Page Kimberly, Stein Ellen S, Carrico Adam W, Evans Jennifer L, Sokunny Muth, Nil Ean, Ngak Song, Sophal Chhit, McCulloch Charles, Maher Lisa
Division of Epidemiology, Biostatistics and Preventive Medicine, Department of Internal Medicine, University of New Mexico Health Sciences Center, Albuquerque, New Mexico, USA.
Department of Epidemiology & Biostatistics, University of California San Francisco, San Francisco, California, USA.
BMJ Open. 2016 May 9;6(5):e010854. doi: 10.1136/bmjopen-2015-010854.
HIV risk among female entertainment and sex workers (FESW) remains high and use of amphetamine-type stimulants (ATS) significantly increases this risk. We designed a cluster randomised stepped wedge trial (The Cambodia Integrated HIV and Drug Prevention Implementation (CIPI) study) to test sequentially delivered behavioural interventions targeting ATS use.
The trial combines a 12-week Conditional Cash Transfer (CCT) intervention with 4 weeks of cognitive-behavioural group aftercare (AC) among FESW who use ATS. The primary goal is to reduce ATS use and unprotected sex among FESW. The CCT+AC intervention is being implemented in 10 provinces where order of delivery was randomised. Outcome assessments (OEs) including biomarkers and self-reported measures of recent sexual and drug use behaviours are conducted prior to implementation, and at three 6-month intervals after completion. Consultation with multiple groups and stakeholders on implementation factors facilitated acceptance and operationalisation of the trial. Statistical power and sample size calculations were based on expected changes in ATS use and unprotected sex at the population level as well as within subjects.
Ethical approvals were granted by the Cambodia National Ethics Committee; University of New Mexico; University of California, San Francisco; and FHI360. The trial is registered with ClinicalTrials.gov. Dissemination of process indicators during the multiyear trial is carried out through annual in-country Stakeholder Meetings. Provincial 'Close-Out' forums are held at the conclusion of data collection in each province. When analysis is completed, dissemination meetings will be held in Cambodia with stakeholders, including community-based discussion sessions, policy briefs and results published and presented in the HIV prevention scientific journals and conferences.
CIPI is the first trial of an intervention to reduce ATS use and HIV risk among FESW in Cambodia.
Will inform both CCT+AC implementation in low and middle-income countries and programmes designed to reach FESW.
NCT01835574; Pre-results.
女性娱乐工作者和性工作者（FESW）感染艾滋病毒的风险仍然很高，使用苯丙胺类兴奋剂（ATS）会显著增加这种风险。我们设计了一项整群随机阶梯楔形试验（柬埔寨艾滋病毒与毒品综合预防实施（CIPI）研究），以测试针对ATS使用的一系列行为干预措施。
该试验将一项为期12周的有条件现金转移（CCT）干预措施与针对使用ATS的FESW进行的为期4周的认知行为小组后续护理（AC）相结合。主要目标是减少FESW中ATS的使用以及无保护性行为。CCT + AC干预措施正在10个省份实施，实施顺序是随机的。在实施之前以及完成后每6个月进行三次结果评估（OE），包括生物标志物以及近期性和毒品使用行为的自我报告测量。与多个团体和利益相关者就实施因素进行协商有助于该试验被接受并投入实施。统计功效和样本量计算基于人群层面以及个体内部ATS使用和无保护性行为的预期变化。
柬埔寨国家伦理委员会、新墨西哥大学、加利福尼亚大学旧金山分校和FHI360均已批准该试验的伦理申请。该试验已在ClinicalTrials.gov上注册。在多年试验期间，通过每年在国内举行的利益相关者会议来传播过程指标。在每个省份的数据收集结束时举行省级“收尾”论坛。分析完成后，将在柬埔寨与利益相关者举行传播会议，包括社区讨论会议、政策简报，并将结果发表在艾滋病毒预防科学期刊上并在相关会议上展示。
CIPI是柬埔寨首次针对减少FESW中ATS使用和艾滋病毒风险的干预措施进行的试验。
将为中低收入国家的CCT + AC实施以及旨在覆盖FESW的项目提供参考。
NCT01835574；预结果。
