Epidemiologic Study on Changing HIV Risks Among FSW-IDUs on the Mexico-US Border
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 584
- 试验地点
- 2
- 主要终点
- Combined HIV/STI 12-month Incidence Rates of HIV, Syphilis, Chlamydia, Gonorrhea and Trichomonas Vaginalis.
研究概览
简要总结
The investigators propose a highly efficient four-arm (factorial) trial to simultaneously test the efficacy of two behavioral interventions aimed at:
- increasing condom use in the context of ongoing drug use and
- decreasing needle and paraphernalia sharing
among female sex workers who also inject drugs in two Mexican-U.S. border cities: Tijuana and Ciudad Juarez.
详细描述
Our specific aims are:
- Aim 1: To evaluate the efficacy of a behavioral intervention to decrease sharing of syringes and injection paraphernalia among FSW-IDUs. We hypothesize that FSW-IDUs in the active experimental injection risk reduction condition will report: (a) less receptive and distributive needle sharing; (b) less sharing of injection paraphernalia; (c) obtaining syringes and injection paraphernalia from safer sources.
- Aim 2: To evaluate the efficacy of a behavioral intervention to increase condom use among FSW-IDUs in the context of ongoing drug use. We hypothesize that FSW-IDUs in the active experimental sexual risk reduction condition will: (a) report less unprotected vaginal and anal sex; and (b) have fewer incident cases of specific STIs.
- Aim 3: To evaluate the joint effects of these two behavioral interventions to increase condom use and reduce sharing of needles and syringes/injection paraphernalia among FSW-IDUs. We hypothesize that the joint effect of these interventions will generate greater risk reductions compared to either intervention alone.
- Aim 4: To determine the extent to which theoretically-important components of our interventions (i.e., self-efficacy, outcome expectancies, attitudes, intentions) represent underlying mechanisms of change in primary outcomes (i.e., sexual- and injection-related risk reductions).
- Aim 5: To explore subgroup differences in the efficacy of: a) the sexual risk reduction, and b) the injection risk reduction intervention based on background characteristics, contextual factors, social factors and intrapersonal factors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •be biologically female
- •be at least 18 years old
- •report having exchanged sex for money, goods or drugs within the last month
- •report having injected drugs within the last month
- •report having unprotected vaginal or anal sex at least once in last 30 days
- •report sharing needles/syringes or other injection paraphernalia (i.e., cottons, cookers, water) at least once in the last month
- •live in Tijuana, Ciudad Juarez or its suburbs, as determined through municipal boundaries in each city
- •test HIV-negative at baseline
- •agree to receive antibiotic treatment for chlamydia, gonorrhea, syphilis trichomonas vaginalis or bacterial vaginosis if they test positive at baseline.
排除标准
- •If women report:
- •consistent use of condoms for vaginal and anal sex with all male partners during the previous month
- •not being able to provide verification of injection drug use (i.e. track marks)
- •not sharing needles/syringes or paraphernalia at least once in the last month
- •being under 18 years of age
- •being male or transgender
- •being incapable of giving informed consent
- •planning to permanently move outside of the municipal boundaries of Tijuana or Ciudad Juarez within the next year.
研究组 & 干预措施
Group A
Didactic safer injection & sexual activity education: In each city, 75 women will participate in a 60 minute lecture-format presentation and printed materials on safer sex and safer injection based on CDC guidelines for HIV counseling, testing, and referral and materials from Mexico's National Center for AIDS Studies (CENSIDA). In this component, there will be no theory-driven active skill building elements oriented towards safer sex or safer injection.
干预措施: Lecture-format presentation (Behavioral)
Group B
Interactive injection risk intervention and didactic safer sex education: In each city, 75 women will participate in the 60 minute "Di No a las Jeringas Contaminadas" ['Say No to Contaminated Syringes'] counseling session. This one-on-one intervention incorporates elements of motivational interviewing (MI) and principles of Social Cognitive Theory and Theory of Reasoned Action (SCT/TRA) to address the context of unsafe injection sharing and the extent to which syringes and other injection paraphernalia is shared. In addition, participants will be provided a lecture-format presentation on safer sex. However, in this component, there will be no theory-driven active skill building elements oriented towards safer sex.
干预措施: Interactive Injection Risk Intervention (Behavioral)
Group C
Interactive sexual risk intervention and didactic safer injection education: In each city, 75 women will participate in the 60 minute "Di No Al Sexo Inseguro" [Say No to Unsafe Sex'] counseling session. This one on one intervention incorporates elements of MI and principles of Social Cognitive Theory and Theory of Reasoned Action (SCT/TRA) to address the context of unsafe sex and condom use with clients. In addition, participants will be provided a lecture format presentation on safer injection sharing. However, in this component, there will be no theory-driven active skill building elements oriented towards safer injection behavior.
干预措施: Interactive Sexual Risk Intervention (Behavioral)
Group D
Interactive injection and sexual risk intervention: In each city, 75 women will participate in the 60 minute "Di No a las Jeringas Contaminadas" ['Say No to Contaminated Syringes'] and "Di No Al Sexo Inseguro" [Say No to Unsafe Sex'] counseling session. This one-on-one intervention incorporates elements of MI and principles of Social Cognitive Theory and Theory of Reasoned Action (SCT/TRA) to address the context of both, a) unsafe injection sharing and the extent to which syringes and other injection paraphernalia is shared; and b) unsafe sex and condom use with clients, and associated risks (e.g., HIV (Human Immuno-deficiency Virus), STIs (Sexually Transmitted Infections), pregnancy).
干预措施: Interactive injection and sexual risk intervention (Behavioral)
结局指标
主要结局
Combined HIV/STI 12-month Incidence Rates of HIV, Syphilis, Chlamydia, Gonorrhea and Trichomonas Vaginalis.
时间窗: 12 months, with measuring points at baseline and at 4, 8, and 12 months past baseline
Combined incidence for HIV/STI was calculated over the 12-month study period and included only those who a) had at least one follow-up visit and b) at baseline tested negative for HIV and any of the aforementioned STIs. In the calculations we accounted for the time each participant spent at risk of HIV/any STI during the follow-up period, by using available information on each participant for each time point (i.e. baseline, 4-, 8-, and 12-months was used). The analytic method used for this outcome analysis was Poisson regression with robust variance estimation. The outcome variable was a binary variable indicating whether a participant has contracted HIV or a new STI during the 12-month follow-up period. The primary factor of interest was the intervention group. The log ("time spent at risk of HIV/any STI") was used as an offset variable in order to account for the time spent at risk of HIV/any STI by each participant.
次要结局
- Change (Baseline to 4-, 8-, and 12-months) in the Mean Number of Unprotected Sex Acts With Clients.(12 months, with measuring points at baseline and at 4, 8, and 12 months past baseline)
- Change (Baseline to 4-, 8-, and 12-months) in the Proportional Odds of Higher Receptive Needle Sharing(12 months, with measuring points at baseline and at 4, 8, and 12 months past baseline)
- Change (Baseline to 4-, 8-, and 12-months) in the Mean Score of the Injection Risk Index (IRI).(12 months, with measuring points at baseline and at 4, 8, and 12 months past baseline)
研究者
Steffanie Strathdee
Principal Investigator
University of California, San Diego