Behavioral Intervention to Reduce Sexual and Injection Risks Among Female Sex Workers Who Also Inject Drugs in Mexico
Condition: HIV; HIV Infections
MeSH terms: HIV Infections
Intervention: Interactive injection and sexual risk intervention; Interactive Sexual Risk Intervention; Interactive Injection Risk Intervention; Lecture-format presentation
Intervention description: 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).; 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).; 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.; 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.
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Participant, Investigator)
Enrollment: 584.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: HIV; Injection drug users; Female sex workers; STIs; HIV Seronegativity

Summary:

      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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  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.

        Exclusion Criteria:

        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.