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

说明(申请人提供)：乌干达卫生部于2012年10月通过了预防母婴传播艾滋病毒的备选方案B+(终身三联抗逆转录病毒疗法[ART])。方案B+的全国推广提供了在乌干达消除母婴传播艾滋病毒的机会。然而，感染艾滋病毒的孕妇在资源有限的情况下坚持终身三联抗逆转录病毒疗法带来了独特的挑战，因为在将艾滋病毒传播给婴儿的风险停止后，通常健康的妇女的正常生活中断、旅行和生活困难，因此坚持三重抗逆转录病毒疗法是一个独特的挑战。将在乌干达城市和农村进行的这项业务研究的总体目标是改善感染艾滋病毒的孕妇和新分娩的母亲对备选方案B Plus的遵守情况。我们将使用形成性研究，然后进行增强比较的随机临床试验，这是一种基于社区的干预措施，以改善母亲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选择B+的方法相比，被称为‘终身之友’的社区同龄人支持策略结合了药物获取、健康教育和创收活动，将更有效地支持妇女坚持她们的治疗和护理访问以及她们的药物，以实现和保持对病毒的抑制，并将艾滋病毒的母婴传播降至最低。这项业务研究的具体目标是：目标1：开展形成性研究，以评估个人、家庭和社区对备选方案B+的态度。目的2：进行一项随机对照试验，比较基于社区的同伴群体支持和卫生部基于医院的B PLUS方案的护理标准。目的3：与卫生部以医院为基础的方案B+护理标准进行比较，评估基于社区的同伴群体支持干预方案B+的依从性和有效性。形成性研究将为基于社区的团体同伴支持干预的实施提供参考。这项研究将以随机临床试验的形式进行。总共540名怀孕期间登记的可评估的艾滋病毒感染妇女将被随机分配到生命之友(FLC)或乌干达中部农村和城市地区标准的卫生部关于遵守的咨询中。被分配到团体同伴支持(FLC)部门的艾滋病毒感染妇女将每月在社区会面，并参加圈子。小组会议将包括药物分发、关于坚持抗逆转录病毒药物和后续访问的咨询、男性伴侣披露、婴儿喂养和营养，以及促进心理社会健康。在艾滋病毒传播给婴儿的风险期结束后，将利用创收活动促进这些圈子的可持续性。与卫生部合作，将对生活之友圈子的调查结果进行评估，并将记录成功的组成部分和吸取的经验教训，以便在地区和全国范围内扩大干预力度。

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.