PDF(Pubmed)
Abstract：
BACKGROUND: Adverse sexual and reproductive health (SRH) outcomes, such as unplanned pregnancies and HIV infection, disproportionately affect adolescent girls and young women (AGYW; aged 15-24 years) in east Africa. Increasing uptake of preventive SRH services via innovative, youth-centred interventions is imperative to addressing disparities in SRH outcomes.
METHODS: From 2018 to 2019, we used human-centred design to co-develop a theoretically driven HIV and pregnancy prevention intervention for AGYW at private drug shops called Accredited Drug Dispensing Outlets (ADDOs) in Tanzania. The result, Malkia Klabu (Queen Club), was a customer loyalty programme designed to strengthen ADDOs\' role as SRH providers while encouraging uptake of critical SRH prevention products among AGYW. Malkia Klabu members had access to free contraceptives and oral HIV self-test (HIVST) kits and earned punches on a loyalty card for other shop purchases; punches were redeemable for small prizes. Our pilot among 40 shops showed that intervention ADDOs had higher AGYW patronage and distributed more HIVST kits and contraceptives to AGYW relative to business-as-usual (ie, client purchasing) comparison shops. We will conduct a cluster-randomised controlled trial (c-RCT) among 120-140 ADDOs in 40 health catchment areas in Shinyanga and Mwanza Regions (Lake Zone), Tanzania. ADDO shop recruitment includes a 1-month run-in with a tablet-based electronic inventory management system for tracking shop transactions, followed by enrolment, randomisation and a 24-month trial period. Our c-RCT evaluating the human-centred design-derived intervention will assess population impact on the primary outcomes of HIV diagnoses and antenatal care registrations, measured with routine health facility data. We will also assess secondary outcomes focusing on mechanisms of action, evaluate programme exposure and AGYW behaviour change in interviews with AGYW, and assess shop-level implementation strategies and fidelity.
BACKGROUND: Ethical approval was granted from both the University of California, San Francisco and the Tanzanian National Institute for Medical Research. Study progress and final outcomes will be posted annually to the National Clinical Trials website; study dissemination will occur at conferences, peer-reviewed manuscripts and local convenings of stakeholders.
BACKGROUND: NCT05357144.
METHODS: From 2018 to 2019, we used human-centred design to co-develop a theoretically driven HIV and pregnancy prevention intervention for AGYW at private drug shops called Accredited Drug Dispensing Outlets (ADDOs) in Tanzania. The result, Malkia Klabu (Queen Club), was a customer loyalty programme designed to strengthen ADDOs\' role as SRH providers while encouraging uptake of critical SRH prevention products among AGYW. Malkia Klabu members had access to free contraceptives and oral HIV self-test (HIVST) kits and earned punches on a loyalty card for other shop purchases; punches were redeemable for small prizes. Our pilot among 40 shops showed that intervention ADDOs had higher AGYW patronage and distributed more HIVST kits and contraceptives to AGYW relative to business-as-usual (ie, client purchasing) comparison shops. We will conduct a cluster-randomised controlled trial (c-RCT) among 120-140 ADDOs in 40 health catchment areas in Shinyanga and Mwanza Regions (Lake Zone), Tanzania. ADDO shop recruitment includes a 1-month run-in with a tablet-based electronic inventory management system for tracking shop transactions, followed by enrolment, randomisation and a 24-month trial period. Our c-RCT evaluating the human-centred design-derived intervention will assess population impact on the primary outcomes of HIV diagnoses and antenatal care registrations, measured with routine health facility data. We will also assess secondary outcomes focusing on mechanisms of action, evaluate programme exposure and AGYW behaviour change in interviews with AGYW, and assess shop-level implementation strategies and fidelity.
BACKGROUND: Ethical approval was granted from both the University of California, San Francisco and the Tanzanian National Institute for Medical Research. Study progress and final outcomes will be posted annually to the National Clinical Trials website; study dissemination will occur at conferences, peer-reviewed manuscripts and local convenings of stakeholders.
BACKGROUND: NCT05357144.
摘要：
背景：不良性健康和生殖健康（SRH）结果，如意外怀孕和艾滋病毒感染，在东非，青春期女孩和年轻女性（AGYW；15-24岁）受到不成比例的影响。通过创新增加预防性SRH服务的吸收，以青年为中心的干预措施对于解决SRH结果的差异至关重要。
方法：从2018年到2019年，我们使用以人为中心的设计，在坦桑尼亚名为“认可的药物分配商店”（ADDO）的私人药店，为AGYW共同开发了理论上驱动的艾滋病毒和怀孕预防干预措施。结果,MalkiaKlabu（女王俱乐部），是一项客户忠诚度计划，旨在加强ADDOs作为SRH提供商的作用，同时鼓励AGYW采用关键的SRH预防产品。MalkiaKlabu成员可以获得免费的避孕药具和口服艾滋病毒自检（HIVST）工具包，并在其他商店购买的会员卡上赢得了拳头；拳头可以兑换小额奖品。我们在40家商店中的试点表明，相对于照常营业，干预ADDOs的AGYW赞助者更高，并向AGYW分发了更多的HIVST工具包和避孕药具（即，客户购买)比较商店。我们将在Shinyanga和Mwanza地区（湖区）的40个健康集水区对120-140个ADDOs进行集群随机对照试验（c-RCT），坦桑尼亚。ADDO店铺招募包括与基于平板电脑的电子库存管理系统进行为期1个月的磨合，用于跟踪店铺交易，其次是入学，随机化和24个月的试验期。我们的c-RCT评估以人为本的设计衍生干预措施将评估人群对艾滋病毒诊断和产前护理登记的主要结果的影响。用常规卫生设施数据测量。我们还将评估次要成果，重点是行动机制，在与AGYW的访谈中评估程序暴露和AGYW行为变化，并评估商店层面的实施策略和保真度。
背景：加州大学都获得了道德批准，旧金山和坦桑尼亚国家医学研究所。研究进展和最终结果将每年发布到国家临床试验网站;研究传播将在会议上进行，同行评审的手稿和利益相关者的地方会议。
背景：NCT05357144。
方法：从2018年到2019年，我们使用以人为中心的设计，在坦桑尼亚名为“认可的药物分配商店”（ADDO）的私人药店，为AGYW共同开发了理论上驱动的艾滋病毒和怀孕预防干预措施。结果,MalkiaKlabu（女王俱乐部），是一项客户忠诚度计划，旨在加强ADDOs作为SRH提供商的作用，同时鼓励AGYW采用关键的SRH预防产品。MalkiaKlabu成员可以获得免费的避孕药具和口服艾滋病毒自检（HIVST）工具包，并在其他商店购买的会员卡上赢得了拳头；拳头可以兑换小额奖品。我们在40家商店中的试点表明，相对于照常营业，干预ADDOs的AGYW赞助者更高，并向AGYW分发了更多的HIVST工具包和避孕药具（即，客户购买)比较商店。我们将在Shinyanga和Mwanza地区（湖区）的40个健康集水区对120-140个ADDOs进行集群随机对照试验（c-RCT），坦桑尼亚。ADDO店铺招募包括与基于平板电脑的电子库存管理系统进行为期1个月的磨合，用于跟踪店铺交易，其次是入学，随机化和24个月的试验期。我们的c-RCT评估以人为本的设计衍生干预措施将评估人群对艾滋病毒诊断和产前护理登记的主要结果的影响。用常规卫生设施数据测量。我们还将评估次要成果，重点是行动机制，在与AGYW的访谈中评估程序暴露和AGYW行为变化，并评估商店层面的实施策略和保真度。
背景：加州大学都获得了道德批准，旧金山和坦桑尼亚国家医学研究所。研究进展和最终结果将每年发布到国家临床试验网站;研究传播将在会议上进行，同行评审的手稿和利益相关者的地方会议。
背景：NCT05357144。
