Using Enhanced Peer Group Strategies to Support Option B+ in Uganda

描述（由申请人提供）：乌干达卫生部于2012年10月采用了B+方案（终身三联抗逆转录病毒疗法[ART]）来预防母婴艾滋病毒传播（PMTCT）。方案B+的全国推广为乌干达消除母婴艾滋病毒传播提供了机会。然而，在资源有限的情况下，受艾滋病毒感染的孕妇终生坚持接受三联抗逆转录病毒治疗，这是一项独特的挑战，因为正常的日常活动受到干扰，往往是向内陆旅行，而且在将艾滋病毒传播给婴儿的风险消失后，一般健康的妇女终生坚持接受抗逆转录病毒治疗存在困难。将在乌干达城市和农村开展的这项业务研究的总体目标是，提高感染艾滋病毒的孕妇和新分娩母亲对备选方案B +的依从性。我们将采用形成性研究，然后进行一项随机临床试验，以增强比较基于社区的干预措施，以提高产妇对预约和服用抗逆转录病毒药物的依从性。我们的假设是，与目前卫生部支持母亲坚持B+方案的方法相比，以社区为基础的同伴团体支持战略，称为“生命圈的朋友”，结合药物获取、健康教育和创收活动，将更有效地支持妇女坚持接受治疗和护理，并坚持服用药物，以实现和维持病毒抑制，并最大限度地减少艾滋病毒的母婴传播。目标1：进行形成性研究，以评估个人、家庭和社区对选项B +的态度。目标2：进行一项随机对照试验，比较基于社区的同伴团体支持与卫生部基于医院的B +选项标准护理。目的3：比较基于社区的同伴团体支持干预与基于卫生部的基于医院的护理标准的B +方案的依从性和有效性。形成性研究将为社区团体同伴支持干预的实施提供信息。该研究将以随机临床试验的形式进行。在乌干达中部的一个农村地区和一个城市地区，共有540名可评估的怀孕期间感染艾滋病毒的妇女将被随机分配到生活圈之友（FLC）或卫生部关于坚持治疗的标准咨询中。被分配到同侪互助小组的感染艾滋病毒的妇女将每月在社区开会并参加小组活动。小组会议将包括药物分发、抗逆转录病毒药物依从性咨询和随访、男性伴侣披露、婴儿喂养和营养以及促进社会心理健康。在婴儿感染艾滋病毒的危险时期结束后，将利用创收活动来促进各圈子的可持续性。与卫生部合作，将评估“生命圈之友”的调查结果，并将记录成功的组成部分和吸取的经验教训，以便为在地区和全国范围内扩大干预提供信息。

DESCRIPTION (provided by applicant): The Uganda's Ministry of Health (MOH) in October 2012 adopted Option B+ (life-long triple antiretroviral therapy [ART]) for the prevention of mother-to-child HIV transmission (PMTCT). The national scale up of option B+ provides an opportunity to eliminate mother-to-child HIV transmission (MTCT) in Uganda. However, adherence to life-long triple ART by HIV-infected pregnant women in resource-limited settings presents unique challenges given disruptions in normal routines often with travel upcountry and difficulties of life time adherence among generally healthy women after the risk of transmitting HIV to their infant has ceased. The overall goal of this operational research to be conducted in urban and rural Uganda is to improve adherence to option B Plus among HIV-infected pregnant and newly delivered mothers. We will use formative research followed by a randomized clinical trial of an enhanced compare a community based intervention to improve maternal adherence to appointments and taking ARVs. Our hypothesis is that the community-based peer group support strategy called 'Friends for Life Circles' combining drug access, health education and income- generating activities will be more effective to support women to adhere to their treatment and care visits and to their drugs to achieve and maintain viral suppression and minimize MTCT of HIV when compared to the current MOH approach to support mothers adherence to option B+. The specific aims of this operational research are: AIM 1: To conduct formative research to assess individual, family and community attitudes regarding Option B plus. AIM 2: To conduct a randomized controlled trial that compares community-based peer group support versus Ministry of Health hospital-based standard of care for Option B plus. AIM 3: To evaluate the adherence to option B plus and effectiveness of the community- based peer group support intervention compared to Ministry of Health hospital-based standard of care for Option B plus. The formative research will inform the implementation of the community-based group peer support intervention. The research will be conducted as a randomized clinical trial. A total of 540 evaluable HIV-infected women enrolled during pregnancy will be randomized to either Friends for Life Circles (FLC) or the standard MOH counseling on adherence in a rural and an urban district of Central Uganda. HIV-infected women assigned to the group peer support (FLC) arm will meet on a monthly basis in the community and participate in the circles. Group sessions will include drug distribution, counseling on adherence to ARVs and follow-up visits, male partner disclosure, infant feeding and nutrition, and promotion of psychosocial well-being. Income-generating activities will be used to foster sustainability of the Circles after the period of risk of transmission of HIV to the infant has ceased. In partnership with the MOH, the findings from the Friends for Life Circles will be evaluated and the successful components and lessons learned will be documented to inform the scaling up of the intervention within the districts and nationally.