Behavioral Intervention to Reduce Sexual and Injection Risks Among Female Sex Workers Who Also Inject Drugs in Mexico
NCT ID: NCT00840658
Last Updated: 2020-04-30
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
584 participants
INTERVENTIONAL
2008-10-31
2011-07-31
Brief Summary
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* 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.
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Detailed Description
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* 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.
Conditions
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Study Design
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RANDOMIZED
FACTORIAL
PREVENTION
DOUBLE
Study Groups
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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.
Lecture-format presentation
60 minute lecture-format presentation 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). There are no theory-driven active skill building elements oriented towards safer sex or safer injection.
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.
Interactive Injection Risk Intervention
This is a one-on-one intervention that incorporates elements of motivational interviewing (MI) and principles of Social Cognitive Theory (SCT) and Theory of Reasoned Action (TRA) to address the context of unsafe injection sharing and the extent to which syringes and other injection paraphernalia is shared.
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.
Interactive Sexual Risk Intervention
This is a one-on-one intervention that incorporates elements of motivational interviewing (MI) and principles of Social Cognitive Theory (SCT) and Theory of Reasoned Action (TRA) to address the context of unsafe sex and condom use with clients, and associated risks (e.g., HIV (Human Immuno-deficiency Virus), STIs (Sexually Transmitted Infections), pregnancy).
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).
Interactive injection and sexual risk intervention
This is a one-on-one intervention that incorporates elements of motivational interviewing (MI) and principles of Social Cognitive Theory (SCT) and Theory of Reasoned Action (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).
Interventions
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Interactive injection and sexual risk intervention
This is a one-on-one intervention that incorporates elements of motivational interviewing (MI) and principles of Social Cognitive Theory (SCT) and Theory of Reasoned Action (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).
Interactive Sexual Risk Intervention
This is a one-on-one intervention that incorporates elements of motivational interviewing (MI) and principles of Social Cognitive Theory (SCT) and Theory of Reasoned Action (TRA) to address the context of unsafe sex and condom use with clients, and associated risks (e.g., HIV (Human Immuno-deficiency Virus), STIs (Sexually Transmitted Infections), pregnancy).
Interactive Injection Risk Intervention
This is a one-on-one intervention that incorporates elements of motivational interviewing (MI) and principles of Social Cognitive Theory (SCT) and Theory of Reasoned Action (TRA) to address the context of unsafe injection sharing and the extent to which syringes and other injection paraphernalia is shared.
Lecture-format presentation
60 minute lecture-format presentation 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). There are no theory-driven active skill building elements oriented towards safer sex or safer injection.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
FEMALE
Yes
Sponsors
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National Institute on Drug Abuse (NIDA)
NIH
University of California, San Diego
OTHER
ISSESALUD
UNKNOWN
Universidad Autonoma de Ciudad Juarez
OTHER
Northeastern University
OTHER
San Diego State University
OTHER
University of California, Los Angeles
OTHER
Steffanie Strathdee
OTHER
Responsible Party
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Steffanie Strathdee
Principal Investigator
Principal Investigators
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Steffanie A Strathdee, PhD
Role: PRINCIPAL_INVESTIGATOR
University of California, San Diego
Locations
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Sadec-Femap
Ciudad Juárez, Chihuahua, Mexico
PrevenCasa, AC
Tijuana, Estado de Baja California, Mexico
Countries
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References
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Jain JP, Bristow CC, Pines HA, Harvey-Vera A, Rangel G, Staines H, Patterson TL, Strathdee SA. Factors in the HIV risk environment associated with bacterial vaginosis among HIV-negative female sex workers who inject drugs in the Mexico-United States border region. BMC Public Health. 2018 Aug 20;18(1):1032. doi: 10.1186/s12889-018-5965-9.
Strathdee SA, Abramovitz D, Lozada R, Martinez G, Rangel MG, Vera A, Staines H, Magis-Rodriguez C, Patterson TL. Reductions in HIV/STI incidence and sharing of injection equipment among female sex workers who inject drugs: results from a randomized controlled trial. PLoS One. 2013 Jun 13;8(6):e65812. doi: 10.1371/journal.pone.0065812. Print 2013.
Vera A, Abramovitz D, Lozada R, Martinez G, Rangel MG, Staines H, Patterson TL, Strathdee SA. Mujer Mas Segura (Safer Women): a combination prevention intervention to reduce sexual and injection risks among female sex workers who inject drugs. BMC Public Health. 2012 Aug 14;12:653. doi: 10.1186/1471-2458-12-653.
Other Identifiers
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