Martin Kevin, Dziva Chikwari Chido, Dauya Ethel, Mackworth-Young Constance Rs, Tucker Joseph D, Simms Victoria, Bandason Tsitsi, Ndowa Francis, Machiha Anna, Bernays Sarah, Marks Michael, Kranzer Katharina, Ferrand Rashida A
Department of Clinical Research, London School of Hygiene & Tropical Medicine, London, UK.
Department of Global Health and Infection, Brighton and Sussex Medical School, Brighton, UK.
Wellcome Open Res. 2023 Oct 18;8:263. doi: 10.12688/wellcomeopenres.19199.1. eCollection 2023.
Sexually transmitted infections (STIs) such as chlamydia, gonorrhoea, trichomoniasis, and syphilis, are associated with adverse birth outcomes. Treatment should be accompanied by partner services to prevent re-infection and break cycles of transmission. Partner services include the processes of partner notification (PN) as well as arranging for their attendance for testing and/or treatment. However, due to a complex mix of cultural, socio-economic, and health access factors, uptake of partner services is often very low, in many settings globally. Alternative strategies to facilitate partner services are therefore needed.The aim of this study is to assess the impact of a small financial incentive on uptake of partner services for STIs as part of antenatal care (ANC) services in Zimbabwe.
This trial will be embedded within a prospective interventional study in Harare, aiming to evaluate integration of point-of-care diagnostics for STIs into ANC settings. One thousand pregnant women will be screened for chlamydia, gonorrhoea, trichomoniasis, and syphilis. All individuals with STIs will be offered treatment, risk reduction counselling, and client PN. Each clinic day will be randomised 1:1 to be an incentive or non-incentive day. On incentive days, participants diagnosed with a curable STI will be offered a PN slip, that when returned will entitle their partners to $3 (USD) in compensation. On non-incentive days, regular PN slips with no incentive are provided.The primary outcome measure is the proportion of individuals with at least one partner who returns for partner services based on administrative records. Secondary outcomes will include the number of days between index case diagnosis and the partner attending for partner services, uptake of PN slips by pregnant women, adverse birth outcomes in index cases, partners who receive treatment, and intervention cost.
Pan African Clinical Trials Registry: PACTR202302702036850 (Approval date 18 February 2022).
衣原体、淋病、滴虫病和梅毒等性传播感染与不良分娩结局相关。治疗应辅以性伴服务，以防止再次感染并打破传播循环。性伴服务包括性伴通知（PN）流程以及安排他们接受检测和/或治疗。然而，由于文化、社会经济和卫生服务可及性等多种因素的复杂交织，在全球许多地区，性伴服务的利用率往往非常低。因此，需要采取替代策略来促进性伴服务。本研究的目的是评估小额经济激励措施对津巴布韦作为产前护理（ANC）服务一部分的性传播感染性伴服务利用率的影响。
本试验将纳入哈拉雷一项前瞻性干预研究，旨在评估将性传播感染即时检验诊断整合到产前护理环境中的效果。将对1000名孕妇进行衣原体、淋病、滴虫病和梅毒筛查。所有性传播感染患者将接受治疗、降低风险咨询和患者性伴通知。每个临床日将按1:1随机分为激励日或无激励日。在激励日，被诊断患有可治愈性传播感染的参与者将获得一张性伴通知单，若其性伴返回则可获得3美元（美元）补偿。在无激励日，提供无激励的常规性伴通知单。主要结局指标是根据行政记录，至少有一名性伴返回接受性伴服务的个体比例。次要结局将包括索引病例诊断与性伴接受性伴服务之间的天数、孕妇对性伴通知单的接受情况、索引病例的不良分娩结局、接受治疗的性伴以及干预成本。
泛非临床试验注册中心：PACTR202302702036850（批准日期：2022年2月18日）
