Sickle Cell Reproductive CHOICES: Efficacy of a Primary Prevention Intervention

描述（由申请人提供）：我们的长期目标是促进患有镰状细胞病（SCD）或镰状细胞性状（SCT）的年轻人做出知情的生殖健康决定。不幸的是，对于许多患有SCD和SCT的年轻人来说，怀孕时没有机会做出充分知情的生殖健康决定，这与对自己或伴侣的SCD/SCT状态或其遗传传播的知识不足或不正确有关。我们将在两组设计中确定12个月、18个月和24个月对生殖知识和生殖健康行为的长期影响，其中包括选择或常规护理注意力控制[电子书]干预。在这项混合方法申请中，我们将完成疗效试验，增加一项新的24个月定性目标，以了解研究参与如何影响参与者的生殖行为，并与国家咨询委员会（NAB）一起，计划并初步测试在4个州（CA，TX，NC，CT）进行多中心网络研究的可行性。具体目标是：目标1。在236名患有SCD或SCT的年轻人（18至35岁）中，比较常规护理和选择加强（12个月）组对生殖健康知识和生殖健康行为（12，18和24个月）的持续影响。在所有时间点，我们假设知识得分和行为与育儿计划一致的选择组将比通常的护理组更大。目标2.通过对其中60名参与者的访谈，探讨他们对aim 1研究参与的看法和经验，以及研究期间影响他们生殖健康行为的因素。我们将确定参与者是否改变了他们的生殖健康行为的条件，作为对照组或选择组的参与者，这对于解释结果很重要，如果定性结果表明需要修改干预措施。目标3：在100名新招募的SCD或SCT年轻成人（18至35岁）中，确定复制CHOICES试验作为一项24个月多中心、基于社区的研究的可行性，该研究采用基于互联网和网络的招募、交付和保留策略。招募率和保留率以及NAB咨询将指导CHOICES干预措施的多中心国家有效性研究的程序设计。 公共卫生相关性：在这项研究中测试的是选择干预，这是与镰状细胞社区的广泛投入开发。选择是一个新的基于网络的，量身定制的，多媒体教育计划，关于镰状细胞病，生殖选择和后果，旨在帮助患有镰状细胞病或镰状细胞病的年轻男女在怀孕前实施育儿计划。

DESCRIPTION (provided by applicant): Our long-term goal is to foster informed reproductive health decisions by young adults with sickle cell disease (SCD) or sickle cell trait (SCT). Unfortunately for many young adults with SCD and SCT pregnancies occur without the opportunity to make well-informed reproductive health decisions, which is related to insufficient or incorrect knowledge of one's or the partner's SCD/SCT status or its genetic transmission. We will determine the long-term 12-, 18- and 24-mo effects on reproductive knowledge and reproductive health behaviors in a two-group design with CHOICES or usual care attention control [eBook] interventions. In this mixed-method application we will complete the efficacy trial, add a new qualitative aim at 24 mos to understand how study participation influenced participants' reproductive behaviors, and with a National Advisory Board (NAB), plan and pilot test the feasibility of a multi-site web-based study in 4 states (CA, TX, NC, CT). Specific aims are to: Aim 1. In 236 young adults (18 to 35 yr) with SCD or SCT, compare usual care and CHOICES boosted (at 12 mos) groups for sustained effects on reproductive health knowledge and reproductive health behaviors (at 12, 18, & 24 mo). At all time points, we hypothesize that knowledge scores and behaviors consistent with the parenting plan will be greater in the CHOICES group than the usual care group. Aim 2. From interviews with 60 of these participants, explore their views about and experience with the aim1 study participation and what influenced their reproductive health behaviors during the study. We will identify conditions under which participants did or did not change their reproductive health behaviors as participants in the control or CHOICES groups, which will be important for interpretation of outcomes and if indicated by qualitative findings to modify the intervention(s). Aim 3. In 100 newly recruited young adults (18 to 35 yr) with SCD or SCT, determine the feasibility of replicating the CHOICES trial as a 24-mo multi-site, community-based study with Internet- and web-based recruitment, delivery, and retention strategies. The recruitment and retention rates and NAB consultation will guide design of procedures for a multi-site national effectiveness study of the CHOICES intervention. PUBLIC HEALTH RELEVANCE: Tested in this study is the CHOICES intervention, which was developed with extensive input from the sickle cell community. CHOICES is a new web-based, tailored, multimedia education program about sickle cell disease, reproductive options and consequences that is designed to help young men and women with sickle cell disease or sickle cell trait to implement a parenting plan in advance of pregnancy.