在中国，男男性行为者和男性性传播疾病患者中推行“代际传递”型淋病和衣原体检测：一项实用、集群随机对照试验方案。
Pay-it-forward gonorrhea and chlamydia testing among men who have sex with men and male STD patients in China: the PIONEER pragmatic, cluster randomized controlled trial protocol.
机构信息
University of North Carolina Project-China, Guangzhou, China.
Clinical Research Department, London School of Hygiene and Tropical Medicine, London, UK.
出版信息
BMC Public Health. 2023 Jun 20;23(1):1182. doi: 10.1186/s12889-023-16095-8.
BACKGROUND
Gonorrhea and chlamydia are the most common sexually transmitted diseases (STDs) among men who have sex with men (MSM) in China. Previous studies have shown pay-it-forward (PIF) interventions to be associated with a substantial increase in gonorrhea and chlamydia test uptake compared to standard-of-care. We propose a 'pay-it-forward' gonorrhea and chlamydia testing randomized controlled trial (PIONEER). The trial would evaluate the effectiveness of two pay-it-forward strategies in promoting testing uptake compared to the standard of care (in which men pay for their tests out-of-pocket) among MSM and male STD patients in China.
METHODS
PIONEER will be a three-armed, pragmatic cluster randomized controlled trial (RCT), conducted across 12 clinics (six MSM-led and six public STD clinics) to compare the effectiveness of three implementation strategies. Each facility will be randomized to a standard pay-it-forward intervention of gonorrhea/ chlamydia testing with minimal encouragement for testing, a community-engaged pay-it-forward arm, or a control arm where men pay for their tests out-of-pockets. The primary outcome will be dual gonorrhea/chlamydia test uptake. Secondary outcomes will include syphilis testing, amount donated in pay-it-forward, number of positive gonorrhea and chlamydia tests, and measures of antimicrobial resistance. A sequential transformative mixed methods design will be used to evaluate the implementation process in type 2 effectiveness-implementation hybrid design. Data sources will include survey on acceptability, and feelings and attitudes towards the interventions among participants; testing and treatment uptake data from clinic records, WeChat records, and qualitative data to gain insights into men's perceptions and attitudes towards the pay-it-forward, mechanisms driving uptake, and donating behaviors. Implementers and organizers will be interviewed about fidelity and adherence to protocol, sustainability of pay-it-forward intervention, and barriers and facilitators of implementing the intervention.
DISCUSSION
PIONEER will substantially increase gonorrhea/chlamydia testing among MSM in China, providing an innovative and new financial mechanism to sustain STD screening among sexual minorities in low- and middle-income countries. This study will answer compelling scientific questions about how best to implement pay-it-forward and the individual and organizational characteristics that moderate it.
TRIAL REGISTRATION
The study with identification number NCT05723263 has been registered on clinicaltrials.gov/.
背景
淋病和衣原体是中国男男性行为者（MSM）中最常见的性传播疾病（STD）。先前的研究表明，与标准护理相比，预付款（PIF）干预措施与淋病和衣原体检测的大量增加相关。我们提出了一项“预付款”淋病和衣原体检测随机对照试验（PIONEER）。该试验将评估与标准护理（其中男性自掏腰包支付检测费用）相比，在中国的 MSM 和男性性传播疾病患者中，两种预付款策略在促进检测率方面的有效性。
方法
PIONEER 将是一项三臂、实用的群组随机对照试验（RCT），在 12 个诊所（6 个 MSM 主导和 6 个公共性传播疾病诊所）进行，以比较三种实施策略的有效性。每个设施都将随机分配到标准预付款干预措施中，即进行淋病/衣原体检测，同时进行最小程度的检测鼓励，社区参与的预付款干预措施，或男性自掏腰包支付检测费用的对照组。主要结果将是双重淋病/衣原体检测率。次要结果将包括梅毒检测、预付款中的捐赠金额、阳性淋病和衣原体检测的数量以及抗菌药物耐药性的测量。将使用顺序变革性混合方法设计来评估 2 型有效性-实施混合设计中的实施过程。数据来源将包括参与者对干预措施的可接受性、感受和态度的调查；来自诊所记录、微信记录的检测和治疗使用率数据，以及定性数据，以深入了解男性对预付款的看法和态度、推动检测率的机制以及捐赠行为。将对实施者和组织者进行访谈，了解对方案的遵守情况、预付款干预措施的可持续性以及实施干预措施的障碍和促进因素。
讨论
PIONEER 将大大增加中国 MSM 中的淋病/衣原体检测率，为中低收入国家的性少数群体提供创新和新的财务机制，以维持性传播疾病筛查。这项研究将回答关于如何最好地实施预付款以及调节预付款的个人和组织特征的引人入胜的科学问题。
试验注册
这项研究的识别号为 NCT05723263，已在 clinicaltrials.gov/ 上注册。
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