Department of Medicine, University of California, San Diego, 9500 Gilman Drive # 0507, La Jolla, CA 92093-0507, USA.
BMC Public Health. 2012 Aug 14;12:653. doi: 10.1186/1471-2458-12-653.
Female sex workers who inject drugs (FSW-IDUs) are at risk of acquiring HIV, sexually transmitted infections (STI) and blood-borne infections through unprotected sex and sharing injection equipment. We conducted a 2×2 factorial randomized controlled trial to evaluate combination interventions to simultaneously reduce sexual and injection risks among FSW-IDUs in Tijuana and Ciudad Juarez, Mexico.
METHODS/DESIGN: FSW-IDUs ≥18 years reporting sharing injection equipment and unprotected sex with clients within the last month were randomized to one of four conditions based on an a priori randomization schedule, blinding interviewer/counselors to assignment. Due to the extreme vulnerability of this population, we did not include a control group that would deny some women access to preventive information. All women received similar information regardless of group allocation; the difference was in the way the information was delivered and the extent to which women had an interactive role. Each condition was a single 60-minute session, including either an interactive or didactic version of an injection risk intervention and sexual risk intervention. Women underwent interviewer-administered surveys and testing for HIV, syphilis, gonorrhea, Chlamydia, and Trichomonas at baseline and quarterly for 12 months. Combined HIV/STI incidence will be the primary outcome. Secondary outcomes are proportionate reductions in sharing of injection equipment and unprotected sex with clients.
Of 1,132 women, 548 (48.4%) were excluded (88.9% were ineligible; 11.1% refused to participate or did not return); 584 eligible women enrolled (284 in Tijuana; 300 in Ciudad Juarez). All 584 participants completed the baseline interview, provided biological samples and were randomized to one of the four groups. During follow-up, 17 participants (2.9%) were lost to follow-up, of whom 10 (58.8%) had died, leaving 567 participants for analysis. This study appears to be the first intervention to attempt to simultaneously reduce injection and sexual risk behaviors among FSW-IDUs. The factorial design will permit analysis to determine whether the combination of the two interactive interventions and/or its respective components are effective in reducing injection and/or sexual risks, which will have direct, tangible policy implications for Mexico and potentially other resource-poor countries.
NCT00840658.
注射吸毒的女性性工作者（FSW-IDUs）由于无保护的性行为和共用注射器具，存在感染艾滋病毒、性传播感染（STI）和血源感染的风险。我们进行了一项 2×2 析因随机对照试验，以评估联合干预措施，以同时降低墨西哥蒂华纳和华雷斯城 FSW-IDUs 的性和注射风险。
方法/设计：报告过去一个月内与客户共用注射器具和无保护性行为的 FSW-IDUs，年龄≥18 岁，按事先随机化时间表，根据预先制定的随机分组方案，对访谈员/顾问进行分组。由于该人群极度脆弱，我们没有包括一个对照组，因为对照组会剥夺一些妇女获得预防信息的机会。所有妇女都接受了相同的信息，无论分组如何；区别在于信息的传递方式和妇女的互动角色程度。每个条件都是一个 60 分钟的单一疗程，包括注射风险干预和性风险干预的互动或教学版本。在基线和 12 个月的每季度，妇女接受访谈者进行的调查和艾滋病毒、梅毒、淋病、衣原体和滴虫检测。合并 HIV/STI 发病率将是主要结果。次要结果是减少与客户共用注射器具和无保护性行为的比例。
在 1132 名妇女中，548 名（48.4%）被排除在外（88.9%不合格；11.1%拒绝参与或未返回）；584 名符合条件的妇女入组（蒂华纳 284 名；华雷斯城 300 名）。所有 584 名参与者都完成了基线访谈，提供了生物样本，并被随机分配到四个组之一。在随访期间，有 17 名（2.9%）参与者失访，其中 10 名（58.8%）死亡，留下 567 名参与者进行分析。这项研究似乎是第一个试图同时降低注射吸毒者的注射和性行为风险的干预措施。析因设计将允许进行分析，以确定两种互动干预措施及其各自的组成部分的组合是否能有效降低注射和/或性风险，这将对墨西哥和潜在的其他资源匮乏国家产生直接、切实的政策影响。
NCT00840658。
