案的女性的妊娠发生率。方法：按目标：(1) 我们将对南非目前正在接受 ART 的 800 名 HIV 阳性非孕妇进行一项前瞻性临床队列研究。将对基线妇女进行深入、结构化的调查，了解她们的生育史、关系状况和未来怀孕的意愿。在常规门诊就诊期间，将在一年的随访期间每月收集怀孕状况和治疗方案。将使用决策分析方法来确定最能预测艾滋病毒阳性女性怀孕的临床、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向的敏感性进行比较。 (2) 将在一年内每月收集妊娠和 ART 数据，以比较依非韦伦和奈韦拉平治疗组之间妊娠发生率的差异。 Cox 比例风险模型将比较两个治疗组之间的妊娠风险，并控制随时间变化的 CD4 计数和避孕措施的使用。早期妊娠丢失将作为次要结果报告。公共卫生相关性：艾滋病毒阳性者的药物治疗正在全球范围内扩大，接受治疗的妇女可以延长生存期并提高生育能力。目前，人们对艾滋病毒阳性女性的意图以及如何在新的治疗时代管理生殖决策知之甚少。这项研究的总体目标是进一步了解接受治疗的艾滋病毒阳性女性的生育愿望、生殖决策过程和生殖健康结果。