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

描述(由调查人员提供)：据估计，全世界有3300万艾滋病毒携带者，其中一半是妇女。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受到了极大的关注。然而，改善艾滋病毒携带者的健康还必须包括确保这些人的生殖和性健康需求。随着获得抗逆转录病毒治疗的机会的扩大和经历长期生存的艾滋病毒阳性者人数的增加，我们可能会看到越来越多的人意识到自己的血清状态，并希望尽可能正常地生活，其中可能包括生孩子。在启动抗逆转录病毒疗法后，艾滋病毒阳性妇女的生育率和生育率有所增加，但关于这些怀孕是否是有意怀孕以及在治疗时代如何管理生殖决策过程的证据或知识仍然很少。对妇女如何作出生殖决定的了解不足，限制了提供者提供最适合其患者需要的生殖保健或艺术护理的能力。这项研究的总体目标是通过抗逆转录病毒疗法进一步了解HIV阳性妇女的生育意愿、生殖决策过程和生殖健康结果。 具体目标：(1)确定南非可获得抗逆转录病毒治疗的非怀孕艾滋病毒阳性妇女临床队列中生殖决策过程的特征；(2)比较使用非核苷类逆转录酶抑制剂(NNRTI)的ART方案的妇女与奈韦拉平作为非核苷逆转录酶抑制剂(NNRTI)的妇女的妊娠率。 方法：目的：(1)我们将对目前在南非接受抗逆转录病毒治疗的800名HIV阳性的未怀孕妇女进行前瞻性临床队列研究。将对基线上的妇女进行深入、有条理的调查，了解她们的生育史、关系状况和未来怀孕的意图。怀孕情况和治疗方案将在常规诊所就诊期间进行为期一年的随访，每月收集一次。将使用决策分析方法来确定最能预测艾滋病毒阳性妇女怀孕的临床、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Eefavirenz和奈韦拉平治疗组之间妊娠率的差异。COX比例风险模型将比较两个治疗组之间的怀孕风险，控制时变的CD4计数和避孕药的使用。早孕丢失将被报告为感兴趣的次要结果。 与公共卫生相关：针对艾滋病毒阳性个人的药物治疗正在全球范围内扩大，并使接受治疗的妇女能够延长生存时间并提高生育率。目前对艾滋病毒阳性妇女的意图知之甚少，也不知道如何在这个治疗的新时代管理生殖决策。这项研究的总体目标是加深我们对艾滋病毒阳性妇女治疗期间的生育意愿、生殖决策过程和生殖健康结果的了解。

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.