Wilkinson D, Rutherford G
South Australian Centre for Rural and Remote Health, University of South Australia - Whyalla Campus, Nicolson Avenue, Whyalla, South Australia, Australia, SA 5608.
Cochrane Database Syst Rev. 2001(2):CD001220. doi: 10.1002/14651858.CD001220.
Sexually transmitted infections (STI) are common in developing countries. The World Health Organisation (WHO) estimates that in 1995, 333 million new cases of syphilis, gonorrhoea, chlamydial infection and trichomoniasis occurred. Human immunodeficiency virus (HIV) infection is also common in developing countries. UNAIDS estimates that over 90% of the 33 million people infected with HIV by December 1999 live in developing countries (UNAIDS 1999). The STI and HIV epidemics are interdependent. Similar behaviours, such as frequent unprotected intercourse with different partners, place people at high risk of both infections, and there is clear evidence that conventional STIs increase the likelihood of HIV transmission. Several studies have demonstrated a strong association between both ulcerative and non-ulcerative STIs, and HIV infection (Cameron 1989, Laga 1993) and there is biological evidence that the presence of an STI increases shedding of HIV and that STI treatment reduces HIV shedding (Cohen 1997, Robinson 1997). Therefore, STI control may have the potential to contribute substantially to HIV prevention.
To determine the impact of population-based STI interventions on the frequency of HIV infection, frequency of STIs and quality of STI management.
The following electronic databases were searched for relevant randomised trials or reviews: 1) MEDLINE for the years 1966 to current using the search terms sexually transmitted diseases and human immunodeficiency virus infection 2) The Cochrane Database of Systematic Reviews, Database of Abstracts of Reviews of Effectiveness and the Cochrane Clinical Trials Register in the most recent issue of the Cochrane Library 3) The specialist register of trials maintained by the Cochrane Infectious Diseases Group. 4) EMBASE The abstracts of relevant conferences were searched and reference lists of all review articles and primary studies were scanned. Finally, authors of included trials and other experts in the field were contacted as appropriate.
Randomised controlled trials in which the unit of randomisation is either a community or a treatment facility. Studies where individuals are randomised were excluded.
Two reviewers independently applied the inclusion criteria to potential studies with any disagreements resolved by discussion. Trials were examined for completeness of reporting. The methodological quality of each trial was assessed by the same two reviewers with details recorded of randomisation method, blinding, use of intention-to-treat analysis and the number of patients lost to follow-up using standard guidelines of the Cochrane Infectious Diseases Group.
Four trials were included. Frequency of HIV infection: In Rakai, after 3 rounds of treatment of all community members for STIs the rate ratio of incident HIV infection was 0.97 (95%CI 0.81 to 1.16), indicating no effect of the intervention. In Mwanza, the incidence of HIV infection in the intervention groups (strengthened syndromic management of STIs in primary care clinics) was 1.2% compared with 1.9% in the control groups (OR=0.58, 95% CI 0.42-0.70), corresponding to a 38% reduction (95%CI 15% to 55%) in HIV incidence in the intervention group. Frequency of STIs: In both Mwanza and Rakai, there was no significant reduction in gonorrhoea, chlamydia, urethritis, or reported STI symptoms among intervention communities. The prevalence ratio of syphilis between intervention and control groups in Rakai was 0.8 (95%CI 0.71-0.89), of trichmoniasis was 0.59 (0.38-0.91), and of bacterial vaginosis was 0.87 (0.74-1.02). In Mwanza, the prevalence of serologically diagnosed syphilis in the intervention community was 5% compared with 7% in the control community at the end of the trial (adjusted relative risk 0.71 (95%CI 0.54-0.93). Quality of treatment: In Lima, following training of pharmacy assistants in STI syndromic management, symptoms were recognised as being due to an STI in 65% of standardised simulated patients (SSPs) visiting intervention and 60% of SSPs visiting control pharmacies (p=0.35). Medication was offered without referral to a doctor in most cases (83% intervention and 78% control, p=0.61). Of those SSPs offered medication, only 1.4% that visited intervention pharmacies and only 0.7% of those that visited control pharmacies (p=0.57) were offered a recommended regimen. Similarly in only 15% and 16% of SSP visits respectively was any recommended drug offered. However, education and counseling were more likely to be given to SSPs visiting intervention pharmacies (40% vs 27%, p=0.01). No SSPs were given partner cards or condoms. In Hlabisa, following the intervention targeting primary care clinic nurses (strengthened STI syndromic management and provision of STI syndrome packets containing recommended drugs, condom, partner cards and patient information leaflets), SSPs were more likely to be given recommended drugs in intervention clinics (83% vs 12%, p <0.005) and more likely to be correctly case managed [given correct drugs, partner cards and condoms] (88% vs 50%, p <0.005). There were no significant difference in the proportions adequately counseled (68% vs 46%, p=0.06), experiencing good staff attitude (84% vs 58%, p=0.07), and being consulted in privacy (92% vs 86%, p=0.4). There was no strong evidence of any impact on treatment seeking behaviour, utilisation of services, or sexual behaviour in any of the four trials.
REVIEWERS' CONCLUSIONS: There is limited evidence from randomised controlled trials for STI control as an effective HIV prevention strategy. Improved STI treatment services have been shown to reduce HIV incidence in an environment characterised by an emerging HIV epidemic (low and slowly rising prevalence), where STI treatment services are poor and where STIs are highly prevalent. There is no evidence for substantial benefit from treatment of all community members. There are however other compelling reasons why STI treatment services should be strengthened and the available evidence suggests that when an intervention is accepted it can substantially improve quality of services provided. Further community based randomised controlled trials that test a range of alternative STI control strategies are needed in a variety of different settings. Such trials should aim to measure a range of factors that include health seeking behaviour and quality of treatment as well as HIV, STI and other biological endpoints.
性传播感染(STI)在发展中国家很常见。世界卫生组织(WHO)估计,1995年梅毒、淋病、衣原体感染和滴虫病新增病例达3.33亿例。人类免疫缺陷病毒(HIV)感染在发展中国家也很普遍。联合国艾滋病规划署(UNAIDS)估计,截至1999年12月,感染HIV的3300万人中超过90%生活在发展中国家(UNAIDS,1999年)。性传播感染和HIV流行相互关联。频繁与不同性伴进行无保护性行为等类似行为,使人们面临这两种感染的高风险,且有明确证据表明,传统性传播感染会增加HIV传播的可能性。多项研究表明,溃疡性和非溃疡性性传播感染与HIV感染之间存在密切关联(Cameron,1989年;Laga,1993年),并且有生物学证据表明,性传播感染的存在会增加HIV的脱落,而性传播感染的治疗可减少HIV的脱落(Cohen,1997年;Robinson,1997年)。因此,控制性传播感染可能对预防HIV有很大帮助。
确定基于人群的性传播感染干预措施对HIV感染频率、性传播感染频率及性传播感染管理质量的影响。
检索了以下电子数据库以查找相关随机试验或综述:1)MEDLINE,检索1966年至今,检索词为性传播疾病和人类免疫缺陷病毒感染;2)Cochrane系统评价数据库、有效性综述摘要数据库及Cochrane图书馆最新一期中的Cochrane临床试验注册库;3)Cochrane传染病组维护的试验专业注册库;4)EMBASE。检索了相关会议的摘要,并浏览了所有综述文章和原始研究的参考文献列表。最后,酌情联系了纳入试验的作者及该领域的其他专家。
随机对照试验,随机单位为社区或治疗机构。排除个体随机分组的研究。
两名综述作者独立将纳入标准应用于潜在研究,如有分歧通过讨论解决。检查试验报告的完整性。由这两名综述作者评估每个试验的方法学质量,使用Cochrane传染病组的标准指南详细记录随机方法、盲法、意向性分析的使用情况以及失访患者数量。
纳入四项试验。HIV感染频率:在拉凯,对所有社区成员进行三轮性传播感染治疗后,HIV感染发病率的率比为0.97(95%CI 0.81至1.16),表明干预无效果。在姆万扎,干预组(基层医疗诊所加强性传播感染综合征管理)的HIV感染发病率为1.2%,而对照组为1.9%(OR = 0.58,95%CI 0.42 - 0.70),相当于干预组HIV发病率降低了38%(95%CI 15%至55%)。性传播感染频率:在姆万扎和拉凯,干预社区的淋病、衣原体感染、尿道炎或报告的性传播感染症状均无显著减少。拉凯干预组与对照组梅毒患病率比为0.8(95%CI 0.71 - 0.89),滴虫病为0.59(0.38 - 0.91),细菌性阴道病为0.87(0.74 - 1.02)。在姆万扎,试验结束时,干预社区血清学诊断梅毒患病率为5%,而对照社区为7%(调整后相对风险0.71(95%CI 0.54 - 0.93))。治疗质量:在利马,对药房助理进行性传播感染综合征管理培训后,在干预药房就诊的标准化模拟患者(SSP)中,65%的症状被识别为性传播感染所致,在对照药房就诊的SSP中这一比例为60%(p = 0.35)。大多数情况下(干预组83%,对照组78%,p = 0.61)无需转诊给医生即可提供药物。在接受药物治疗的SSP中,前往干预药房的仅1.4%、前往对照药房的仅0.7%(p = 0.57)获得了推荐治疗方案。同样,分别只有15%和16%的SSP就诊时获得了任何推荐药物。然而,前往干预药房的SSP更有可能接受教育和咨询(40%对27%,p = 0.01)。没有SSP获得性伴卡片或避孕套。在赫拉比萨,针对基层医疗诊所护士进行干预(加强性传播感染综合征管理并提供包含推荐药物、避孕套、性伴卡片和患者信息传单的性传播感染综合征包)后,干预诊所的SSP更有可能获得推荐药物(83%对12%,p < 0.005),更有可能得到正确的病例管理(给予正确药物、性伴卡片和避孕套)(88%对50%,p < 0.005)。在接受充分咨询的比例(68%对46%,p = 0.06)、体验到良好工作人员态度的比例(84%对58%,p = 0.07)以及在隐私环境中接受咨询的比例(92%对86%,p = 0.4)方面没有显著差异。在这四项试验中,均没有有力证据表明对寻求治疗行为、服务利用或性行为有任何影响。
随机对照试验提供的证据有限,表明控制性传播感染作为一种有效的HIV预防策略。在HIV疫情正在出现(患病率低且缓慢上升)、性传播感染治疗服务差且性传播感染高度流行的环境中,改善性传播感染治疗服务已被证明可降低HIV发病率。没有证据表明对所有社区成员进行治疗有实质性益处。然而,有其他令人信服的理由应加强性传播感染治疗服务,现有证据表明,当一项干预措施被接受时,它可以大幅提高所提供服务的质量。需要在各种不同环境中开展更多基于社区的随机对照试验,以测试一系列替代性性传播感染控制策略。此类试验应旨在衡量一系列因素,包括寻求健康行为和治疗质量以及HIV、性传播感染和其他生物学终点。