Study protocol of "Our Choice": a randomized controlled trial of the integration of safer conception counseling to transform HIV family planning services in Uganda.
Study protocol of "Our Choice": a randomized controlled trial of the integration of safer conception counseling to transform HIV family planning services in Uganda.
复制标题
DOI：
10.1186/s13012-018-0793-y
复制
发表时间：
2018-08-14
期刊：
影响因子：
--
通讯作者：
Wagner GJ
中科院分区：
文献类型：
--
作者：
Goggin K;Hurley EA;Beyeza-Kashesya J;Gwokyalya V;Finocchario-Kessler S;Birungi J;Mindry D;Wanyenze RK;Wagner GJ
撒哈拉以南非洲地区约40%的艾滋病毒阳性妇女在确诊后怀孕。尽管约有一半的怀孕是有计划的，但在血清不一致的夫妇中，安全受孕方法(SCM)没有得到充分利用，部分原因是更安全的受孕咨询(SCC)没有被纳入常规的艾滋病毒计划生育(FP)服务。我们的选择是一项全面的计划生育干预措施，旨在促进无偏见的生育咨询，以确保患者获得SCC或避孕服务，以实现他们预期的生育目标。该干预措施在理论上是有根据的，并通过试点试验初步证明了其可行性和接受性。这项三臂整群随机对照试验比较了将我们的选择整合到常规FP服务中的两种实施策略与常规护理。乌干达的六个地点将随机接受(1)由研究人员提供加强培训和监督的Our Choice干预(SCC1)，(2)由卫生部传播新服务的标准方法实施的Our Choice干预(SCC2)，或(3)现有的FP服务(通常护理)。我们的选择和日常护理FP服务将在30个月内同时实施。60名血清不协调关系中表达生育意愿的客户将由每个地点的一名研究协调员登记(n = 360)，并跟踪12个月或怀孕后(如果适用)。分析将在正确使用SCM(如果试图怀孕)或双重避孕(如果不希望怀孕)的主要结果上比较干预措施(SCC1和SCC2)与常规护理，然后相互比较(SCC1与SCC2)。还将审查次级结果(即怀孕、预防母婴传播服务的使用、避孕套的使用和伴侣血清转换)和成本效益。调查结果将提供关键信息，说明不同强度的执行模式将SCC纳入初级方案的成功情况，从而为乌干达内外的政策和资源分配提供信息。NCT03167879 ClinicalTrials.gov，2017年5月30日注册。
About 40% of HIV-positive women in sub-Saharan Africa become pregnant post-diagnosis. Despite about half of their pregnancies being planned, safer conception methods (SCM) are underutilized among serodiscordant couples, partially due to the fact that safer conception counseling (SCC) has not been integrated into routine HIV family planning (FP) services. Our Choice is a comprehensive FP intervention that promotes unbiased childbearing consultations to ensure clients receive SCC or contraception services to achieve their desired reproductive goals. The intervention is theoretically grounded and has demonstrated preliminarily feasibility and acceptance through pilot testing. This three-arm cluster randomized controlled trial compares two implementation strategies for integrating Our Choice into routine FP services vs. usual care. Six sites in Uganda will be randomized to receive either (1) Our Choice intervention with enhanced training and supervision provided by study staff (SCC1), (2) Our Choice intervention implemented by the Ministry of Health’s standard approach to disseminating new services (SCC2), or (3) existing FP services (usual care). Our Choice and usual care FP services will be implemented simultaneously over a 30-month period. Sixty clients in serodiscordant relationships who express childbearing desires will be enrolled by a study coordinator at each site (n = 360) and followed for 12 months or post-pregnancy (once, if applicable). Analysis will compare intervention arms (SCC1 and SCC2) to usual care and then to each other (SCC1 vs. SCC2) on the primary outcome of correct use of either SCM (if trying to conceive) or dual contraception (if pregnancy is not desired). Secondary outcomes (i.e., pregnancy, use of prevention of mother-to-child transmission services, condom use, and partner seroconversion) and cost-effectiveness will also be examined. Findings will provide critical information about the success of implementation models of varying intensity for integrating SCC into FP, thereby informing policy and resource allocation within and beyond Uganda. NCT03167879 ClinicalTrials.gov, Registered 30 May, 2017.
登录
查看更多内容
影响因子：
3.8
作者：
Heys, Jennifer;Kipp, Walter;Rubaale, Tom
通讯作者：
Rubaale, Tom
影响因子：
4.4
作者：
Agadjanian, Victor;Hayford, Sarah R.
通讯作者：
Hayford, Sarah R.
DOI：
10.1016/j.ijgo.2012.06.004
发表时间：
2012-10-01
影响因子：
3.8
作者：
Loutfy, Mona R.;Margolese, Shari;Yudin, Mark H.
通讯作者：
Yudin, Mark H.
影响因子：
4.4
作者：
Goggin, Kathy;Hurley, Emily A.;Wagner, Glenn J.;Staggs, Vincent;Finocchario-Kessler, Sarah;Beyeza-Kashesya, Jolly;Mindry, Deborah;Birungi, Josephine;Wanyenze, Rhoda K.
通讯作者：
Wanyenze, Rhoda K.
影响因子：
3.8
作者：
Fritz MS;Taylor AB;Mackinnon DP
通讯作者：
Mackinnon DP