Epidemiology, STD/AIDS Unit, School of Public Health and Administration, Universidad Peruana Cayetano Heredia, Lima, Peru.
Lancet. 2012 Mar 24;379(9821):1120-8. doi: 10.1016/S0140-6736(11)61846-1. Epub 2012 Feb 15.
Previous community-randomised trials of interventions to control sexually transmitted infections (STIs) have involved rural settings, were rarely multicomponent, and had varying results. We aimed to assess the effect of a multicomponent intervention on curable STIs in urban young adults and female sex workers (FSWs).
In this community-randomised trial, baseline STI screening was done between August, and November, 2002, in random household samples of young adults (aged 18-29 years) and in FSWs in Peruvian cities with more than 50,000 inhabitants. Geographically separate cities were selected, matched into pairs, and randomly allocated to intervention or control groups with an S-PLUS program. Follow-up surveys of random samples were done after 2 years and 3 years. The intervention comprised four modalities: strengthened STI syndromic management by pharmacy workers and clinicians; mobile-team outreach to FSWs for STI screening and pathogen-specific treatment; periodic presumptive treatment of FSWs for trichomoniasis; and condom promotion for FSWs and the general population. Individuals in control cities received standard care. The composite primary endpoint was infection of young adults with Chlamydia trachomatis, Trichomonas vaginalis, or Neisseria gonorrhoeae, or syphilis seroreactivity. Laboratory workers and the data analyst were masked, but fieldworkers, the Peruvian study team, and participants in the outcome surveys were not. All analyses were done by intention to treat. This trial is registered, ISRCTN43722548.
We did baseline surveys of 15,261 young adults in 24 Peruvian cities. Of those, 20 geographically separate cities were matched into pairs, in each of which one city was assigned to intervention and the other to standard of care. In the 2006 follow-up survey, data for the composite primary outcome were available for 12,930 young adults. We report a non-significant reduction in prevalence of STIs in young adults, adjusted for baseline prevalence, in intervention cities compared with control cities (relative risk 0·84, 95% CI 0·69-1·02; p=0·096). In subgroup analyses, significant reductions were noted in intervention cities in young adult women and FSWs.
Syndromic management of STIs, mobile-team outreach to FSWs, presumptive treatment for trichomoniasis in FSWs, and condom promotion might reduce the composite prevalence of any of the four curable STIs investigated in this trial.
Wellcome Trust and Burroughs Wellcome Fund, National Institutes of Health, Center for AIDS Research, CIPRA, and USAID-Peru.
先前针对控制性传播感染（STIs）的干预措施的社区随机试验涉及农村环境，很少是多组分的，并且结果各异。我们旨在评估多组分干预措施对城市年轻成年人和女性性工作者（FSWs）可治愈性 STIs 的影响。
在这项社区随机试验中，于 2002 年 8 月至 11 月在秘鲁拥有超过 50,000 居民的城市中，对年轻成年人（18-29 岁）和 FSWs 进行了随机家庭样本的基线 STI 筛查。选择地理位置分开的城市，将其配对，并使用 S-PLUS 程序随机分配到干预组或对照组。在 2 年和 3 年后对随机样本的随访调查进行了调查。干预措施包括四个部分：药剂师和临床医生加强 STI 症状管理；流动小组针对 FSWs 进行 STI 筛查和针对病原体的治疗；周期性对 FSWs 进行滴虫病的推定治疗；以及为 FSWs 和一般人群推广避孕套。对照组城市的个人接受了标准护理。主要复合终点是年轻成年人感染沙眼衣原体，阴道毛滴虫或淋病奈瑟菌或梅毒血清反应性。实验室工作人员和数据分析人员受到了蒙蔽，但实地工作人员，秘鲁研究小组和结局调查的参与者并未受到蒙蔽。所有分析均按意向治疗进行。这项试验已注册，ISRCTN43722548。
我们对秘鲁 24 个城市的 15261 名年轻人进行了基线调查。在这些年轻人中，20 个地理位置分开的城市被配对，每个城市都被分配到干预组和标准护理组。在 2006 年的随访调查中，12930 名年轻人提供了主要复合结局的数据。我们报告说，与对照组城市相比，干预组城市中年轻人的 STIs 患病率（调整基线患病率）呈非显着降低（相对风险 0.84，95％CI 0.69-1.02；p=0.096）。在亚组分析中，在干预组城市中，年轻女性和 FSWs 的 STIs 发生率显着降低。
STIs 的症状管理，针对 FSWs 的流动小组服务，针对 FSWs 的滴虫病推定治疗以及避孕套的推广可能会降低本试验中研究的四种可治愈性 STIs 中任何一种的复合患病率。
惠康信托基金和 Burroughs Wellcome 基金，美国国立卫生研究院，艾滋病研究中心，CIPRA 和美国国际开发署秘鲁。
