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临床试验/NCT01835574
NCT01835574
已完成
不适用

Cambodia Integrated HIV and Drug Prevention Implementation Program

University of California, San Francisco1 个研究点 分布在 1 个国家目标入组 1,198 人2013年4月
适应症HIV

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
HIV
发起方
University of California, San Francisco
入组人数
1198
试验地点
1
主要终点
Amphetamine type stimulant use (ATS)
状态
已完成
最后更新
8年前

概览

简要总结

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 randomized stepped wedge trial: The Cambodia Integrated HIV and Drug Prevention Implementation [CIPI) study. The CIPI study is embedded within the SMARTgirl HIV prevention program. The CIPI study aimed to recruit FESW from 10 provinces, assessing HIV risk exposures including ATS use. The CIPI study then tested sequentially delivered, behavioral interventions targeting ATS use. The trial combines a 12-week Conditional Cash Transfer (CCT) intervention with four-weeks of cognitive-behavioral group aftercare (AC) among FESW who use ATS. The primary goal of the CIPI study is to reduce ATS use and unprotected sex among FESW. The CCT+AC intervention is being implemented in ten provinces where order of delivery was randomized. Outcome assessments (OEs) including biomarkers and self-reported measures of recent sexual and ATS use behaviors are conducted prior to implementation, and at three 6-month intervals after completion. All women who are ATS negative at 6-months, including those who have completed the CCT+AC intervention are eligible to participate in a micro-enterprise (ME) opportunity. Consultation with multiple groups and stakeholders on implementation factors facilitated acceptance and operationalization 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. Dissemination of process indicators during the multi-year 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 discussions 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. Results will inform both CCT+AC implementation in low and middle-income countries and programs designed to reach FESW.

详细描述

The CIPI Study is 16-week program that combines Conditional Cash Transfer (CCT) and group-based supportive After Care (AC) for moderate and high risk FESW ATS users using a stepped wedge randomized cluster design. The trial tests the CCT+AC intervention in 10 Cambodian provinces (clusters). Outcome Evaluation (OE) data is collected at 1 time-point prior to implementation of the CCT+AC program (Baseline), and 3 time-points after the intervention (OE-1, OE-2, and Post-OE) at 6, 12, and 18 months after baseline in each province. CCT+AC is followed by a linked economic capacity building opportunity. Women who are ATS-free, including those negative at baseline and those who successfully complete the CCT+AC intervention are eligible for referral to a MicroEnterprise (ME) program. The ME program combines financial literacy education and referral to a Cambodian registered microfinance organization (Chamroeun) for loan applications that may support alternate economic options for participating eligible women.

注册库
clinicaltrials.gov
开始日期
2013年4月
结束日期
2016年12月
最后更新
8年前
研究类型
Interventional
研究设计
Single Group
性别
Female

研究者

入排标准

入选标准

  • 18 years of age or older
  • biological female
  • speaks Khmer language
  • self reports 2 or more sex partners and/or transactional sex in last month
  • able to provide informed consent

排除标准

  • under 18 years of age
  • unable to speak Khmer language
  • unable to consent

结局指标

主要结局

Amphetamine type stimulant use (ATS)

时间窗: 6, 12, and 18 months

Change in ATS use as measured by urine toxicology screening.

Sexual risk

时间窗: 6, 12 and 18 months

Change in number of sexual partners in the past 3 months (measured as a numeric variable).

次要结局

  • Sexual risk 2(6,12, and 18 months)
  • Sexual risk 3(6, 12 and 18 months)
  • ATS 3(6, 12, and 18 months)
  • Sexual risk 4(6,12, and 18 months)
  • ATS 2(6,12 and 18 months)
  • Sexual risk 5(6,12, and 18 months)

研究点 (1)

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